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Sample records for children randomised controlled

  1. Effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections: open randomised controlled trial.

    NARCIS (Netherlands)

    Aardweg, M.T. van den; Boonacker, C.W.; Rovers, M.M.; Hoes, A.W.; Schilder, A.G.M.

    2011-01-01

    OBJECTIVE: To assess the effectiveness of adenoidectomy in children with recurrent upper respiratory tract infections. DESIGN: Open randomised controlled trial. SETTING: 11 general hospitals and two academic centres. PARTICIPANTS: 111 children aged 1-6 with recurrent upper respiratory tract

  2. Skeletal effects and functional outcome with olpadronate in children with osteogenesis imperfecta: a 2-year randomised placebo-controlled study

    NARCIS (Netherlands)

    Sakkers, Ralph; Kok, Dieke; Engelbert, Raoul; van Dongen, Alice; Jansen, Maarten; Pruijs, Hans; Verbout, Ab; Schweitzer, Dave; Uiterwaal, Cuno

    2004-01-01

    Non-randomised studies have suggested beneficial effects of bisphosphonates in osteogenesis imperfecta. We assessed the effects of oral olpadronate in children with this disorder in a randomised double-blind placebo-controlled trial. 34 children recruited from the Dutch national centre for

  3. Reading and Language Intervention for Children at Risk of Dyslexia: A Randomised Controlled Trial

    Science.gov (United States)

    Duff, Fiona J.; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J.; Miles, Jeremy N. V.; Snowling, Margaret J.

    2014-01-01

    Background: Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. Methods: This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children…

  4. Children, parents, and pets exercising together (CPET randomised controlled trial: study rationale, design, and methods

    Directory of Open Access Journals (Sweden)

    Yam Philippa S

    2012-03-01

    Full Text Available Abstract Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry; body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical

  5. Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods.

    Science.gov (United States)

    Yam, Philippa S; Morrison, Ryan; Penpraze, Viki; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; Reilly, John J

    2012-03-19

    Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry); body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical activity promotion in families. It should advance our

  6. Educational outreach to general practitioners reduces children's asthma symptoms: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sladden Michael

    2007-09-01

    Full Text Available Abstract Background Childhood asthma is common in Cape Town, a province of South Africa, but is underdiagnosed by general practitioners. Medications are often prescribed inappropriately, and care is episodic. The objective of this study is to assess the impact of educational outreach to general practitioners on asthma symptoms of children in their practice. Methods This is a cluster randomised trial with general practices as the unit of intervention, randomisation, and analysis. The setting is Mitchells Plain (population 300,000, a dormitory town near Cape Town. Solo general practitioners, without nurse support, operate from storefront practices. Caregiver-reported symptom data were collected for 318 eligible children (2 to 17 years with moderate to severe asthma, who were attending general practitioners in Mitchells Plain. One year post-intervention follow-up data were collected for 271 (85% of these children in all 43 practices. Practices randomised to intervention (21 received two 30-minute educational outreach visits by a trained pharmacist who left materials describing key interventions to improve asthma care. Intervention and control practices received the national childhood asthma guideline. Asthma severity was measured in a parent-completed survey administered through schools using a symptom frequency and severity scale. We compared intervention and control group children on the change in score from pre-to one-year post-intervention. Results Symptom scores declined an additional 0.84 points in the intervention vs. control group (on a nine-point scale. p = 0.03. For every 12 children with asthma exposed to a doctor allocated to the intervention, one extra child will have substantially reduced symptoms. Conclusion Educational outreach was accepted by general practitioners and was effective. It could be applied to other health care quality problems in this setting.

  7. CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial.

    Science.gov (United States)

    Hutchings, Natalie; Wood, Wendy; Reading, Isabel; Walker, Erin; Blazeby, Jane M; Van't Hoff, William; Young, Bridget; Crawley, Esther M; Eaton, Simon; Chorozoglou, Maria; Sherratt, Frances C; Beasant, Lucy; Corbett, Harriet; Stanton, Michael P; Grist, Simon; Dixon, Elizabeth; Hall, Nigel J

    2018-03-02

    Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial. The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment

  8. A novel school-based intervention to improve nutrition knowledge in children: cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ong Ken K

    2010-03-01

    Full Text Available Abstract Background Improving nutrition knowledge among children may help them to make healthier food choices. The aim of this study was to assess the effectiveness and acceptability of a novel educational intervention to increase nutrition knowledge among primary school children. Methods We developed a card game 'Top Grub' and a 'healthy eating' curriculum for use in primary schools. Thirty-eight state primary schools comprising 2519 children in years 5 and 6 (aged 9-11 years were recruited in a pragmatic cluster randomised controlled trial. The main outcome measures were change in nutrition knowledge scores, attitudes to healthy eating and acceptability of the intervention by children and teachers. Results Twelve intervention and 13 control schools (comprising 1133 children completed the trial. The main reason for non-completion was time pressure of the school curriculum. Mean total nutrition knowledge score increased by 1.1 in intervention (baseline to follow-up: 28.3 to 29.2 and 0.3 in control schools (27.3 to 27.6. Total nutrition knowledge score at follow-up, adjusted for baseline score, deprivation, and school size, was higher in intervention than in control schools (mean difference = 1.1; 95% CI: 0.05 to 2.16; p = 0.042. At follow-up, more children in the intervention schools said they 'are currently eating a healthy diet' (39.6% or 'would try to eat a healthy diet' (35.7% than in control schools (34.4% and 31.7% respectively; chi-square test p Conclusions The 'Top Grub' card game facilitated the enjoyable delivery of nutrition education in a sample of UK primary school age children. Further studies should determine whether improvements in nutrition knowledge are sustained and lead to changes in dietary behaviour.

  9. Antidepressants for depressive disorder in children and adolescents: a database of randomised controlled trials.

    Science.gov (United States)

    Zhang, Yuqing; Zhou, Xinyu; Pu, Juncai; Zhang, Hanping; Yang, Lining; Liu, Lanxiang; Zhou, Chanjuan; Yuan, Shuai; Jiang, Xiaofeng; Xie, Peng

    2018-05-31

    In recent years, whether, when and how to use antidepressants to treat depressive disorder in children and adolescents has been hotly debated. Relevant evidence on this topic has increased rapidly. In this paper, we present the construction and content of a database of randomised controlled trials of antidepressants to treat depressive disorder in children and adolescents. This database can be freely accessed via our website and will be regularly updated. Major bibliographic databases (PubMed, the Cochrane Library, Web of Science, Embase, CINAHL, PsycINFO and LiLACS), international trial registers and regulatory agencies' websites were systematically searched for published and unpublished studies up to April 30, 2017. We included randomised controlled trials in which the efficacy or tolerability of any oral antidepressant was compared with that of a control group or any other treatment. In total, 7377 citations from bibliographical databases and 3289 from international trial registers and regulatory agencies' websites were identified. Of these, 53 trials were eligible for inclusion in the final database. Selected data were extracted from each study, including characteristics of the participants (the study population, setting, diagnostic criteria, type of depression, age, sex, and comorbidity), characteristics of the treatment conditions (the treatment conditions, general information, and detail of pharmacotherapy and psychotherapy) and study characteristics (the sponsor, country, number of sites, blinding method, sample size, treatment duration, depression scales, other scales, and primary outcome measure used, and side-effect monitoring method). Moreover, the risk of bias for each trial were assessed. This database provides information on nearly all randomised controlled trials of antidepressants in children and adolescents. By using this database, researchers can improve research efficiency, avoid inadvertent errors and easily focus on the targeted subgroups in

  10. Internet-delivered cognitive behavioural therapy for children with anxiety disorders: A randomised controlled trial.

    Science.gov (United States)

    Vigerland, Sarah; Ljótsson, Brjánn; Thulin, Ulrika; Öst, Lars-Göran; Andersson, Gerhard; Serlachius, Eva

    2016-01-01

    Cognitive behaviour therapy (CBT) has been shown to be an effective treatment for anxiety disorders in children, but few affected seek or receive treatment. Internet-delivered CBT (ICBT) could be a way to increase the availability of empirically supported treatments. A randomised controlled trial was conducted to evaluate ICBT for children with anxiety disorders. Families (N = 93) with a child aged 8-12 years with a principal diagnosis of generalised anxiety disorder, panic disorder, separation anxiety, social phobia or specific phobia were recruited through media advertisement. Participants were randomised to 10 weeks of ICBT with therapist support, or to a waitlist control condition. The primary outcome measure was the Clinician Severity Rating (CSR) and secondary measures included child- and parent-reported anxiety. Assessments were made at pre-treatment, post-treatment and at three-month follow-up. At post-treatment, there were significant reductions on CSR in the treatment group, with a large between-group effect size (Cohen's d = 1.66). Twenty per cent of children in the treatment group no longer met criteria for their principal diagnosis at post-treatment and at follow-up this number had increased to 50%. Parent-reported child anxiety was significantly lower in the treatment group than in the waitlist group at post-treatment, with a small between-group effect size (Cohen's d = 0.45). There were no significant differences between the groups regarding child-ratings of anxiety at post-treatment. Improvements were maintained at three-month follow-up, although this should be interpreted cautiously due to missing data. Within the limitations of this study, results suggest that ICBT with therapist support for children with anxiety disorders can reduce clinician- and parent-rated anxiety symptoms. Clinicaltrials.gov: NCT01533402. Copyright © 2015 The Authors. Published by Elsevier Ltd.. All rights reserved.

  11. Intervention for children with word-finding difficulties: a parallel group randomised control trial.

    Science.gov (United States)

    Best, Wendy; Hughes, Lucy Mari; Masterson, Jackie; Thomas, Michael; Fedor, Anna; Roncoli, Silvia; Fern-Pollak, Liory; Shepherd, Donna-Lynn; Howard, David; Shobbrook, Kate; Kapikian, Anna

    2017-07-31

    The study investigated the outcome of a word-web intervention for children diagnosed with word-finding difficulties (WFDs). Twenty children age 6-8 years with WFDs confirmed by a discrepancy between comprehension and production on the Test of Word Finding-2, were randomly assigned to intervention (n = 11) and waiting control (n = 9) groups. The intervention group had six sessions of intervention which used word-webs and targeted children's meta-cognitive awareness and word-retrieval. On the treated experimental set (n = 25 items) the intervention group gained on average four times as many items as the waiting control group (d = 2.30). There were also gains on personally chosen items for the intervention group. There was little change on untreated items for either group. The study is the first randomised control trial to demonstrate an effect of word-finding therapy with children with language difficulties in mainstream school. The improvement in word-finding for treated items was obtained following a clinically realistic intervention in terms of approach, intensity and duration.

  12. A Randomised Controlled Trial to Determine the Effectiveness of an Early Psychological Intervention with Children Involved in Road Traffic Accidents

    Science.gov (United States)

    Stallard, Paul; Velleman, Richard; Salter, Emma; Howse, Imogen; Yule, William; Taylor, Gordon

    2006-01-01

    Objective: To determine whether an early intervention using a psychological debriefing format is effective in preventing psychological distress in child road traffic accident survivors. Design: Randomised controlled trial. Setting: Accident and Emergency Department, Royal United Hospital, Bath. Subjects: 158 children aged 7-18. Follow-up…

  13. Can exercise improve self esteem in children and young people? A systematic review of randomised controlled trials

    OpenAIRE

    Ekeland, E; Heian, F; Hagen, K; Coren, E

    2005-01-01

    Twenty three randomised controlled trials were analysed. A synthesis of several small, low quality trials indicates that exercise may have short term beneficial effects on self esteem in children and adolescents. However, high quality research on defined populations with adequate follow up is needed.

  14. Can exercise improve self esteem in children and young people? A systematic review of randomised controlled trials.

    Science.gov (United States)

    Ekeland, E; Heian, F; Hagen, K B

    2005-11-01

    A systematic review to determine if exercise alone or as part of a comprehensive intervention can improve self esteem in children and young people is described. Twenty three randomised controlled trials were analysed. A synthesis of several small, low quality trials indicates that exercise may have short term beneficial effects on self esteem in children and adolescents. However, high quality research on defined populations with adequate follow up is needed.

  15. Reading and language intervention for children at risk of dyslexia: a randomised controlled trial.

    Science.gov (United States)

    Duff, Fiona J; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J; Miles, Jeremy N V; Snowling, Margaret J

    2014-11-01

    Intervention studies for children at risk of dyslexia have typically been delivered preschool, and show short-term effects on letter knowledge and phoneme awareness, with little transfer to literacy. This randomised controlled trial evaluated the effectiveness of a reading and language intervention for 6-year-old children identified by research criteria as being at risk of dyslexia (n = 56), and their school-identified peers (n = 89). An Experimental group received two 9-week blocks of daily intervention delivered by trained teaching assistants; the Control group received 9 weeks of typical classroom instruction, followed by 9 weeks of intervention. Following mixed effects regression models and path analyses, small-to-moderate effects were shown on letter knowledge, phoneme awareness and taught vocabulary. However, these were fragile and short lived, and there was no reliable effect on the primary outcome of word-level reading. This new intervention was theoretically motivated and based on previous successful interventions, yet failed to show reliable effects on language and literacy measures following a rigorous evaluation. We suggest that the intervention may have been too short to yield improvements in oral language; and that literacy instruction in and beyond the classroom may have weakened training effects. We argue that reporting of null results makes an important contribution in terms of raising standards both of trial reporting and educational practice. © 2014 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

  16. Parent-mediated communication-focused treatment in children with autism (PACT): a randomised controlled trial.

    Science.gov (United States)

    Green, Jonathan; Charman, Tony; McConachie, Helen; Aldred, Catherine; Slonims, Vicky; Howlin, Pat; Le Couteur, Ann; Leadbitter, Kathy; Hudry, Kristelle; Byford, Sarah; Barrett, Barbara; Temple, Kathryn; Macdonald, Wendy; Pickles, Andrew

    2010-06-19

    Results of small trials suggest that early interventions for social communication are effective for the treatment of autism in children. We therefore investigated the efficacy of such an intervention in a larger trial. Children with core autism (aged 2 years to 4 years and 11 months) were randomly assigned in a one-to-one ratio to a parent-mediated communication-focused (Preschool Autism Communication Trial [PACT]) intervention or treatment as usual at three specialist centres in the UK. Those assigned to PACT were also given treatment as usual. Randomisation was by use of minimisation of probability in the marginal distribution of treatment centre, age (42 months), and autism severity (Autism Diagnostic Observation Schedule-Generic [ADOS-G] algorithm score 12-17 or 18-24). Primary outcome was severity of autism symptoms (a total score of social communication algorithm items from ADOS-G, higher score indicating greater severity) at 13 months. Complementary secondary outcomes were measures of parent-child interaction, child language, and adaptive functioning in school. Analysis was by intention to treat. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN58133827. 152 children were recruited. 77 were assigned to PACT (London [n=26], Manchester [n=26], and Newcastle [n=25]); and 75 to treatment as usual (London [n=26], Manchester [n=26], and Newcastle [n=23]). At the 13-month endpoint, the severity of symptoms was reduced by 3.9 points (SD 4.7) on the ADOS-G algorithm in the group assigned to PACT, and 2.9 (3.9) in the group assigned to treatment as usual, representing a between-group effect size of -0.24 (95% CI -0.59 to 0.11), after adjustment for centre, sex, socioeconomic status, age, and verbal and non-verbal abilities. Treatment effect was positive for parental synchronous response to child (1.22, 0.85 to 1.59), child initiations with parent (0.41, 0.08 to 0.74), and for parent-child shared attention (0.33, -0.02 to

  17. Children, parents and pets exercising together (CPET): exploratory randomised controlled trial.

    Science.gov (United States)

    Morrison, Ryan; Reilly, John J; Penpraze, Victoria; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; McNicol, Lindsay; Calvert, Michael; Yam, Philippa S

    2013-11-27

    Levels of physical activity (PA) in UK children are much lower than recommended and novel approaches to its promotion are needed. The Children, Parents and Pets Exercising Together (CPET) study is the first exploratory randomised controlled trial (RCT) to develop and evaluate an intervention aimed at dog-based PA promotion in families. CPET aimed to assess the feasibility, acceptability and potential efficacy of a theory-driven, family-based, dog walking intervention for 9-11 year olds. Twenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group. Families in the intervention group were motivated and supported to increase the frequency, intensity and duration of dog walking using a number of behaviour change techniques. Parents in the intervention group were asked to complete a short study exit questionnaire. In addition, focus groups with parents and children in the intervention group, and with key stakeholders were undertaken. The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute (cpm). Intervention and control groups were compared using analysis of covariance. Analysis was performed on an intention to treat basis. Twenty five families were retained at follow up (89%) and 97% of all outcome data were collected at baseline and follow up. Thirteen of 14 (93%) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable. There was a mean difference in child total volume of PA of 27 cpm (95% CI -70, 123) and -3 cpm (95% CI -60, 54) for intervention and control group children, respectively. This was not statistically significant. Approximately 21% of dog walking time for parents and 39% of dog walking time for children was moderate-vigorous PA. The acceptability of the CPET intervention and outcome measures was high. Using pet dogs as the agent of lifestyle change in

  18. Children, parents and pets exercising together (CPET): exploratory randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background Levels of physical activity (PA) in UK children are much lower than recommended and novel approaches to its promotion are needed. The Children, Parents and Pets Exercising Together (CPET) study is the first exploratory randomised controlled trial (RCT) to develop and evaluate an intervention aimed at dog-based PA promotion in families. CPET aimed to assess the feasibility, acceptability and potential efficacy of a theory-driven, family-based, dog walking intervention for 9–11 year olds. Methods Twenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group. Families in the intervention group were motivated and supported to increase the frequency, intensity and duration of dog walking using a number of behaviour change techniques. Parents in the intervention group were asked to complete a short study exit questionnaire. In addition, focus groups with parents and children in the intervention group, and with key stakeholders were undertaken. The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute (cpm). Intervention and control groups were compared using analysis of covariance. Analysis was performed on an intention to treat basis. Results Twenty five families were retained at follow up (89%) and 97% of all outcome data were collected at baseline and follow up. Thirteen of 14 (93%) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable. There was a mean difference in child total volume of PA of 27 cpm (95% CI -70, 123) and -3 cpm (95% CI -60, 54) for intervention and control group children, respectively. This was not statistically significant. Approximately 21% of dog walking time for parents and 39% of dog walking time for children was moderate-vigorous PA. Conclusions The acceptability of the CPET intervention and outcome measures was high. Using

  19. Effects of improved home heating on asthma in community dwelling children: randomised controlled trial.

    Science.gov (United States)

    Howden-Chapman, Philippa; Pierse, Nevil; Nicholls, Sarah; Gillespie-Bennett, Julie; Viggers, Helen; Cunningham, Malcolm; Phipps, Robyn; Boulic, Mikael; Fjällström, Pär; Free, Sarah; Chapman, Ralph; Lloyd, Bob; Wickens, Kristin; Shields, David; Baker, Michael; Cunningham, Chris; Woodward, Alistair; Bullen, Chris; Crane, Julian

    2008-09-23

    To assess whether non-polluting, more effective home heating (heat pump, wood pellet burner, flued gas) has a positive effect on the health of children with asthma. Randomised controlled trial. Households in five communities in New Zealand. 409 children aged 6-12 years with doctor diagnosed asthma. Installation of a non-polluting, more effective home heater before winter. The control group received a replacement heater at the end of the trial. The primary outcome was change in lung function (peak expiratory flow rate and forced expiratory volume in one second, FEV(1)). Secondary outcomes were child reported respiratory tract symptoms and daily use of preventer and reliever drugs. At the end of winter 2005 (baseline) and winter 2006 (follow-up) parents reported their child's general health, use of health services, overall respiratory health, and housing conditions. Nitrogen dioxide levels were measured monthly for four months and temperatures in the living room and child's bedroom were recorded hourly. Improvements in lung function were not significant (difference in mean FEV(1) 130.7 ml, 95% confidence interval -20.3 to 281.7). Compared with children in the control group, however, children in the intervention group had 1.80 fewer days off school (95% confidence interval 0.11 to 3.13), 0.40 fewer visits to a doctor for asthma (0.11 to 0.62), and 0.25 fewer visits to a pharmacist for asthma (0.09 to 0.32). Children in the intervention group also had fewer reports of poor health (adjusted odds ratio 0.48, 95% confidence interval 0.31 to 0.74), less sleep disturbed by wheezing (0.55, 0.35 to 0.85), less dry cough at night (0.52, 0.32 to 0.83), and reduced scores for lower respiratory tract symptoms (0.77, 0.73 to 0.81) than children in the control group. The intervention was associated with a mean temperature rise in the living room of 1.10 degrees C (95% confidence interval 0.54 degrees C to 1.64 degrees C) and in the child's bedroom of 0.57 degrees C (0.05 degrees C

  20. The clinical effectiveness of different parenting programmes for children with conduct problems: a systematic review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Taylor Rod S

    2009-03-01

    Full Text Available Abstract Background Conduct problems are common, disabling and costly. The prognosis for children with conduct problems is poor, with outcomes in adulthood including criminal behaviour, alcoholism, drug abuse, domestic violence, child abuse and a range of psychiatric disorders. There has been a rapid expansion of group based parent-training programmes for the treatment of children with conduct problems in a number of countries over the past 10 years. Existing reviews of parent training have methodological limitations such as inclusion of non-randomised studies, the absence of investigation for heterogeneity prior to meta-analysis or failure to report confidence intervals. The objective of the current study was to systematically review randomised controlled trials of parenting programmes for the treatment of children with conduct problems. Methods Standard systematic review methods were followed including duplicate inclusion decisions, data extraction and quality assessment. Twenty electronic databases from the fields of medicine, psychology, social science and education were comprehensively searched for RCTs and systematic reviews to February 2006. Inclusion criteria were: randomised controlled trial; of structured, repeatable parenting programmes; for parents/carers of children up to the age of 18 with a conduct problem; and at least one measure of child behaviour. Meta-analysis and qualitative synthesis were used to summarise included studies. Results 57 RCTs were included. Studies were small with an average group size of 21. Meta-analyses using both parent (SMD -0.67; 95% CI: -0.91, -0.42 and independent (SMD -0.44; 95% CI: -0.66, -0.23 reports of outcome showed significant differences favouring the intervention group. There was insufficient evidence to determine the relative effectiveness of different approaches to delivering parenting programmes. Conclusion Parenting programmes are an effective treatment for children with conduct problems

  1. Preventing academic difficulties in preterm children: a randomised controlled trial of an adaptive working memory training intervention - IMPRINT study.

    Science.gov (United States)

    Pascoe, Leona; Roberts, Gehan; Doyle, Lex W; Lee, Katherine J; Thompson, Deanne K; Seal, Marc L; Josev, Elisha K; Nosarti, Chiara; Gathercole, Susan; Anderson, Peter J

    2013-09-16

    Very preterm children exhibit difficulties in working memory, a key cognitive ability vital to learning information and the development of academic skills. Previous research suggests that an adaptive working memory training intervention (Cogmed) may improve working memory and other cognitive and behavioural domains, although further randomised controlled trials employing long-term outcomes are needed, and with populations at risk for working memory deficits, such as children born preterm.In a cohort of extremely preterm (memory and attention 2 weeks', 12 months' and 24 months' post-intervention, and to investigate training related neuroplasticity in working memory neural networks 2 weeks' post-intervention. This double-blind, placebo-controlled, randomised controlled trial aims to recruit 126 extremely preterm/extremely low birthweight 7-year-old children. Children attending mainstream school without major intellectual, sensory or physical impairments will be eligible. Participating children will undergo an extensive baseline cognitive assessment before being randomised to either an adaptive or placebo (non-adaptive) version of Cogmed. Cogmed is a computerised working memory training program consisting of 25 sessions completed over a 5 to 7 week period. Each training session takes approximately 35 minutes and will be completed in the child's home. Structural, diffusion and functional Magnetic Resonance Imaging, which is optional for participants, will be completed prior to and 2 weeks following the training period. Follow-up assessments focusing on academic skills (primary outcome), working memory and attention (secondary outcomes) will be conducted at 2 weeks', 12 months' and 24 months' post-intervention. To our knowledge, this study will be the first randomised controlled trial to (a) assess the effectiveness of Cogmed in school-aged extremely preterm/extremely low birthweight children, while incorporating advanced imaging techniques to investigate neural changes

  2. Teaching school children basic life support improves teaching and basic life support skills of medical students: A randomised, controlled trial.

    Science.gov (United States)

    Beck, Stefanie; Meier-Klages, Vivian; Michaelis, Maria; Sehner, Susanne; Harendza, Sigrid; Zöllner, Christian; Kubitz, Jens Christian

    2016-11-01

    The "kids save lives" joint-statement highlights the effectiveness of training all school children worldwide in cardiopulmonary resuscitation (CPR) to improve survival after cardiac arrest. The personnel requirement to implement this statement is high. Until now, no randomised controlled trial investigated if medical students benefit from their engagement in the BLS-education of school children regarding their later roles as physicians. The objective of the present study is to evaluate if medical students improve their teaching behaviour and CPR-skills by teaching school children in basic life support. The study is a randomised, single blind, controlled trial carried out with medical students during their final year. In total, 80 participants were allocated alternately to either the intervention or the control group. The intervention group participated in a CPR-instructor-course consisting of a 4h-preparatory seminar and a teaching-session in BLS for school children. The primary endpoints were effectiveness of teaching in an objective teaching examination and pass-rates in a simulated BLS-scenario. The 28 students who completed the CPR-instructor-course had significantly higher scores for effective teaching in five of eight dimensions and passed the BLS-assessment significantly more often than the 25 students of the control group (Odds Ratio (OR): 10.0; 95%-CI: 1.9-54.0; p=0.007). Active teaching of BLS improves teaching behaviour and resuscitation skills of students. Teaching school children in BLS may prepare medical students for their future role as a clinical teacher and support the implementation of the "kids save lives" statement on training all school children worldwide in BLS at the same time. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  3. Effect of removing direct payment for health care on utilisation and health outcomes in Ghanaian children: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Evelyn Korkor Ansah

    2009-01-01

    Full Text Available Delays in accessing care for malaria and other diseases can lead to disease progression, and user fees are a known barrier to accessing health care. Governments are introducing free health care to improve health outcomes. Free health care affects treatment seeking, and it is therefore assumed to lead to improved health outcomes, but there is no direct trial evidence of the impact of removing out-of-pocket payments on health outcomes in developing countries. This trial was designed to test the impact of free health care on health outcomes directly.2,194 households containing 2,592 Ghanaian children under 5 y old were randomised into a prepayment scheme allowing free primary care including drugs, or to a control group whose families paid user fees for health care (normal practice; 165 children whose families had previously paid to enrol in the prepayment scheme formed an observational arm. The primary outcome was moderate anaemia (haemoglobin [Hb] < 8 g/dl; major secondary outcomes were health care utilisation, severe anaemia, and mortality. At baseline the randomised groups were similar. Introducing free primary health care altered the health care seeking behaviour of households; those randomised to the intervention arm used formal health care more and nonformal care less than the control group. Introducing free primary health care did not lead to any measurable difference in any health outcome. The primary outcome of moderate anaemia was detected in 37 (3.1% children in the control and 36 children (3.2% in the intervention arm (adjusted odds ratio 1.05, 95% confidence interval 0.66-1.67. There were four deaths in the control and five in the intervention group. Mean Hb concentration, severe anaemia, parasite prevalence, and anthropometric measurements were similar in each group. Families who previously self-enrolled in the prepayment scheme were significantly less poor, had better health measures, and used services more frequently than those in

  4. Melatonin versus Placebo in Children with Autism Spectrum Conditions and Severe Sleep Problems Not Amenable to Behaviour Management Strategies: A Randomised Controlled Crossover Trial

    Science.gov (United States)

    Wright, Barry; Sims, David; Smart, Siobhan; Alwazeer, Ahmed; Alderson-Day, Ben; Allgar, Victoria; Whitton, Clare; Tomlinson, Heather; Bennett, Sophie; Jardine, Jenni; McCaffrey, Nicola; Leyland, Charlotte; Jakeman, Christine; Miles, Jeremy

    2011-01-01

    Twenty-two children with autism spectrum disorders who had not responded to supported behaviour management strategies for severe dysomnias entered a double blind, randomised, controlled crossover trial involving 3 months of placebo versus 3 months of melatonin to a maximum dose of 10 mg. 17 children completed the study. There were no significant…

  5. Evaluation of the impact of a school gardening intervention on children's fruit and vegetable intake: a randomised controlled trial.

    Science.gov (United States)

    Christian, Meaghan S; Evans, Charlotte El; Nykjaer, Camilla; Hancock, Neil; Cade, Janet E

    2014-08-16

    Current academic literature suggests that school gardening programmes can provide an interactive environment with the potential to change children's fruit and vegetable intake. This is the first cluster randomised controlled trial (RCT) designed to evaluate whether a school gardening programme can have an effect on children's fruit and vegetable intake. The trial included children from 23 schools; these schools were randomised into two groups, one to receive the Royal Horticultural Society (RHS)-led intervention and the other to receive the less involved Teacher-led intervention. A 24-hour food diary (CADET) was used to collect baseline and follow-up dietary intake 18 months apart. Questionnaires were also administered to evaluate the intervention implementation. A total of 641 children completed the trial with a mean age of 8.1 years (95% CI: 8.0, 8.4). The unadjusted results from multilevel regression analysis revealed that for combined daily fruit and vegetable intake the Teacher-led group had a higher daily mean change of 8 g (95% CI: -19, 36) compared to the RHS-led group -32 g (95% CI: -60, -3). However, after adjusting for possible confounders this difference was not significant (intervention effect: -40 g, 95% CI: -88, 1; p = 0.06). The adjusted analysis of process measures identified that if schools improved their gardening score by 3 levels (a measure of school gardening involvement - the scale has 6 levels from 0 'no garden' to 5 'community involvement'), irrespective of group allocation, children had, on average, a daily increase of 81 g of fruit and vegetable intake (95% CI: 0, 163; p = 0.05) compared to schools that had no change in gardening score. This study is the first cluster randomised controlled trial designed to evaluate a school gardening intervention. The results have found very little evidence to support the claims that school gardening alone can improve children's daily fruit and vegetable intake. However, when a gardening

  6. International multicentre randomised controlled trial of improvisational music therapy for children with autism spectrum disorder: TIME-A study.

    Science.gov (United States)

    Crawford, Mike J; Gold, Christian; Odell-Miller, Helen; Thana, Lavanya; Faber, Sarah; Assmus, Jörg; Bieleninik, Łucja; Geretsegger, Monika; Grant, Claire; Maratos, Anna; Sandford, Stephan; Claringbold, Amy; McConachie, Helen; Maskey, Morag; Mössler, Karin Antonia; Ramchandani, Paul; Hassiotis, Angela

    2017-10-01

    Preliminary studies have indicated that music therapy may benefit children with autism spectrum disorders (ASD). To examine the effects of improvisational music therapy (IMT) on social affect and responsiveness of children with ASD. International, multicentre, three-arm, single-masked randomised controlled trial, including a National Institute for Health Research (NIHR)-funded centre that recruited in London and the east of England. Randomisation was via a remote service using permuted blocks, stratified by study site. Schools and private, voluntary and state-funded health-care services. Children aged between 4 and 7 years with a confirmed diagnosis of ASD and a parent or guardian who provided written informed consent. We excluded children with serious sensory disorder and those who had received music therapy within the past 12 months. All parents and children received enhanced standard care (ESC), which involved three 60-minute sessions of advice and support in addition to treatment as usual. In addition, they were randomised to either one (low-frequency) or three (high-frequency) sessions of IMT per week, or to ESC alone, over 5 months in a ratio of 1 : 1 : 2. The primary outcome was measured using the social affect score derived from the Autism Diagnostic Observation Schedule (ADOS) at 5 months: higher scores indicated greater impairment. Secondary outcomes included social affect at 12 months and parent-rated social responsiveness at 5 and 12 months (higher scores indicated greater impairment). A total of 364 participants were randomised between 2011 and 2015. A total of 182 children were allocated to IMT (90 to high-frequency sessions and 92 to low-frequency sessions), and 182 were allocated to ESC alone. A total of 314 (86.3%) of the total sample were followed up at 5 months [165 (90.7%) in the intervention group and 149 (81.9%) in the control group]. Among those randomised to IMT, 171 (94.0%) received it. From baseline to 5 months, mean scores of ADOS

  7. A multicenter randomised controlled trial of hydroxyurea (hydroxycarbamide) in very young children with sickle cell anaemia

    Science.gov (United States)

    Wang, Winfred C; Ware, Russell E; Miller, Scott T; Iyer, Rathi V; Casella, James F; Minniti, Caterina P; Rana, Sohail; Thornburg, Courtney D; Rogers, Zora R; Kalpatthi, Ram V; Barredo, Julio C; Brown, R Clark; Sarnaik, Sharada A; Howard, Thomas H; Wynn, Lynn W; Kutlar, Abdullah; Armstrong, F Daniel; Files, Beatrice A; Goldsmith, Jonathan C; Waclawiw, Myron A; Huang, Xiangke; Thompson, Bruce W

    2011-01-01

    Background Sickle cell anaemia (SCA) is associated with significant morbidity from acute complications and organ dysfunction beginning in the first year of life. In the first multicenter randomised double-blinded trial in very young children with SCA, the impact of hydroxyurea (hydroxycarbamide) therapy on organ dysfunction, clinical complications, and laboratory findings, and its toxicity, were examined. Methods Eligible subjects had HbSS or Sβ0thalassaemia, were age 9–18 months at randomisation, and were not selected for clinical severity. Subjects received liquid hydroxyurea, 20 mg/kg/day, or placebo for two years. Primary study endpoints were splenic function (qualitative uptake on 99Tc spleen scan) and renal function (glomerular filtration rate by 99mTc-DTPA clearance). Additional evaluations included: blood counts, HbF, chemistry profiles, spleen function biomarkers, urine osmolality, neurodevelopment, transcranial Doppler ultrasonography, growth, and mutagenicity. Study visits occurred every two to four weeks. Findings Ninety-six subjects received hydroxyurea and 97 placebo; 86% completed the study. Significant differences were not seen for the primary endpoints, but suggestive benefit was noted in quantitative measures of spleen function. Hydroxyurea significantly decreased pain and dactylitis with trends for decreased acute chest syndrome, hospitalisation and transfusion. Hydroxyurea increased haemoglobin and HbF and decreased WBC count. Toxicity was limited to mild-moderate neutropaenia. Interpretation Although hydroxyurea treatment did not reduce splenic and renal dysfunction assessed by primary endpoint measures, it resulted in major clinical benefit because of diminished acute complications, favorable haematologic results, and a lack of unexpected toxicities. Based on the safety and efficacy data from this trial, hydroxyurea can now be considered for all very young children with SCA. PMID:21571150

  8. Cervical auscultation in the diagnosis of oropharyngeal aspiration in children: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Frakking, Thuy T; Chang, Anne B; O'Grady, Kerry-Ann F; Walker-Smith, Katie; Weir, Kelly A

    2013-11-07

    Oropharyngeal aspiration (OPA) can lead to recurrent respiratory illnesses and chronic lung disease in children. Current clinical feeding evaluations performed by speech pathologists have poor reliability in detecting OPA when compared to radiological procedures such as the modified barium swallow (MBS). Improved ability to diagnose OPA accurately via clinical evaluation potentially reduces reliance on expensive, less readily available radiological procedures. Our study investigates the utility of adding cervical auscultation (CA), a technique of listening to swallowing sounds, in improving the diagnostic accuracy of a clinical evaluation for the detection of OPA. We plan an open, unblinded, randomised controlled trial at a paediatric tertiary teaching hospital. Two hundred and sixteen children fulfilling the inclusion criteria will be randomised to one of the two clinical assessment techniques for the clinical detection of OPA: (1) clinical feeding evaluation only (CFE) group or (2) clinical feeding evaluation with cervical auscultation (CFE + CA) group. All children will then undergo an MBS to determine radiologically assessed OPA. The primary outcome is the presence or absence of OPA, as determined on MBS using the Penetration-Aspiration Scale. Our main objective is to determine the sensitivity, specificity, negative and positive predictive values of 'CFE + CA' versus 'CFE' only compared to MBS-identified OPA. Early detection and appropriate management of OPA is important to prevent chronic pulmonary disease and poor growth in children. As the reliability of CFE to detect OPA is low, a technique that can improve the diagnostic accuracy of the CFE will help minimise consequences to the paediatric respiratory system. Cervical auscultation is a technique that has previously been documented as a clinical adjunct to the CFE; however, no published RCTs addressing the reliability of this technique in children exist. Our study will be the first to establish the utility

  9. Antibiotics for bronchiectasis exacerbations in children: rationale and study protocol for a randomised placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Chang Anne B

    2012-08-01

    Full Text Available Abstract Background Despite bronchiectasis being increasingly recognised as an important cause of chronic respiratory morbidity in both indigenous and non-indigenous settings globally, high quality evidence to inform management is scarce. It is assumed that antibiotics are efficacious for all bronchiectasis exacerbations, but not all practitioners agree. Inadequately treated exacerbations may risk lung function deterioration. Our study tests the hypothesis that both oral azithromycin and amoxicillin-clavulanic acid are superior to placebo at improving resolution rates of respiratory exacerbations by day 14 in children with bronchiectasis unrelated to cystic fibrosis. Methods We are conducting a bronchiectasis exacerbation study (BEST, which is a multicentre, randomised, double-blind, double-dummy, placebo-controlled, parallel group trial, in five centres (Brisbane, Perth, Darwin, Melbourne, Auckland. In the component of BEST presented here, 189 children fulfilling inclusion criteria are randomised (allocation-concealed to receive amoxicillin-clavulanic acid (22.5 mg/kg twice daily with placebo-azithromycin; azithromycin (5 mg/kg daily with placebo-amoxicillin-clavulanic acid; or placebo-azithromycin with placebo-amoxicillin-clavulanic acid for 14 days. Clinical data and a paediatric cough-specific quality of life score are obtained at baseline, at the start and resolution of exacerbations, and at day 14. In most children, blood and deep nasal swabs are also collected at the same time points. The primary outcome is the proportion of children whose exacerbations have resolved at day 14. The main secondary outcome is the paediatric cough-specific quality of life score. Other outcomes are time to next exacerbation; requirement for hospitalisation; duration of exacerbation; and spirometry data. Descriptive viral and bacteriological data from nasal samples and blood markers will also be reported. Discussion Effective, evidence-based management

  10. Splint: the efficacy of orthotic management in rest to prevent equinus in children with cerebral palsy, a randomised controlled trial.

    Science.gov (United States)

    Maas, Josina C; Dallmeijer, Annet J; Huijing, Peter A; Brunstrom-Hernandez, Janice E; van Kampen, Petra J; Jaspers, Richard T; Becher, Jules G

    2012-03-26

    Range of motion deficits of the lower extremity occur in about the half of the children with spastic cerebral palsy (CP). Over time, these impairments can cause joint deformities and deviations in the children's gait pattern, leading to limitations in moblity. Preventing a loss of range of motion is important in order to reduce secondary activity limitations and joint deformities. Sustained muscle stretch, imposed by orthotic management in rest, might be an effective method of preventing a decrease in range of motion. However, no controlled study has been performed. A single blind randomised controlled trial will be performed in 66 children with spastic CP, divided over three groups with each 22 participants. Two groups will be treated for 1 year with orthoses to prevent a decrease in range of motion in the ankle (either with static or dynamic knee-ankle-foot-orthoses) and a third group will be included as a control group and will receive usual care (physical therapy, manual stretching). Measurements will be performed at baseline and at 3, 6, 9 and 12 months after treatment allocation. The primary outcome measure will be ankle dorsiflexion at full knee extension, measured with a custom designed hand held dynamometer. Secondary outcome measures will be i) ankle and knee flexion during gait and ii) gross motor function. Furthermore, to gain more insight in the working mechanism of the orthotic management in rest, morphological parameters like achilles tendon length, muscle belly length, muscle fascicle length, muscle physiological cross sectional area length and fascicle pennation angle will be measured in a subgroup of 18 participants using a 3D imaging technique. This randomised controlled trial will provide more insight into the efficacy of orthotic management in rest and the working mechanisms behind this treatment. The results of this study could lead to improved treatments. Nederlands Trial Register NTR2091.

  11. Splint: the efficacy of orthotic management in rest to prevent equinus in children with cerebral palsy, a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Maas Josina C

    2012-03-01

    Full Text Available Abstract Background Range of motion deficits of the lower extremity occur in about the half of the children with spastic cerebral palsy (CP. Over time, these impairments can cause joint deformities and deviations in the children's gait pattern, leading to limitations in moblity. Preventing a loss of range of motion is important in order to reduce secondary activity limitations and joint deformities. Sustained muscle stretch, imposed by orthotic management in rest, might be an effective method of preventing a decrease in range of motion. However, no controlled study has been performed. Methods A single blind randomised controlled trial will be performed in 66 children with spastic CP, divided over three groups with each 22 participants. Two groups will be treated for 1 year with orthoses to prevent a decrease in range of motion in the ankle (either with static or dynamic knee-ankle-foot-orthoses and a third group will be included as a control group and will receive usual care (physical therapy, manual stretching. Measurements will be performed at baseline and at 3, 6, 9 and 12 months after treatment allocation. The primary outcome measure will be ankle dorsiflexion at full knee extension, measured with a custom designed hand held dynamometer. Secondary outcome measures will be i ankle and knee flexion during gait and ii gross motor function. Furthermore, to gain more insight in the working mechanism of the orthotic management in rest, morphological parameters like achilles tendon length, muscle belly length, muscle fascicle length, muscle physiological cross sectional area length and fascicle pennation angle will be measured in a subgroup of 18 participants using a 3D imaging technique. Discussion This randomised controlled trial will provide more insight into the efficacy of orthotic management in rest and the working mechanisms behind this treatment. The results of this study could lead to improved treatments. Trial Registration Number

  12. Randomised controlled trial and economic evaluation of the 'Families for Health' programme to reduce obesity in children.

    Science.gov (United States)

    Robertson, Wendy; Fleming, Joanna; Kamal, Atiya; Hamborg, Thomas; Khan, Kamran A; Griffiths, Frances; Stewart-Brown, Sarah; Stallard, Nigel; Petrou, Stavros; Simkiss, Douglas; Harrison, Elizabeth; Kim, Sung Wook; Thorogood, Margaret

    2017-05-01

    Evaluating effectiveness and cost-effectiveness of 'Families for Health V2' (FFH) compared with usual care (UC). Multicentre randomised controlled trial (RCT) (investigators blinded, families unblinded) and economic evaluation. Stratified randomisation by family; target of 120 families. Three National Health Service Primary Care Trusts in West Midlands, England. Overweight or obese (≥91st or ≥98th centile body mass index (BMI)) children aged 6-11 years and their parents/carers, recruited March 2012-February 2014. FFH; a 10-week community-based family programme addressing parenting, lifestyle change and social and emotional development. UC; usual support for childhood obesity at each site. Primary outcomes were 12-months change in children's BMI z-score and incremental cost per quality-adjusted life-year gained (QALY). Secondary outcomes included changes in children's physical activity, fruit and vegetable consumption and quality of life, parents' BMI and mental well-being, family eating/activity, parent-child relationships and parenting style. 115 families (128 children) were randomised to FFH (n=56) or UC (n=59). There was no significant difference in BMI z-score 12-months change (0.114, 95% CI -0.001 to 0.229, p=0.053; p=0.026 in favour of UC with missing value multiple imputation). One secondary outcome, change in children's waist z-score, was significantly different between groups in favour of UC (0.15, 95% CI 0.00 to 0.29). Economic evaluation showed that mean costs were significantly higher for FFH than UC (£998 vs £548, p<0.001). Mean incremental cost-effectiveness of FFH was estimated at £552 175 per QALY. FFH was neither effective nor cost-effective for the management of obesity compared with UC. ISRCTN45032201. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  13. The effect of pelvic physiotherapy on reduction of functional constipation in children: design of a multicentre randomised controlled trial.

    Science.gov (United States)

    van Engelenburg-van Lonkhuyzen, Marieke L; Bols, Esther M J; Benninga, Marc A; Verwijs, Wim A; Bluijssen, Netty M W L; de Bie, Rob A

    2013-08-02

    Functional constipation is a common disorder worldwide and is found in all paediatric age groups. Functional constipation can be caused by delayed colonic transit or dysfunction of the pelvic floor muscles. Standard medical care in paediatric practice is often based on clinical experience and mainly consists of a behavioural approach and toilet training, along with the prescription of laxatives. Evidence to evaluate the effectiveness of pelvic physiotherapy for this complaint is lacking. A two-armed multicentre randomised controlled trial has been designed. We hypothesise that the combination of pelvic physiotherapy and standard medical care will be more effective than standard medical care alone for constipated children, aged 5 to 17 years. Children with functional constipation according to the Rome III will be included. Web-based baseline and follow-up measurements, scheduled at 3 and 6 months after inclusion, consist of the numeric rating scale in relation to the perceived severity of the problem, the Strength and Difficulties Questionnaire and subjective improvement post-intervention (global perceived effect). Examination of the pelvic floor muscle functions, including digital testing and biofeedback, will take place during baseline and follow-up measurements at the physiotherapist. The control group will only receive standard medical care, involving at least three contacts during five months, whereas the experimental group will receive standard medical care plus pelvic physiotherapy, with a maximum of six contacts. The physiotherapy intervention will include standard medical care, pelvic floor muscle training, attention to breathing, relaxation and awareness of body and posture. The study duration will be six months from randomisation, with a three-year recruitment period. The primary outcome is the absence of functional constipation according to the Rome III criteria. This section discusses the relevance of publishing the study design and the development of

  14. Study of the therapeutic effects of an advanced hippotherapy simulator in children with cerebral palsy: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Oliván Barbara

    2010-04-01

    Full Text Available Abstract Background Although hippotherapy treatment has been demonstrated to have therapeutic effects on children with cerebral palsy, the samples used in research studies have been very small. In the case of hippotherapy simulators, there are no studies that either recommend or advise against their use in the treatment of children with cerebral palsy. The aim of this randomised clinical study is to analyse the therapeutic effects or the contraindications of the use of a commercial hippotherapy simulator on several important factors relating to children with cerebral palsy such as their motor development, balance control in the sitting posture, hip abduction range of motion and electromyographic activity of adductor musculature. Methods/Design The study is a randomised controlled trial. It will be carried out with a sample of 37 children with cerebral palsy divided into two treatment groups. Eligible participants will be randomly allocated to receive either (a Treatment Group with hippotherapy simulator, maintaining sitting posture, with legs in abduction and rhythmic movement of the simulator or (b Treatment Group maintaining sitting posture, with legs in abduction and without rhythmic movement of the simulator. Data collection and analysis: all measurements will be carried out by a specially trained blind assessor. To ensure standardization quality of the assessors, an inter-examiner agreement will be worked out at the start of the study. The trial is funded by the Department of Research, Innovation and Development of the Regional Government of Aragon (Official Bulletin of Aragon 23 July 2007, project number PM059/2007. Discussion Interest in this project is due to the following factors: Clinical originality (there are no previous studies analysing the effect of simulators on the population group of children with CP, nor any studies using as many variables as this project; Clinical impact (infantile cerebral palsy is a chronic multisystemic

  15. Study of the therapeutic effects of an advanced hippotherapy simulator in children with cerebral palsy: a randomised controlled trial.

    Science.gov (United States)

    Herrero, Pablo; Asensio, Angel; García, Elena; Marco, Alvaro; Oliván, Barbara; Ibarz, Alejandro; Gómez-Trullén, Eva M; Casas, Roberto

    2010-04-16

    Although hippotherapy treatment has been demonstrated to have therapeutic effects on children with cerebral palsy, the samples used in research studies have been very small. In the case of hippotherapy simulators, there are no studies that either recommend or advise against their use in the treatment of children with cerebral palsy. The aim of this randomised clinical study is to analyse the therapeutic effects or the contraindications of the use of a commercial hippotherapy simulator on several important factors relating to children with cerebral palsy such as their motor development, balance control in the sitting posture, hip abduction range of motion and electromyographic activity of adductor musculature. The study is a randomised controlled trial. It will be carried out with a sample of 37 children with cerebral palsy divided into two treatment groups. Eligible participants will be randomly allocated to receive either (a) Treatment Group with hippotherapy simulator, maintaining sitting posture, with legs in abduction and rhythmic movement of the simulator or (b) Treatment Group maintaining sitting posture, with legs in abduction and without rhythmic movement of the simulator. all measurements will be carried out by a specially trained blind assessor. To ensure standardization quality of the assessors, an inter-examiner agreement will be worked out at the start of the study. The trial is funded by the Department of Research, Innovation and Development of the Regional Government of Aragon (Official Bulletin of Aragon 23 July 2007), project number PM059/2007. Interest in this project is due to the following factors: Clinical originality (there are no previous studies analysing the effect of simulators on the population group of children with CP, nor any studies using as many variables as this project); Clinical impact (infantile cerebral palsy is a chronic multisystemic condition that affects not only the patient but also the patient's family and their close

  16. The Effectiveness of Picture Exchange Communication System (PECS) Training for Teachers of Children with Autism: A Pragmatic, Group Randomised Controlled Trial

    Science.gov (United States)

    Howlin, Patricia; Gordon, R. Kate; Pasco, Greg; Wade, Angie; Charman, Tony

    2007-01-01

    Objective: To assess the effectiveness of expert training and consultancy for teachers of children with autism spectrum disorder in the use of the Picture Exchange Communication System (PECS). Method: Design: Group randomised, controlled trial (3 groups: immediate treatment, delayed treatment, no treatment). Participants: 84 elementary school…

  17. A Randomised Group Comparison Controlled Trial of "Preschoolers with Autism": A Parent Education and Skills Training Intervention for Young Children with Autistic Disorder

    Science.gov (United States)

    Tonge, Bruce; Brereton, Avril; Kiomall, Melissa; Mackinnon, Andrew; Rinehart, Nicole J.

    2014-01-01

    Aim: To determine the effect of parent education on adaptive behaviour, autism symptoms and cognitive/language skills of young children with autistic disorder. Method: A randomised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent…

  18. Randomised controlled trial of improvisational music therapy's effectiveness for children with autism spectrum disorders (TIME-A): study protocol

    Science.gov (United States)

    2012-01-01

    Background Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication. However, generalisability of previous findings has been restricted, as studies were limited in either methodological accuracy or the clinical relevance of their approach. The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if variation in dose of treatment (i.e., number of music therapy sessions per week) affects outcome of therapy, and to determine cost-effectiveness. Methods/Design Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions. Parents of all participants will receive three sessions of parent counselling (at 0, 2, and 5 months). In addition, children randomised to the two intervention groups will be offered individual, improvisational music therapy over a period of five months, either one session (low-intensity) or three sessions (high-intensity) per week. Generalised effects of music therapy will be measured using standardised scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS) and parents (Social Responsiveness Scale, SRS) before and 2, 5, and 12 months after randomisation. Cost effectiveness will be calculated as man years. A group sequential design with first interim look at N = 235 will ensure both power and efficiency. Discussion Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice. Addressing the issue of dose variation, this study's results will also provide information on the relevance of session frequency for therapy

  19. Randomised controlled trial of improvisational music therapy's effectiveness for children with autism spectrum disorders (TIME-A: study protocol

    Directory of Open Access Journals (Sweden)

    Geretsegger Monika

    2012-01-01

    Full Text Available Abstract Background Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication. However, generalisability of previous findings has been restricted, as studies were limited in either methodological accuracy or the clinical relevance of their approach. The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if variation in dose of treatment (i.e., number of music therapy sessions per week affects outcome of therapy, and to determine cost-effectiveness. Methods/Design Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions. Parents of all participants will receive three sessions of parent counselling (at 0, 2, and 5 months. In addition, children randomised to the two intervention groups will be offered individual, improvisational music therapy over a period of five months, either one session (low-intensity or three sessions (high-intensity per week. Generalised effects of music therapy will be measured using standardised scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS and parents (Social Responsiveness Scale, SRS before and 2, 5, and 12 months after randomisation. Cost effectiveness will be calculated as man years. A group sequential design with first interim look at N = 235 will ensure both power and efficiency. Discussion Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice. Addressing the issue of dose variation, this study's results will also provide information on the relevance of session

  20. Randomised controlled trial of improvisational music therapy's effectiveness for children with autism spectrum disorders (TIME-A): study protocol.

    Science.gov (United States)

    Geretsegger, Monika; Holck, Ulla; Gold, Christian

    2012-01-05

    Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication. However, generalisability of previous findings has been restricted, as studies were limited in either methodological accuracy or the clinical relevance of their approach. The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if variation in dose of treatment (i.e., number of music therapy sessions per week) affects outcome of therapy, and to determine cost-effectiveness. Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions. Parents of all participants will receive three sessions of parent counselling (at 0, 2, and 5 months). In addition, children randomised to the two intervention groups will be offered individual, improvisational music therapy over a period of five months, either one session (low-intensity) or three sessions (high-intensity) per week. Generalised effects of music therapy will be measured using standardised scales completed by blinded assessors (Autism Diagnostic Observation Schedule, ADOS) and parents (Social Responsiveness Scale, SRS) before and 2, 5, and 12 months after randomisation. Cost effectiveness will be calculated as man years. A group sequential design with first interim look at N = 235 will ensure both power and efficiency. Responding to the need for more rigorously designed trials examining the effectiveness of music therapy in autism spectrum disorders, this pragmatic trial sets out to generate findings that will be well generalisable to clinical practice. Addressing the issue of dose variation, this study's results will also provide information on the relevance of session frequency for therapy outcome. Current Controlled Trials

  1. Preventing anxiety problems in children with Cool Little Kids Online: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Morgan, Amy J; Rapee, Ronald M; Tamir, Elli; Goharpey, Nahal; Salim, Agus; McLellan, Lauren F; Bayer, Jordana K

    2015-11-05

    Anxiety disorders are the most common type of mental health problem and begin early in life. Early intervention to prevent anxiety problems in young children who are at risk has the potential for long-term impact. The 'Cool Little Kids' parenting group program was previously established to prevent anxiety disorders in young children at risk because of inhibited temperament. This group program was efficacious in two randomised controlled trials and has recently been adapted into an online format. 'Cool Little Kids Online' was developed to widen and facilitate access to the group program's preventive content. A pilot evaluation of the online program demonstrated its perceived utility and acceptability among parents. This study aims to evaluate the efficacy of Cool Little Kids Online in a large randomised controlled trial. Parents of young children who are 3-6 years old and who have an inhibited temperament will be recruited (n = 385) and randomly assigned to either immediate access to Cool Little Kids Online or delayed access after a waiting period of 24 weeks. The online program contains eight modules that help parents address key issues in the development of anxiety problems in inhibited children, including children's avoidant coping styles, overprotective parenting behaviours, and parents' own fears and worries. Intervention participants will be offered clinician support when requested. The primary outcome will be change in parent-reported child anxiety symptoms. Secondary outcomes will be child internalising symptoms, child and family life interference due to anxiety, over-involved/protective parenting, plus child anxiety diagnoses assessed by using a new online diagnostic tool. Assessments will take place at baseline and 12 and 24 weeks after baseline. This trial expands upon previous research on the Cool Little Kids parenting group program and will evaluate the efficacy of online delivery. Online delivery of the program could result in an easily accessible

  2. Evaluating implementation of a fire-prevention injury prevention briefing in children's centres: Cluster randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Toity Deave

    Full Text Available Many developed countries have high mortality rates for fire-related deaths in children aged 0-14 years with steep social gradients. Evidence-based interventions to promote fire safety practices exist, but the impact of implementing a range of these interventions in children's services has not been assessed. We developed an Injury Prevention Briefing (IPB, which brought together evidence about effective fire safety interventions and good practice in delivering interventions; plus training and facilitation to support its use and evaluated its implementation.We conducted a cluster randomised controlled trial, with integrated qualitative and cost-effectiveness nested studies, across four study sites in England involving children's centres in disadvantaged areas; participants were staff and families attending those centres. Centres were stratified by study site and randomised within strata to one of three arms: IPB plus facilitation (IPB+, IPB only, usual care. IPB+ centres received initial training and facilitation at months 1, 3, and 8. Baseline data from children's centres were collected between August 2011 and January 2012 and follow-up data were collected between June 2012 and June 2013. Parent baseline data were collected between January 2012 and May 2012 and follow-up data between May 2013 and September 2013. Data comprised baseline and 12 month parent- and staff-completed questionnaires, facilitation contact data, activity logs and staff interviews. The primary outcome was whether families had a plan for escaping from a house fire. Treatment arms were compared using multilevel models to account for clustering by children's centre.1112 parents at 36 children's centres participated. There was no significant effect of the intervention on families' possession of plans for escaping from a house fire (adjusted odds ratio (AOR IPB only vs. usual care: 0.93, 95%CI 0.58, 1.49; AOR IPB+ vs. usual care 1.41, 95%CI 0.91, 2.20. However, significantly more

  3. Psychological and psychosocial functioning of children with burn scarring using cosmetic camouflage: a multi-centre prospective randomised controlled trial.

    Science.gov (United States)

    Maskell, Jessica; Newcombe, Peter; Martin, Graham; Kimble, Roy

    2014-02-01

    Burns leave patients with long-term physical scarring. Children with scarring are required to face challenges of reintegration into their community, including acceptance of an altered appearance and acceptance by others. This can be difficult given society's preoccupation with physical appearance. Limited research exists investigating validity of cosmetic camouflage as a psychosocial intervention for children with scarring. This study investigated whether using cosmetic camouflage (Microskin™) had a positive impact on health-related quality of life, self-concept and psychopathology for children and adolescents (8-17 years) with burn scarring. A prospective multi-centre randomised controlled trial was conducted across Australian and New Zealand paediatric hospitals. 63 participants (49 females, mean age 12.7 ± 2.1 years) were enrolled. Data points were baseline (Time 1) and at 8 weeks (Time 2) using reliable and valid psychometric measures. Findings indicate there were significant improvements in socialisation, school and appearance scales on the Paediatric Quality of Life Inventory and psychopathology scores particularly peer problems decreased. However self-concept remained stable from baseline throughout intervention use. Cosmetic camouflage appears to have a positive impact on quality of life particularly socialisation. Cosmetic camouflage is a valid tool to assist children with scarring to actively participate socially within their communities. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  4. A randomised controlled trial of a CBT intervention for anxiety in children with Asperger syndrome.

    Science.gov (United States)

    Sofronoff, Kate; Attwood, Tony; Hinton, Sharon

    2005-11-01

    The aim of the study was to evaluate the effectiveness of a brief CBT intervention for anxiety with children diagnosed with Asperger syndrome (AS). A second interest was to evaluate whether more intensive parent involvement would increase the child's ability to manage anxiety outside of the clinic setting. Seventy-one children aged ten to twelve years were recruited to participate in the anxiety programme. All children were diagnosed with AS and the presence of anxiety symptoms was accepted on parent report via brief interview. Children were randomly assigned to one of three conditions: intervention for child only, intervention for child and parent, wait-list control. The two intervention groups demonstrated significant decreases in parent-reported anxiety symptoms at follow-up and a significant increase in the child's ability to generate positive strategies in an anxiety-provoking situation. There were a number of significant differences between the two interventions to suggest parent involvement as beneficial. The sample of children with AS in this study presented with a profile of anxiety similar to a sample of clinically diagnosed anxious children. The intervention was endorsed by parents as a useful programme for children diagnosed with Asperger syndrome and exhibiting anxiety symptoms, and active parent involvement enhanced the usefulness of the programme. Limitations of the study and future research are discussed.

  5. A randomised controlled trial of ion-exchange water softeners for the treatment of eczema in children.

    Directory of Open Access Journals (Sweden)

    Kim S Thomas

    2011-02-01

    Full Text Available Epidemiological studies and anecdotal reports suggest a possible link between household use of hard water and atopic eczema. We sought to test whether installation of an ion-exchange water softener in the home can improve eczema in children.This was an observer-blind randomised trial involving 336 children (aged 6 months to 16 years with moderate/severe atopic eczema. All lived in hard water areas (≥200 mg/l calcium carbonate. Participants were randomised to either installation of an ion-exchange water softener plus usual eczema care, or usual eczema care alone. The primary outcome was change in eczema severity (Six Area Six Sign Atopic Dermatitis Score, SASSAD at 12 weeks, measured by research nurses who were blinded to treatment allocation. Analysis was based on the intent-to-treat population. Eczema severity improved for both groups during the trial. The mean change in SASSAD at 12 weeks was -5.0 (20% improvement for the water softener group and -5.7 (22% improvement for the usual care group (mean difference 0.66, 95% confidence interval -1.37 to 2.69, p = 0.53. No between-group differences were noted in the use of topical corticosteroids or calcineurin inhibitors.Water softeners provided no additional benefit to usual care in this study population. Small but statistically significant differences were found in some secondary outcomes as reported by parents, but it is likely that such improvements were the result of response bias, since participants were aware of their treatment allocation. A detailed report for this trial is also available at http://www.hta.ac.uk.Current Controlled Trials ISRCTN71423189 Please see later in the article for the Editors' Summary.

  6. Habit reversal training and educational group treatments for children with tourette syndrome: A preliminary randomised controlled trial.

    Science.gov (United States)

    Yates, Rachel; Edwards, Katie; King, John; Luzon, Olga; Evangeli, Michael; Stark, Daniel; McFarlane, Fiona; Heyman, Isobel; İnce, Başak; Kodric, Jana; Murphy, Tara

    2016-05-01

    Quality of life of children with Tourette Syndrome (TS) is impacted greatly by its symptoms and their social consequences. Habit Reversal Training (HRT) is effective but has not, until now, been empirically evaluated in groups. This randomised controlled trial evaluated feasibility and preliminary efficacy of eight HRT group sessions compared to eight Education group sessions. Thirty-three children aged 9-13 years with TS or Chronic Tic Disorder took part. Outcomes evaluated were tic severity and quality of life (QoL). Tic severity improvements were found in both groups. Motor tic severity (Yale Global Tic Severity Scale) showed greatest improvements in the HRT group. Both groups showed a strong tendency toward improvements in patient reported QoL. In conclusion, group-based treatments for TS are feasible and exposure to other children with tics did not increase tic expression. HRT led to greater reductions in tic severity than Education. Implications, such as cost-effectiveness of treatment delivery, are discussed. Copyright © 2016. Published by Elsevier Ltd.

  7. Hand sanitisers for reducing illness absences in primary school children in New Zealand: a cluster randomised controlled trial study protocol

    Directory of Open Access Journals (Sweden)

    Poore Marion R

    2010-01-01

    Full Text Available Abstract Background New Zealand has relatively high rates of morbidity and mortality from infectious disease compared with other OECD countries, with infectious disease being more prevalent in children compared with others in the population. Consequences of infectious disease in children may have significant economic and social impact beyond the direct effects of the disease on the health of the child; including absence from school, transmission of infectious disease to other pupils, staff, and family members, and time off work for parents/guardians. Reduction of the transmission of infectious disease between children at schools could be an effective way of reducing the community incidence of infectious disease. Alcohol based no-rinse hand sanitisers provide an alternative hand cleaning technology, for which there is some evidence that they may be effective in achieving this. However, very few studies have investigated the effectiveness of hand sanitisers, and importantly, the potential wider economic implications of this intervention have not been established. Aims The primary objective of this trial is to establish if the provision of hand sanitisers in primary schools in the South Island of New Zealand, in addition to an education session on hand hygiene, reduces the incidence rate of absence episodes due to illness in children. In addition, the trial will establish the cost-effectiveness and conduct a cost-benefit analysis of the intervention in this setting. Methods/Design A cluster randomised controlled trial will be undertaken to establish the effectiveness and cost-effectiveness of hand sanitisers. Sixty-eight primary schools will be recruited from three regions in the South Island of New Zealand. The schools will be randomised, within region, to receive hand sanitisers and an education session on hand hygiene, or an education session on hand hygiene alone. Fifty pupils from each school in years 1 to 6 (generally aged from 5 to 11 years

  8. Increasing physical activity in young primary school children-it's child's play: A cluster randomised controlled trial

    NARCIS (Netherlands)

    Engelen, L.; Bundy, A.C.; Naughton, G.; Simpson, J.M.; Bauman, A.; Ragen, J.; Baur, L.; Wyver, S.; Tranter, P.; Niehues, A.; Schiller, W.; Perry, G.; Jessup, G.; van der Ploeg, H.P.

    2013-01-01

    Objective: To explore the effects of an innovative school-based intervention for increasing physical activity. Methods: 226 children (5-7. years old) randomly selected from 12 Australian primary schools were recruited to a cluster randomised trial with schools randomly allocated to intervention or

  9. Effect of a universal anxiety prevention programme (FRIENDS) on children's academic performance: results from a randomised controlled trial.

    Science.gov (United States)

    Skryabina, Elena; Taylor, Gordon; Stallard, Paul

    2016-11-01

    Evaluations of school-based anxiety prevention programmes have reported improvements in psychological functioning although little is known about their effect upon educational outcomes. One thousand three hundred and sixty-two children from 40 primary schools in England took part in the randomised controlled trial, Preventing Anxiety in Children through Education in Schools. The trial investigated the effectiveness of a universal school-based cognitive behaviour therapy prevention programme, FRIENDS, delivered by health care staff or school staff compared with usual personal, social, health and education (PSHE) lessons. Self-report psychological outcomes and educational attainment on national standardised attainment tests in reading, writing and maths were collected 12 months postintervention. Analysis was performed at individual level using multivariable mixed effect models controlling for gender, type of intervention and school effect. Registered trial: ISRCTN: 23563048. At 12 months, anxiety reduced in the health-led FRIENDS group compared to school-led FRIENDS and PSHE. There were no between-group differences in academic performance regardless of gender, deprivation, ethnicity and additional educational needs. School-based mental health interventions should assess psychological and educational outcomes. Further research should directly compare the effects of interventions led by health and school staff. © 2016 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

  10. A pilot effectiveness study of the Enhancing Parenting Skills (EPaS) 2014 programme for parents of children with behaviour problems: study protocol for a randomised controlled trial

    OpenAIRE

    Williams, Margiad Elen; Hutchings, Judy

    2015-01-01

    Background The Enhancing Parenting Skills (EPaS) 2014 programme is a home-based, health visitor-delivered parenting support programme for parents of children with identified behaviour problems. This trial aims to evaluate the effectiveness of the EPaS 2014 programme compared to a waiting-list treatment as usual control group. Methods/Design This is a pragmatic, multicentre randomised controlled trial. Sixty health visitors will each be asked to identify two families that have a child scoring ...

  11. [Effect of supplementation with a single dose of vitamin D in children with cerebral palsy. Preliminary randomised controlled study].

    Science.gov (United States)

    Le Roy, Catalina; Meier, Martina; Witting, Scarlett; Pérez-Bravo, Francisco; Solano, Carlos; Castillo-Durán, Carlos

    2015-01-01

    Children with cerebral palsy (CP) have an increased risk of vitamin D (VD) deficiency. Although there are many studies on VD and CP, there is limited information about VD supplementation in these patients. To evaluate the effect of supplementation with a single dose of VD on the plasma concentrations of 25-hydroxy-vitamin-D (25OHD) in children with CP. Prospective-randomised-controlled-trial, including 30 Chilean children (19 males) with CP, median age 9.9 years (6.2-13.5). Clinical and biochemical variables including 25OHD, were recorded (time 0 and 8 weeks). Patients were allocated to the supplemented (S) group receiving 100,000 IU oral D3 at baseline, and compared with the placebo (P) group. Among clinical features are highlighted: gastrostomy (60%), underweight (30%), bed-ridden (93.3%), antiepileptic drugs (70%), and 43.3% used VD metabolism inducing antiepileptics. Baseline biochemical measurements were normal. The 25OHD was insufficient in 4/30 and deficient in 6/30. 25OHD levels were not associated with the variables studied. Eight patients completed the study in the S group, and 10 in P group. The placebo and supplementation groups had no significant difference in baseline variables. Serum calcium, phosphate, and alkaline phosphatase levels at 8 weeks were normal in both groups, with no statistically significant differences. 25OHD in the P group was normal in 6/10, and insufficient+deficient in 4/10, and the S group was normal in all (8/8) (exact Fisher test P=.07). A single dose of 100,000 IU VD could normalise the concentrations of 25OHD after 8 weeks of supplementation in Children with CP, but more studies are required to confirm these results. Copyright © 2015 Sociedad Chilena de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.

  12. Benefits of combining inspiratory muscle with 'whole muscle' training in children with cystic fibrosis: a randomised controlled trial

    NARCIS (Netherlands)

    Santana-Sosa, Elena; Gonzalez-Saiz, Laura; Groeneveld, Iris F.; Villa-Asensi, José R.; Barrio Gómez de Aguero, María I.; Fleck, Steven J.; López-Mojares, Luis M.; Pérez, Margarita; Lucia, Alejandro

    2014-01-01

    The purpose of this study (randomised controlled trial) was to assess the effects of an 8-week combined 'whole muscle' (resistance+aerobic) and inspiratory muscle training (IMT) on lung volume, inspiratory muscle strength (PImax) and cardiorespiratory fitness (VO2 peak) (primary outcomes), and

  13. Intra-operative lidocaine in the prevention of vomiting after elective tonsillectomy in children: A randomised controlled trial.

    Science.gov (United States)

    Echevarría, Ghislaine C; Altermatt, Fernando R; Paredes, Sebastian; Puga, Valentina; Auad, Hernán; Veloso, Ana M; Elgueta, María F

    2018-05-01

    Postoperative vomiting (POV) is a frequent complication of tonsillectomy in children. In adult patients undergoing abdominal surgeries, the use of intravenous lidocaine infusion can prevent POV. To evaluate the anti-emetic effect of an intravenous lidocaine infusion used as an adjuvant to general anaesthesia, in children undergoing elective ear, nose and throat surgery. Double-blind, randomised, controlled study. Hospital-based, single-centre study in Chile. ASA I-II children, aged 2 to 12 years, scheduled for elective tonsillectomy. We standardised the induction and maintenance of anaesthesia. Patients were randomly allocated to lidocaine (1.5 mg kg intravenous lidocaine over 5 min followed by 2 mg kg h) or 0.9% saline (at the same rate and volume). Infusions were continued until the end of the surgery. Presence of at least one episode of vomiting, retching or both in the first 24 h postoperatively (POV). Plasma concentrations of lidocaine and postoperative pain. Ninety-two children were enrolled. Primary outcome data were available for 91. In the Lidocaine group, 28 of 46 patients (60.8%) experienced POV, compared with 37 of 45 patients (82.2%) in the Saline group [difference in proportions 21.3% (95% confidence interval (CI) 2.8 to 38.8), P = 0.024]. The intention-to-treat analysis showed that when we assumed that the patient in the Saline group lost to follow-up did not have POV, the difference in proportions decreased to 19.6% (95% CI, 0.9 to 37.2), with an unadjusted odds ratio of 0.38 (95% CI, 0.15 to 0.97, P = 0.044). The odds of having POV were 62% less likely in those patients receiving lidocaine compared with patients in the Saline group. The mean lidocaine plasma concentration was 3.91 μg ml (range: 0.87 to 4.88). Using an intravenous lidocaine infusion as an adjuvant to general anaesthesia decreased POV in children undergoing elective tonsillectomy. ClinicalTrials.gov Identifier: NCT01986309.

  14. Probiotics and vitamin C for the prevention of respiratory tract infections in children attending preschool: a randomised controlled pilot study.

    Science.gov (United States)

    Garaiova, I; Muchová, J; Nagyová, Z; Wang, D; Li, J V; Országhová, Z; Michael, D R; Plummer, S F; Ďuračková, Z

    2015-03-01

    This pilot study investigates the efficacy of a probiotic consortium (Lab4) in combination with vitamin C on the prevention of respiratory tract infections in children attending preschool facilities. In a double-blind, randomised, placebo-controlled pilot study with children aged 3-6 years, 57 received 1.25 × 10(10) colony-forming units of Lactobacillus acidophilus CUL21 (NCIMB 30156), Lactobacillus acidophilus CUL60 (NCIMB 30157), Bifidobacterium bifidum CUL20 (NCIMB 30153) and Bifidobacterium animalis subsp. lactis CUL34 (NCIMB 30172) plus 50 mg vitamin C or a placebo daily for 6 months. Significant reductions in the incidence rate of upper respiratory tract infection (URTI; 33%, P=0.002), the number of days with URTI symptoms (mean difference: -21.0, 95% confidence interval (CI):-35.9, -6.0, P=0.006) and the incidence rate of absence from preschool (30%, P=0.007) were observed in the active group compared with the placebo. The number of days of use of antibiotics, painkillers, cough medicine or nasal sprays was lower in the active group and reached significance for use of cough medicine (mean difference: -6.6, 95% CI: -12.9, -0.3, P=0.040). No significant differences were observed in the incidence rate ratio or duration of lower respiratory tract infection or in the levels of plasma cytokines, salivary immunoglobulin A or urinary metabolites. Supplementation with a probiotic/vitamin C combination may be beneficial in the prevention and management of URTIs.

  15. The Children and Parents in Focus project: a population-based cluster-randomised controlled trial to prevent behavioural and emotional problems in children.

    Science.gov (United States)

    Salari, Raziye; Fabian, Helena; Prinz, Ron; Lucas, Steven; Feldman, Inna; Fairchild, Amanda; Sarkadi, Anna

    2013-10-16

    There is large body of knowledge to support the importance of early interventions to improve child health and development. Nonetheless, it is important to identify cost-effective blends of preventive interventions with adequate coverage and feasible delivery modes. The aim of the Children and Parents in Focus trial is to compare two levels of parenting programme intensity and rate of exposure, with a control condition to address impact and cost-effectiveness of a universally offered evidence-based parenting programme in the Swedish context. The trial has a cluster randomised controlled design comprising three arms: Universal arm (with access to participation in Triple P - Positive Parenting Program, level 2); Universal Plus arm (with access to participation in Triple P - Positive Parenting Program, level 2 as well as level 3, and level 4 group); and Services as Usual arm. The sampling frame is Uppsala municipality in Sweden. Child health centres consecutively recruit parents of children aged 3 to 5 years before their yearly check-ups (during the years 2013-2017). Outcomes will be measured annually. The primary outcome will be children's behavioural and emotional problems as rated by three informants: fathers, mothers and preschool teachers. The other outcomes will be parents' behaviour and parents' general health. Health economic evaluations will analyse cost-effectiveness of the interventions versus care as usual by comparing the costs and consequences in terms of impact on children's mental health, parent's mental health and health-related quality of life. This study addresses the need for comprehensive evaluation of the long-term effects, costs and benefits of early parenting interventions embedded within existing systems. In addition, the study will generate population-based data on the mental health and well-being of preschool aged children in Sweden. ISRCTN16513449.

  16. Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol

    Science.gov (United States)

    Dias, Katrin A; Coombes, Jeff S; Green, Daniel J; Gomersall, Sjaan R; Keating, Shelley E; Tjonna, Arnt Erik; Hollekim-Strand, Siri Marte; Hosseini, Mansoureh Sadat; Ro, Torstein Baade; Haram, Margrete; Huuse, Else Marie; Davies, Peter S W; Cain, Peter A; Leong, Gary M; Ingul, Charlotte B

    2016-01-01

    Introduction The prevalence of paediatric obesity is increasing, and with it, lifestyle-related diseases in children and adolescents. High-intensity interval training (HIIT) has recently been explored as an alternate to traditional moderate-intensity continuous training (MICT) in adults with chronic disease and has been shown to induce a rapid reversal of subclinical disease markers in obese children and adolescents. The primary aim of this study is to compare the effects of HIIT with MICT on myocardial function in obese children and adolescents. Methods and analysis Multicentre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). The trial will examine the efficacy of HIIT to improve cardiometabolic outcomes in obese children and adolescents. Participants will be randomised to (1) HIIT and nutrition advice, (2) MICT and nutrition advice or (3) nutrition advice. Participants will partake in supervised exercise training and/or nutrition sessions for 3 months. Measurements for study end points will occur at baseline, 3 months (postintervention) and 12 months (follow-up). The primary end point is myocardial function (peak systolic tissue velocity). Secondary end points include vascular function (flow-mediated dilation assessment), quantity of visceral and subcutaneous adipose tissue, myocardial structure and function, body composition, cardiorespiratory fitness, autonomic function, blood biochemistry, physical activity and nutrition. Lean, healthy children and adolescents will complete measurements for all study end points at one time point for comparative cross-sectional analyses. Ethics and dissemination This randomised controlled trial will generate substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardiometabolic health of this at-risk population. It is expected that communication of results will allow for the development of

  17. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial.

    Science.gov (United States)

    Veldhuis, Lydian; Struijk, Mirjam K; Kroeze, Willemieke; Oenema, Anke; Renders, Carry M; Bulk-Bunschoten, Anneke Mw; Hirasing, Remy A; Raat, Hein

    2009-06-08

    The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change.The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games), parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years), and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the use of this protocol will result in a healthier lifestyle of the

  18. Randomised controlled trials in Scandinavian educational research

    DEFF Research Database (Denmark)

    Pontoppidan, Maiken; Keilow, Maria; Dietrichson, Jens

    2018-01-01

    of this paper is to examine the history of randomised controlled trials in Scandinavian compulsory schools (grades 0–10; pupil ages 6-15). Specifically, we investigate drivers and barriers for randomised controlled trials in educational research and the differences between the three Scandinavian countries...... crucial for the implementation of RCTs and are likely more important in smaller countries such as the Scandinavian ones. Supporting institutions have now been established in all three countries, and we believe that the use of RCTs in Scandinavian educational research is likely to continue....... or more interventions were randomly assigned to groups of students and carried out in a school setting with the primary aim of improving the academic performance of children aged 6-15 in grades 0–10 in Denmark, Norway, or Sweden. We included both conducted and ongoing trials. Publications that seemed...

  19. Computerised Attention Training for Children with Intellectual and Developmental Disabilities: A Randomised Controlled Trial

    Science.gov (United States)

    Kirk, Hannah E.; Gray, Kylie M.; Ellis, Kirsten; Taffe, John; Cornish, Kim M.

    2016-01-01

    Background: Children with intellectual and developmental disabilities (IDD) experience heightened attention difficulties which have been linked to poorer cognitive, academic and social outcomes. Although, increasing research has focused on the potential of computerised cognitive training in reducing attention problems, limited studies have…

  20. Music therapy for children and adolescents with behavioural and emotional problems: a randomised controlled trial.

    Science.gov (United States)

    Porter, Sam; McConnell, Tracey; McLaughlin, Katrina; Lynn, Fiona; Cardwell, Christopher; Braiden, Hannah-Jane; Boylan, Jackie; Holmes, Valerie

    2017-05-01

    Although music therapy (MT) is considered an effective intervention for young people with mental health needs, its efficacy in clinical settings is unclear. We therefore examined the efficacy of MT in clinical practice. Two hundred and fifty-one child (8-16 years, with social, emotional, behavioural and developmental difficulties) and parent dyads from six Child and Adolescent Mental Health Service community care facilities in Northern Ireland were randomised to 12 weekly sessions of MT plus usual care [n = 123; 76 in final analyses] or usual care alone [n = 128; 105 in final analyses]. Follow-up occurred at 13 weeks and 26 weeks postrandomisation. Primary outcome was improvement in communication (Social Skills Improvement System Rating Scales) (SSIS) at 13 weeks. Secondary outcomes included social functioning, self-esteem, depression and family functioning. There was no significant difference for the child SSIS at week 13 (adjusted difference in mean 2.4; 95% CI -1.2 to 6.1; p = .19) or for the guardian SSIS (0.5; 95% CI -2.9 to 3.8; p = .78). However, for participants aged 13 and over in the intervention group, the child SSIS communication was significantly improved (6.1, 95% CI 1.6 to 10.5; p = .007) but not the guardian SSIS (1.1; 95% CI -2.9 to 5.2; p = .59). Overall, self-esteem was significantly improved and depression scores were significantly lower at week 13. There was no significant difference in family or social functioning at week 13. While the findings provide some evidence for the integration of music therapy into clinical practice, differences relating to subgroups and secondary outcomes indicate the need for further study. ISRCTN Register; ISRCTN96352204. © 2016 The Authors. Journal of Child Psychology and Psychiatry published by John Wiley & Sons Ltd on behalf of Association for Child and Adolescent Mental Health.

  1. A randomised controlled trial of a web-based multi-modal therapy program to improve executive functioning in children and adolescents with acquired brain injury.

    Science.gov (United States)

    Piovesana, Adina; Ross, Stephanie; Lloyd, Owen; Whittingham, Koa; Ziviani, Jenny; Ware, Robert S; McKinlay, Lynne; Boyd, Roslyn N

    2017-10-01

    To examine the efficacy of a multi-modal web-based therapy program, Move it to improve it (Mitii™) delivered at home to improve Executive Functioning (EF) in children with an acquired brain injury (ABI). Randomised Waitlist controlled trial. Home environment. Sixty children with an ABI were matched in pairs by age and intelligence quotient then randomised to either 20-weeks of Mitii™ training or 20 weeks of Care As Usual (waitlist control; n=30; 17 males; mean age=11y, 11m (±2y, 6m); Full Scale IQ=76.24±17.84). Fifty-eight children completed baseline assessments (32 males; mean age=11.87±2.47; Full Scale IQ=75.21±16.76). Executive functioning was assessed on four domains: attentional control, cognitive flexibility, goal setting, and information processing using subtests from the Wechsler Intelligence Scale for Children (WISC-IV), Delis-Kaplan Executive Functioning System (D-KEFS), Comprehensive Trail Making Test (CTMT), Tower of London (TOL), and Test of Everyday Attention for Children (Tea-Ch). Executive functioning performance in everyday life was assessed via parent questionnaire (Behaviour Rating Inventory of Executive Functioning; BRIEF). No differences were observed at baseline measures. Groups were compared at 20-weeks using linear regression with no significant differences found between groups on all measures of EF. Out of a potential total dose of 60 hours, children in the Mitii™ group completed a mean of 17 hours of Mitii™ intervention. Results indicate no additional benefit to receiving Mitii™ compared to standard care. Mitii™, in its current form, was not shown to improve EF in children with ABI.

  2. Behavioural and physiological outcomes of biofeedback therapy on dental anxiety of children undergoing restorations: a randomised controlled trial.

    Science.gov (United States)

    Dedeepya, P; Nuvvula, S; Kamatham, R; Nirmala, S V S G

    2014-04-01

    To explore the efficacy of biofeedback as possible alternative means of psychological behaviour guidance in children receiving dental restorations. Randomised clinical trial with a cross over design carried out on 40 children (19 boys and 21 girls) to determine the efficacy of biofeedback in reducing the dental anxiety through subjective and objective measures during restorative treatments under cotton roll isolation without administration of local analgesia. Highly anxious children with a minimum of five carious lesions were trained to lower their anxiety using biofeedback in five sessions within a 4-week interval, each session lasting for 45 min. After initial training, children were randomly divided into two groups and restorations were placed in four sequential therapeutic sessions with a 1-week interval and a follow-up visit 3 months later. First group received biofeedback in the second and third sessions; whereas the second group received biofeedback in the first and third sessions. Biofeedback therapy in children led to lower levels of anxiety in the initial appointments when assessed objectively, however the subjective methods of evaluation could not depict any statistically significant difference. Biofeedback can be used in the initial visits for dentally anxious children and the usage of simpler biofeedback machines for these appointments in dental setup is suggested.

  3. Effect of High Intensity Interval Training on Cardiac Function in Children with Obesity: A Randomised Controlled Trial.

    Science.gov (United States)

    Ingul, Charlotte B; Dias, Katrin A; Tjonna, Arnt E; Follestad, Turid; Hosseini, Mansoureh S; Timilsina, Anita S; Hollekim-Strand, Siri M; Ro, Torstein B; Davies, Peter S W; Cain, Peter A; Leong, Gary M; Coombes, Jeff S

    2018-02-13

    High intensity interval training (HIIT) confers superior cardiovascular health benefits to moderate intensity continuous training (MICT) in adults and may be efficacious for improving diminished cardiac function in obese children. The aim of this study was to compare the effects of HIIT, MICT and nutrition advice interventions on resting left ventricular (LV) peak systolic tissue velocity (S') in obese children. Ninety-nine obese children were randomised into one of three 12-week interventions, 1) HIIT [n = 33, 4 × 4 min bouts at 85-95% maximum heart rate (HR max ), 3 times/week] and nutrition advice, 2) MICT [n = 32, 44 min at 60-70% HR max , 3 times/week] and nutrition advice, and 3) nutrition advice only (nutrition) [n = 34]. Twelve weeks of HIIT and MICT were equally efficacious, but superior to nutrition, for normalising resting LV S' in children with obesity (estimated mean difference 1.0 cm/s, 95% confidence interval 0.5 to 1.6 cm/s, P HIIT and MICT were superior to nutrition advice only for improving resting LV systolic function in obese children. Copyright © 2017 Elsevier Inc. All rights reserved.

  4. A randomised controlled trial of bumetanide in the treatment of autism in children.

    Science.gov (United States)

    Lemonnier, E; Degrez, C; Phelep, M; Tyzio, R; Josse, F; Grandgeorge, M; Hadjikhani, N; Ben-Ari, Y

    2012-12-11

    Gamma aminobutyric acid (GABA)-mediated synapses and the oscillations they orchestrate are altered in autism. GABA-acting benzodiazepines exert in some patients with autism paradoxical effects, raising the possibility that like in epilepsies, GABA excites neurons because of elevated intracellular concentrations of chloride. Following a successful pilot study,(1) we have now performed a double-blind clinical trial using the diuretic, chloride-importer antagonist bumetanide that reduces intracellular chloride reinforcing GABAergic inhibition. Sixty children with autism or Asperger syndrome (3-11 years old) received for 3 months placebo or bumetanide (1 mg daily), followed by 1-month wash out. Determination of the severity of autism was made with video films at day 0 (D0) and D90 by blind, independent evaluators. Bumetanide reduced significantly the Childhood Autism Rating Scale (CARS) (D90-D0; P<0.004 treated vs placebo), Clinical Global Impressions (P<0.017 treated vs placebo) and Autism Diagnostic Observation Schedule values when the most severe cases (CARS values above the mean ± s.d.; n=9) were removed (Wilcoxon test: P-value=0.031; Student's t-test: P-value=0.017). Side effects were restricted to an occasional mild hypokalaemia (3.0-3.5 mM l(-1) K(+)) that was treated with supplemental potassium. In a companion study, chronic bumetanide treatment significantly improved accuracy in facial emotional labelling, and increased brain activation in areas involved in social and emotional perception (Hadjikhani et al., submitted). Therefore, bumetanide is a promising novel therapeutic agent to treat autism. Larger trials are warranted to better determine the population best suited for this treatment.

  5. A multicentre randomised controlled trial and economic evaluation of ion-exchange water softeners for the treatment of eczema in children:the Softened Water Eczema Trial (SWET)

    OpenAIRE

    Thomas, K. S.; Koller, K.; Dean, Tara; O'Leary, C. J.; Sach, T. H.; Frost, A.; Pallett, I.; Crook, A. M.; Meredith, S.; Nunn, A. J.; Burrows, N.; Pollock, I.; Graham-Brown, R.; O'Toole, E.; Potter, D.

    2011-01-01

    Objectives: To determine whether installation of an ion-exchange water softener in the home could improve atopic eczema in children and, if so, to establish its likely cost and cost-effectiveness. Design: An observer-blind, parallel-group randomised controlled trial of 12 weeks duration followed by a 4-week observational period. Eczema was assessed by research nurses blinded to intervention at baseline, 4 weeks, 12 weeks and 16 weeks. The primary outcome was analysed as intent-to-treat, using...

  6. A pilot effectiveness study of the Enhancing Parenting Skills (EPaS) 2014 programme for parents of children with behaviour problems: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Williams, Margiad Elen; Hutchings, Judy

    2015-05-20

    The Enhancing Parenting Skills (EPaS) 2014 programme is a home-based, health visitor-delivered parenting support programme for parents of children with identified behaviour problems. This trial aims to evaluate the effectiveness of the EPaS 2014 programme compared to a waiting-list treatment as usual control group. This is a pragmatic, multicentre randomised controlled trial. Sixty health visitors will each be asked to identify two families that have a child scoring above the clinical cut-off for behaviour problems using the Eyberg Child Behaviour Inventory (ECBI). Families recruited to the trial will be randomised in a 1:1 ratio into an intervention or waiting-list control group. Randomisation will occur within health visitor to ensure that each health visitor has one intervention family and one control family. The primary outcome is change in child behaviour problems as measured by the parent-reported ECBI. Secondary outcomes include other measures of child behaviour, parent behaviour, and parental depression as measured by parent-reports and an independent observation of parent and child behaviour. Follow-up measures will be collected 6-months after the collection of baseline measures. This is the first rigorous evaluation of the EPaS 2014 programme. The trial will provide important information on the effectiveness of a one-to-one home-based intervention, delivered by health visitors, for pre-school children with behaviour problems. It will also examine potential mediating (improved parent behaviour and/or improved parental depression) and moderating (single parent, teenage parent, poverty, low education level) factors. Current Controlled Trials ISRCTN06867279 (18 June 2014).

  7. The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand

    Directory of Open Access Journals (Sweden)

    Wilder-Smith Annelies

    2012-11-01

    Full Text Available Abstract Background There is an urgent need to protect children against dengue since this age group is particularly sensitive to the disease. Since dengue vectors are active mainly during the day, a potential target for control should be schools where children spend a considerable amount of their day. School uniforms are the cultural norm in most developing countries, worn throughout the day. We hypothesise that insecticide-treated school uniforms will reduce the incidence of dengue infection in school-aged children. Our objective is to determine the impact of impregnated school uniforms on dengue incidence. Methods A randomised controlled trial will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7–18 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent, high-quality insecticide impregnation with permethrin. A double-blind, randomised, crossover trial at the school level will cover two dengue transmission seasons. Discussion Practical issues and plans concerning intervention implementation, evaluation, analysing and interpreting the data, and possible policy implications arising from the trial are discussed. Trial registration clinicaltrial.gov. Registration number: NCT01563640

  8. The impact of insecticide-treated school uniforms on dengue infections in school-aged children: study protocol for a randomised controlled trial in Thailand.

    Science.gov (United States)

    Wilder-Smith, Annelies; Byass, Peter; Olanratmanee, Phanthip; Maskhao, Pongsri; Sringernyuang, Luechai; Logan, James G; Lindsay, Steve W; Banks, Sarah; Gubler, Duane; Louis, Valérie R; Tozan, Yesim; Kittayapong, Pattamaporn

    2012-11-15

    There is an urgent need to protect children against dengue since this age group is particularly sensitive to the disease. Since dengue vectors are active mainly during the day, a potential target for control should be schools where children spend a considerable amount of their day. School uniforms are the cultural norm in most developing countries, worn throughout the day. We hypothesise that insecticide-treated school uniforms will reduce the incidence of dengue infection in school-aged children. Our objective is to determine the impact of impregnated school uniforms on dengue incidence. A randomised controlled trial will be conducted in eastern Thailand in a group of schools with approximately 2,000 students aged 7-18 years. Pre-fabricated school uniforms will be commercially treated to ensure consistent, high-quality insecticide impregnation with permethrin. A double-blind, randomised, crossover trial at the school level will cover two dengue transmission seasons. Practical issues and plans concerning intervention implementation, evaluation, analysing and interpreting the data, and possible policy implications arising from the trial are discussed. clinicaltrial.gov. NCT01563640.

  9. The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma.

    Science.gov (United States)

    Thompson, E A; Shaw, A; Nichol, J; Hollinghurst, S; Henderson, A J; Thompson, T; Sharp, D

    2011-07-01

    To test the feasibility of a pragmatic trial design with economic evaluation and nested qualitative study, comparing usual care (UC) with UC plus individualised homeopathy, in children requiring secondary care for asthma. This included recruitment and retention, acceptability of outcome measures patients' and health professionals' views and experiences and a power calculation for a definitive trial. In a pragmatic parallel group randomised controlled trial (RCT) design, children on step 2 or above of the British Thoracic Society Asthma Guidelines (BTG) were randomly allocated to UC or UC plus a five visit package of homeopathic care (HC). Outcome measures included the Juniper Asthma Control Questionnaire, Quality of Life Questionnaire and a resource use questionnaire. Qualitative interviews were used to gain families' and health professionals' views and experiences. 226 children were identified from hospital clinics and related patient databases. 67 showed an interest in participating, 39 children were randomised, 18 to HC and 21 to UC. Evidence in favour of adjunctive homeopathic treatment was lacking. Economic evaluation suggests that the cost of additional consultations was not offset by the reduced cost of homeopathic remedies and the lower use of primary care by children in the homeopathic group. Qualitative data gave insights into the differing perspectives of families and health care professionals within the research process. A future study using this design is not feasible, further investigation of a potential role for homeopathy in asthma management might be better conducted in primary care with children with less severe asthma. Copyright © 2011 The Faculty of Homeopathy. Published by Elsevier Ltd. All rights reserved.

  10. A Randomised Controlled Trial of a Play-Based Intervention to Improve the Social Play Skills of Children with Attention Deficit Hyperactivity Disorder (ADHD)

    Science.gov (United States)

    Wilkes-Gillan, Sarah; Lincoln, Michelle; Chen, Yu-Wei

    2016-01-01

    There is a need for effective interventions to address the social difficulties of children with ADHD. This randomised controlled trial examined the effectiveness of a play-based intervention for improving the social play skills of children with ADHD in peer-to-peer interactions. Children with ADHD (5 to 11 years) were randomised to an intervention-first (n = 15) or waitlist control-first group (n = 14). Participants allocated to the control-first group received the intervention after a 10-week wait period. Children invited a typically-developing playmate and parents of children with ADHD participated. The intervention involved: six clinic play-sessions, weekly home-modules and a one-month home follow up. The Test of Playfulness (ToP) was scored by a blinded rater. Parent reported treatment adherence was used to assess treatment fidelity. Between group statistics were used to compare the change of the intervention-first (10-week intervention period) and control-first (10-week wait period) groups. Once all children had received the intervention, repeated measures ANOVA, post hoc Least Significance Difference tests and Cohen’s-d were used to measure effect. Changes in ToP social items were analysed using Friedman’s ANOVA. Linear regression analyses were used to identify variables that predicted change. The control-first group did not change during the wait period. The change in the intervention-first group was significantly greater than the change in the control-first group (during the wait period). When the data from the two groups were combined, the mean ToP scores of the children with ADHD (n = 29) improved significantly following the intervention, with a large effect from pre to post intervention and from pre intervention to follow up. Children maintained treatment gains at follow up. All ToP social items improved significantly following the intervention. The findings support the use of play involving parent and peer mediated components to enhance the social

  11. A Randomised Controlled Trial of a Play-Based Intervention to Improve the Social Play Skills of Children with Attention Deficit Hyperactivity Disorder (ADHD).

    Science.gov (United States)

    Wilkes-Gillan, Sarah; Bundy, Anita; Cordier, Reinie; Lincoln, Michelle; Chen, Yu-Wei

    2016-01-01

    There is a need for effective interventions to address the social difficulties of children with ADHD. This randomised controlled trial examined the effectiveness of a play-based intervention for improving the social play skills of children with ADHD in peer-to-peer interactions. Children with ADHD (5 to 11 years) were randomised to an intervention-first (n = 15) or waitlist control-first group (n = 14). Participants allocated to the control-first group received the intervention after a 10-week wait period. Children invited a typically-developing playmate and parents of children with ADHD participated. The intervention involved: six clinic play-sessions, weekly home-modules and a one-month home follow up. The Test of Playfulness (ToP) was scored by a blinded rater. Parent reported treatment adherence was used to assess treatment fidelity. Between group statistics were used to compare the change of the intervention-first (10-week intervention period) and control-first (10-week wait period) groups. Once all children had received the intervention, repeated measures ANOVA, post hoc Least Significance Difference tests and Cohen's-d were used to measure effect. Changes in ToP social items were analysed using Friedman's ANOVA. Linear regression analyses were used to identify variables that predicted change. The control-first group did not change during the wait period. The change in the intervention-first group was significantly greater than the change in the control-first group (during the wait period). When the data from the two groups were combined, the mean ToP scores of the children with ADHD (n = 29) improved significantly following the intervention, with a large effect from pre to post intervention and from pre intervention to follow up. Children maintained treatment gains at follow up. All ToP social items improved significantly following the intervention. The findings support the use of play involving parent and peer mediated components to enhance the social play

  12. Increasing physical activity among young children from disadvantaged communities: study protocol of a group randomised controlled effectiveness trial.

    Science.gov (United States)

    Stanley, Rebecca M; Jones, Rachel A; Cliff, Dylan P; Trost, Stewart G; Berthelsen, Donna; Salmon, Jo; Batterham, Marijka; Eckermann, Simon; Reilly, John J; Brown, Ngiare; Mickle, Karen J; Howard, Steven J; Hinkley, Trina; Janssen, Xanne; Chandler, Paul; Cross, Penny; Gowers, Fay; Okely, Anthony D

    2016-10-19

    Participation in regular physical activity (PA) during the early years helps children achieve healthy body weight and can substantially improve motor development, bone health, psychosocial health and cognitive development. Despite common assumptions that young children are naturally active, evidence shows that they are insufficiently active for health and developmental benefits. Exploring strategies to increase physical activity in young children is a public health and research priority. Jump Start is a multi-component, multi-setting PA and gross motor skill intervention for young children aged 3-5 years in disadvantaged areas of New South Wales, Australia. The intervention will be evaluated using a two-arm, parallel group, randomised cluster trial. The Jump Start protocol was based on Social Cognitive Theory and includes five components: a structured gross motor skill lesson (Jump In); unstructured outdoor PA and gross motor skill time (Jump Out); energy breaks (Jump Up); activities connecting movement to learning experiences (Jump Through); and a home-based family component to promote PA and gross motor skill (Jump Home). Early childhood education and care centres will be demographically matched and randomised to Jump Start (intervention) or usual practice (comparison) group. The intervention group receive Jump Start professional development, program resources, monthly newsletters and ongoing intervention support. Outcomes include change in total PA (accelerometers) within centre hours, gross motor skill development (Test of Gross Motor Development-2), weight status (body mass index), bone strength (Sunlight MiniOmni Ultrasound Bone Sonometer), self-regulation (Heads-Toes-Knees-Shoulders, executive function tasks, and proxy-report Temperament and Approaches to learning scales), and educator and parent self-efficacy. Extensive quantitative and qualitative process evaluation and a cost-effectiveness evaluation will be conducted. The Jump Start intervention is a

  13. Increasing physical activity among young children from disadvantaged communities: study protocol of a group randomised controlled effectiveness trial

    Directory of Open Access Journals (Sweden)

    Rebecca M. Stanley

    2016-10-01

    Full Text Available Abstract Background Participation in regular physical activity (PA during the early years helps children achieve healthy body weight and can substantially improve motor development, bone health, psychosocial health and cognitive development. Despite common assumptions that young children are naturally active, evidence shows that they are insufficiently active for health and developmental benefits. Exploring strategies to increase physical activity in young children is a public health and research priority. Methods Jump Start is a multi-component, multi-setting PA and gross motor skill intervention for young children aged 3–5 years in disadvantaged areas of New South Wales, Australia. The intervention will be evaluated using a two-arm, parallel group, randomised cluster trial. The Jump Start protocol was based on Social Cognitive Theory and includes five components: a structured gross motor skill lesson (Jump In; unstructured outdoor PA and gross motor skill time (Jump Out; energy breaks (Jump Up; activities connecting movement to learning experiences (Jump Through; and a home-based family component to promote PA and gross motor skill (Jump Home. Early childhood education and care centres will be demographically matched and randomised to Jump Start (intervention or usual practice (comparison group. The intervention group receive Jump Start professional development, program resources, monthly newsletters and ongoing intervention support. Outcomes include change in total PA (accelerometers within centre hours, gross motor skill development (Test of Gross Motor Development-2, weight status (body mass index, bone strength (Sunlight MiniOmni Ultrasound Bone Sonometer, self-regulation (Heads-Toes-Knees-Shoulders, executive function tasks, and proxy-report Temperament and Approaches to learning scales, and educator and parent self-efficacy. Extensive quantitative and qualitative process evaluation and a cost-effectiveness evaluation will be conducted

  14. SMART lunch box intervention to improve the food and nutrient content of children's packed lunches: UK wide cluster randomised controlled trial.

    Science.gov (United States)

    Evans, C E L; Greenwood, D C; Thomas, J D; Cleghorn, C L; Kitchen, M S; Cade, J E

    2010-11-01

    Government standards are now in place for children's school meals but not for lunches prepared at home. The aim of this trial is to improve the content of children's packed lunches. A cluster randomised controlled trial in 89 primary schools across the UK involving 1291 children, age 8-9 years at baseline. Follow-up was 12 months after baseline. A "SMART" lunch box intervention programme consisted of food boxes, bag and supporting materials. The main outcome measures were weights of foods and proportion of children provided with sandwiches, fruit, vegetables, dairy food, savoury snacks and confectionery in each packed lunch. Levels of nutrients provided including energy, total fat, saturated fat, protein, non-milk extrinsic sugar, sodium, calcium, iron, folate, zinc, vitamin A and vitamin C. Moderately higher weights of fruit, vegetables, dairy and starchy food and lower weights of savoury snacks were provided to children in the intervention group. Children in the intervention group were provided with slightly higher levels of vitamin A and folate. 11% more children were provided with vegetables/salad in their packed lunch, and 13% fewer children were provided with savoury snacks (crisps). Children in the intervention group were more likely to be provided with packed lunches meeting the government school meal standards. The SMART lunch box intervention, targeting parents and children, led to small improvements in the food and nutrient content of children's packed lunches. Further interventions are required to bring packed lunches in line with the new government standards for school meals. Current controlled trials ISRCTN77710993.

  15. Guided self-help interventions for mental health disorders in children with neurological conditions: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Bennett, Sophie; Heyman, Isobel; Coughtrey, Anna; Simmonds, Jess; Varadkar, Sophia; Stephenson, Terence; DeJong, Margaret; Shafran, Roz

    2016-11-04

    Rates of mental health disorders are significantly greater in children with physical illnesses than in physically well children. Children with neurological conditions, such as epilepsy, are known to have particularly high rates of mental health disorders. Despite this, mental health problems in children with neurological conditions have remained under-recognised and under-treated in clinical settings. Evidence-based guided self-help interventions are efficacious in reducing symptoms of mental health disorders in children, but their efficacy in reducing symptoms of common mental health disorders in children with neurological conditions has not been investigated. We aim to pilot a guided self-help intervention for the treatment of mental health disorders in children with neurological conditions. A pilot randomised controlled trial with 18 patients with neurological conditions and mental health disorders will be conducted. Participants attending specialist neurology clinics at a National UK Children's Hospital will be randomised to receive guided self-help for common mental health disorders or to a 12-week waiting list control. Participants in the treatment group will receive 10 sessions of guided self-help delivered over the telephone. The waiting list control group will receive the intervention after a waiting period of 12 weeks. The primary outcome measure is reduction in symptoms of mental health disorders. Exclusion criteria are limited to those at significant risk of harm to self or others, the presence of primary mental health disorder other than anxiety, depression or disruptive behaviour (e.g. psychosis, eating disorder, obsessive-compulsive disorder) or intellectual disability at a level meaning potential participants would be unable to access the intervention. The study has ethical approval from the Camden and Islington NHS Research Ethics Committee, registration number 14.LO.1353. Results will be disseminated to patients, the wider public, clinicians and

  16. A Randomised Control Trial of the Impact of a Computer-Based Activity Programme upon the Fitness of Children with Autism

    Directory of Open Access Journals (Sweden)

    Kathleen Dickinson

    2014-01-01

    Full Text Available The poor levels of fitness in children with autism are prompting concern for the children’s future health. This study looked to assess if a computer-based activity programme could improve fitness levels (as reflected in cardiopulmonary function of these children, and achieve a reduction in their body mass index. In a randomised controlled trial, 50 children with autism (of which 33 were under the age of 11 years and 39 were boys were allocated to an intervention group which encouraged them to use the Nintendo Wii and the software package “Mario and Sonics at the Olympics” in addition to their routine physical education classes. 50 children with autism (34 under the age of 11 years and 40 being boys acted as controls. At the end of one year, analysis of the changes in scores using analysis of covariance (ANCOVA on the Eurofit fitness tests showed that the intervention group had made statistically significant improvement on all tests other than flexibility. These improvements were also significantly better than controls. This type of intervention appears to be an effective addition to standard fitness training in order to help children with autism improve their fitness levels.

  17. Effects of exercise intensity and nutrition advice on myocardial function in obese children and adolescents: a multicentre randomised controlled trial study protocol.

    Science.gov (United States)

    Dias, Katrin A; Coombes, Jeff S; Green, Daniel J; Gomersall, Sjaan R; Keating, Shelley E; Tjonna, Arnt Erik; Hollekim-Strand, Siri Marte; Hosseini, Mansoureh Sadat; Ro, Torstein Baade; Haram, Margrete; Huuse, Else Marie; Davies, Peter S W; Cain, Peter A; Leong, Gary M; Ingul, Charlotte B

    2016-04-04

    The prevalence of paediatric obesity is increasing, and with it, lifestyle-related diseases in children and adolescents. High-intensity interval training (HIIT) has recently been explored as an alternate to traditional moderate-intensity continuous training (MICT) in adults with chronic disease and has been shown to induce a rapid reversal of subclinical disease markers in obese children and adolescents. The primary aim of this study is to compare the effects of HIIT with MICT on myocardial function in obese children and adolescents. Multicentre randomised controlled trial of 100 obese children and adolescents in the cities of Trondheim (Norway) and Brisbane (Australia). The trial will examine the efficacy of HIIT to improve cardiometabolic outcomes in obese children and adolescents. Participants will be randomised to (1) HIIT and nutrition advice, (2) MICT and nutrition advice or (3) nutrition advice. Participants will partake in supervised exercise training and/or nutrition sessions for 3 months. Measurements for study end points will occur at baseline, 3 months (postintervention) and 12 months (follow-up). The primary end point is myocardial function (peak systolic tissue velocity). Secondary end points include vascular function (flow-mediated dilation assessment), quantity of visceral and subcutaneous adipose tissue, myocardial structure and function, body composition, cardiorespiratory fitness, autonomic function, blood biochemistry, physical activity and nutrition. Lean, healthy children and adolescents will complete measurements for all study end points at one time point for comparative cross-sectional analyses. This randomised controlled trial will generate substantial information regarding the effects of exercise intensity on paediatric obesity, specifically the cardiometabolic health of this at-risk population. It is expected that communication of results will allow for the development of more effective evidence-based exercise prescription

  18. Efficacy of Motivational Interviewing in Conjunction with Caries Risk Assessment (MICRA) Programmes in Improving the Dental Health Status of Preschool Children: A Randomised Controlled Trial.

    Science.gov (United States)

    Saengtipbovorn, Saruta

    To assess the efficacy of motivational interviewing in conjuction with a caries risk assessment (MICRA) programme to improve the dental health status of preschool children. A randomised controlled trial was conducted among 214 parents or caregivers and their children at Health Centre 54, Bangkok, Thailand, from September 2015 to February 2016. The participants were randomised to the intervention and the control groups (107 participants per group). At baseline, the intervention group received a caries risk assessment, individual counseling by using motivational interviewing, and oral hygiene instruction. The intervention group received reinforcement education and individual counseling by motivational interviewing every 3 months. The control group received a routine programme. Participants were assessed at baseline, 3 months, and 6 months for plaque index and caries. The data were analysed by using descriptive statistics, the chi-squared test, Fisher's exact test, t-test, repeated-measures ANOVA, and negative binomial distribution. After the 6-month follow-up, participants in the intervention group had a significantly lower plaque index, non-cavitated plus cavitated carious lesions, and cavitated carious lesions when compared to the control group. The intervention group had a lower caries incidence, non-cavitated plus cavitated carious lesions (1.81 times) and cavitated carious lesions (2.04 times) than the control group. The combination of motivational interviewing and caries risk assessment in one programme decreased early childhood caries in preschool children. It is not known whether the effects are due to the motivational interviewing, the caries risk assessment, or the combination of both.

  19. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Veldhuis Lydian

    2009-06-01

    Full Text Available Abstract Background The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of overweight and health behaviour among children. Methods and design A cluster randomised controlled trial is conducted among 5-year-old children included by 44 Youth Health Care teams randomised within 9 Municipal Health Services. The teams are randomly allocated to the intervention or control group. The teams measure the weight and height of all children. When a child in the intervention group is detected with overweight according to the international age and gender specific cut-off points of BMI, the prevention protocol is applied. According to this protocol parents of overweight children are invited for up to three counselling sessions during which they receive personal advice about a healthy lifestyle, and are motivated for and assisted in behavioural change. The primary outcome measures are Body Mass Index and waist circumference of the children. Parents will complete questionnaires to assess secondary outcome measures: levels of overweight inducing/reducing behaviours (i.e. being physically active, having breakfast, drinking sweet beverages and watching television/playing computer games, parenting styles, parenting practices, and attitudes of parents regarding these behaviours, health-related quality of life of the children, and possible negative side effects of the prevention protocol. Data will be collected at baseline (when the children are aged 5 years, and after 12 and 24 months of follow-up. Additionally, a process and a cost-effectiveness evaluation will be conducted. Discussion In this study called 'Be active, eat right' we evaluate an overweight prevention protocol for use in the setting of Youth Health Care. It is hypothesized that the

  20. Building the capacity of family day care educators to promote children's social and emotional wellbeing: an exploratory cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Sims Margaret

    2011-11-01

    Full Text Available Abstract Background Childhood mental health problems are highly prevalent, experienced by one in five children living in socioeconomically disadvantaged families. Although childcare settings, including family day care are ideal to promote children's social and emotional wellbeing at a population level in a sustainable way, family day care educators receive limited training in promoting children's mental health. This study is an exploratory wait-list control cluster randomised controlled trial to test the appropriateness, acceptability, cost, and effectiveness of "Thrive," an intervention program to build the capacity of family day care educators to promote children's social and emotional wellbeing. Thrive aims to increase educators' knowledge, confidence and skills in promoting children's social and emotional wellbeing. Methods/Design This study involves one family day care organisation based in a low socioeconomic area of Melbourne. All family day care educators (term used for registered carers who provide care for children for financial reimbursement in the carers own home are eligible to participate in the study. The clusters for randomisation will be the fieldworkers (n = 5 who each supervise 10-15 educators. The intervention group (field workers and educators will participate in a variety of intervention activities over 12 months, including workshops; activity exchanges with other educators; and focused discussion about children's social and emotional wellbeing during field worker visits. The control group will continue with their normal work practice. The intervention will be delivered to the intervention group and then to the control group after a time delay of 15 months post intervention commencement. A baseline survey will be conducted with all consenting educators and field workers (n = ~70 assessing outcomes at the cluster and individual level. The survey will also be administered at one month, six months and 12 months post

  1. Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials

    Science.gov (United States)

    Bellemare, Steven; Hartling, Lisa; Wiebe, Natasha; Russell, Kelly; Craig, William R; McConnell, Don; Klassen, Terry P

    2004-01-01

    Background Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children. Methods RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques. Results The quality of the 14 included trials ranged from 0 to 3 (Jadad score); allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6). The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5) favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02). Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100); paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20,100). These results

  2. Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    McConnell Don

    2004-04-01

    Full Text Available Abstract Background Despite treatment recommendations from various organizations, oral rehydration therapy (ORT continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs to compare ORT and intravenous therapy (IVT for the treatment of dehydration secondary to acute gastroenteritis in children. Methods RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques. Results The quality of the 14 included trials ranged from 0 to 3 (Jadad score; allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6. The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5 favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02. Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100; paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20

  3. Oral rehydration versus intravenous therapy for treating dehydration due to gastroenteritis in children: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Bellemare, Steven; Hartling, Lisa; Wiebe, Natasha; Russell, Kelly; Craig, William R; McConnell, Don; Klassen, Terry P

    2004-04-15

    Despite treatment recommendations from various organizations, oral rehydration therapy (ORT) continues to be underused, particularly by physicians in high-income countries. We conducted a systematic review of randomised controlled trials (RCTs) to compare ORT and intravenous therapy (IVT) for the treatment of dehydration secondary to acute gastroenteritis in children. RCTs were identified through MEDLINE, EMBASE, CENTRAL, authors and references of included trials, pharmaceutical companies, and relevant organizations. Screening and inclusion were performed independently by two reviewers in order to identify randomised or quasi-randomised controlled trials comparing ORT and IVT in children with acute diarrhea and dehydration. Two reviewers independently assessed study quality using the Jadad scale and allocation concealment. Data were extracted by one reviewer and checked by a second. The primary outcome measure was failure of rehydration. We analyzed data using standard meta-analytic techniques. The quality of the 14 included trials ranged from 0 to 3 (Jadad score); allocation concealment was unclear in all but one study. Using a random effects model, there was no significant difference in treatment failures (risk difference [RD] 3%; 95% confidence intervals [CI]: 0, 6). The Mantel-Haenzsel fixed effects model gave a significant difference between treatment groups (RD 4%; 95% CI: 2, 5) favoring IVT. Based on the four studies that reported deaths, there were six in the IVT groups and two in ORT. There were no significant differences in total fluid intake at six and 24 hours, weight gain, duration of diarrhea, or hypo/hypernatremia. Length of stay was significantly shorter for the ORT group (weighted mean difference [WMD] -1.2 days; 95% CI: -2.4,-0.02). Phlebitis occurred significantly more often with IVT (number needed to treat [NNT] 33; 95% CI: 25,100); paralytic ileus occurred more often with ORT (NNT 33; 95% CI: 20,100). These results may not be generalizable to

  4. Efficacy and safety of intravenous sodium valproate versus phenobarbital in controlling convulsive status epilepticus and acute prolonged convulsive seizures in children: a randomised trial.

    Science.gov (United States)

    Malamiri, Reza Azizi; Ghaempanah, Mahdieh; Khosroshahi, Nahid; Nikkhah, Ali; Bavarian, Behrouz; Ashrafi, Mahmoud Reza

    2012-09-01

    Status epilepticus and acute prolonged seizures are the most commonly occurring neurological emergencies in children. Such events have high morbidity and mortality rates along with poor long-term outcomes, depending on their duration and causes. Therefore, such seizures warrant urgent treatment using appropriate doses of anticonvulsants. Benzodiazepines, phenobarbital, and phenytoin are the most commonly used anticonvulsants for controlling status epilepticus and acute prolonged seizures. However, these medications have several well-known adverse effects. Previous studies on both adults and children have shown the efficacy and safety of rapid infusion of valproate in controlling status epilepticus. However, few well-designed randomised trials have been carried out in children, and there remains a paucity of data regarding intravenous sodium valproate use in children. Therefore, our aim was to compare the efficacy and safety of rapid loading of valproate with those of intravenous phenobarbital in children with status epilepticus and acute prolonged seizures. Sixty children (30 in each group) with convulsive status epilepticus and acute prolonged seizures were enrolled and randomly assigned to receive either valproate or phenobarbital. The main outcome variable was termination of all convulsive activity within 20 min of starting anticonvulsant infusion. Intravenous rapid loading of valproate was successful in seizure termination in (27/30, 90%) of patients compared to phenobarbital (23/30, 77%) (p = 0.189). Clinically significant adverse effects occurred in 74% patients of the phenobarbital group and 24% patients of the valproate group (p < 0.001). In conclusion, rapid loading of valproate is effective and safe in controlling convulsive status epilepticus and acute prolonged convulsive seizures in children. Intravenous valproate should be considered as a suitable choice for terminating status epilepticus and acute prolonged seizures in children. Copyright

  5. Impact of a behavioural sleep intervention on symptoms and sleep in children with attention deficit hyperactivity disorder, and parental mental health: randomised controlled trial.

    Science.gov (United States)

    Hiscock, Harriet; Sciberras, Emma; Mensah, Fiona; Gerner, Bibi; Efron, Daryl; Khano, Sonia; Oberklaid, Frank

    2015-01-20

    To examine whether behavioural strategies designed to improve children's sleep problems could also improve the symptoms, behaviour, daily functioning, and working memory of children with attention deficit hyperactivity disorder (ADHD) and the mental health of their parents. Randomised controlled trial. 21 general paediatric practices in Victoria, Australia. 244 children aged 5-12 years with ADHD attending the practices between 2010 and 2012. Sleep hygiene practices and standardised behavioural strategies delivered by trained psychologists or trainee paediatricians during two fortnightly consultations and a follow-up telephone call. Children in the control group received usual clinical care. At three and six months after randomisation: severity of ADHD symptoms (parent and teacher ADHD rating scale IV-primary outcome), sleep problems (parent reported severity, children's sleep habits questionnaire, actigraphy), behaviour (strengths and difficulties questionnaire), quality of life (pediatric quality of life inventory 4.0), daily functioning (daily parent rating of evening and morning behavior), working memory (working memory test battery for children, six months only), and parent mental health (depression anxiety stress scales). Intervention compared with control families reported a greater decrease in ADHD symptoms at three and six months (adjusted mean difference for change in symptom severity -2.9, 95% confidence interval -5.5 to -0.3, P=0.03, effect size -0.3, and -3.7, -6.1 to -1.2, P=0.004, effect size -0.4, respectively). Compared with control children, intervention children had fewer moderate-severe sleep problems at three months (56% v 30%; adjusted odds ratio 0.30, 95% confidence interval 0.16 to 0.59; Pfamilies reported greater improvements in all other child and family outcomes except parental mental health. Teachers reported improved behaviour of the children at three and six months. Working memory (backwards digit recall) was higher in the intervention

  6. A randomised group comparison controlled trial of 'preschoolers with autism': a parent education and skills training intervention for young children with autistic disorder.

    Science.gov (United States)

    Tonge, Bruce; Brereton, Avril; Kiomall, Melissa; Mackinnon, Andrew; Rinehart, Nicole J

    2014-02-01

    To determine the effect of parent education on adaptive behaviour, autism symptoms and cognitive/language skills of young children with autistic disorder. A randomised group comparison design involving a parent education and counselling intervention and a parent education and behaviour management intervention to control for parent skills training and a control sample. Two rural and two metropolitan regions were randomly allocated to intervention groups (n = 70) or control (n = 35). Parents from autism assessment services in the intervention regions were randomly allocated to parent education and behaviour management (n = 35) or parent education and counselling (n = 35). Parent education and behaviour management resulted in significant improvement in adaptive behaviour and autism symptoms at 6 months follow-up for children with greater delays in adaptive behaviour. Parent education and behaviour management was superior to parent education and counselling. We conclude that a 20-week parent education programme including skills training for parents of young children with autistic disorder provides significant improvements in child adaptive behaviour and symptoms of autism for low-functioning children.

  7. Targeting children of substance-using parents with the community-based group intervention TRAMPOLINE: A randomised controlled trial - design, evaluation, recruitment issues

    Science.gov (United States)

    2012-01-01

    Background Children of substance-abusing parents are at risk for developing psychosocial development problems. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated programme for children from substance-affected families exists in Germany. The study described in this protocol is designed to test the effectiveness of the group programme TRAMPOLINE for children aged 8-12 years with at least one substance-abusing or -dependent caregiver. The intervention is specifically geared to issues and needs of children from substance-affected families. Methods/Design The effectiveness of the manualised nine-session group programme TRAMPOLINE is tested among N = 218 children from substance-affected families in a multicentre randomised controlled trial. Outpatient counselling facilities across the nation from different settings (rural/urban, Northern/Southern/Eastern/Western regions of the country) will deliver the interventions, as they hold the primary access to the target group in Germany. The control condition is a group programme with the same duration that is not addiction-specific. We expect that participants in the intervention condition will show a significant improvement in the use of adaptive coping strategies (in general and within the family) compared to the control condition as a direct result of the intervention. Data is collected shortly before and after as well as six months after the intervention. Discussion In Germany, the study presented here is the first to develop and evaluate a programme for children of substance-abusing parents. Limitations and strengths are discussed with a special focus on recruitment challenges as they appear to be the most potent threat to feasibility in the difficult-to-access target group at hand (Trial registration: ISRCTN81470784). PMID:22439919

  8. Targeting children of substance-using parents with the community-based group intervention TRAMPOLINE: A randomised controlled trial - design, evaluation, recruitment issues

    Directory of Open Access Journals (Sweden)

    Bröning Sonja

    2012-03-01

    Full Text Available Abstract Background Children of substance-abusing parents are at risk for developing psychosocial development problems. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated programme for children from substance-affected families exists in Germany. The study described in this protocol is designed to test the effectiveness of the group programme TRAMPOLINE for children aged 8-12 years with at least one substance-abusing or -dependent caregiver. The intervention is specifically geared to issues and needs of children from substance-affected families. Methods/Design The effectiveness of the manualised nine-session group programme TRAMPOLINE is tested among N = 218 children from substance-affected families in a multicentre randomised controlled trial. Outpatient counselling facilities across the nation from different settings (rural/urban, Northern/Southern/Eastern/Western regions of the country will deliver the interventions, as they hold the primary access to the target group in Germany. The control condition is a group programme with the same duration that is not addiction-specific. We expect that participants in the intervention condition will show a significant improvement in the use of adaptive coping strategies (in general and within the family compared to the control condition as a direct result of the intervention. Data is collected shortly before and after as well as six months after the intervention. Discussion In Germany, the study presented here is the first to develop and evaluate a programme for children of substance-abusing parents. Limitations and strengths are discussed with a special focus on recruitment challenges as they appear to be the most potent threat to feasibility in the difficult-to-access target group at hand (Trial registration: ISRCTN81470784.

  9. Targeting children of substance-using parents with the community-based group intervention TRAMPOLINE: a randomised controlled trial--design, evaluation, recruitment issues.

    Science.gov (United States)

    Bröning, Sonja; Wiedow, Annika; Wartberg, Lutz; Ruths, Sylvia; Haevelmann, Andrea; Kindermann, Sally-Sophie; Moesgen, Diana; Schaunig-Busch, Ines; Klein, Michael; Thomasius, Rainer

    2012-03-22

    Children of substance-abusing parents are at risk for developing psychosocial development problems. In Germany it is estimated that approx. 2.65 million children are affected by parental substance abuse or dependence. Only ten percent of them receive treatment when parents are treated. To date, no evaluated programme for children from substance-affected families exists in Germany. The study described in this protocol is designed to test the effectiveness of the group programme TRAMPOLINE for children aged 8-12 years with at least one substance-abusing or -dependent caregiver. The intervention is specifically geared to issues and needs of children from substance-affected families. The effectiveness of the manualised nine-session group programme TRAMPOLINE is tested among N = 218 children from substance-affected families in a multicentre randomised controlled trial. Outpatient counselling facilities across the nation from different settings (rural/urban, Northern/Southern/Eastern/Western regions of the country) will deliver the interventions, as they hold the primary access to the target group in Germany. The control condition is a group programme with the same duration that is not addiction-specific. We expect that participants in the intervention condition will show a significant improvement in the use of adaptive coping strategies (in general and within the family) compared to the control condition as a direct result of the intervention. Data is collected shortly before and after as well as six months after the intervention. In Germany, the study presented here is the first to develop and evaluate a programme for children of substance-abusing parents. Limitations and strengths are discussed with a special focus on recruitment challenges as they appear to be the most potent threat to feasibility in the difficult-to-access target group at hand (Trial registration: ISRCTN81470784).

  10. Teaching emotion recognition skills to young children with autism: a randomised controlled trial of an emotion training programme.

    Science.gov (United States)

    Williams, Beth T; Gray, Kylie M; Tonge, Bruce J

    2012-12-01

    Children with autism have difficulties in emotion recognition and a number of interventions have been designed to target these problems. However, few emotion training interventions have been trialled with young children with autism and co-morbid ID. This study aimed to evaluate the efficacy of an emotion training programme for a group of young children with autism with a range of intellectual ability. Participants were 55 children with autistic disorder, aged 4-7 years (FSIQ 42-107). Children were randomly assigned to an intervention (n = 28) or control group (n = 27). Participants in the intervention group watched a DVD designed to teach emotion recognition skills to children with autism (the Transporters), whereas the control group watched a DVD of Thomas the Tank Engine. Participants were assessed on their ability to complete basic emotion recognition tasks, mindreading and theory of mind (TOM) tasks before and after the 4-week intervention period, and at 3-month follow-up. Analyses controlled for the effect of chronological age, verbal intelligence, gender and DVD viewing time on outcomes. Children in the intervention group showed improved performance in the recognition of anger compared with the control group, with few improvements maintained at 3-month follow-up. There was no generalisation of skills to TOM or social skills. The Transporters programme showed limited efficacy in teaching basic emotion recognition skills to young children with autism with a lower range of cognitive ability. Improvements were limited to the recognition of expressions of anger, with poor maintenance of these skills at follow-up. These findings provide limited support for the efficacy of the Transporters programme for young children with autism of a lower cognitive range. © 2012 The Authors. Journal of Child Psychology and Psychiatry © 2012 Association for Child and Adolescent Mental Health.

  11. Randomised controlled trial of Lactobacillus rhamnosus (LGG) versus placebo in children presenting to the emergency department with acute gastroenteritis: the PECARN probiotic study protocol

    Science.gov (United States)

    Schnadower, David; Tarr, Phillip I; Charles, Casper T; Gorelick, Marc H; Dean, Michael J; O’Connell, Karen J; Mahajan, Prashant; Chun, Thomas H; Bhatt, Seema R; Roskind, Cindy G; Powell, Elizabeth C; Rogers, Alexander J; Vance, Cheryl; Sapien, Robert E; Gao, Feng; Freedman, Stephen B

    2017-01-01

    Introduction Acute gastroenteritis (AGE) is a common and burdensome condition that affects millions of children worldwide each year. Currently available strategies are limited to symptomatic management, treatment and prevention of dehydration and infection control; no disease-modifying interventions exist. Probiotics, defined as live microorganisms beneficial to the host, have shown promise in improving AGE outcomes, but existing studies have sufficient limitations such that the use of probiotics cannot currently be recommended with confidence. Here we present the methods of a large, rigorous, randomised, double-blind placebo-controlled study to assess the effectiveness and side effect profile of Lactobacillus rhamnosus GG (LGG) (ATCC 53103) in children with AGE. Methods and analysis The study is being conducted in 10 US paediatric emergency departments (EDs) within the federally funded Pediatric Emergency Care Applied Research Network, in accordance with current SPIRIT and CONSORT statement recommendations. We will randomise 970 children presenting to participating EDs with AGE to either 5 days of treatment with LGG (1010colony-forming unit twice a day) or placebo between July 2014 to December 2017. The main outcome is the occurrence of moderate-to-severe disease over time, as defined by the Modified Vesikari Scale. We also record adverse events and side effects related to the intervention. We will conduct intention-to-treat analyses and use an enrichment design to restore the statistical power in case the presence of a subpopulation with a substantially low treatment effect is identified. Ethics and dissemination Institutional review board approval has been obtained at all sites, and data and material use agreements have been established between the participating sites. The results of the trial will be published in peer-reviewed journals. A deidentified public data set will be made available after the completion of all study procedures. Trial registration number

  12. A randomised, double blind, placebo-controlled trial of a fixed dose of N-acetyl cysteine in children with autistic disorder.

    Science.gov (United States)

    Dean, Olivia M; Gray, Kylie M; Villagonzalo, Kristi-Ann; Dodd, Seetal; Mohebbi, Mohammadreza; Vick, Tanya; Tonge, Bruce J; Berk, Michael

    2017-03-01

    Oxidative stress, inflammation and heavy metals have been implicated in the aetiology of autistic disorder. N-acetyl cysteine has been shown to modulate these pathways, providing a rationale to trial N-acetyl cysteine for autistic disorder. There are now two published pilot studies suggesting efficacy, particularly in symptoms of irritability. This study aimed to explore if N-acetyl cysteine is a useful treatment for autistic disorder. This was a placebo-controlled, randomised clinical trial of 500 mg/day oral N-acetyl cysteine over 6 months, in addition to treatment as usual, in children with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of autistic disorder. The study was conducted in Victoria, Australia. The primary outcome measures were the Social Responsiveness Scale, Children's Communication Checklist-Second Edition and the Repetitive Behavior Scale-Revised. Additionally, demographic data, the parent-completed Vineland Adaptive Behavior Scales, Social Communication Questionnaire and clinician-administered Autism Diagnostic Observation Schedule were completed. A total of 102 children were randomised into the study, and 98 (79 male, 19 female; age range: 3.1-9.9 years) attended the baseline appointment with their parent/guardian, forming the Intention to Treat sample. There were no differences between N-acetyl cysteine and placebo-treated groups on any of the outcome measures for either primary or secondary endpoints. There was no significant difference in the number and severity of adverse events between groups. This study failed to demonstrate any benefit of adjunctive N-acetyl cysteine in treating autistic disorder. While this may reflect a true null result, methodological issues particularly the lower dose utilised in this study may be confounders.

  13. Effectiveness of a single-session early psychological intervention for children after road traffic accidents: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Meuli Martin

    2010-02-01

    Full Text Available Abstract Background Road traffic accidents (RTAs are the leading health threat to children in Europe, resulting in 355 000 injuries annually. Because children can suffer significant and long-term mental health problems following RTAs, there is considerable interest in the development of early psychological interventions. To date, the research in this field is scarce, and currently no evidence-based recommendations can be made. Methods To evaluate the effectiveness of a single-session early psychological intervention, 99 children age 7-16 were randomly assigned to an intervention or control group. The manualised intervention was provided to the child and at least one parent around 10 days after the child's involvement in an RTA. It included reconstruction of the accident using drawings and accident-related toys, and psychoeducation. All of the children were interviewed at 10 days, 2 months and 6 months after the accident. Parents filled in questionnaires. Standardised instruments were used to assess acute stress disorder (ASD, posttraumatic stress disorder (PTSD, depressive symptoms and behavioural problems. Results The children of the two study groups showed no significant differences concerning posttraumatic symptoms and other outcome variables at 2 or at 6 months. Interestingly, analyses showed a significant intervention × age-group effect, indicating that for preadolescent children the intervention was effective in decreasing depressive symptoms and behavioural problems. Conclusions This study is the first to show a beneficial effect of a single-session early psychological intervention after RTA in preadolescent children. Therefore, an age-specific approach in an early stage after RTAs may be a promising way for further research. Younger children can benefit from the intervention evaluated here. However, these results have to be interpreted with caution, because of small subgroup sizes. Future studies are needed to examine specific

  14. Rationale, design and methods for a randomised and controlled trial to investigate whether home access to electronic games decreases children's physical activity

    Directory of Open Access Journals (Sweden)

    Piek Jan P

    2009-06-01

    Full Text Available Abstract Background Many children are reported to have insufficient physical activity (PA placing them at greater risk of poor health outcomes. Participating in sedentary activities such as playing electronic games is widely believed to contribute to less PA. However there is no experimental evidence that playing electronic games reduces PA. There is also no evidence regarding the effect of different types of electronic games (traditional sedentary electronic games versus new active input electronic games on PA. Further, there is a poor understanding about how characteristics of children may moderate the impact of electronic game access on PA and about what leisure activities are displaced when children play electronic games. Given that many children play electronic games, a better understanding of the effect of electronic game use on PA is critical to inform child health policy and intervention. Methods This randomised and controlled trial will examine whether PA is decreased by access to electronic games and whether any effect is dependent on the type of game input or the child's characteristics. Children aged 10–12 years (N = 72, 36 females will be recruited and randomised to a balanced ordering of 'no electronic games', 'traditional' electronic games and 'active' electronic games. Each child will participate in each condition for 8 weeks, and be assessed prior to participation and at the end of each condition. The primary outcome is PA, assessed by Actical accelerometers worn for 7 days on the wrist and hip. Energy expenditure will be assessed by the doubly labelled water technique and motor coordination, adiposity, self-confidence, attitudes to technology and PA and leisure activities will also be assessed. A sample of 72 will provide a power of > 0.9 for detecting a 15 mins difference in PA (sd = 30 mins. Discussion This is the first such trial and will provide critical information to understand whether access to electronic games affects

  15. Efficacy of Bacillus coagulans Unique IS2 in treatment of irritable bowel syndrome in children: a double blind, randomised placebo controlled study.

    Science.gov (United States)

    Sudha, M Ratna; Jayanthi, N; Aasin, M; Dhanashri, R D; Anirudh, T

    2018-04-26

    The efficacy of the probiotic strain, Bacillus coagulans Unique IS2 in the treatment of Irritable Bowel Syndrome (IBS) was evaluated in children. A total of 141 children of either sex in the age group 4-12 years, diagnosed with IBS according to the Rome III criteria, participated in the double-blind randomised controlled trial. Children received either B. coagulans Unique IS2 chewable tablets or placebo once daily for eight weeks followed by a two week follow-up period. Reduction in pain intensity as well as other symptoms associated with Irritable Bowel Syndrome like abdominal discomfort, bloating, distension, sense of incomplete evacuation, straining at stool, urgency of bowel movement, passage of gas and mucus, and bowel habit satisfaction were assessed. B. coagulans Unique IS2 treated group showed a greater reduction in pain scores as evaluated by a weekly pain intensity scale. There was a significant reduction (Pcoagulans Unique IS2 treated group as compared to the placebo group. This study demonstrates the efficacy of B. coagulans Unique IS2 in reducing the symptoms of Irritable Bowel Syndrome in children in the age group of 4-12 years.

  16. A prospective randomised control study: reduction of children's pain expectation using a picture book during blood withdrawal.

    Science.gov (United States)

    Zieger, B; Praskova, M; Busse, E; Barth, M

    2013-05-01

    Blood drawings are very painful and stressful for children. In a prospective control group study we investigated if using a picture book could reduce the children's pain expectation. In addition, the children's pain experience and the observed pain behaviour was monitored. Block-randomization were used and 120 children at the age of 6-12 years who were visiting the general pediatric and coagulation outpatient clinics were included in this study. Pain expectation and experience were assessed with the Face-Pain-Scale-Revised and the pain behavior with the Faces-Legs-Activity-Cry-Consolability Scale. Multivariate covariance analysis was used for data analysis. The results showed that with statistical controlling the influence of the primary pain expectation (baseline) the pain expectation before blood withdrawal was reduced significantly (p=0.001) and effectively (ES=0.56) using the picture book. Children who received no local anaesthesia reported that they felt less pain during blood drawing after reading the picture book. The few children with local anaesthesia reported no benefit from the picture book. The observed use of local anaesthesia was very heterogeneous. The results recommend the usage of this picture book in everyday practice, if the use of local anaesthesia could not be used in an appropriate way. © Georg Thieme Verlag KG Stuttgart · New York.

  17. Children and youth perceive smoking messages in an unbranded advertisement from a NIKE marketing campaign: a cluster randomised controlled trial

    Science.gov (United States)

    2011-01-01

    Background How youth perceive marketing messages in sports is poorly understood. We evaluated whether youth perceive that the imagery of a specific sports marketing advertisement contained smoking-related messages. Methods Twenty grade 7 to 11 classes (397 students) from two high schools in Montréal, Canada were recruited to participate in a cluster randomised single-blind controlled trial. Classes were randomly allocated to either a NIKE advertisement containing the phrase 'LIGHT IT UP' (n = 205) or to a neutral advertisement with smoking imagery reduced and the phrase replaced by 'GO FOR IT' (n = 192). The NIKE logo was removed from both advertisements. Students responded in class to a questionnaire asking open-ended questions about their perception of the messages in the ad. Reports relating to the appearance and text of the ad, and the product being promoted were evaluated. Results Relative to the neutral ad, more students reported that the phrase 'LIGHT IT UP' was smoking-related (37.6% vs. 0.5%) and that other parts of the ad resembled smoking-related products (50.7% vs. 10.4%). The relative risk of students reporting that the NIKE ad promoted cigarettes was 4.41 (95% confidence interval: 2.64-7.36; P promoting NIKE hockey products appears to have contained smoking-related messages. This particular marketing campaign may have promoted smoking. This suggests that the regulation of marketing to youth may need to be more tightly controlled. PMID:21477307

  18. Children and youth perceive smoking messages in an unbranded advertisement from a NIKE marketing campaign: a cluster randomised controlled trial.

    Science.gov (United States)

    Auger, Nathalie; Daniel, Mark; Knäuper, Bärbel; Raynault, Marie-France; Pless, Barry

    2011-04-08

    How youth perceive marketing messages in sports is poorly understood. We evaluated whether youth perceive that the imagery of a specific sports marketing advertisement contained smoking-related messages. Twenty grade 7 to 11 classes (397 students) from two high schools in Montréal, Canada were recruited to participate in a cluster randomised single-blind controlled trial. Classes were randomly allocated to either a NIKE advertisement containing the phrase 'LIGHT IT UP' (n = 205) or to a neutral advertisement with smoking imagery reduced and the phrase replaced by 'GO FOR IT' (n = 192). The NIKE logo was removed from both advertisements. Students responded in class to a questionnaire asking open-ended questions about their perception of the messages in the ad. Reports relating to the appearance and text of the ad, and the product being promoted were evaluated. Relative to the neutral ad, more students reported that the phrase 'LIGHT IT UP' was smoking-related (37.6% vs. 0.5%) and that other parts of the ad resembled smoking-related products (50.7% vs. 10.4%). The relative risk of students reporting that the NIKE ad promoted cigarettes was 4.41 (95% confidence interval: 2.64-7.36; P NIKE hockey products appears to have contained smoking-related messages. This particular marketing campaign may have promoted smoking. This suggests that the regulation of marketing to youth may need to be more tightly controlled.

  19. Emergency treatment with levetiracetam or phenytoin in status epilepticus in children-the EcLiPSE study: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Lyttle, Mark D; Gamble, Carrol; Messahel, Shrouk; Hickey, Helen; Iyer, Anand; Woolfall, Kerry; Humphreys, Amy; Bacon, Naomi E A; Roper, Louise; Babl, Franz E; Dalziel, Stuart R; Ryan, Mary; Appleton, Richard E

    2017-06-19

    Convulsive status epilepticus (CSE) is the most common life-threatening neurological emergency in childhood. These children are also at risk of significant morbidity, with acute and chronic impact on the family and the health and social care systems. The current recommended first-choice, second-line treatment in children aged 6 months and above is intravenous phenytoin (fosphenytoin in the USA), although there is a lack of evidence for its use and it is associated with significant side effects. Emerging evidence suggests that intravenous levetiracetam may be effective as a second-line agent for CSE, and fewer adverse effects have been described. This trial therefore aims to determine whether intravenous phenytoin or levetiracetam is more effective, and safer, in treating childhood CSE. This is a phase IV, multi-centre, parallel group, randomised controlled, open-label trial. Following treatment for CSE with first-line treatment, children with ongoing seizures are randomised to receive either phenytoin (20 mg/kg, maximum 2 g) or levetiracetam (40 mg/kg, maximum 2.5 g) intravenously. The primary outcome measure is the cessation of all visible signs of CSE as determined by the treating clinician. Secondary outcome measures include the need for further anti-seizure medications or rapid sequence induction for ongoing CSE, admission to critical care areas, and serious adverse reactions. Patients are recruited without prior consent, with deferred consent sought at an appropriate time for the family. The primary analysis will be by intention-to-treat. The primary outcome is a time to event outcome and a sample size of 140 participants in each group will have 80% power to detect an increase in CSE cessation rates from 60% to 75%. Our total sample size of 308 randomised and treated participants will allow for 10% loss to follow-up. This clinical trial will determine whether phenytoin or levetiracetam is more effective as an intravenous second-line agent for CSE, and

  20. Improving lifetime trajectories for vulnerable young children and families living with significant stress and social disadvantage: the early years education program randomised controlled trial.

    Science.gov (United States)

    Jordan, Brigid; Tseng, Yi-Ping; Coombs, Nichola; Kennedy, Anne; Borland, Jeff

    2014-09-17

    Children who experience neglect and abuse are likely to have impaired brain development and entrenched learning deficiencies. Early years interventions such as intensive education and care for these children are known to have the potential to increase their human capital. The Early Years Education Program (EYEP) is a new program offered by the Children's Protection Society (CPS) in Melbourne, Australia. EYEP is targeted at the needs of children who have been or are at risk of being abused or neglected. It has the dual focus of seeking to address the consequences of abuse and neglect on children's brain development and redressing their learning deficiencies. Our objective is to determine whether EYEP can improve school readiness by conducting a randomised controlled trial (RCT) of its impacts. The RCT is being conducted with 90 participants (45 intervention and 45 control). Eligible children must be aged under three years and assessed as having two or more risk factors as defined in the Department of Human Services Best Interest Case Practice Model. The intervention group participate for three years (or until school entry) in EYEP. The trial does not provide any early years education or care to the control group. Data are being collected on outcome measures for participants in EYEP and the control group at the baseline, at yearly intervals for three years, and six months after commencing the first year of school. Outcome measures encompass children's health and development, academic ability and emotional and behavioural regulation; and quality of parenting practices. The study will evaluate the impact of EYEP on these outcomes, and undertake a benefit-cost analysis of the program. Findings from the study have the potential to influence the quality of care and education for the large population of children in Australia who are at risk of abuse and neglect, as well as for children in mainstream childcare. The study will provide up-to-date evidence on the impact of an

  1. Comparison of three different dressings for partial thickness burns in children: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Gee Kee, Emma; Kimble, Roy M; Cuttle, Leila; Stockton, Kellie

    2013-11-25

    In the paediatric population, pain and distress associated with burn injuries during wound care procedures remain a constant challenge. Although silver dressings are the gold standard for burn care in Australasia, very few high-level trials have been conducted that compare silver dressings to determine which will provide the best level of care clinically. Therefore, for paediatric patients in particular, identifying silver dressings that are associated with lower levels of pain and rapid wound re-epithelialisation is imperative. This study will determine whether there is a difference in time to re-epithelialisation and pain and distress experienced during wound care procedures among Acticoat™, Acticoat™ combined with Mepitel™ and Mepilex Ag™ dressings for acute, paediatric partial thickness burns. Children aged 0 to 15 years with an acute partial thickness (superficial partial to deep partial thickness inclusive) burn injury and a burn total body surface area of ≤ 10% will be eligible for the trial. Patients will be randomised to one of the three dressing groups: (1) Acticoat™ or (2) Acticoat™ combined with Mepitel™ or (3) Mepilex Ag™. A minimum of 28 participants will be recruited for each treatment group. Primary measures of pain, distress and healing will be repeated at each dressing change until complete wound re-epithelialisation occurs or skin grafting is required. Additional data collected will include infection status at each dressing change, physical function, scar outcome and scar management requirements, cost effectiveness of each dressing and staff perspectives of the dressings. The results of this study will determine the effects of three commonly used silver and silicone burn dressing combinations on the rate of wound re-epithelialisation and pain experienced during dressing procedures in acute, paediatric partial thickness burn injuries. Australian New Zealand Clinical Trials Registry ACTRN12613000105741.

  2. e-Monitoring of Asthma Therapy to Improve Compliance in children (e-MATIC): a randomised controlled trial.

    NARCIS (Netherlands)

    Vasbinder, E.C.; Goossens, J.M.A.W.; Rutten-van Mölken, M.P.M.H.; Winter, B.C.M. de; Dijk, L. van; Vulto, A.G.; Blankman, E.; Dehhan, N; Veenstra-van Schie, M.T.M.; Versteegh, F.G.A.; Wolf, B.H.M.; Janssens, H.M.; Bemt, P.M.L.A. van den

    2016-01-01

    Real-time medication monitoring (RTMM) is a promising tool for improving adherence to inhaled corticosteroids (ICS), but has not been sufficiently tested in children with asthma. We aimed to study the effects of RTMM with short message service (SMS) reminders on adherence to ICS, asthma control,

  3. A mobile technology intervention to reduce sedentary behaviour in 2- to 4-year-old children (Mini Movers): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Downing, Katherine L; Salmon, Jo; Hinkley, Trina; Hnatiuk, Jill A; Hesketh, Kylie D

    2017-03-03

    Sedentary behaviour (e.g. television viewing, sitting time) tracks over time and is associated with adverse health and developmental outcomes across the lifespan. Young children (5 years or younger) spend up to 12 h/day sedentary, of which around 2 h is spent in screen time (e.g. watching television). Interventions to reduce sedentary behaviour in early childhood report mixed results and many have limited potential for scalability. Mobile phones offer a wide-reaching, low-cost avenue for the delivery of health behaviour programmes to parents but their potential to reduce young children's sedentary behaviour has not been widely tested. This study aims to test the feasibility and efficacy of a parent-focused, predominantly mobile telephone-delivered intervention to support parents to minimise the amount of time their child spends using screens and in overall sitting time. Mini Movers is a pilot randomised controlled trial recruiting 100 parents and children. Inclusion criteria include having a child aged between 2 and 4 years, being able to speak, read and write English, and smartphone ownership. Participants will be randomised to the intervention or a wait-list control group at a 1:1 ratio. Intervention group parents will receive printed materials including a content booklet and goal-checking magnet and will participate in a one-on-one discussion with the interventionist to plan two goals to reduce their child's sedentary behaviour. Subsequently, the intervention will be delivered over 6 weeks via personalised and interactive text messages promoting positive health behaviours (strategies for decreasing screen time and overall sitting time), goal setting and self-monitoring. Outcomes to be assessed include intervention feasibility and children's screen time and objectively-assessed sitting time. Few studies have used mobile phone technology to deliver health behaviour programmes to parents of young children. Findings will inform the development of larger

  4. A randomised controlled trial of the effectiveness of providing free fluoride toothpaste from the age of 12 months on reducing caries in 5-6 year old children.

    Science.gov (United States)

    Davies, G M; Worthington, H V; Ellwood, R P; Bentley, E M; Blinkhorn, A S; Taylor, G O; Davies, R M

    2002-09-01

    To assess the impact of regularly supplying free fluoride toothpaste regularly to children, initially aged 12 months, and living in deprived areas of the north west of England on the level of caries in the deciduous dentition at 5-6 years of age. A further aim was to compare the effectiveness of a programme using a toothpaste containing 440 ppmF (Colgate 0-6 Gel) with one containing 1,450 ppmF (Colgate Great Regular Flavour) in reducing caries. Randomised controlled parallel group clinical trial. Clinical data were collected from test and control groups when the children were 5-6 years old. A programme of posting toothpaste with dental health messages to the homes of children initially aged 12 months. Clinical examinations took place in primary schools. 7,422 children born in 3-month birth cohorts living in high caries areas in nine health districts in north west England. Within each district children were randomly assigned to test or control groups. Toothpaste, containing either 440 ppmF or 1450 ppmF, and dental health literature posted at three monthly intervals to children in test groups until they were aged 5-6 years. The dmft index, missing teeth and the prevalence of caries experience. An analysis of 3,731 children who were examined and remained in the programme showed the mean dmft to be 2.15 for the group who had received 1,450 ppmF toothpaste and 2.49 for the 440 ppmF group. The mean dmft for the control group was 2.57. This 16% reduction between the 1,450 ppmF and control group was statistically significant (Pcontrol was not significant. Further analyses to estimate the population effect of the programme also confirmed this relationship. This study demonstrates that a programme distributing free toothpaste containing 1,450 ppmF provides a significant clinical benefit for high caries risk children living in deprived, non-fluoridated districts.

  5. Evidence for short duration of antibiotic treatment for non-severe community acquired pneumonia (CAP in children - are we there yet? A systematic review of randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Shalom Ben-Shimol

    2014-03-01

    Full Text Available Context: The ideal duration of antibiotic treatment for childhood community acquired pneumonia (CAP has not yet been established. Objective: A literature search was conducted to evaluate the efficacy of shorter than 7 days duration of oral antibiotic treatment for childhood non-severe CAP. Data sources: A systematic literature search was performed using the PubMed database. The search was limited to randomised controlled trials (RCTs conducted between January 1996 and May 2013 in children up to 18 years old. Search terms included pneumonia, treatment, duration, child, children, days, short, respiratory infection and non-severe (nonsevere. Study selection: Only RCTs of oral antibiotic treatment for non-severe CAP in children were included. Data extraction: Independent extraction of articles was done by 3 authors using a preformed questionnaire. Data synthesis: Eight articles meeting the selection criteria were identified: 7 from 2 developing countries (India and Pakistan, and 1 from a developed country (The Netherlands. Studies from developing countries used the World Health Organization clinical criteria for diagnosing CAP, which includes mainly tachypnoea. None of those studies included fever, chest radiography or any laboratory test in their case definition. The Dutch study case definition used laboratory tests and chest radiographies (x-rays in addition to clinical criteria. Five articles concluded that 3 days of treatment are sufficient for non-severe childhood CAP, 2 articles found 5 days treatment to be sufficient, and one article found no difference between 3 days of amoxicillin treatment and placebo. Conclusions: The efficacy of short duration oral antibiotic treatment for non-severe CAP in children has not been established in developed countries. Current RCTs from developing countries used clinical criteria that may have failed to appropriately identify children with true bacterial pneumonia necessitating antibiotic treatment. More RCTs

  6. Effects of the Informed Health Choices podcast on the ability of parents of primary school children in Uganda to assess claims about treatment effects: a randomised controlled trial.

    Science.gov (United States)

    Semakula, Daniel; Nsangi, Allen; Oxman, Andrew D; Oxman, Matt; Austvoll-Dahlgren, Astrid; Rosenbaum, Sarah; Morelli, Angela; Glenton, Claire; Lewin, Simon; Kaseje, Margaret; Chalmers, Iain; Fretheim, Atle; Kristoffersen, Doris Tove; Sewankambo, Nelson K

    2017-07-22

    As part of the Informed Health Choices project, we developed a podcast called The Health Choices Programme to help improve the ability of people to assess claims about the benefits and harms of treatments. We aimed to evaluate the effects of the podcast on the ability of parents of primary school children in Uganda to assess claims about the effects of treatments. We did this randomised controlled trial in central Uganda. We recruited parents of children aged 10-12 years who were in their fifth year of school at 35 schools that were participating in a linked trial of the Informed Health Choices primary school resources. The parents were randomly allocated (1:1), via a web-based random number generator with block sizes of four and six, to listen to either the Informed Health Choices podcast (intervention group) or typical public service announcements about health issues (control group). Randomisation was stratified by parents' highest level of formal education attained (primary school, secondary school, or tertiary education) and the allocation of their children's school in the trial of the primary school resources (intervention vs control). The primary outcome, measured after listening to the entire podcast, was the mean score and the proportion of parents with passing scores on a test with two multiple choice questions for each of nine key concepts essential to assessing claims about treatments (18 questions in total). We did intention-to-treat analyses. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201606001676150. We recruited parents between July 21, 2016, and Oct 7, 2016. We randomly assigned 675 parents to the podcast group (n=334) or the public service announcement group (n=341); 561 (83%) participants completed follow-up. The mean score for parents in the podcast group was 67·8% (SD 19·6) compared with 52·4% (17·6) in the control group (adjusted mean difference 15·5%, 95% CI 12·5-18·6; pparents had a predetermined

  7. Do healthy school meals affect illness, allergies and school attendance in 8- to 11-year-old children? A cluster-randomised controlled study.

    Science.gov (United States)

    Laursen, R P; Lauritzen, L; Ritz, C; Dyssegaard, C B; Astrup, A; Michaelsen, K F; Damsgaard, C T

    2015-05-01

    A nutritionally adequate diet in childhood is important for health and resistance of allergies and infections. This study explored the effects of school meals rich in fish, vegetables and fibre on school attendance, asthma, allergies and illness in 797 Danish 8- to 11-year-old children. No comparable studies conducted in high-income settings have been identified. The OPUS School Meal Study was a cluster-randomised cross-over trial. Children from third and fourth grades at nine Danish schools received school meals or usual packed lunch (control) for two 3-month periods. Occurrence and duration of illnesses, asthma and allergies during the last 14 days were recorded by parental questionnaires at baseline and after each 3-month period. Self-reported well-being was assessed by visual analogue scales. The school meals did not affect school attendance, parent-reported occurrence or duration of asthma and allergies or self-reported well-being. The most common symptoms of illness were stomach pain (24%), headache (28%) and cold (24%). A slightly higher number of children experienced headaches in the school meal (27%) compared with the control period (22%) (P=0.02). However, subgroup analyses showed that this effect was only seen in children eating school meals in the classroom (P=0.007), and not in common dining areas (P=0.2). No effect was found on other symptoms of illness. Provision of nutritionally balanced school meals did not affect school attendance, asthma, allergies, illness or well-being in 8- to 11-year-old children. The slight increase in occurrence of headaches seems to be related to the physical eating environment.

  8. Reducing electronic media use in 2-3 year-old children: feasibility and efficacy of the Family@play pilot randomised controlled trial.

    Science.gov (United States)

    Hinkley, Trina; Cliff, Dylan P; Okely, Anthony D

    2015-08-14

    Participation in electronic media use among 2-3 year olds is high and associated with adverse health and developmental outcomes. This study sought to test the feasibility and potential efficacy of a family-based program to decrease electronic media (EM) use in 2-3-year-old children. Family@play was a six-session pilot randomised controlled trial delivered to parents of 2-3 year-old children from August to September 2012 in a community environment in the Illawarra region of New South Wales, Australia. Development of program content was guided by Social Cognitive and Family Systems Theories. The primary outcome was children's electronic media use. Secondary outcomes included children's time in sitting, standing and stepping. Data collectors were blinded to group allocation. Parents completed comprehensive process evaluation measures and participated in focus group discussions following completion of the program. Regression analyses were undertaken and effect sizes calculated using principles of intention to treat. Twenty-two participants (n = 12 intervention; n = 10 control) provided complete baseline data; complete data from 16 participants (n = 6 intervention; n = 10 control) were available post-intervention. Process evaluation results were high, showing the acceptability of the program. Compared with children in the control group, there were greater decreases in total EM use among children in the intervention group (adjusted difference [95 % CI] = -31.2 mins/day [-71.0-8.6] Cohen's d = 0.70). Differences for other outcomes were in the hypothesised direction and ranged from small for postural (sitting, standing, stepping) outcomes to moderate to large for individual electronic media (e.g. TV viewing, DVD/video viewing). This is the first family-based study to engage families of 2-3 year old children outside the United States and target multiple EM behaviours. Family@play was shown to be a feasible and acceptable intervention to deliver to

  9. Cognitive behavioral therapy of socially phobic children focusing on cognition: a randomised wait-list control study

    Directory of Open Access Journals (Sweden)

    Stadler Christina

    2011-02-01

    Full Text Available Abstract Background Although literature provides support for cognitive behavioral therapy (CBT as an efficacious intervention for social phobia, more research is needed to improve treatments for children. Methods Forty four Caucasian children (ages 8-14 meeting diagnostic criteria of social phobia according to the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; APA, 1994 were randomly allocated to either a newly developed CBT program focusing on cognition according to the model of Clark and Wells (n = 21 or a wait-list control group (n = 23. The primary outcome measure was clinical improvement. Secondary outcomes included improvements in anxiety coping, dysfunctional cognitions, interaction frequency and comorbid symptoms. Outcome measures included child report and clinican completed measures as well as a diagnostic interview. Results Significant differences between treatment participants (4 dropouts and controls (2 dropouts were observed at post test on the German version of the Social Phobia and Anxiety Inventory for Children. Furthermore, in the treatment group, significantly more children were free of diagnosis than in wait-list group at post-test. Additional child completed and clinician completed measures support the results. Discussion The study is a first step towards investigating whether CBT focusing on cognition is efficacious in treating children with social phobia. Future research will need to compare this treatment to an active treatment group. There remain the questions of whether the effect of the treatment is specific to the disorder and whether the underlying theoretical model is adequate. Conclusion Preliminary support is provided for the efficacy of the cognitive behavioral treatment focusing on cognition in socially phobic children. Active comparators should be established with other evidence-based CBT programs for anxiety disorders, which differ significantly in their dosage and type of cognitive

  10. Children and youth perceive smoking messages in an unbranded advertisement from a NIKE marketing campaign: a cluster randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Daniel Mark

    2011-04-01

    Full Text Available Abstract Background How youth perceive marketing messages in sports is poorly understood. We evaluated whether youth perceive that the imagery of a specific sports marketing advertisement contained smoking-related messages. Methods Twenty grade 7 to 11 classes (397 students from two high schools in Montréal, Canada were recruited to participate in a cluster randomised single-blind controlled trial. Classes were randomly allocated to either a NIKE advertisement containing the phrase 'LIGHT IT UP' (n = 205 or to a neutral advertisement with smoking imagery reduced and the phrase replaced by 'GO FOR IT' (n = 192. The NIKE logo was removed from both advertisements. Students responded in class to a questionnaire asking open-ended questions about their perception of the messages in the ad. Reports relating to the appearance and text of the ad, and the product being promoted were evaluated. Results Relative to the neutral ad, more students reported that the phrase 'LIGHT IT UP' was smoking-related (37.6% vs. 0.5% and that other parts of the ad resembled smoking-related products (50.7% vs. 10.4%. The relative risk of students reporting that the NIKE ad promoted cigarettes was 4.41 (95% confidence interval: 2.64-7.36; P Conclusions The unbranded imagery of an advertisement in a specific campaign aimed at promoting NIKE hockey products appears to have contained smoking-related messages. This particular marketing campaign may have promoted smoking. This suggests that the regulation of marketing to youth may need to be more tightly controlled.

  11. The Good Schools Toolkit to prevent violence against children in Ugandan primary schools: study protocol for a cluster randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background We aim to evaluate the effectiveness of the Good School Toolkit, developed by Raising Voices, in preventing violence against children attending school and in improving child mental health and educational outcomes. Methods/design We are conducting a two-arm cluster randomised controlled trial with parallel assignment in Luwero District, Uganda. We will also conduct a qualitative study, a process evaluation and an economic evaluation. A total of 42 schools, representative of Luwero District, Uganda, were allocated to receive the Toolkit plus implementation support, or were allocated to a wait-list control condition. Our main analysis will involve a cross-sectional comparison of the prevalence of past-week violence from school staff as reported by children in intervention and control primary schools at follow-up. At least 60 children per school and all school staff members will be interviewed at follow-up. Data collection involves a combination of mobile phone-based, interviewer-completed questionnaires and paper-and-pen educational tests. Survey instruments include the ISPCAN Child Abuse Screening Tools to assess experiences of violence; the Strengths and Difficulties Questionnaire to measure symptoms of common childhood mental disorders; and word recognition, reading comprehension, spelling, arithmetic and sustained attention tests adapted from an intervention trial in Kenya. Discussion To our knowledge, this is the first study to rigorously investigate the effects of any intervention to prevent violence from school staff to children in primary school in a low-income setting. We hope the results will be informative across the African region and in other settings. Trial registration clinicaltrials.gov NCT01678846 PMID:23883138

  12. The Good Schools Toolkit to prevent violence against children in Ugandan primary schools: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Devries, Karen M; Allen, Elizabeth; Child, Jennifer C; Walakira, Eddy; Parkes, Jenny; Elbourne, Diana; Watts, Charlotte; Naker, Dipak

    2013-07-24

    We aim to evaluate the effectiveness of the Good School Toolkit, developed by Raising Voices, in preventing violence against children attending school and in improving child mental health and educational outcomes. We are conducting a two-arm cluster randomised controlled trial with parallel assignment in Luwero District, Uganda. We will also conduct a qualitative study, a process evaluation and an economic evaluation. A total of 42 schools, representative of Luwero District, Uganda, were allocated to receive the Toolkit plus implementation support, or were allocated to a wait-list control condition. Our main analysis will involve a cross-sectional comparison of the prevalence of past-week violence from school staff as reported by children in intervention and control primary schools at follow-up.At least 60 children per school and all school staff members will be interviewed at follow-up. Data collection involves a combination of mobile phone-based, interviewer-completed questionnaires and paper-and-pen educational tests. Survey instruments include the ISPCAN Child Abuse Screening Tools to assess experiences of violence; the Strengths and Difficulties Questionnaire to measure symptoms of common childhood mental disorders; and word recognition, reading comprehension, spelling, arithmetic and sustained attention tests adapted from an intervention trial in Kenya. To our knowledge, this is the first study to rigorously investigate the effects of any intervention to prevent violence from school staff to children in primary school in a low-income setting. We hope the results will be informative across the African region and in other settings. clinicaltrials.gov NCT01678846.

  13. Silk garments plus standard care compared with standard care for treating eczema in children: A randomised, controlled, observer-blind, pragmatic trial (CLOTHES Trial.

    Directory of Open Access Journals (Sweden)

    Kim S Thomas

    2017-04-01

    Full Text Available The role of clothing in the management of eczema (also called atopic dermatitis or atopic eczema is poorly understood. This trial evaluated the effectiveness and cost-effectiveness of silk garments (in addition to standard care for the management of eczema in children with moderate to severe disease.This was a parallel-group, randomised, controlled, observer-blind trial. Children aged 1 to 15 y with moderate to severe eczema were recruited from secondary care and the community at five UK medical centres. Participants were allocated using online randomisation (1:1 to standard care or to standard care plus silk garments, stratified by age and recruiting centre. Silk garments were worn for 6 mo. Primary outcome (eczema severity was assessed at baseline, 2, 4, and 6 mo, by nurses blinded to treatment allocation, using the Eczema Area and Severity Index (EASI, which was log-transformed for analysis (intention-to-treat analysis. A safety outcome was number of skin infections. Three hundred children were randomised (26 November 2013 to 5 May 2015: 42% girls, 79% white, mean age 5 y. Primary analysis included 282/300 (94% children (n = 141 in each group. The garments were worn more often at night than in the day (median of 81% of nights [25th to 75th centile 57% to 96%] and 34% of days [25th to 75th centile 10% to 76%]. Geometric mean EASI scores at baseline, 2, 4, and 6 mo were, respectively, 9.2, 6.4, 5.8, and 5.4 for silk clothing and 8.4, 6.6, 6.0, and 5.4 for standard care. There was no evidence of any difference between the groups in EASI score averaged over all follow-up visits adjusted for baseline EASI score, age, and centre: adjusted ratio of geometric means 0.95, 95% CI 0.85 to 1.07, (p = 0.43. This confidence interval is equivalent to a difference of -1.5 to 0.5 in the original EASI units, which is not clinically important. Skin infections occurred in 36/142 (25% and 39/141 (28% of children in the silk clothing and standard care groups

  14. Evaluation of the impact of school gardening interventions on children's knowledge of and attitudes towards fruit and vegetables. A cluster randomised controlled trial.

    Science.gov (United States)

    Hutchinson, Jayne; Christian, Meaghan Sarah; Evans, Charlotte Elizabeth Louise; Nykjaer, Camilla; Hancock, Neil; Cade, Janet Elizabeth

    2015-08-01

    Involvement of children in gardening has the potential to increase liking of fruit and vegetables (FV) and consequently, intake, but research results are mixed. School gardening led by external specialists such as the Royal Horticultural Society (RHS) could have more impact than teacher-led gardening on children's knowledge of, and attitudes towards, FV. Data from a cluster randomised controlled trial were used to compare a RHS-led school gardening intervention with a teacher-led gardening intervention amongst 7-10 year olds in 21 London schools. A short questionnaire was developed and used to identify children's knowledge and attitudes towards FV consumption before the garden intervention and 18 months afterwards. Results from multilevel regression models, both unadjusted and adjusted for baseline responses and socio-demographic factors, were reported. Attitudes to FV intake were compared between groups. Change in FV knowledge was used to predict change in FV consumption assessed using 24-hour food diaries. In comparison with the RHS-led group (n = 373), teacher-led children (n = 404) were more likely to agree they ate lots of fruit (p gardening was associated with a greater increase in the total number of vegetables recognised (p = 0.031). No other differences in improvements in attitudes, or associations between change in FV recognition and intake were found. In relation to improvements in children's recognition and attitudes towards eating FV, this trial produced limited evidence that gardening activity packages led by external specialists (RHS-led) provide additional benefits over those led by teachers trained by the RHS. Indeed, the latter were potentially more effective. Copyright © 2015 Elsevier Ltd. All rights reserved.

  15. A Multinational Cluster Randomised Controlled Trial to Assess the Efficacy of '11+ Kids': A Warm-Up Programme to Prevent Injuries in Children's Football.

    Science.gov (United States)

    Rössler, Roland; Junge, Astrid; Bizzini, Mario; Verhagen, Evert; Chomiak, Jiri; Aus der Fünten, Karen; Meyer, Tim; Dvorak, Jiri; Lichtenstein, Eric; Beaudouin, Florian; Faude, Oliver

    2018-06-01

    The objective of this study was to assess the efficacy of a newly developed warm-up programme ('11+ Kids') regarding its potential to reduce injuries in children's football. Children's football teams (under 9 years, under 11 years, and under 13 years age groups) from Switzerland, Germany, the Czech Republic and the Netherlands were invited. Clubs were randomised to an intervention group and a control group, and followed for one season. The intervention group replaced their usual warm-up by '11+ Kids', while the control group warmed up as usual. The primary outcome was the overall risk of football-related injuries. Secondary outcomes were the risks of severe and lower extremity injuries. We calculated hazard ratios using extended Cox models, and performed a compliance analysis. In total, 292,749 h of football exposure of 3895 players were recorded. The mean age of players was 10.8 (standard deviation 1.4) years. During the study period, 374 (intervention group = 139; control group = 235) injuries occurred. The overall injury rate in the intervention group was reduced by 48% compared with the control group (hazard ratio 0.52; 95% confidence interval 0.32-0.86). Severe (74% reduction, hazard ratio 0.26; 95% confidence interval 0.10-0.64) and lower extremity injuries (55% reduction, hazard ratio 0.45; 95% confidence interval 0.24-0.84) were also reduced. Injury incidence decreased with increasing compliance. '11+ Kids' is efficacious in reducing injuries in children's football. We observed considerable effects for overall, severe and lower extremity injuries. The programme should be performed at least once per week to profit from an injury preventive effect. However, two sessions per week can be recommended to further increase the protective benefit. ClinicalTrials.gov identifier: NCT02222025.

  16. Acute effects of advertisements on children's choices, preferences, and ratings of liking for physical activities and sedentary behaviours: a randomised controlled pilot study.

    Science.gov (United States)

    Atlantis, Evan; Salmon, Jo; Bauman, Adrian

    2008-11-01

    The acute decision prompting effects of social marketing via television (TV) advertisements promoting physical activity to children are unknown. This pilot study aimed to determine the acute effects of an Australian government-sponsored TV advertisement (called 'Get Moving'), promoting more physical activity and less sedentary behaviour, on children's choices, preferences, and ratings of liking for physical activities and sedentary behaviours. Thirty-one children aged 10-12 years were recruited from a single public school, and randomised to one of two treatment groups or two control groups (Solomon four-group design). Treatment participants watched an episode of The Simpsons embedded every 10min with three 30s Get Moving advertisements plus standard advertisements. Control participants watched the same episode plus standard advertisements, but without the Get Moving advertisements. The following dependent variables were assessed immediately before and/or after exposure: activity preference (participants selected either verbally or by pointing to one of eight picture cards depicting four physical activities and four sedentary behaviours); ratings of liking (participants rated how much they liked or disliked each of these activities/behaviours either verbally or by pointing to one of nine values with an adjacent smile or frown on a Likert-type scale); and time spent in physical activities was assessed by direct observation during a 10min free-time session. No significant effects or trends were seen for any of the dependent variables. Further research is needed to determine whether different content and/or higher doses of exposure to physical activity promoting advertisements are needed to influence children's activity choices.

  17. The effectiveness of Stepping stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual

    Science.gov (United States)

    2011-01-01

    Background Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual) disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. Methods/Design The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14) will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P) or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. Discussion This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community-based population of

  18. The effectiveness of Stepping Stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual.

    Science.gov (United States)

    Kleefman, Marijke; Jansen, Daniëlle E M C; Reijneveld, Sijmen A

    2011-08-30

    Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual) disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14) will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P) or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community-based population of children with a mild intellectual

  19. The effectiveness of Stepping stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual

    Directory of Open Access Journals (Sweden)

    Jansen Daniëlle EMC

    2011-08-01

    Full Text Available Abstract Background Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effectiveness of parenting counselling using Stepping Stones Triple P compared to Care as Usual. Methods/Design The effects of Stepping Stones Triple P will be studied in a Randomised Controlled Trial. Parents of children aged 5-12 years with an IQ of 50-85 will be recruited from schools. Prior to randomisation, parents complete a screening questionnaire about their child's psychosocial problems and their parenting skills. Subsequently, parents of children with increased levels of psychosocial problems (score on Strengths and Difficulties Questionnaire ≥ 14 will be invited to participate in the intervention study. After obtaining consent, parents will be randomised either to the experimental group (Stepping Stones Triple P or to Care as Usual. The primary outcome is a change in the child's psychosocial problems according to parents and teachers. The secondary outcome is a change in parenting skills. Data will be collected before the start of the intervention, immediately after the intervention, and six months after. Discussion This paper presents an outline of the background and design of a randomised controlled trial to investigate the effectiveness of Stepping Stones Triple P, which aims to decrease psychosocial problems in children with a mild intellectual disability. Stepping Stones Triple P seems promising, but evidence on its effectiveness for this population is still lacking. This study provides evidence about the effects of this intervention in a community

  20. Comparative efficacy of active and passive distraction during restorative treatment in children using an iPad versus audiovisual eyeglasses: a randomised controlled trial.

    Science.gov (United States)

    Attar, R H; Baghdadi, Z D

    2015-02-01

    This study aimed to compare the effects of two types of distraction techniques: passive, using audiovisual glasses (AV glasses), versus active, using an iPad, as an adjunct to local analgesia during vital pulp therapy in children. Pain behaviour, and heart rates from an exposure group (treatment with the aid of an iPad) and control group (treatment with the aid of AV glasses) were compared in a randomised, split-mouth design using the Wilcoxon signed rank test (pain and behaviour) and paired t test for heart rate scores at p 0.05. Children (39) (mean age 6.27 years) received the two treatment sessions. Generally, AV glasses had higher pain and behaviour scores than iPad. Pain results demonstrated marginal significant differences between the two distraction techniques during local analgesia administration (p 0.076) and caries removal (p 0.071). A significant difference between the two techniques during local analgesia administration only (p 0.017), in favour of an iPad. Average heart rates over the treatment intervals were lower among iPad group than those using AV glasses group. Patients preferred an iPad more than AV glasses (24 versus 15). Treatment sessions were significantly shorter for iPad. Active distraction using an iPad demonstrated better performance than passive distraction using AV glasses.

  1. Does n-3 LCPUFA supplementation during pregnancy increase the IQ of children at school age? Follow-up of a randomised controlled trial.

    Science.gov (United States)

    Gould, Jacqueline F; Treyvaud, Karli; Yelland, Lisa N; Anderson, Peter J; Smithers, Lisa G; Gibson, Robert A; McPhee, Andrew J; Makrides, Maria

    2016-05-17

    Despite recommendations that pregnant women increase their docosahexaenoic acid (DHA) intake to support fetal brain development, a recent systematic review found a lack of high-quality data to support the long-term effects of DHA supplementation on children's neurodevelopment. We will assess child neurodevelopment at 7 years of age in follow-up of a multicentre double-blind randomised controlled trial of DHA supplementation in pregnancy. In 2010-2012, n=2399 Australian women with a singleton pregnancy Intelligence, Second Edition. Specific measures of executive functioning (Fruit Stroop and the Rey Complex Figure), attention (Test of Everyday Attention for Children), memory and learning (Rey Auditory Verbal Learning Test), language (Clinical Evaluation of Language Fundamentals, Fourth Edition) and basic educational skills (Wide Range Achievement Test, Fourth Edition) will also be administered. Caregivers will be asked to complete questionnaires measuring behaviour and executive functioning. Families, clinicians and research personnel are blinded to group assignment with the exception of families who requested unblinding prior to the follow-up. All analyses will be conducted according to the intention-to-treat principal. All procedures will be approved by the relevant institutional ethics committees prior to start of the study. The results of this study will be disseminated in peer-reviewed journal publications and academic presentations. ACTRN12605000569606 and ACTRN12614000770662. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  2. Improving postoperative tonsillectomy pain management in children--a double blinded randomised control trial of a patient analgesia information sheet.

    Science.gov (United States)

    Bailey, Lucas; Sun, Jing; Courtney, Mark; Murphy, Paul

    2015-05-01

    To evaluate paediatric post-tonsillectomy pain management using oxycodone when a specific analgesia information sheet is included with standard postoperative information. Oxycodone information sheets were randomly allocated to half the study children's post-tonsillectomy information pack. The trial was double-blinded to the surgeon, anaesthetist, nursing and administrative staff. Parents and children completed the pain assessment on day 3, 5 and 7. On day 10 the parents completed a questionnaire. A postoperative analgesia information sheet provides for higher satisfaction and knowledge for parents using oxycodone (psheet, most significantly at day 3 and 7 post operatively (psheets are useful in education and use of postoperative analgesia. The primary objective to explore the efficacy of the information sheet has proved to be successful in this setting. Given risks of opioid analgesia, it is recommended that postoperative information sheets be given to all parents, to provide for improved analgesia control and safe management of children in the postoperative period. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

  3. The BBaRTS Healthy Teeth Behaviour Change Programme for preventing dental caries in primary school children: study protocol for a cluster randomised controlled trial.

    Science.gov (United States)

    Pine, Cynthia; Adair, Pauline; Robinson, Louise; Burnside, Girvan; Moynihan, Paula; Wade, William; Kistler, James; Curnow, Morag; Henderson, Mary

    2016-02-20

    Oral health behaviours such as establishing twice-daily toothbrushing and sugar control intake need parental self-efficacy (PSE) to prevent the development of childhood dental caries. A previous study has shown that behaviour change techniques (BCTs) delivered via a storybook can improve parental self-efficacy to undertake twice-daily toothbrushing. to determine whether an intervention (BBaRTS, Bedtime Brush and Read Together to Sleep), designed to increase PSE; delivered through storybooks with embedded BCTs, parenting skills and oral health messages, can improve child oral health compared to (1) an exactly similar intervention containing no behaviour change techniques, and (2) the BBaRTS intervention supplemented with home supply of fluoride toothpaste and supervised toothbrushing on schooldays. A 2-year, three-arm, multicentre, cluster randomised controlled trial. children (estimated 2000-2600) aged 5-7 years and their families from 60 UK primary schools. Test group 1: a series of eight children's storybooks developed by a psychologist, public health dentist, science educator, children's author and illustrators, with guidance from the Department for Education (England). The books feature animal characters and contain embedded dental health messages, parenting skills and BCTs to promote good oral health routines focused on controlling sugar intake and toothbrushing, as well as reading at bedtime. Books are given out over 2 years. Test group 2: as Test group 1 plus home supplies of fluoride toothpaste (1000 ppmF), and daily supervised toothbrushing in school on schooldays. Active Control group: series of eight books with exactly the same stories, characters and illustrations, but without BCTs, dental health messages or parenting skills. Annual child dental examinations and parental questionnaires will be undertaken. A sub-set of participants will be invited to join an embedded study of the child's diet and salivary microbiota composition. dental caries experience

  4. Effect of participatory women's groups and counselling through home visits on children's linear growth in rural eastern India (CARING trial): a cluster-randomised controlled trial.

    Science.gov (United States)

    Nair, Nirmala; Tripathy, Prasanta; Sachdev, H S; Pradhan, Hemanta; Bhattacharyya, Sanghita; Gope, Rajkumar; Gagrai, Sumitra; Rath, Shibanand; Rath, Suchitra; Sinha, Rajesh; Roy, Swati Sarbani; Shewale, Suhas; Singh, Vijay; Srivastava, Aradhana; Costello, Anthony; Copas, Andrew; Skordis-Worrall, Jolene; Haghparast-Bidgoli, Hassan; Saville, Naomi; Prost, Audrey

    2017-10-01

    Around 30% of the world's stunted children live in India. The Government of India has proposed a new cadre of community-based workers to improve nutrition in 200 districts. We aimed to find out the effect of such a worker carrying out home visits and participatory group meetings on children's linear growth. We did a cluster-randomised controlled trial in two adjoining districts of Jharkhand and Odisha, India. 120 clusters (around 1000 people each) were randomly allocated to intervention or control using a lottery. Randomisation took place in July, 2013, and was stratified by district and number of hamlets per cluster (0, 1-2, or ≥3), resulting in six strata. In each intervention cluster, a worker carried out one home visit in the third trimester of pregnancy, monthly visits to children younger than 2 years to support feeding, hygiene, care, and stimulation, as well as monthly women's group meetings to promote individual and community action for nutrition. Participants were pregnant women identified and recruited in the study clusters and their children. We excluded stillbirths and neonatal deaths, infants whose mothers died, those with congenital abnormalities, multiple births, and mother and infant pairs who migrated out of the study area permanently during the trial period. Data collectors visited each woman in pregnancy, within 72 h of her baby's birth, and at 3, 6, 9, 12, and 18 months after birth. The primary outcome was children's length-for-age Z score at 18 months of age. Analyses were by intention to treat. Due to the nature of the intervention, participants and the intervention team were not masked to allocation. Data collectors and the data manager were masked to allocation. The trial is registered as ISCRTN (51505201) and with the Clinical Trials Registry of India (number 2014/06/004664). Between Oct 1, 2013, and Dec 31, 2015, we recruited 5781 pregnant women. 3001 infants were born to pregnant women recruited between Oct 1, 2013, and Feb 10, 2015

  5. Daily co-trimoxazole prophylaxis to prevent mortality in children with complicated severe acute malnutrition: a multicentre, double-blind, randomised placebo-controlled trial.

    Science.gov (United States)

    Berkley, James A; Ngari, Moses; Thitiri, Johnstone; Mwalekwa, Laura; Timbwa, Molline; Hamid, Fauzat; Ali, Rehema; Shangala, Jimmy; Mturi, Neema; Jones, Kelsey D J; Alphan, Hassan; Mutai, Beatrice; Bandika, Victor; Hemed, Twahir; Awuondo, Ken; Morpeth, Susan; Kariuki, Samuel; Fegan, Gregory

    2016-07-01

    Children with complicated severe acute malnutrition (SAM) have a greatly increased risk of mortality from infections while in hospital and after discharge. In HIV-infected children, mortality and admission to hospital are prevented by daily co-trimoxazole prophylaxis, despite locally reported bacterial resistance to co-trimoxazole. We aimed to assess the efficacy of daily co-trimoxazole prophylaxis on survival in children without HIV being treated for complicated SAM. We did a multicentre, double-blind, randomised, placebo-controlled study in four hospitals in Kenya (two rural hospitals in Kilifi and Malindi, and two urban hospitals in Mombasa and Nairobi) with children aged 60 days to 59 months without HIV admitted to hospital and diagnosed with SAM. We randomly assigned eligible participants (1:1) to 6 months of either daily oral co-trimoxazole prophylaxis (given as water-dispersible tablets; 120 mg per day for age malnutrition (kwashiorkor), and 1221 (69%) were stunted (length-for-age Z score child-years of observation, 122 (14%) of 887 children in the co-trimoxazole group died, compared with 135 (15%) of 891 in the placebo group (unadjusted hazard ratio [HR] 0·90, 95% CI 0·71-1·16, p=0·429; 16·0 vs 17·7 events per 100 child-years observed (CYO); difference -1·7 events per 100 CYO, 95% CI -5·8 to 2·4]). In the first 6 months of the study (while participants received study medication), 63 suspected grade 3 or 4 associated adverse events were recorded among 57 (3%) children; 31 (2%) in the co-trimoxazole group and 32 (2%) in the placebo group (incidence rate ratio 0·98, 95% CI 0·58-1·65). The most common adverse events of these grades were urticarial rash (grade 3, equally common in both groups), neutropenia (grade 4, more common in the co-trimoxazole group), and anaemia (both grades equally common in both groups). One child in the placebo group had fatal toxic epidermal necrolysis with concurrent Pseudomonas aeruginosa bacteraemia. Daily co

  6. Clinical efficacy and safety of a novel tetravalent dengue vaccine in healthy children in Asia: a phase 3, randomised, observer-masked, placebo-controlled trial.

    Science.gov (United States)

    Capeding, Maria Rosario; Tran, Ngoc Huu; Hadinegoro, Sri Rezeki S; Ismail, Hussain Imam H J Muhammad; Chotpitayasunondh, Tawee; Chua, Mary Noreen; Luong, Chan Quang; Rusmil, Kusnandi; Wirawan, Dewa Nyoman; Nallusamy, Revathy; Pitisuttithum, Punnee; Thisyakorn, Usa; Yoon, In-Kyu; van der Vliet, Diane; Langevin, Edith; Laot, Thelma; Hutagalung, Yanee; Frago, Carina; Boaz, Mark; Wartel, T Anh; Tornieporth, Nadia G; Saville, Melanie; Bouckenooghe, Alain

    2014-10-11

    An estimated 100 million people have symptomatic dengue infection every year. This is the first report of a phase 3 vaccine efficacy trial of a candidate dengue vaccine. We aimed to assess the efficacy of the CYD dengue vaccine against symptomatic, virologically confirmed dengue in children. We did an observer-masked, randomised controlled, multicentre, phase 3 trial in five countries in the Asia-Pacific region. Between June 3, and Dec 1, 2011, healthy children aged 2-14 years were randomly assigned (2:1), by computer-generated permuted blocks of six with an interactive voice or web response system, to receive three injections of a recombinant, live, attenuated, tetravalent dengue vaccine (CYD-TDV), or placebo, at months 0, 6, and 12. Randomisation was stratified by age and site. Participants were followed up until month 25. Trial staff responsible for the preparation and administration of injections were unmasked to group allocation, but were not included in the follow-up of the participants; allocation was concealed from the study sponsor, investigators, and parents and guardians. Our primary objective was to assess protective efficacy against symptomatic, virologically confirmed dengue, irrespective of disease severity or serotype, that took place more than 28 days after the third injection. The primary endpoint was for the lower bound of the 95% CI of vaccine efficacy to be greater than 25%. Analysis was by intention to treat and per procotol. This trial is registered with ClinicalTrials.gov, number NCT01373281. We randomly assigned 10,275 children to receive either vaccine (n=6851) or placebo (n=3424), of whom 6710 (98%) and 3350 (98%), respectively, were included in the primary analysis. 250 cases of virologically confirmed dengue took place more than 28 days after the third injection (117 [47%] in the vaccine group and 133 [53%] in the control group). The primary endpoint was achieved with 56·5% (95% CI 43·8-66·4) efficacy. We recorded 647 serious adverse

  7. A continuous quality improvement intervention to improve the effectiveness of community health workers providing care to mothers and children: a cluster randomised controlled trial in South Africa.

    Science.gov (United States)

    Horwood, Christiane; Butler, Lisa; Barker, Pierre; Phakathi, Sifiso; Haskins, Lyn; Grant, Merridy; Mntambo, Ntokozo; Rollins, Nigel

    2017-06-13

    Community health workers (CHWs) play key roles in delivering health programmes in many countries worldwide. CHW programmes can improve coverage of maternal and child health services for the most disadvantaged and remote communities, leading to substantial benefits for mothers and children. However, there is limited evidence of effective mentoring and supervision approaches for CHWs. This is a cluster randomised controlled trial to investigate the effectiveness of a continuous quality improvement (CQI) intervention amongst CHWs providing home-based education and support to pregnant women and mothers. Thirty CHW supervisors were randomly allocated to intervention (n = 15) and control (n = 15) arms. Four CHWs were randomly selected from those routinely supported by each supervisor (n = 60 per arm). In the intervention arm, these four CHWs and their supervisor formed a quality improvement team. Intervention CHWs received a 2-week training in WHO Community Case Management followed by CQI mentoring for 12 months (preceded by 3 months lead-in to establish QI processes). Baseline and follow-up surveys were conducted with mothers of infants Improved training and CQI-based mentoring of CHWs can improve quantity and quality of CHW-mother interactions at household level, leading to improvements in mothers' knowledge and infant feeding practices. ClinicalTrials.Gov NCT01774136.

  8. Effect of two different house screening interventions on exposure to malaria vectors and on anaemia in children in The Gambia: a randomised controlled trial.

    Science.gov (United States)

    Kirby, Matthew J; Ameh, David; Bottomley, Christian; Green, Clare; Jawara, Musa; Milligan, Paul J; Snell, Paul C; Conway, David J; Lindsay, Steve W

    2009-09-19

    House screening should protect people against malaria. We assessed whether two types of house screening--full screening of windows, doors, and closing eaves, or installation of screened ceilings--could reduce house entry of malaria vectors and frequency of anaemia in children in an area of seasonal malaria transmission. During 2006 and 2007, 500 occupied houses in and near Farafenni town in The Gambia, an area with low use of insecticide-treated bednets, were randomly assigned to receive full screening, screened ceilings, or no screening (control). Randomisation was done by computer-generated list, in permuted blocks of five houses in the ratio 2:2:1. Screening was not treated with insecticide. Exposure to mosquitoes indoors was assessed by fortnightly light trap collections during the transmission season. Primary endpoints included the number of female Anopheles gambiae sensu lato mosquitoes collected per trap per night. Secondary endpoints included frequency of anaemia (haemoglobin concentration ceilings, n=178; control, n=96). The mean number of A gambiae caught in houses without screening was 37.5 per trap per night (95% CI 31.6-43.3), compared with 15.2 (12.9-17.4) in houses with full screening (ratio of means 0.41, 95% CI 0.31-0.54; pceilings (ratio 0.53, 0.40-0.70; pceilings (OR 0.51, 0.27-0.96; p=0.04). Frequency of parasitaemia did not differ between intervention and control groups. House screening substantially reduced the number of mosquitoes inside houses and could contribute to prevention of anaemia in children. Medical Research Council.

  9. Improved cognitive performance in preadolescent Danish children after the school-based physical activity programme "FIFA 11 for Health" for Europe - A cluster-randomised controlled trial.

    Science.gov (United States)

    Lind, Rune Rasmussen; Geertsen, Svend Sparre; Ørntoft, Christina; Madsen, Mads; Larsen, Malte Nejst; Dvorak, Jiri; Ritz, Christian; Krustrup, Peter

    2018-02-01

    Recent studies have shown promising effects of physical activity on cognitive function, but there is a need to investigate this link in real-life settings such as schools. Hence, the objective of the present pilot study was to investigate whether the school-based physical activity programme "FIFA 11 for Health" for Europe could improve cognitive performance in preadolescent Danish children. The pilot study used an 11-week cluster-randomised intervention study design. School classes were randomly assigned to either a control group (CG) (n = 93 children, age = 11.8, s = 0.2 years), which performed the obligatory daily school-based physical activity (5 × 45 minutes per week); or an intervention group (IG) (n = 838 children, age = 11.9, s = 0.4 years), which substituted 2 × 45 minutes per week of the daily school physical activity with the "FIFA 11 for Health" for Europe programme. The programme combines small-sided football games, drills and health education. Cognitive performance was evaluated at baseline and follow-up. The IG improved their cognitive performance compared to the CG for psychomotor function (56, s x -  = 22 ms, p school-based physical activity programme "FIFA 11 for Health" for Europe can improve cognitive performance in preadolescent Danish schoolchildren. Future studies should attempt to disentangle the effects of "FIFA 11 for Health" for Europe on cognitive performance by investigating the characteristics of the programme's physical activity.

  10. Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC). A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats.

    Science.gov (United States)

    Bond, John; Wilson, Janet; Eccles, Martin; Vanoli, Alessandra; Steen, Nick; Clarke, Ray; Zarod, Andrew; Lock, Catherine; Brittain, Katie; Speed, Chris; Rousseau, Nikki

    2006-08-09

    Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4-15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001-July 2008). As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in consultation rates, the results from the National Prospective Tonsillectomy

  11. Protocol for north of England and Scotland study of tonsillectomy and adeno-tonsillectomy in children (NESSTAC. A pragmatic randomised controlled trial comparing surgical intervention with conventional medical treatment in children with recurrent sore throats

    Directory of Open Access Journals (Sweden)

    Lock Catherine

    2006-08-01

    Full Text Available Abstract Background Uncertainties surrounding the effectiveness and cost-effectiveness of childhood tonsillectomy for recurrent sore throat led the NHS Health Technology Assessment Programme to commission this research to evaluate the effectiveness and cost-effectiveness of tonsillectomy and adeno-tonsillectomy in comparison with standard non-surgical management in children aged under 16 with recurrent throat infections. The aim is to evaluate if tonsillectomy and adeno-tonsillectomy reduces the number of episodes of sore throats among children to a clinically significant extent. Methods/design A simple prospective pragmatic randomised controlled trial with economic analysis and prospective cohort study of non-trial participants comparing surgical intervention with conventional medical treatment. The treatment arm will receive tonsillectomy and adeno-tonsillectomy while in the control arm non-surgical conventional medical treatment only will be used. The primary outcome measure will be reported number of episodes of sore throat over two years with secondary outcomes measures of reported number of episodes of sore throat, otitis media and upper respiratory tract infection which invoke a GP consultation; reported number of symptom-free days; reported severity of sore throats and surgical and anaesthetic morbidity. The study will take place in five hospitals in the UK. The trial population will be 406 children aged 4–15 on their last birthday with recurrent sore throat referred by primary care to the 5 otolaryngology departments. The duration of the study is seven years (July 2001- July 2008. Discussion As with all pragmatic randomised controlled trials it is impossible to control the external environment in which the research is taking place. Since this trial began a number of factors have arisen which could affect the outcome including; a reduction in the incidence of respiratory tract infections, marked socio-economic differences in

  12. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder--study protocol of the randomised, multi-centre controlled SOSTA--net trial.

    Science.gov (United States)

    Freitag, Christine M; Cholemkery, Hannah; Elsuni, Leyla; Kroeger, Anne K; Bender, Stephan; Kunz, Cornelia Ursula; Kieser, Meinhard

    2013-01-07

    Group-based social skills training (SST) has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD). To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA-FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS) compared to treatment as usual (TAU). It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. The SOSTA - net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. ISRCTN94863788--SOSTA--net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

  13. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder - study protocol of the randomised, multi-centre controlled SOSTA - net trial

    Directory of Open Access Journals (Sweden)

    Freitag Christine M

    2013-01-01

    Full Text Available Abstract Background Group-based social skills training (SST has repeatedly been recommended as treatment of choice in high-functioning autism spectrum disorder (HFASD. To date, no sufficiently powered randomised controlled trial has been performed to establish efficacy and safety of SST in children and adolescents with HFASD. In this randomised, multi-centre, controlled trial with 220 children and adolescents with HFASD it is hypothesized, that add-on group-based SST using the 12 weeks manualised SOSTA–FRA program will result in improved social responsiveness (measured by the parent rated social responsiveness scale, SRS compared to treatment as usual (TAU. It is further expected, that parent and self reported anxiety and depressive symptoms will decline and pro-social behaviour will increase in the treatment group. A neurophysiological study in the Frankfurt HFASD subgroup will be performed pre- and post treatment to assess changes in neural function induced by SST versus TAU. Methods/design The SOSTA – net trial is designed as a prospective, randomised, multi-centre, controlled trial with two parallel groups. The primary outcome is change in SRS score directly after the intervention and at 3 months follow-up. Several secondary outcome measures are also obtained. The target sample consists of 220 individuals with ASD, included at the six study centres. Discussion This study is currently one of the largest trials on SST in children and adolescents with HFASD worldwide. Compared to recent randomised controlled studies, our study shows several advantages with regard to in- and exclusion criteria, study methods, and the therapeutic approach chosen, which can be easily implemented in non-university-based clinical settings. Trial registration ISRCTN94863788 – SOSTA – net: Group-based social skills training in children and adolescents with high functioning autism spectrum disorder.

  14. Tablet computers versus optical aids to support education and learning in children and young people with low vision: protocol for a pilot randomised controlled trial, CREATE (Children Reading with Electronic Assistance To Educate).

    Science.gov (United States)

    Crossland, Michael D; Thomas, Rachel; Unwin, Hilary; Bharani, Seelam; Gothwal, Vijaya K; Quartilho, Ana; Bunce, Catey; Dahlmann-Noor, Annegret

    2017-06-21

    Low vision and blindness adversely affect education and independence of children and young people. New 'assistive' technologies such as tablet computers can display text in enlarged font, read text out to the user, allow speech input and conversion into typed text, offer document and spreadsheet processing and give access to wide sources of information such as the internet. Research on these devices in low vision has been limited to case series. We will carry out a pilot randomised controlled trial (RCT) to assess the feasibility of a full RCT of assistive technologies for children/young people with low vision. We will recruit 40 students age 10-18 years in India and the UK, whom we will randomise 1:1 into two parallel groups. The active intervention will be Apple iPads; the control arm will be the local standard low-vision aid care. Primary outcomes will be acceptance/usage, accessibility of the device and trial feasibility measures (time to recruit children, lost to follow-up). Exploratory outcomes will be validated measures of vision-related quality of life for children/young people as well as validated measures of reading and educational outcomes. In addition, we will carry out semistructured interviews with the participants and their teachers. NRES reference 15/NS/0068; dissemination is planned via healthcare and education sector conferences and publications, as well as via patient support organisations. NCT02798848; IRAS ID 179658, UCL reference 15/0570. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  15. Effectiveness of a low-cost virtual reality system for children with developmental delay: a preliminary randomised single-blind controlled trial.

    Science.gov (United States)

    Salem, Yasser; Gropack, Stacy Jaffee; Coffin, Dale; Godwin, Ellen M

    2012-09-01

    Physical and occupational therapists have started to use the Nintendo Wii™ gaming system with adults and children as part of their regular treatment. Despite the growing use of the Wii and trend towards evidence-based practice, limited evidence is available on the effectiveness of virtual reality using the Wii for children with developmental delay. The purpose of this study was to determine the feasibility and preliminary effectiveness of a low-cost gaming system for young children with developmental delay. Single-blind, randomised controlled trial. Forty children with developmental delay (age 39 to 58 months) who attended a segregated or integrated preschool participated in this study. All children's parents read and signed an informed consent form approved by the institutional review board. Children were assigned at random to an experimental (Wii) group (n=20) or a control group (n=20). Two weekly sessions for 10 weeks using Nintendo Wii Sports™ and Nintendo Wii Fit™, including balance, strength training and aerobics games. Participants were evaluated 1 week before and 1 week after the programme by a blinded investigator. Primary outcomes were gait speed, timed up and go test, single leg stance test, five-times-sit-to-stand test, timed up and down stairs test, 2-minute walk test and grip strength. The Gross Motor Function Measure (GMFM) was used to assess gross motor skills. The two groups were homogenous regarding all parameters at baseline. The Wii training was feasible and enjoyable for those in the experimental group. There were no adverse effects or injuries reported over 267 training sessions. Comparison of groups following the intervention indicated that the experimental group showed significant improvements compared with the control group in single leg stance test {mean difference 1.03 [standard deviation (SD) 1.7], 95% confidence interval (CI) 0.2 to 1.9; P=0.017}, right grip strength [mean difference 1.11 (SD 1.84), 95% CI 0.15 to 2.06; P=0

  16. Improved Speech Following Parent-Delivered Qigong Massage in Young Children with Down Syndrome: A Pilot Randomised Controlled Trial

    Science.gov (United States)

    Silva, Louisa M. T.; Schalock, Mark; Williams, Mary

    2013-01-01

    Qigong massage is an eastern form of massage that can be delivered by western parents to their children with appropriate training and support. It has been shown to improve developmental measures in young children with autism when given daily for five months. A recent trial evaluating its effect on motor development in young children with Down…

  17. The effect of motivational interviewing on oral healthcare knowledge, attitudes and behaviour of parents and caregivers of preschool children: an exploratory cluster randomised controlled study.

    Science.gov (United States)

    Naidu, Rahul; Nunn, June; Irwin, Jennifer D

    2015-09-02

    Motivational Interviewing (MI) has been used across primary healthcare and been shown to be effective in reducing the prevalence of early childhood caries (ECC) in preschool children. This study aimed to compare the effect of MI, in contrast to traditional dental health education (DHE), on oral health knowledge, attitudes, beliefs and behaviours among parents and caregivers of preschool children in Trinidad. The design of this exploratory study included a cluster randomised controlled trial and semi-structured focus groups. Six preschools (79 parents and caregivers) in Eastern Trinidad were randomly assigned to a test or control group (3 preschools in each group). Parents and caregivers in the test-group (n = 25) received a talk on dental health using an MI approach and the control-group (n = 54) received a talk using traditional DHE. Both groups received additional, written dental health information. The MI group also received two telephone call follow-ups as part of the MI protocol. Both groups were given questionnaires before the talks and four months later. Question items included oral health knowledge, beliefs, attitudes, brushing behaviour, oral health self-efficacy, oral health fatalism and a specific instrument to asses 'readiness for change', the Readiness Assessment of Parents Concerning Infant Dental Decay (RAPIDD). Participants in the test-group were also invited to take part in a focus group to share their views on the dental health talk. At four month follow-up, knowledge items on fluoride use, tooth brushing, dietary practice and dental attendance increased in both the test (DHE + MI) and control (DHE) groups ((p oral health fatalism (p parent and caregiver efforts to improve oral health practices for their preschool children. In this exploratory controlled study there was some evidence that using an MI approach when delivering oral health information had a positive effect on parent/ caregiver oral health knowledge, attitudes and behaviours compared

  18. Effect of household-based drinking water chlorination on diarrhoea among children under five in Orissa, India: a double-blind randomised placebo-controlled trial.

    Directory of Open Access Journals (Sweden)

    Sophie Boisson

    2013-08-01

    Full Text Available Boiling, disinfecting, and filtering water within the home can improve the microbiological quality of drinking water among the hundreds of millions of people who rely on unsafe water supplies. However, the impact of these interventions on diarrhoea is unclear. Most studies using open trial designs have reported a protective effect on diarrhoea while blinded studies of household water treatment in low-income settings have found no such effect. However, none of those studies were powered to detect an impact among children under five and participants were followed-up over short periods of time. The aim of this study was to measure the effect of in-home water disinfection on diarrhoea among children under five.We conducted a double-blind randomised controlled trial between November 2010 and December 2011. The study included 2,163 households and 2,986 children under five in rural and urban communities of Orissa, India. The intervention consisted of an intensive promotion campaign and free distribution of sodium dichloroisocyanurate (NaDCC tablets during bi-monthly households visits. An independent evaluation team visited households monthly for one year to collect health data and water samples. The primary outcome was the longitudinal prevalence of diarrhoea (3-day point prevalence among children aged under five. Weight-for-age was also measured at each visit to assess its potential as a proxy marker for diarrhoea. Adherence was monitored each month through caregiver's reports and the presence of residual free chlorine in the child's drinking water at the time of visit. On 20% of the total household visits, children's drinking water was assayed for thermotolerant coliforms (TTC, an indicator of faecal contamination. The primary analysis was on an intention-to-treat basis. Binomial regression with a log link function and robust standard errors was used to compare prevalence of diarrhoea between arms. We used generalised estimating equations to account

  19. Do prebiotics reduce the number of fever episodes in healthy children in their first year of life : a randomised controlled trial

    NARCIS (Netherlands)

    van Stuijvenberg, Margriet; Eisses, Annemieke M.; Gruber, Christoph; Mosca, Fabio; Arslanoglu, Sertac; Chirico, Gaetano; Braegger, Christian P.; Riedler, Josef; Boehm, Gunther; Sauer, Pieter J. J.

    2011-01-01

    The objective of the present study was to assess the effect of adding specific prebiotics to standard formula feeding on the number of fever episodes in the first year of life. In the present randomised, double-blind, placebo-controlled trial in seven centres in five West European countries, 830

  20. Supporting teachers and children in schools: the effectiveness and cost-effectiveness of the Incredible Years teacher classroom management programme in primary school children: a cluster randomised controlled trial, with parallel economic and process evaluations.

    Science.gov (United States)

    Ford, Tamsin; Edwards, Vanessa; Sharkey, Siobhan; Ukoumunne, Obioha C; Byford, Sarah; Norwich, Brahm; Logan, Stuart

    2012-08-30

    Childhood antisocial behaviour has high immediate and long-term costs for society and the individual, particularly in relation to mental health and behaviours that jeopardise health. Managing challenging behaviour is a commonly reported source of stress and burn out among teachers, ultimately resulting in a substantial number leaving the profession. Interventions to improve parenting do not transfer easily to classroom-based problems and the most vulnerable parents may not be easily able to access them. Honing teachers' skills in proactive behaviour management and the promotion of socio-emotional regulation, therefore, has the potential to improve both child and teacher mental health and well-being and the advantage that it might potentially benefit all the children subsequently taught by any teacher that accesses the training. Cluster randomised controlled trial (RCT) of the Incredible Years teacher classroom management (TCM) course with combined economic and process evaluations.One teacher of children aged 4-9 years, from 80 schools in the South West Peninsula will be randomised to attend the TCM (intervention arm) or to "teach as normal" (control arm). The primary outcome measure will be the total difficulties score from the Strengths and Difficulties Questionnaire (SDQ) completed by the current class teachers prior to randomisation, and at 9, 18 and 30 months follow-up, supplemented by parent SDQs. Secondary measures include academic attainment (teacher report supplemented by direct measurement in a sub-sample), children's enjoyment of school, and teacher reports of their professional self-efficacy, and levels of burn out and stress, supplemented by structured observations of teachers classroom management skills in a subsample. Cost data for the economic evaluation will be based on parental reports of services accessed. Cost-effectiveness, using the SDQ as the measure of effect, will be examined over the period of the RCT and over the longer term using decision

  1. Developing and piloting a peer mentoring intervention to reduce teenage pregnancy in looked-after children and care leavers: an exploratory randomised controlled trial.

    Science.gov (United States)

    Mezey, Gillian; Meyer, Deborah; Robinson, Fiona; Bonell, Chris; Campbell, Rona; Gillard, Steve; Jordan, Peter; Mantovani, Nadia; Wellings, Kaye; White, Sarah

    2015-10-01

    Looked-after children (LAC) are at greater risk of teenage pregnancy than non-LAC, which is associated with adverse health and social consequences. Existing interventions have failed to reduce rates of teenage pregnancy in LAC. Peer mentoring is proposed as a means of addressing many of the factors associated with the increased risk of teenage pregnancy in this group. To develop a peer mentoring intervention to reduce teenage pregnancy in LAC. Phase I and II randomised controlled trial of a peer mentoring intervention for LAC; scoping exercise and literature search; national surveys of social care professionals and LAC; and focus groups and interviews with social care professionals, mentors and mentees. Three local authorities (LAs) in England. LAC aged 14-18 years (mentees/care as usual) and 19-25 years (mentors). Recruitment and training of mentors; randomisation and matching of mentors to mentees; and 1-year individual peer mentoring. pregnancy in LAC aged 14-18 years. sexual attitudes, behaviour and knowledge; psychological health; help-seeking behaviour; locus of control; and attachment style. A health economic evaluation was also carried out. In total, 54% of target recruitment was reached for the exploratory trial and 13 out of 20 mentors (65%) and 19 out of 30 LAC aged 14-18 years (63%) (recruited during Phases I and II) were retained in the research. The training programme was acceptable and could be manualised and replicated. Recruitment and retention difficulties were attributed to systemic problems and LA lack of research infrastructure and lack of additional funding to support and sustain such an intervention. Mentees appeared to value the intervention but had difficulty in meeting weekly as required. Only one in four of the relationships continued for the full year. A future Phase III trial would require the intervention to be modified to include provision of group and individual peer mentoring; internal management of the project, with support from an

  2. Effectiveness and cost-effectiveness of a brief school-based group programme for parents of children at risk of ADHD: a cluster randomised controlled trial.

    Science.gov (United States)

    Sayal, K; Taylor, J A; Valentine, A; Guo, B; Sampson, C J; Sellman, E; James, M; Hollis, C; Daley, D

    2016-07-01

    National Institute for Health and Care Excellence guidelines recommend a stepped care approach for the identification and management of children with, or at risk of, attention-deficit/hyperactivity disorder (ADHD). We investigated the effectiveness, cost-effectiveness and acceptability of a group parenting intervention programme (+/- a teacher session) for children at risk of ADHD. In a three-arm cluster randomised controlled trial, 12 primary schools were randomly assigned to control, parent-only and combined (parent + teacher) intervention arms. Eligible children had high levels of parent-rated hyperactivity/inattention (n = 199). At 6 month follow-up, the primary outcome measure was the parent-completed Conners' Rating Scale - Revised (ADHD index). Secondary outcomes included the Conners' sub-scales (hyperactivity, cognitive problems/inattention and oppositional behaviour), the teacher-completed Conners' Rating Scale - Revised, child health-related quality of life, parental burden and parental mental health. The cost-effectiveness analyses reflected a health and personal social services perspective. ISRCTN87634685. Follow-up data were obtained from 76 parents and 169 teachers. There was no effect of the parent-only (mean difference = -1.1, 95% CI -5.1,2.9; p = 0.57) or combined interventions (mean difference = -2.1, 95% CI -6.4,2.1; p = 0.31) on the ADHD index. The combined intervention was associated with reduced parent-reported hyperactivity symptoms (mean difference = -5.3; 95% CI -10.5,-0.01; p = 0.05) and the parent-only intervention with improved parental mental health (mean difference = -1.9; 95% CI -3.2,-0.5; p = 0.009). The incremental costs of the parent-only and the combined interventions were £73 and £123, respectively. Above a willingness-to-pay of £31 per one-point improvement in the ADHD index, the parent-only programme had the highest probability of cost-effectiveness. Participants found the

  3. A multicentre randomised controlled trial and economic evaluation of ion-exchange water softeners for the treatment of eczema in children: the Softened Water Eczema Trial (SWET).

    Science.gov (United States)

    Thomas, K S; Koller, K; Dean, T; O'Leary, C J; Sach, T H; Frost, A; Pallett, I; Crook, A M; Meredith, S; Nunn, A J; Burrows, N; Pollock, I; Graham-Brown, R; O'Toole, E; Potter, D; Williams, H C

    2011-02-01

    To determine whether installation of an ion-exchange water softener in the home could improve atopic eczema in children and, if so, to establish its likely cost and cost-effectiveness. An observer-blind, parallel-group randomised controlled trial of 12 weeks duration followed by a 4-week observational period. Eczema was assessed by research nurses blinded to intervention at baseline, 4 weeks, 12 weeks and 16 weeks. The primary outcome was analysed as intent-to-treat, using the randomised allocation rather than actual treatment received. A secondary per-protocol analysis excluded participants who failed to receive their allocated treatment and who were deemed to be protocol violators. Secondary and primary care referral centres in England (UK) serving a variety of ethnic and social groups and including children living in both urban and periurban homes. Three hundred and thirty-six children (aged 6 months to 16 years) with moderate/severe atopic eczema, living in homes in England supplied by hard water (≥ 200 mg/l calcium carbonate). Participants were randomised to either installation of an ion-exchange water softener plus usual eczema care (group A) for 12 weeks or usual eczema care alone (group B) for 12 weeks. This was followed by a 4-week observational period, during which water softeners were switched off/removed from group A homes and installed in group B homes. Standard procedure was to soften all water in the home, but to provide mains (hard) water at a faucet-style tap in the kitchen for drinking and cooking. Participants were therefore exposed to softened water for bathing and washing of clothes, but continued to drink mains (hard) water. Usual care was defined as any treatment that the child was currently using in order to control his or her eczema. New treatment regimens used during the trial period were documented. Primary outcome was the difference between group A and group B in mean change in disease severity at 12 weeks compared with baseline, as

  4. a randomised controlled trial oftwo prostaglandin regitnens

    African Journals Online (AJOL)

    Design. A prospective randomised controlled trial. Setting. Department of Obstetrics and Gynae- ... hours after the original administration of either prostaglandin regimen. If abortion had not taken place 36 .... Tygerberg Hospital for permission to publish, and Upjohn. (Pry) Ltd for supplying the Prepidil gel used in the study. 1.

  5. Is the randomised controlled trial the best?

    African Journals Online (AJOL)

    The randomised controlled trial (RCT) is recog nised as the gold standard of research methods, particularly to test efficacy. The primary benefit of the RCT, as everyone knows, is to prevent patient selection bias. And it should also guarantee some rigour of research methodology. It is always prospective. In a nonrandomised ...

  6. Splint: The efficacy of orthotic management in rest to prevent equinus in children with cerebral palsy, a randomised controlled trial

    NARCIS (Netherlands)

    Maas, J.C.; Dallmeijer, A.J.; Huijing, P.A.; Brunstrom-Hernandez, J.E; van Kampen, P.J.; Jaspers, R.T.; Becher, J.G.

    2012-01-01

    Background: Range of motion deficits of the lower extremity occur in about the half of the children with spastic cerebral palsy (CP). Over time, these impairments can cause joint deformities and deviations in the children's gait pattern, leading to limitations in moblity. Preventing a loss of range

  7. Safety and immunogenicity of neonatal pneumococcal conjugate vaccination in Papua New Guinean children: a randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    William S Pomat

    Full Text Available Approximately 826,000 children, mostly young infants, die annually from invasive pneumococcal disease. A 6-10-14-week schedule of pneumococcal conjugate vaccine (PCV is efficacious but neonatal PCV may provide earlier protection and better coverage. We conducted an open randomized controlled trial in Papua New Guinea to compare safety, immunogenicity and priming for memory of 7-valent PCV (PCV7 given in a 0-1-2-month (neonatal schedule with that of the routine 1-2-3-month (infant schedule.We randomized 318 infants at birth to receive PCV7 in the neonatal or infant schedule or no PCV7. All infants received 23-valent pneumococcal polysaccharide vaccine (PPV at age 9 months. Serotype-specific serum IgG for PCV7 (VT serotypes and non-VT serotypes 2, 5 and 7F were measured at birth and 2, 3, 4, 9, 10 and 18 months of age. Primary outcomes were geometric mean concentrations (GMCs and proportions with concentration ≥ 0.35 µg/ml of VT serotype-specific pneumococcal IgG at age 2 months and one month post-PPV.We enrolled 101, 105 and 106 infants, respectively, into neonatal, infant and control groups. Despite high background levels of maternally derived antibody, both PCV7 groups had higher GMCs than controls at age 2 months for serotypes 4 (p<0.001 and 9V (p<0.05 and at age 3 months for all VTs except 6B. GMCs for serotypes 4, 9V, 18C and 19F were significantly higher (p<0.001 at age 2 months in the neonatal (one month post-dose2 PCV7 than in the infant group (one month post-dose1 PCV7. PPV induced significantly higher VT antibody responses in PCV7-primed than unprimed infants, with neonatal and infant groups equivalent. High VT and non-VT antibody concentrations generally persisted to age 18 months.PCV7 is well-tolerated and immunogenic in PNG neonates and young infants and induces immunologic memory to PPV booster at age 9 months with antibody levels maintained to age 18 months.ClinicalTrials.gov NCT00219401.

  8. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services.

    Science.gov (United States)

    Tickle, Martin; Milsom, Keith M; Donaldson, Michael; Killough, Seamus; O'Neill, Ciaran; Crealey, Grainne; Sutton, Matthew; Noble, Solveig; Greer, Margaret; Worthington, Helen V

    2011-10-10

    Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group.The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will be obtained from parental

  9. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    Directory of Open Access Journals (Sweden)

    Noble Solveig

    2011-10-01

    Full Text Available Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education with dental health education alone in young children. Methods/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years, fluoride toothpaste (1,450 ppm F (supplied twice per year, a toothbrush (supplied twice a year or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit. 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs

  10. Protocol for Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial: a randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services

    LENUS (Irish Health Repository)

    Tickle, Martin

    2011-10-10

    Abstract Background Dental caries is a persistent public health problem with little change in the prevalence in young children over the last 20 years. Once a child contracts the disease it has a significant impact on their quality of life. There is good evidence from Cochrane reviews including trials that fluoride varnish and regular use of fluoride toothpaste can prevent caries. The Northern Ireland Caries Prevention in Practice Trial (NIC-PIP) trial will compare the costs and effects of a caries preventive package (fluoride varnish, toothpaste, toothbrush and standardised dental health education) with dental health education alone in young children. Methods\\/Design A randomised controlled trial on children initially aged 2 and 3 years old who are regular attenders at the primary dental care services in Northern Ireland. Children will be recruited and randomised in dental practices. Children will be randomised to the prevention package of both fluoride varnish (twice per year for three years), fluoride toothpaste (1,450 ppm F) (supplied twice per year), a toothbrush (supplied twice a year) or not; both test and control groups receive standardised dental health education delivered by the dentist twice per year. Randomisation will be conducted by the Belfast Trust Clinical Research Support Centre ([CRSC] a Clinical Trials Unit). 1200 participants will be recruited from approximately 40 dental practices. Children will be examined for caries by independent dental examiners at baseline and will be excluded if they have caries. The independent dental examiners will examine the children again at 3 years blinded to study group. The primary end-point is whether the child develops caries (cavitation into dentine) or not over the three years. One secondary outcome is the number of carious surfaces in the primary dentition in children who experience caries. Other secondary outcomes are episodes of pain, extraction of primary teeth, other adverse events and costs which will

  11. Strategies for understanding and reducing the Plasmodium vivax and Plasmodium ovale hypnozoite reservoir in Papua New Guinean children: a randomised placebo-controlled trial and mathematical model.

    Directory of Open Access Journals (Sweden)

    Leanne J Robinson

    2015-10-01

    Full Text Available The undetectable hypnozoite reservoir for relapsing Plasmodium vivax and P. ovale malarias presents a major challenge for malaria control and elimination in endemic countries. This study aims to directly determine the contribution of relapses to the burden of P. vivax and P. ovale infection, illness, and transmission in Papua New Guinean children.From 17 August 2009 to 20 May 2010, 524 children aged 5-10 y from East Sepik Province in Papua New Guinea (PNG participated in a randomised double-blind placebo-controlled trial of blood- plus liver-stage drugs (chloroquine [CQ], 3 d; artemether-lumefantrine [AL], 3 d; and primaquine [PQ], 20 d, 10 mg/kg total dose (261 children or blood-stage drugs only (CQ, 3 d; AL, 3 d; and placebo [PL], 20 d (263 children. Participants, study staff, and investigators were blinded to the treatment allocation. Twenty children were excluded during the treatment phase (PQ arm: 14, PL arm: 6, and 504 were followed actively for 9 mo. During the follow-up time, 18 children (PQ arm: 7, PL arm: 11 were lost to follow-up. Main primary and secondary outcome measures were time to first P. vivax infection (by qPCR, time to first clinical episode, force of infection, gametocyte positivity, and time to first P. ovale infection (by PCR. A basic stochastic transmission model was developed to estimate the potential effect of mass drug administration (MDA for the prevention of recurrent P. vivax infections. Targeting hypnozoites through PQ treatment reduced the risk of having at least one qPCR-detectable P. vivax or P. ovale infection during 8 mo of follow-up (P. vivax: PQ arm 0.63/y versus PL arm 2.62/y, HR = 0.18 [95% CI 0.14, 0.25], p < 0.001; P. ovale: 0.06 versus 0.14, HR = 0.31 [95% CI 0.13, 0.77], p = 0.011 and the risk of having at least one clinical P. vivax episode (HR = 0.25 [95% CI 0.11, 0.61], p = 0.002. PQ also reduced the molecular force of P. vivax blood-stage infection in the first 3 mo of follow-up (PQ arm 1.90/y

  12. Telephone Consultation as a Substitute for Routine Out-patient Face-to-face Consultation for Children With Inflammatory Bowel Disease: Randomised Controlled Trial and Economic Evaluation.

    Science.gov (United States)

    Akobeng, Anthony K; O'Leary, Neil; Vail, Andy; Brown, Nailah; Widiatmoko, Dono; Fagbemi, Andrew; Thomas, Adrian G

    2015-09-01

    Evidence for the use of telephone consultation in childhood inflammatory bowel disease (IBD) is lacking. We aimed to assess the effectiveness and cost consequences of telephone consultation compared with the usual out-patient face-to-face consultation for young people with IBD. We conducted a randomised-controlled trial in Manchester, UK, between July 12, 2010 and June 30, 2013. Young people (aged 8-16 years) with IBD were randomized to receive telephone consultation or face-to-face consultation for 24 months. The primary outcome measure was the paediatric IBD-specific IMPACT quality of life (QOL) score at 12 months. Secondary outcome measures included patient satisfaction with consultations, disease course, anthropometric measures, proportion of consultations attended, duration of consultations, and costs to the UK National Health Service (NHS). Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT02319798. Eighty six patients were randomised to receive either telephone consultation (n = 44) or face-to-face consultation (n = 42). Baseline characteristics of the two groups were well balanced. At 12 months, there was no evidence of difference in QOL scores (estimated treatment effect in favour of the telephone consultation group was 5.7 points, 95% CI - 2.9 to 14.3; p = 0.19). Mean consultation times were 9.8 min (IQR 8 to 12.3) for telephone consultation, and 14.3 min (11.6 to 17.0) for face-to-face consultation with an estimated reduction (95% CI) of 4.3 (2.8 to 5.7) min in consultation times (p consultation had a mean cost of UK£35.41 per patient consultation compared with £51.12 for face-face consultation, difference £15.71 (95% CI 11.8-19.6; P consultation compared with face-to-face consultation with regard to improvements in QOL scores, and telephone consultation reduced consultation time and NHS costs. Telephone consultation is a cost-effective alternative to face-to-face consultation for the

  13. Interventions to improve executive functioning and working memory in school-aged children with AD(H)D: a randomised controlled trial and stepped-care approach.

    Science.gov (United States)

    van der Donk, Marthe L A; Hiemstra-Beernink, Anne-Claire; Tjeenk-Kalff, Ariane C; van der Leij, Aryan V; Lindauer, Ramón J L

    2013-01-11

    Deficits in executive functioning are of great significance in attention-deficit/hyperactivity disorder (ADHD). One of these executive functions, working memory, plays an important role in academic performance and is often seen as the core deficit of this disorder. There are indications that working memory problems and academic performance can be improved by school-oriented interventions but this has not yet been studied systematically. In this study we will determine the short- and long-term effects of a working memory--and an executive function training applied in a school situation for children with AD(H)D, taking individual characteristics, the level of impairment and costs (stepped-care approach) into account. The study consists of two parts: the first part is a randomised controlled trial with school-aged children (8-12 yrs) with AD(H)D. Two groups (each n = 50) will be randomly assigned to a well studied computerized working memory training 'Cogmed', or to the 'Paying attention in class' intervention which is an experimental school-based executive function training. Children will be selected from regular -and special education primary schools in the region of Amsterdam, the Netherlands. The second part of the study will determine which specific characteristics are related to non-response of the 'Paying attention in class' intervention. School-aged children (8-12 yrs) with AD(H)D will follow the experimental school-based executive function training 'Paying attention in class' (n = 175). Academic performance and neurocognitive functioning (primary outcomes) are assessed before, directly after and 6 months after training. Secondary outcome measures are: behaviour in class, behaviour problems and quality of life. So far, there is limited but promising evidence that working memory - and other executive function interventions can improve academic performance. Little is know about the applicability and generalization effects of these interventions in a classroom

  14. Interventions to improve executive functioning and working memory in school-aged children with AD(HD: a randomised controlled trial and stepped-care approach

    Directory of Open Access Journals (Sweden)

    van der Donk Marthe LA

    2013-01-01

    Full Text Available Abstract Background Deficits in executive functioning are of great significance in attention-deficit/hyperactivity disorder (ADHD. One of these executive functions, working memory, plays an important role in academic performance and is often seen as the core deficit of this disorder. There are indications that working memory problems and academic performance can be improved by school-oriented interventions but this has not yet been studied systematically. In this study we will determine the short- and long-term effects of a working memory - and an executive function training applied in a school situation for children with AD(HD, taking individual characteristics, the level of impairment and costs (stepped-care approach into account. Methods/design The study consists of two parts: the first part is a randomised controlled trial with school-aged children (8–12 yrs with AD(HD. Two groups (each n = 50 will be randomly assigned to a well studied computerized working memory training ‘Cogmed’, or to the ‘Paying attention in class’ intervention which is an experimental school-based executive function training. Children will be selected from regular -and special education primary schools in the region of Amsterdam, the Netherlands. The second part of the study will determine which specific characteristics are related to non-response of the ‘Paying attention in class’ intervention. School-aged children (8–12 yrs with AD(HD will follow the experimental school-based executive function training ‘Paying attention in class’ (n = 175. Academic performance and neurocognitive functioning (primary outcomes are assessed before, directly after and 6 months after training. Secondary outcome measures are: behaviour in class, behaviour problems and quality of life. Discussion So far, there is limited but promising evidence that working memory – and other executive function interventions can improve academic performance. Little is know about the

  15. Initial non-operative management of uncomplicated appendicitis in children: a protocol for a multicentre randomised controlled trial (APAC trial)

    NARCIS (Netherlands)

    Knaapen, Max; van der Lee, Johanna H.; Bakx, Roel; The, Sarah-May L.; van Heurn, Ernst W. E.; Heij, Hugo A.; Gorter, Ramon R.; Rippen, H.; Bet, P. M.; Kazemier, G.; Kneepkens, C. M. F.; Wijnen, R.; Offringa, M.; Ahmadi, N.; Bonjer, H. J.; van Rijn, R. R.; Benninga, M. A.; Bemelman, W. A.; Hilarius, D. L.; van Veen, S. A. J. M.; Go, P. M. N. Y. H.; Cense, H. A.; de Vries, A.; Straatman, J.; in ’t Hof, K. H.; van Beek, E. J. A. H.; Bender, M. H. M.; van den Hill, L. C. L.; Bolhuis, H. W.; Treskes, K.; Bijlsma, T. S.; Geubbels, N.; de Blaauw, I.; Botden, S. M. B. I.; Leijdekkers, V. J.; Boonstra, M. C.; Rongen, L. H.; Boerma, E. J. G.; Luyer, M. D. P.; Vugts, G.; Copper, T.; Garssen, F. P.; Hulsker, C.; Visschers, R. G. J.

    2017-01-01

    Introduction Based on epidemiological, immunological and pathology data, the idea that appendicitis is not necessarily a progressive disease is gaining ground. Two types are distinguished: simple and complicated appendicitis. Non-operative treatment (NOT) of children with simple appendicitis has

  16. Supporting teachers and children in schools: the effectiveness and cost-effectiveness of the incredible years teacher classroom management programme in primary school children: a cluster randomised controlled trial, with parallel economic and process evaluations

    Directory of Open Access Journals (Sweden)

    Ford Tamsin

    2012-08-01

    Full Text Available Abstract Background Childhood antisocial behaviour has high immediate and long-term costs for society and the individual, particularly in relation to mental health and behaviours that jeopardise health. Managing challenging behaviour is a commonly reported source of stress and burn out among teachers, ultimately resulting in a substantial number leaving the profession. Interventions to improve parenting do not transfer easily to classroom-based problems and the most vulnerable parents may not be easily able to access them. Honing teachers’ skills in proactive behaviour management and the promotion of socio-emotional regulation, therefore, has the potential to improve both child and teacher mental health and well-being and the advantage that it might potentially benefit all the children subsequently taught by any teacher that accesses the training. Methods/Design Cluster randomised controlled trial (RCT of the Incredible Years teacher classroom management (TCM course with combined economic and process evaluations. One teacher of children aged 4–9 years, from 80 schools in the South West Peninsula will be randomised to attend the TCM (intervention arm or to “teach as normal” (control arm. The primary outcome measure will be the total difficulties score from the Strengths and Difficulties Questionnaire (SDQ completed by the current class teachers prior to randomisation, and at 9, 18 and 30 months follow-up, supplemented by parent SDQs. Secondary measures include academic attainment (teacher report supplemented by direct measurement in a sub-sample, children’s enjoyment of school, and teacher reports of their professional self-efficacy, and levels of burn out and stress, supplemented by structured observations of teachers classroom management skills in a subsample. Cost data for the economic evaluation will be based on parental reports of services accessed. Cost-effectiveness, using the SDQ as the measure of effect, will be examined

  17. Lack of efficacy of Lactobacillus GG in reducing pulmonary exacerbations and hospital admissions in children with cystic fibrosis: A randomised placebo controlled trial.

    Science.gov (United States)

    Bruzzese, Eugenia; Raia, Valeria; Ruberto, Eliana; Scotto, Riccardo; Giannattasio, Antonietta; Bruzzese, Dario; Cavicchi, Maria Cristina; Francalanci, Michela; Colombo, Carla; Faelli, Nadia; Daccò, Valeria; Magazzù, Giuseppe; Costa, Stefano; Lucidi, Vincenzina; Majo, Fabio; Guarino, Alfredo

    2017-11-08

    Intestinal dysbiosis has been described in Cystic Fibrosis (CF) and probiotics have been proposed to restore microbial composition. Aim of the study was to investigate the effects of Lactobacillus rhamnosus GG (LGG) on clinical outcomes in children with cystic fibrosis (CF). A multicentre, randomised double-blind, clinical trial was conducted in children with CF. After 6months of baseline assessment, enrolled children (2 to 16years of age) received Lactobacillus GG (6×10 9 CFU/day) or placebo for 12months. Primary outcomes were proportion of subjects with at least one pulmonary exacerbation and hospitalisation over 12months. Secondary endpoints were total number of exacerbations and hospitalisations, pulmonary function, and nutritional status. Ninety-five patients were enrolled (51/95 female; median age of 103±50months). In a multivariate GEE logistic analysis, the odds of experiencing at least one exacerbation was not significantly different between the two groups, also after adjusting for the presence of different microbial organisms and for the number of pulmonary exacerbations within 6months before randomisation (OR 0.83; 95% CI 0.38 to 1.82, p=0.643). Similarly, LGG supplementation did not significantly affect the odds of hospitalisations (OR 1.67; 95% CI 0.75 to 3.72, p=0.211). No significant difference was found for body mass index and FEV1. LGG supplementation had no effect on respiratory and nutritional outcomes in this large study population of children with CF under stringent randomised clinical trial conditions. Whether earlier interventions, larger doses, or different strains of probiotics may be effective is unknown. Copyright © 2017 European Cystic Fibrosis Society. Published by Elsevier B.V. All rights reserved.

  18. The Efficacy of Xylitol, Xylitol-Probiotic and Fluoride Dentifrices in Plaque Reduction and Gingival Inflammation in Children: A Randomised Controlled Clinical Trial.

    Science.gov (United States)

    Arat Maden, Eda; Altun, Ceyhan; Açikel, Cengizhan

    The present prospective, randomised, placebo-controlled, clinical trial was designed to evaluate the clinical effects of a commercially available dentifrice containing fluoride, xylitol or xylitol-probiotic on the decrease of plaque and gingival inflammation in children between 13 and 15 years of age. Forty-eight adolescents were randomly grouped into three groups of n = 16 each: study group A received xylitol (Xyliwhite) toothpaste; study group B received xylitol-probiotic (Periobiotic) toothpaste; and the control group C received fluoride (Colgate Max Fresh) toothpaste. The subjects were instructed to use the dentifrice determined and a modified Bass brushing technique twice a day for two minutes over a 6-week perioed. Clinical evaluation was performed using a gingival index and a plaque index at baseline and at the end of the 6-week period. From day 0 to 42, reductions in the plaque index were statistically significant in all groups, Colgate Max Fresh, PerioBiotic and Xyliwhite (p-values 0.001, 0.001 and 0.035, respectively), but reductions in the gingival index were statistically significant only in the Colgate Max Fresh and PerioBiotic groups (both with p = 0.001), not in the Xyliwhite group (p = 0.116). PerioBiotic toothpaste was found to be better than Xyliwhite and Colgate Max Fresh toothpastes at reducing plaque and gingival scores. However, statistically significant differences with PerioBiotic and Colgate Max Fresh toothpaste were not observed. It was concluded that PerioBiotic was an all-round dentifrice that produced a significant reduction in both gingivitis and plaque.

  19. Transnasal humidified rapid insufflation ventilatory exchange for oxygenation of children during apnoea: a prospective randomised controlled trial.

    Science.gov (United States)

    Riva, T; Pedersen, T H; Seiler, S; Kasper, N; Theiler, L; Greif, R; Kleine-Brueggeney, M

    2018-03-01

    Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) comprises the administration of heated, humidified, and blended air/oxygen mixtures via nasal cannula at rates of ≥2 litres kg -1  min -1 . The aim of this randomized controlled study was to evaluate the length of the safe apnoea time using THRIVE with two different oxygen concentrations (100% vs 30% oxygen) compared with standard low-flow 100% oxygen administration. Sixty patients, aged 1-6 yr, weighing 10-20 kg, undergoing general anaesthesia for elective surgery, were randomly allocated to receive one of the following oxygen administration methods during apnoea: 1) low-flow 100% oxygen at 0.2 litres kg -1  min -1 ; 2) THRIVE 100% oxygen at 2 litres kg -1  min -1 ; and 3) THRIVE 30% oxygen at 2 litres kg -1  min -1 . Primary outcome was time to desaturation to 95%. Termination criteria included SpO 2 decreased to 95%, transcutaneous CO 2 increased to 65 mmHg, or apnoea time of 10 min. The median (interquartile range) [range] apnoea time was 6.9 (5.7-7.8) [2.8-10.0] min for low-flow 100% oxygen, 7.6 (6.2-9.1) [5.2-10.0] min for THRIVE 100% oxygen, and 3.0 (2.4-3.7) [0.2-5.3] min for THRIVE 30% oxygen. No significant difference was detected between apnoea times with low-flow and THRIVE 100% oxygen administration (P=0.15). THRIVE with 30% oxygen demonstrated significantly shorter apnoea times (Prate of transcutaneous CO 2 increase was 0.57 (0.49-0.63) [0.29-8.92] kPa min -1 without differences between the 3 groups (P=0.25). High-flow 100% oxygen (2 litres kg -1  min -1 ) administered via nasal cannulas did not extend the safe apnoea time for children weighing 10-20 kg compared with low-flow nasal cannula oxygen (0.2 litres kg -1  min -1 ). No ventilatory effect was observed with THRIVE at 2.0 litres kg -1  min -1 . NCT02979067. Copyright © 2017 British Journal of Anaesthesia. Published by Elsevier Ltd. All rights reserved.

  20. The Children and Parents in Focus project : a population-based cluster-randomised controlled trial to prevent behavioural and emotional problems in children.

    OpenAIRE

    Salari, Raziye; Fabian, Helena; Prinz, Ron; Lucas, Steven; Feldman, Inna; Fairchild, Amanda; Sarkadi, Anna

    2013-01-01

    BACKGROUND: There is large body of knowledge to support the importance of early interventions to improve child health and development. Nonetheless, it is important to identify cost-effective blends of preventive interventions with adequate coverage and feasible delivery modes. The aim of the Children and Parents in Focus trial is to compare two levels of parenting programme intensity and rate of exposure, with a control condition to address impact and cost-effectiveness of a universally offer...

  1. A qualitative process evaluation of a randomised controlled trial of a parenting intervention in community (school) settings for children at risk of attention deficit hyperactivity disorder (ADHD).

    Science.gov (United States)

    Taylor, John A; Valentine, Althea Z; Sellman, Edward; Bransby-Adams, Kate; Daley, David; Sayal, Kapil

    2015-11-17

    Interventions for parents of children experiencing emotional and/or behavioural difficulties can help to improve their children's health, educational and social outcomes. However, the desirability and acceptability of screening and offering such interventions for attention-deficit hyperactivity disorder (ADHD)-type problems are currently unclear. This article is a qualitative process evaluation of a pragmatic cluster randomised controlled trial (Trial registration: ISRCTN87634685; reported elsewhere) to assess the feasibility and acceptability of a school-based parenting intervention programme for parents and teachers of children with high levels of ADHD symptoms. Parents (n = 22) and teaching staff (n = 29) took part in semi-structured group or individual interviews, either by telephone or face-to-face, following the main trial. Interviews were digitally-recorded, transcribed verbatim and subjected to thematic analysis. The parenting intervention was acceptable to parents and teachers, and they were enthusiastic about the need for parenting groups in the school environment and stressed the importance of parent-school collaboration. Parents generally stated a preference for universal recruitment approaches to such programmes whilst teachers described the need to target specific parents. Most parents who took part in the parenting intervention described it favourably and many saw benefits, at least in the short-term. Parents differed in their preferred group size, with some desiring one-to-one sessions and others favouring a larger group. Non-attending parents reported barriers to attendance such as fear of attending in a group, previous use of the programme, work and other commitments. Suggestions to improve the programme included: clearer communication; offering booster sessions; and greater collaboration with teachers. It is feasible to deliver parenting intervention programmes within or near schools. The intervention was acceptable to the majority of

  2. A randomised controlled trial to measure the effects and costs of a dental caries prevention regime for young children attending primary care dental services: the Northern Ireland Caries Prevention In Practice (NIC-PIP) trial.

    Science.gov (United States)

    Tickle, Martin; O'Neill, Ciaran; Donaldson, Michael; Birch, Stephen; Noble, Solveig; Killough, Seamus; Murphy, Lynn; Greer, Margaret; Brodison, Julie; Verghis, Rejina; Worthington, Helen V

    2016-09-01

    Dental caries is the most common disease of childhood. The NHS guidelines promote preventative care in dental practices, particularly for young children. However, the cost-effectiveness of this policy has not been established. To measure the effects and costs of a composite fluoride intervention designed to prevent caries in young children attending dental services. The study was a two-arm, parallel-group, randomised controlled trial, with an allocation ratio of 1 : 1. Randomisation was by clinical trials unit, using randomised permuted blocks. Children/families were not blinded; however, outcome assessment was blinded to group assessment. The study took place in 22 NHS dental practices in Northern Ireland, UK. The study participants were children aged 2-3 years, who were caries free at baseline. The intervention was composite in nature, comprising a varnish containing 22,600 parts per million (p.p.m.) fluoride, a toothbrush and a 50-ml tube of toothpaste containing 1450 p.p.m. fluoride; plus standardised, evidence-based prevention advice provided at 6-monthly intervals over 3 years. The control group received the prevention advice alone. The primary outcome measure was conversion from caries-free to caries-active states. Secondary outcome measures were the number of decayed, missing or filled tooth surfaces in primary dentition (dmfs) in caries-active children, the number of episodes of pain, the number of extracted teeth and the costs of care. Adverse reactions (ARs) were recorded. A total of 1248 children (624 randomised to each group) were recruited and 1096 (549 in the intervention group and 547 in the control group) were included in the final analyses. A total of 87% of the intervention children and 85% of control children attended every 6-month visit (p = 0.77). In total, 187 (34%) children in the intervention group converted to caries active, compared with 213 (39%) in the control group [odds ratio (OR) 0.81, 95% confidence interval (CI) 0.64 to

  3. The Classroom Communication Resource (CCR) intervention to change peer's attitudes towards children who stutter (CWS): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Mallick, Rizwana; Kathard, Harsha; Thabane, Lehana; Pillay, Mershen

    2018-01-17

    Children who stutter (CWS) are at a high-risk of being teased and bullied in primary school because of negative peer attitudes and perceptions towards stuttering. There is little evidence to determine if classroom-based interventions are effective in changing peer attitudes towards stuttering. The primary objective is to determine the effect of the Classroom Communication Resource (CCR) intervention versus usual practice, measured using the Stuttering Resource Outcomes Measure (SROM) 6-months post-intervention among grade 7 students. The secondary objective is to investigate attitude changes towards stuttering among grade participants on the SROM subscales. A cluster randomised controlled trial (RCT) will be conducted with schools as the unit of randomization. Schools will be stratified into quintile groups, and then randomized to receive the CCR intervention or usual practice. Quintile stratification will be conducted in accordance to the Western Cape Department of Education classification of schools according to geographical location, fee per school and allocation of resources and funding. Participants will include primary schools in the lower (second and third) and higher (fourth and fifth) quintiles and children aged 11 years or older in grade 7 will be included. The study will consist of the CCR intervention program or usual practice as a no-CCR control. The CCR is a classroom-based, teacher led intervention tool including a story, role-play and discussion. The grade 7 teachers allocated to the CCR intervention, will be trained and will administer the intervention. The analysis will follow intention-to-treat (ITT) principle and generalized estimating equations (GEE) to compare groups on the global SROM and its subscales to account for possible clustering within schools. The subgroup hypothesis will be tested by adding an interaction term of quintile group x intervention. This study is designed to assess whether the CCR intervention versus usual practice in

  4. Randomised controlled Trial of Improvisational Music therapy's Effectiveness for children with Autism spectrum disorders (TIME-A)

    DEFF Research Database (Denmark)

    Geretsegger, Monika; Holck, Ulla; Gold, Christian

    2012-01-01

    methodological accuracy or the clinical relevance of their approach. The aim of this study is to determine effects of improvisational music therapy on social communication skills of children with autism spectrum disorders. An additional aim of the study is to examine if variation in dose of treatment (i.......e., number of music therapy sessions per week) affects outcome of therapy, and to determine cost-effectiveness. Methods Children aged between 4;0 and 6;11 years who are diagnosed with autism spectrum disorder will be randomly assigned to one of three conditions. Parents of all participants will receive three......Background Previous research has suggested that music therapy may facilitate skills in areas typically affected by autism spectrum disorders such as social interaction and communication. However, generalisability of previous findings has been restricted, as studies were limited in either...

  5. Telephone Consultation as a Substitute for Routine Out-patient Face-to-face Consultation for Children With Inflammatory Bowel Disease: Randomised Controlled Trial and Economic Evaluation

    OpenAIRE

    Akobeng, Anthony K.; O'Leary, Neil; Vail, Andy; Brown, Nailah; Widiatmoko, Dono; Fagbemi, Andrew; Thomas, Adrian G.

    2015-01-01

    Background: Evidence for the use of telephone consultation in childhood inflammatory bowel disease (IBD) is lacking. We aimed to assess the effectiveness and cost consequences of telephone consultation compared with the usual out-patient face-to-face consultation for young people with IBD. Methods: We conducted a randomised-controlled trial in Manchester, UK, between July 12, 2010 and June 30, 2013. Young people (aged 8–16 years) with IBD were randomized to receive telephone consultation o...

  6. Randomised controlled trial of video clips and interactive games to improve vision in children with amblyopia using the I-BiT system

    OpenAIRE

    Herbison, Nicola; MacKeith, Daisy; Vivian, Anthony; Purdy, Jon; Fakis, Apostolos; Ash, Isabel M.; Cobb, Sue V.; Eastgate, Richard M.; Haworth, Stephen M.; Gregson, Richard M.; Foss, Alexander J.E.

    2016-01-01

    Background Traditional treatment of amblyopia involves either wearing a patch or atropine penalisation of the better eye. A new treatment is being developed on the basis of virtual reality technology allowing either DVD footage or computer games which present a common background to both eyes and the foreground, containing the imagery of interest, only to the amblyopic eye. Methods A randomised control trial was performed on patients with amblyopia aged 4?8?years with three arms. All three arm...

  7. Glycaemic index and glycaemic load of breakfast predict cognitive function and mood in school children: a randomised controlled trial.

    Science.gov (United States)

    Micha, Renata; Rogers, Peter J; Nelson, Michael

    2011-11-01

    The macronutrient composition of a breakfast that could facilitate performance after an overnight fast remains unclear. As glucose is the brain's major energy source, the interest is in investigating meals differing in their blood glucose-raising potential. Findings vary due to unaccounted differences in glucoregulation, arousal and cortisol secretion. We investigated the effects of meals differing in glycaemic index (GI) and glycaemic load (GL) on cognition and mood in school children. A total of seventy-four school children were matched and randomly allocated either to the high-GL or low-GL group. Within each GL group, children received high-GI and low-GI breakfasts. Cognitive function (CF) and mood were measured 95-140 min after breakfast. Blood glucose and salivary cortisol were measured at baseline, before and after the CF tests. Repeated-measures ANOVA was used to identify differences in CF, mood, glucose and cortisol levels between the breakfasts. Low-GI meals predicted feeling more alert and happy, and less nervous and thirsty (P breakfast, and high-GI meals increased cortisol levels (P breakfast may help to improve learning, and of potential value in informing government education policies relating to dietary recommendations and implementation concerning breakfast.

  8. Effectiveness of a cough management algorithm at the transitional phase from acute to chronic cough in Australian children aged <15 years: protocol for a randomised controlled trial.

    Science.gov (United States)

    O'Grady, Kerry-Ann F; Grimwood, Keith; Toombs, Maree; Sloots, Theo P; Otim, Michael; Whiley, David; Anderson, Jennie; Rablin, Sheree; Torzillo, Paul J; Buntain, Helen; Connor, Anne; Adsett, Don; Meng Kar, Oon; Chang, Anne B

    2017-03-03

    Acute respiratory infections (ARIs) are leading causes of hospitalisation in Australian children and, if recurrent, are associated with increased risk of chronic pulmonary disorders later in life. Chronic (>4 weeks) cough in children following ARI is associated with decreased quality-of-life scores and increased health and societal economic costs. We will determine whether a validated evidence-based cough algorithm, initiated when chronic cough is first diagnosed after presentation with ARI, improves clinical outcomes in children compared with usual care. A multicentre, parallel group, open-label, randomised controlled trial, nested within a prospective cohort study in Southeast Queensland, Australia, is underway. 750 children aged algorithm or usual care (107 per group). Randomisation is stratified by reason for presentation, site and total cough duration at day 28 (Ethics Committees have approved the study. The study will inform best-practice management of cough in children. ACTRN12615000132549. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  9. Physical activity stimulation program for children with cerebral palsy did not improve physical activity: a randomised trial

    NARCIS (Netherlands)

    van Wely, L.; Balemans, A.C.J.; Becher, J.G.; Dallmeijer, A.J.

    2014-01-01

    Question: In children with cerebral palsy, does a 6-month physical activity stimulation program improve physical activity, mobility capacity, fitness, fatigue and attitude towards sports more than usual paediatric physiotherapy? Design: Multicentre randomised controlled trial with concealed

  10. The effects of Nordic school meals on concentration and school performance in 8- to 11-year-old children in the OPUS School Meal Study: a cluster-randomised, controlled, cross-over trial

    DEFF Research Database (Denmark)

    Sørensen, Louise B.; Dyssegaard, Camilla B.; Damsgaard, Camilla T.

    2015-01-01

    . The OPUS (Optimal well-being, development and health for Danish children through a healthy New Nordic Diet) School Meal Study was a cluster-randomised, controlled, cross-over trial comparing a healthy school meal programme with the usual packed lunch from home (control) each for 3 months (NCT 01457794......It is widely assumed that nutrition can improve school performance in children; however, evidence remains limited and inconclusive. In the present study, we investigated whether serving healthy school meals influenced concentration and school performance of 8- to 11-year-old Danish children...... than reading speed. There was no effect on overall math performance or outcomes from the LRS. In conclusion, school meals did not affect CP, but improved reading performance, which is a complex cognitive activity that involves inference, and increased errors related to impulsivity and inattention...

  11. A randomised controlled trial evaluating IGF1 titration in contrast to current GH dosing strategies in children born small for gestational age

    DEFF Research Database (Denmark)

    Jensen, Rikke Beck; Thankamony, Ajay; O'Connell, Susan M

    2014-01-01

    BACKGROUND: Short children born small for gestational age (SGA) are treated with a GH dose based on body size, but treatment may lead to high levels of IGF1. The objective was to evaluate IGF1 titration of GH dose in contrast to current dosing strategies. METHODS: In the North European Small......-for-Gestational-Age Study (NESGAS), 92 short pre-pubertal children born SGA were randomised after 1 year of high-dose GH treatment (67 μg/kg per day) to three different regimens: high dose (67 μg/kg per day), low dose (35 μg/kg per day) or IGF1 titration. RESULTS: The average dose during the second year of the randomised...... trial did not differ between the IGF1 titration group (38 μg/kg per day, s.d. 0.019) and the low-dose group (35 μg/kg per day, s.d. 0.002; P=0.46), but there was a wide variation in the IGF1 titration group (range 10-80 μg/kg per day). The IGF1 titration group had significantly lower height gain (0...

  12. Oral steroids for the resolution of otitis media with effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Waldron, Cherry-Ann; Thomas-Jones, Emma; Cannings-John, Rebecca; Hood, Kerenza; Powell, Colin; Roberts, Amanda; Tomkinson, Alun; Fitzsimmons, Deborah; Gal, Micaela; Harris, Debbie; Shepherd, Victoria; Butler, Christopher C; Francis, Nicholas

    2016-03-01

    Otitis media with effusion (OME) is an accumulation of fluid in the middle ear affecting about 80 % of children by the age of 4 years. While OME usually resolves spontaneously, it can affect speech, behaviour and development. Children with persistent hearing loss associated with OME are usually offered hearing aids or insertion of ventilation tubes through the tympanic membrane. Oral steroids may be a safe and effective treatment for OME, which could be delivered in primary care. Treatment with oral steroids has the potential to benefit large numbers of children and reduce the burden of care on them and on health services. However, previous trials have either been too small with too short a follow-up period, or of too poor quality to give a definite answer. The aim of the Oral Steroids for the Resolution of Otitis Media with Effusion in Children (OSTRICH) trial is to determine if a short course of oral steroids improves the hearing of children with OME in the short and longer term. A total of 380 participants (children of 2 to 8 years of age) are recruited from Hospital Ear, Nose and Throat departments in Wales and England. A trained clinician seeks informed consent from parents of children with symptoms for at least 3 months that are attributable to OME and with confirmed bilateral hearing loss at study entry. Participants are randomised to a course of oral steroid or a matched placebo for 1 week. Outcomes include audiometry, tympanometry and otoscopy assessments; symptoms; adverse effects; functional health status; quality of life; resource use; and cost effectiveness. Participants are followed up at 5 weeks, and at 6 and 12 months after the day of randomisation. The primary outcome is audiometry-confirmed satisfactory hearing at 5 weeks. An important evidence gap exists regarding the clinical and cost effectiveness of short courses of oral steroid treatment for OME. Identifying an effective, safe, nonsurgical intervention for OME in children for use in primary

  13. Parent-mediated social communication therapy for young children with autism (PACT): long-term follow-up of a randomised controlled trial.

    Science.gov (United States)

    Pickles, Andrew; Le Couteur, Ann; Leadbitter, Kathy; Salomone, Erica; Cole-Fletcher, Rachel; Tobin, Hannah; Gammer, Isobel; Lowry, Jessica; Vamvakas, George; Byford, Sarah; Aldred, Catherine; Slonims, Vicky; McConachie, Helen; Howlin, Patricia; Parr, Jeremy R; Charman, Tony; Green, Jonathan

    2016-11-19

    It is not known whether early intervention can improve long-term autism symptom outcomes. We aimed to follow-up the Preschool Autism Communication Trial (PACT), to investigate whether the PACT intervention had a long-term effect on autism symptoms and continued effects on parent and child social interaction. PACT was a randomised controlled trial of a parent-mediated social communication intervention for children aged 2-4 years with core autism. Follow-up ascertainment was done at three specialised clinical services centres in the UK (London, Manchester, and Newcastle) at a median of 5·75 years (IQR 5·42-5·92) from the original trial endpoint. The main blinded outcomes were the comparative severity score (CSS) from the Autism Diagnostic Observation Schedule (ADOS), the Dyadic Communication Assessment Measure (DCMA) of the proportion of child initiatiations when interacting with the parent, and an expressive-receptive language composite. All analyses followed the intention-to-treat principle. PACT is registered with the ISRCTN registry, number ISRCTN58133827. 121 (80%) of the 152 trial participants (59 [77%] of 77 assigned to PACT intervention vs 62 [83%] of 75 assigned to treatment as usual) were traced and consented to be assessed between July, 2013, and September, 2014. Mean age at follow-up was 10·5 years (SD 0·8). Group difference in favour of the PACT intervention based on ADOS CSS of log-odds effect size (ES) was 0·64 (95% CI 0·07 to 1·20) at treatment endpoint and ES 0·70 (95% CI -0·05 to 1·47) at follow-up, giving an overall reduction in symptom severity over the course of the whole trial and follow-up period (ES 0·55, 95% CI 0·14 to 0·91, p=0·004). Group difference in DCMA child initiations at follow-up showed a Cohen's d ES of 0·29 (95% CI -0.02 to 0.57) and was significant over the course of the study (ES 0·33, 95% CI 0·11 to 0·57, p=0·004). There were no group differences in the language composite at follow-up (ES 0·15, 95% CI -0

  14. Study Protocol Effect of the consumption of a fermented dairy product containing Bifidobacterium lactis DN-173 010 on constipation in childhood: a multicentre randomised controlled trial (NTRTC: 1571)

    NARCIS (Netherlands)

    Tabbers, Merit M.; Chmielewska, Ania; Roseboom, Maaike G.; Boudet, Claire; Perrin, Catherine; Szajewska, Hania; Benninga, Marc A.

    2009-01-01

    ABSTRACT: BACKGROUND: Constipation is a frustrating symptom affecting 3% of children worldwide. Randomised controlled trials show that both polyethylene glycol and lactulose are effective in increasing defecation frequency in children with constipation. However, in 30-50%, these children reported

  15. Randomised controlled trials: important but overrated?

    LENUS (Irish Health Repository)

    Boylan, J F

    2012-02-01

    Practising physicians individualise treatments, hoping to achieve optimal outcomes by tackling relevant patient variables. The randomised controlled trial (RCT) is universally accepted as the best means of comparison. Yet doctors sometimes wonder if particular patients might benefit more from treatments that fared worse in the RCT comparisons. Such clinicians may even feel ostracised by their peers for stepping outside treatments based on RCTs and guidelines. Are RCTs the only acceptable evaluations of how patient care can be assessed and delivered? In this controversy we explore the interpretation of RCT data for practising clinicians facing individualised patient choices. First, critical care anaesthetists John Boylan and Brian Kavanagh emphasise the dangers of bias and show how Bayesian approaches utilise prior probabilities to improve posterior (combined) probability estimates. Secondly, Jane Armitage, of the Clinical Trial Service Unit in Oxford, argues why RCTs remain essential and explores how the quality of randomisation can be improved through systematic reviews and by avoiding selective reporting.

  16. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Uganda

    Science.gov (United States)

    van der Kam, Saskia; Roll, Stephanie; Swarthout, Todd; Edyegu-Otelu, Grace; Matsumoto, Akiko; Kasujja, Francis Xavier; Casademont, Cristian; Shanks, Leslie; Salse-Ubach, Nuria

    2016-01-01

    Background Globally, Médecins Sans Frontières (MSF) treats more than 300,000 severely malnourished children annually. Malnutrition is not only caused by lack of food but also by illnesses and by poor infant and child feeding practices. Breaking the vicious cycle of illness and malnutrition by providing ill children with nutritional supplementation is a potentially powerful strategy for preventing malnutrition that has not been adequately investigated. Therefore, MSF investigated whether incidence of malnutrition among ill children malnutrition rate between 8.4% and 11.5% of which 2% to 3% severe malnutrition, more than half (58%) of the population in the district of Kaabong is considered food insecure. Methods and Findings We investigated the effect of two types of nutritional supplementation on the incidence of malnutrition in ill children presenting at outpatient clinics during March 2011 to April 2012 in Kaabong, Karamoja region, Uganda, a resource-poor region where malnutrition is a chronic problem for its seminomadic population. A three-armed, partially-blinded, randomised controlled trial was conducted in children diagnosed with malaria, diarrhoea, or lower respiratory tract infection. Non-malnourished children aged 6 to 59 mo were randomised to one of three arms: one sachet/d of ready-to-use therapeutic food (RUTF), two sachets/d of micronutrient powder (MNP), or no supplement (control) for 14 d for each illness over 6 mo. The primary outcome was the incidence of first negative nutritional outcome (NNO) during the 6 mo follow-up. NNO was a study-specific measure used to indicate progression to moderate or severe acute malnutrition; it was defined as weight-for-height z-score malnutrition in eastern Uganda. The low incidence of malnutrition in this population may warrant a more targeted intervention to improve cost effectiveness. Trial Registration clinicaltrials.gov NCT01497236 PMID:26859481

  17. Is hydrotherapy cost-effective? A randomised controlled trial of combined hydrotherapy programmes compared with physiotherapy land techniques in children with juvenile idiopathic arthritis.

    Science.gov (United States)

    Epps, H; Ginnelly, L; Utley, M; Southwood, T; Gallivan, S; Sculpher, M; Woo, P

    2005-10-01

    To compare the effects of combined hydrotherapy and land-based physiotherapy (combined) with land-based physiotherapy only (land) on cost, health-related quality of life (HRQoL) and outcome of disease in children with juvenile idiopathic arthritis (JIA). Also to determine the cost-effectiveness of combined hydrotherapy and land-based physiotherapy in JIA. A multicentre randomised controlled, partially blinded trial was designed with 100 patients in a control arm receiving land-based physiotherapy only (land group) and 100 patients in an intervention arm receiving a combination of hydrotherapy and land-based physiotherapy (combined group). Three tertiary centres in the UK. Patients aged 4-19 years diagnosed more than 3 months with idiopathic arthritides, onset before their 16th birthday, stable on medication with at least one active joint. Patients in the combined and land groups received 16 1-hour treatment sessions over 2 weeks followed by local physiotherapy attendances for 2 months. Disease improvement defined as a decrease of > or =30% in any three of six core set variables without there being a 30% increase in more than one of the remaining three variables was used as the primary outcome measure and assessed at 2 months following completion of intervention. Health services resource use (in- and outpatient care, GP visits, drugs, interventions, and investigations) and productivity costs (parents' time away from paid work) were collected at 6 months follow-up. HRQoL was measured at baseline and 2 and 6 months following intervention using the EQ-5D, and quality-adjusted life-years (QALYs) were calculated. Secondary outcome measures at 2 and 6 months included cardiovascular fitness, pain, isometric muscle strength and patient satisfaction. Seventy-eight patients were recruited into the trial and received treatment. Two months after intervention 47% patients in the combined group and 61% patients in the land group had improved disease with 11 and 5% with worsened

  18. The impact of active stakeholder involvement on recruitment, retention and engagement of schools, children and their families in the cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP): a school-based intervention to prevent obesity.

    Science.gov (United States)

    Lloyd, J; McHugh, C; Minton, J; Eke, H; Wyatt, K

    2017-08-14

    Recruitment and retention of participants is crucial for statistical power and internal and external validity and participant engagement is essential for behaviour change. However, many school-based interventions focus on programme content rather than the building of supportive relationships with all participants and tend to employ specific standalone strategies, such as incentives, to improve retention. We believe that actively involving stakeholders in both intervention and trial design improves recruitment and retention and increases the chances of creating an effective intervention. The Healthy Lifestyles Programme, HeLP (an obesity prevention programme for children 9-10 years old) was developed using intervention mapping and involved extensive stakeholder involvement in both the design of the trial and the intervention to ensure that: (i) delivery methods were suitably engaging, (ii) deliverers had the necessary skills and qualities to build relationships and (iii) the intervention dovetailed with the National Curriculum. HeLP was a year-long intervention consisting of 4 multi-component phases using a range of delivery methods. We recruited 1324 children from 32 schools from the South West of England to a cluster-randomised controlled trial to determine the effectiveness of HeLP in preventing obesity. The primary outcome was change in body mass index standard deviation score (BMI SDS) at 24 months post randomisation. Secondary outcomes included additional anthropometric and behavioural (physical activity and diet) measures at 18 and 24 months. Anthropometric and behavioural measures were taken in 99%, 96% and 94% of children at baseline, 18 and 24 months, respectively, with no differential follow up between the control and intervention groups at each time point. All children participated in the programme and 92% of children and 77% of parents across the socio-economic spectrum were considered to have actively engaged with HeLP. We attribute our excellent

  19. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Uganda.

    Science.gov (United States)

    van der Kam, Saskia; Roll, Stephanie; Swarthout, Todd; Edyegu-Otelu, Grace; Matsumoto, Akiko; Kasujja, Francis Xavier; Casademont, Cristian; Shanks, Leslie; Salse-Ubach, Nuria

    2016-02-01

    Globally, Médecins Sans Frontières (MSF) treats more than 300,000 severely malnourished children annually. Malnutrition is not only caused by lack of food but also by illnesses and by poor infant and child feeding practices. Breaking the vicious cycle of illness and malnutrition by providing ill children with nutritional supplementation is a potentially powerful strategy for preventing malnutrition that has not been adequately investigated. Therefore, MSF investigated whether incidence of malnutrition among ill children malnutrition rate between 8.4% and 11.5% of which 2% to 3% severe malnutrition, more than half (58%) of the population in the district of Kaabong is considered food insecure. We investigated the effect of two types of nutritional supplementation on the incidence of malnutrition in ill children presenting at outpatient clinics during March 2011 to April 2012 in Kaabong, Karamoja region, Uganda, a resource-poor region where malnutrition is a chronic problem for its seminomadic population. A three-armed, partially-blinded, randomised controlled trial was conducted in children diagnosed with malaria, diarrhoea, or lower respiratory tract infection. Non-malnourished children aged 6 to 59 mo were randomised to one of three arms: one sachet/d of ready-to-use therapeutic food (RUTF), two sachets/d of micronutrient powder (MNP), or no supplement (control) for 14 d for each illness over 6 mo. The primary outcome was the incidence of first negative nutritional outcome (NNO) during the 6 mo follow-up. NNO was a study-specific measure used to indicate progression to moderate or severe acute malnutrition; it was defined as weight-for-height z-score children who died in the RUTF, MNP, and control groups were 0%, 0.8%, and 0.4%. The findings apply to ill but not malnourished children and cannot be generalised to a general population including children who are not necessarily ill or who are already malnourished. A 2-wk nutrition supplementation programme with RUTF

  20. Modified constraint-induced movement therapy or bimanual occupational therapy following injection of Botulinum toxin-A to improve bimanual performance in young children with hemiplegic cerebral palsy: a randomised controlled trial methods paper

    Directory of Open Access Journals (Sweden)

    Imms Christine

    2010-07-01

    Full Text Available Abstract Background Use of Botulinum toxin-A (BoNT-A for treatment of upper limb spasticity in children with cerebral palsy has become routine clinical practice in many paediatric treatment centres worldwide. There is now high-level evidence that upper limb BoNT-A injection, in combination with occupational therapy, improves outcomes in children with cerebral palsy at both the body function/structure and activity level domains of the International Classification of Functioning, Disability and Health. Investigation is now required to establish what amount and specific type of occupational therapy will further enhance functional outcomes and prolong the beneficial effects of BoNT-A. Methods/Design A randomised, controlled, evaluator blinded, prospective parallel-group trial. Eligible participants were children aged 18 months to 6 years, diagnosed with spastic hemiplegic cerebral palsy and who were able to demonstrate selective motor control of the affected upper limb. Both groups received upper limb injections of BoNT-A. Children were randomised to either the modified constraint-induced movement therapy group (experimental or bimanual occupational therapy group (control. Outcome assessments were undertaken at pre-injection and 1, 3 and 6 months following injection of BoNT-A. The primary outcome measure was the Assisting Hand Assessment. Secondary outcomes included: the Quality of Upper Extremity Skills Test; Pediatric Evaluation of Disability Inventory; Canadian Occupational Performance Measure; Goal Attainment Scaling; Pediatric Motor Activity Log; modified Ashworth Scale and; the modified Tardieu Scale. Discussion The aim of this paper is to describe the methodology of a randomised controlled trial comparing the effects of modified constraint-induced movement therapy (a uni-manual therapy versus bimanual occupational therapy (a bimanual therapy on improving bimanual upper limb performance of children with hemiplegic cerebral palsy following

  1. Cognitive remediation therapy (CRT) in a specialist inpatient eating disorder service for children and adolescents: CAN-CRT study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Giombini, Lucia; Nesbitt, Sophie; Cox, Hannah; Foxall, Anna; Sharia, Teo; Easter, Abigail; Tchanturia, Kate

    2018-03-26

    Research on treatments for young people (YP) with anorexia nervosa (AN) is scarce. Evidence supports the use of cognitive remediation therapy (CRT) to improve central coherence and set-shifting, inefficiencies that can negatively impact on prognosis. The study aims to evaluate the feasibility of individual CRT in an inpatient setting for YP aged 10-18 years with AN and to qualitatively examine YP's and their parents experiences. In a single-centre, pilot, randomised controlled trial, 80 patients aged 10-18 years with AN will be randomly allocated to the immediate or delayed CRT group, in addition to standard treatment. A repeated measures design will be conducted across 3 time points. The data will provide evidence regarding the feasibility of individual CRT in YP with AN, informing directions of further development of CRT. The study is in preparation for a definitive randomised controlled trial. The aim of this manuscript is to describe the study protocol. Copyright © 2018 John Wiley & Sons, Ltd and Eating Disorders Association.

  2. Fusidic acid cream in the treatment of impetigo in general practice: double blind randomised placebo controlled trial

    NARCIS (Netherlands)

    S. Koning (Sander); L.W.A. van Suijlekom-Smit (Lisette); J.L. Nouwen (Jan); C.M. Verduin (Cees); R.M.D. Bernsen (Roos); A.P. Oranje (Arnold); S. Thomas (Siep); J.C. van der Wouden (Hans)

    2002-01-01

    textabstractOBJECTIVE: To test the hypothesis that fusidic acid would not increase the treatment effect of disinfecting with povidone-iodine alone in children with impetigo. DESIGN: Randomised placebo controlled trial. SETTING: General practices in Greater Rotterdam.

  3. ParticiPAte CP: a protocol of a randomised waitlist controlled trial of a motivational and behaviour change therapy intervention to increase physical activity through meaningful participation in children with cerebral palsy.

    Science.gov (United States)

    Reedman, Sarah Elizabeth; Boyd, Roslyn N; Elliott, Catherine; Sakzewski, Leanne

    2017-08-07

    Children with cerebral palsy (CP) participate in leisure-time physical activities (PA) less often, with less intensity and reduced diversity than their typically developing peers. Participation in leisure-time physical activities may be an important source of habitual physical activity (HPA) for children with CP, who as a group have lower levels of HPA and increased sedentary time compared with their typically developing peers. The proposed study aims to compare the efficacy of a participation focused therapy (ParticiPAte CP) to usual care in a pragmatic, randomised waitlist controlled trial. Thirty-six children with CP (18 in each group), classified as Gross Motor Function Classification System levels I to III, aged between 8 and 12 years will be recruited across South East Queensland, Australia. Children will be randomised to receive either ParticiPAte CP or waitlist usual care using concealed allocation. ParticiPAte CP is an individually tailored, goal-directed intervention model of pragmatic participation-focused therapy using a toolbox of evidence-based strategies in the treatment of children with CP. This will include goal-setting; identification of barriers and facilitators to participation goals, strategy formation and planning and communication guided by principles of Self-Determination Theory using strategies of Motivational Interviewing. The intervention comprises 8 weekly sessions of 1 hour duration conducted by a physiotherapist in the child's home or community. ACTRN12615001064594. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  4. Patterns of soil-transmitted helminth infection and impact of four-monthly albendazole treatments in preschool children from semi-urban communities in Nigeria: a double-blind placebo-controlled randomised trial

    Directory of Open Access Journals (Sweden)

    Jackson Andrew L

    2009-02-01

    Full Text Available Abstract Background Children aged between one and five years are particularly vulnerable to disease caused by soil-transmitted helminths (STH. Periodic deworming has been shown to improve growth, micronutrient status (iron and vitamin A, and motor and language development in preschool children and justifies the inclusion of this age group in deworming programmes. Our objectives were to describe the prevalence and intensity of STH infection and to investigate the effectiveness of repeated four-monthly albendazole treatments on STH infection in children aged one to four years. Methods The study was carried out in four semi-urban villages situated near Ile-Ife, Osun State, Nigeria. The study was a double-blind placebo-controlled randomised trial. Children aged one to four years were randomly assigned to receive either albendazole or placebo every four months for 12 months with a follow-up at 14 months. Results The results presented here revealed that 50% of the preschool children in these semi-urban communities were infected by one or more helminths, the most prevalent STH being Ascaris lumbricoides (47.6%. Our study demonstrated that repeated four-monthly anthelminthic treatments with albendazole were successful in reducing prevalence and intensity of A. lumbricoides infections. At the end of the follow-up period, 12% and 43% of the children were infected with A. lumbricoides and mean epg was 117 (S.E. 50 and 1740 (S.E. 291 in the treatment and placebo groups respectively compared to 45% and 45% of the children being infected with Ascaris and mean epg being 1095 (S.E. 237 and 1126 (S.E. 182 in the treatment and placebo group respectively at baseline. Conclusion Results from this study show that the moderate prevalence and low intensity of STH infection in these preschool children necessitates systematic treatment of the children in child health programmes. Trial Registration Current controlled trials ISRCTN44215995.

  5. Randomised trial of biofeedback training for encopresis

    NARCIS (Netherlands)

    van der Plas, R. N.; Benninga, M. A.; Redekop, W. K.; Taminiau, J. A.; Büller, H. A.

    1996-01-01

    To evaluate biofeedback training in children with encopresis and the effect on psychosocial function. Prospective controlled randomised study. PATIENT INTERVENTIONS: A multimodal treatment of six weeks. Children were randomised into two groups. Each group received dietary and toilet advice, enemas,

  6. A randomised placebo-controlled trial of oral and topical antibiotics for children with clinically infected eczema in the community: the ChildRen with Eczema, Antibiotic Management (CREAM) study.

    Science.gov (United States)

    Francis, Nick A; Ridd, Matthew J; Thomas-Jones, Emma; Shepherd, Victoria; Butler, Christopher C; Hood, Kerenza; Huang, Chao; Addison, Katy; Longo, Mirella; Marwick, Charis; Wootton, Mandy; Howe, Robin; Roberts, Amanda; Haq, Mohammed Inaam-ul; Madhok, Vishnu; Sullivan, Frank

    2016-03-01

    Secondary skin infection is common during eczema exacerbations and many children are treated with antibiotics when this is suspected, although there is little high-quality evidence to justify this practice. To determine the clinical effectiveness of oral and topical antibiotics, in addition to standard treatment with emollients and topical corticosteroids, in children with clinically infected eczema. Multicentre randomised, double-blind, placebo-controlled trial. General practices and dermatology clinics in England, Wales and Scotland. Children (aged 3 months to children (36 to oral antibiotic, 37 to topical antibiotic and 40 to placebo), which was fewer than our revised target sample size of 282. A total of 103 (92.0%) children had one or more clinical features suggestive of infection and 78 (69.6%) children had Staphylococcus aureus cultured from a skin swab. Oral and topical antibiotics resulted in a 1.52 [95% confidence interval (CI) -1.35 to 4.40] and 1.49 (95% CI -1.55 to 4.53) increase (worse subjective severity) in POEM score at 2 weeks, relative to placebo and controlling for baseline POEM score. Eczema Area and Severity Index (objective severity) scores were also higher (worse) in the intervention groups, at 0.20 (95% CI -0.12 to 0.52) and 0.42 (95% CI 0.09 to 0.75) for oral and topical antibiotics, respectively, at 2 weeks. Analyses of impact on the family, quality of life, daily symptom scores, and longer-term outcomes were all consistent with the finding of no or limited difference and a trend towards worse outcomes in the intervention groups. Sensitivity analyses, including adjusting for compliance and imputation for missing data, were consistent with the main findings. Our data suggest that oral and topical antibiotics have no effect, or a harmful effect, on subjective eczema severity in children with clinically infected eczema in the community. The CIs around our estimates exclude a meaningful beneficial effect (published minimal clinically

  7. Active children through individual vouchers – evaluation (ACTIVE: protocol for a mixed method randomised control trial to increase physical activity levels in teenagers

    Directory of Open Access Journals (Sweden)

    Michaela James

    2017-07-01

    Full Text Available Abstract Background Many teenagers are insufficiently active despite the health benefits of physical activity (PA. There is strong evidence to show that inactivity and low fitness levels increase the risk of non-communicable diseases such as coronary heart disease (CHD, type 2 diabetes and breast and colon cancers (Lee et al. Lancet 380:219–29, 2012. A major barrier facing adolescents is accessibility (e.g. cost and lack of local facilities. The ACTIVE project aims to tackle this barrier through a multi-faceted intervention, giving teenagers vouchers to spend on activities of their choice and empowering young people to improve their fitness and PA levels. Design ACTIVE is a mixed methods randomised control trial in 7 secondary schools in Swansea, South Wales. Quantitative and qualitative measures including PA (cooper run test (CRT, accelerometery over 7 days, cardiovascular (CV measures (blood pressure, pulse wave analysis and focus groups will be undertaken at 4 separate time points (baseline, 6 months,12 months and follow-up at 18 months. Intervention schools will receive a multi-component intervention involving 12 months of £20 vouchers to spend on physical activities of their choice, a peer mentor scheme and opportunities to attend advocacy meetings. Control schools are encouraged to continue usual practice. The primary aim is to examine the effect of the intervention in improving cardiovascular fitness. Discussion This paper describes the protocol for the ACTIVE randomised control trial, which aims to increase fitness, physical activity and socialisation of teenagers in Swansea, UK via a voucher scheme combined with peer mentoring. Results can contribute to the evidence base on teenage physical activity and, if effective, the intervention has the potential to inform future physical activity interventions and policy. Trial registration ISRCTN75594310 (Assigned 06/03/2017.

  8. Children’s Oxygen Administration Strategies Trial (COAST:  A randomised controlled trial of high flow versus oxygen versus control in African children with severe pneumonia [version 2; referees: 2 approved

    Directory of Open Access Journals (Sweden)

    Kathryn Maitland

    2018-01-01

    Full Text Available Background: In Africa, the clinical syndrome of pneumonia remains the leading cause of morbidity and mortality in children in the post-neonatal period. This represents a significant burden on in-patient services. The targeted use of oxygen and simple, non-invasive methods of respiratory support may be a highly cost-effective means of improving outcome, but the optimal oxygen saturation threshold that results in benefit and the best strategy for delivery are yet to be tested in adequately powered randomised controlled trials. There is, however, an accumulating literature about the harms of oxygen therapy across a range of acute and emergency situations that have stimulated a number of trials investigating permissive hypoxia. Methods: In 4200 African children, aged 2 months to 12 years, presenting to 5 hospitals in East Africa with respiratory distress and hypoxia (oxygen saturation or = 80% (permissive hypoxia; and High flow using AIrVO2TM compared with low flow delivery (routine care. Discussion: The overarching objective is to address the key research gaps in the therapeutic use of oxygen in resource-limited setting in order to provide a better evidence base for future management guidelines. The trial has been designed to address the poor outcomes of children in sub-Saharan Africa, which are associated with high rates of in-hospital mortality, 9-10% (for those with oxygen saturations of 80-92% and 26-30% case fatality for those with oxygen saturations <80%. Clinical trial registration: ISRCTN15622505 Trial status: Recruiting

  9. Randomised controlled trial of biofeedback training in persistent encopresis with anismus

    OpenAIRE

    Nolan, T.; Catto-Smith, T.; Coffey, C.; Wells, J.

    1998-01-01

    BACKGROUND—Paradoxical external anal sphincter contraction during attempted defecation (anismus) is thought to be an important contributor to chronic faecal retention and encopresis in children. Biofeedback training can be used to teach children to abolish this abnormal contraction.
METHODS—A randomised controlled trial in medical treatment resistant and/or treatment dependent children with anismus using surface electromyographic (EMG) biofeedback training to determine wh...

  10. The Hawthorne Effect: a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    van Haselen Robbert

    2007-07-01

    Full Text Available Abstract Background The 'Hawthorne Effect' may be an important factor affecting the generalisability of clinical research to routine practice, but has been little studied. Hawthorne Effects have been reported in previous clinical trials in dementia but to our knowledge, no attempt has been made to quantify them. Our aim was to compare minimal follow-up to intensive follow-up in participants in a placebo controlled trial of Ginkgo biloba for treating mild-moderate dementia. Methods Participants in a dementia trial were randomised to intensive follow-up (with comprehensive assessment visits at baseline and two, four and six months post randomisation or minimal follow-up (with an abbreviated assessment at baseline and a full assessment at six months. Our primary outcomes were cognitive functioning (ADAS-Cog and participant and carer-rated quality of life (QOL-AD. Results We recruited 176 participants, mainly through general practices. The main analysis was based on Intention to treat (ITT, with available data. In the ANCOVA model with baseline score as a co-variate, follow-up group had a significant effect on outcome at six months on the ADAS-Cog score (n = 140; mean difference = -2.018; 95%CI -3.914, -0.121; p = 0.037 favouring the intensive follow-up group, and on participant-rated quality of life score (n = 142; mean difference = -1.382; 95%CI -2.642, -0.122; p = 0.032 favouring minimal follow-up group. There was no significant difference on carer quality of life. Conclusion We found that more intensive follow-up of individuals in a placebo-controlled clinical trial of Ginkgo biloba for treating mild-moderate dementia resulted in a better outcome than minimal follow-up, as measured by their cognitive functioning. Trial registration Current controlled trials: ISRCTN45577048

  11. Randomised controlled trial of video clips and interactive games to improve vision in children with amblyopia using the I-BiT system

    Science.gov (United States)

    Herbison, Nicola; MacKeith, Daisy; Vivian, Anthony; Purdy, Jon; Fakis, Apostolos; Ash, Isabel M; Cobb, Sue V; Eastgate, Richard M; Haworth, Stephen M; Gregson, Richard M; Foss, Alexander JE

    2016-01-01

    Background Traditional treatment of amblyopia involves either wearing a patch or atropine penalisation of the better eye. A new treatment is being developed on the basis of virtual reality technology allowing either DVD footage or computer games which present a common background to both eyes and the foreground, containing the imagery of interest, only to the amblyopic eye. Methods A randomised control trial was performed on patients with amblyopia aged 4–8 years with three arms. All three arms had dichoptic stimulation using shutter glass technology. One arm had DVD footage shown to the amblyopic eye and common background to both, the second used a modified shooter game, Nux, with sprite and targets presented to the amblyopic eye (and background to both) while the third arm had both background and foreground presented to both eyes (non-interactive binocular treatment (non-I-BiT) games). Results Seventy-five patients were randomised; 67 were residual amblyopes and 70 had an associated strabismus. The visual acuity improved in all three arms by approximately 0.07 logMAR in the amblyopic eye at 6 weeks. There was no difference between I-BiT DVD and non-I-BiT games compared with I-BiT games (stated primary outcome) in terms of gain in vision. Conclusions There was a modest vision improvement in all three arms. Treatment was well tolerated and safe. There was no difference between the three treatments in terms of primary stated outcomes but treatment duration was short and the high proportion of previously treated amblyopia and strabismic amblyopia disadvantaged dichoptic stimulation treatment. Trial registration number NCT01702727, results. PMID:26951772

  12. Randomised controlled trial of video clips and interactive games to improve vision in children with amblyopia using the I-BiT system.

    Science.gov (United States)

    Herbison, Nicola; MacKeith, Daisy; Vivian, Anthony; Purdy, Jon; Fakis, Apostolos; Ash, Isabel M; Cobb, Sue V; Eastgate, Richard M; Haworth, Stephen M; Gregson, Richard M; Foss, Alexander Je

    2016-11-01

    Traditional treatment of amblyopia involves either wearing a patch or atropine penalisation of the better eye. A new treatment is being developed on the basis of virtual reality technology allowing either DVD footage or computer games which present a common background to both eyes and the foreground, containing the imagery of interest, only to the amblyopic eye. A randomised control trial was performed on patients with amblyopia aged 4-8 years with three arms. All three arms had dichoptic stimulation using shutter glass technology. One arm had DVD footage shown to the amblyopic eye and common background to both, the second used a modified shooter game, Nux, with sprite and targets presented to the amblyopic eye (and background to both) while the third arm had both background and foreground presented to both eyes (non-interactive binocular treatment (non-I-BiT) games). Seventy-five patients were randomised; 67 were residual amblyopes and 70 had an associated strabismus. The visual acuity improved in all three arms by approximately 0.07 logMAR in the amblyopic eye at 6 weeks. There was no difference between I-BiT DVD and non-I-BiT games compared with I-BiT games (stated primary outcome) in terms of gain in vision. There was a modest vision improvement in all three arms. Treatment was well tolerated and safe. There was no difference between the three treatments in terms of primary stated outcomes but treatment duration was short and the high proportion of previously treated amblyopia and strabismic amblyopia disadvantaged dichoptic stimulation treatment. NCT01702727, results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  13. The dietary effect of serving school meals based on the new Nordic diet – A randomised controlled trial in Danish children

    DEFF Research Database (Denmark)

    Andersen, Rikke; Biltoft-Jensen, Anja Pia; Christensen, Tue

    2013-01-01

    Background and objectives: The OPUS study is a school-based intervention study testing selected health effects of New Nordic Diet (NND). Children are served lunch and snacks based on NND. The hypothesis is that Danish school children eat a healthier diet when receiving NND school meals as compared...... with packed lunch brought from home. To investigate the effects on intake of selected macronutrients in Danish school children when served school meals based on NND compared with packed lunch. Methods: In a cluster-randomized controlled unblinded cross-over study children received school meals based on NND...... for 3 months and their usual packed lunch for 3 months. The daily intake of food and beverages was recorded 3 times during 7 consecutive days using a validated self-administered web-based dietary assessment software tool for children. Statistical analysis was performed by hierarchical mixed models...

  14. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Nigeria

    Science.gov (United States)

    van der Kam, Saskia; Salse-Ubach, Nuria; Roll, Stephanie; Swarthout, Todd; Gayton-Toyoshima, Sayaka; Jiya, Nma Mohammed; Matsumoto, Akiko; Shanks, Leslie

    2016-01-01

    Background Globally, Médecins Sans Frontières (MSF) treats more than 300,000 severely malnourished children annually. Malnutrition is not only caused by lack of food and poor infant and child feeding practices but also by illnesses. Breaking the vicious cycle of illness and malnutrition by providing ill children with nutritional supplementation is a potentially powerful strategy for preventing malnutrition that has not been adequately investigated. Therefore, MSF investigated whether incidence of malnutrition among ill children malnutrition rates. Methods and Findings We investigated the effect of supplementation with ready-to-use therapeutic food (RUTF) and a micronutrient powder (MNP) on the incidence of malnutrition in ill children presenting at an outpatient clinic in Goronyo during February to September 2012. A three-armed, partially-blinded, randomised controlled trial was conducted in children diagnosed as having malaria, diarrhoea, or lower respiratory tract infection. Children aged 6 to 59 mo were randomised to one of three arms: one sachet/d of RUTF; two sachets/d of micronutrients or no supplement (control) for 14 d for each illness over 6 mo. The primary outcome was the incidence of first negative nutritional outcome (NNO) during the 6 mo follow-up. NNO was a study-specific measure used to indicate occurrence of malnutrition; it was defined as low weight-for-height z-score (malnutrition. The lack of effect in Goronyo may be due to a high frequency of morbidity, which probably further affects a child’s nutritional status and children’s ability to escape from the illness–malnutrition cycle. The duration of the supplementation may have been too short or the doses of the supplements may have been too low to mitigate the effects of high morbidity and pre-existing malnutrition. An integrated approach combining prevention and treatment of diseases and treatment of moderate malnutrition, rather than prevention of malnutrition by nutritional

  15. Efficacy of an internet-based CBT program for children with comorbid High Functioning Autism Spectrum Disorder and anxiety: A randomised controlled trial.

    Science.gov (United States)

    Conaughton, Rebecca J; Donovan, Caroline L; March, Sonja

    2017-08-15

    All trials conducted to date on BRAVE-ONLINE for youth anxiety disorders have excluded children with High Functioning Autism Spectrum Disorder (HFASD) and therefore it is unknown whether these programs might be beneficial to HFASD children. The aim of this study was to evaluate the efficacy of BRAVE-ONLINE in HFASD children with an anxiety disorder. Forty-two HFASD children, aged 8-12 years, with an anxiety disorder, and their parents, were randomly assigned to either the BRAVE-ONLINE condition (NET) or a waitlist control (WLC). Diagnostic interviews and parent/child questionnaires were completed at pre-treatment, post-treatment and 3-month follow-up. At post- assessment, compared to children in the WLC condition, children in the NET condition demonstrated a significantly greater reduction in number of anxiety diagnoses, clinical severity of diagnosis, and self and parent reported anxiety symptoms, as well as significantly greater increases in overall functioning. However, loss of primary diagnosis in this sample was lower than in previous studies. The small sample size, coupled with attrition rates, makes it difficult to generalise the findings of the study to HFASD population and to conduct analyses regarding mediators, moderators and predictors of outcomes. The BRAVE-ONLINE program may be useful in reducing anxiety symptoms in HFASD children, although the effects are less strong than those found in neurotypical children for a variety of reasons. Copyright © 2017. Published by Elsevier B.V.

  16. The effectiveness of the Inspiring Futures parenting programme in improving behavioural and emotional outcomes in primary school children with behavioural or emotional difficulties: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Nick Axford

    2018-02-01

    Full Text Available Abstract Background There is a need to build the evidence base of early interventions promoting children’s health and development in the UK. Malachi Specialist Family Support Services (‘Malachi’ is a voluntary sector organisation based in the UK that delivers a therapeutic parenting group programme called Inspiring Futures to parents of children identified as having behavioural and emotional difficulties. The programme comprises two parts, delivered sequentially: (1 a group-based programme for all parents for 10–12 weeks, and (2 one-to-one sessions with selected parents from the group-based element for up to 12 weeks. Methods/design A randomised controlled trial will be conducted to evaluate Malachi’s Inspiring Futures parenting programme. Participants will be allocated to one of two possible arms, with follow-up measures at 16 weeks (post-parent group programme and at 32 weeks (post-one-to-one sessions with selected parents. The sample size is 248 participants with a randomisation allocation ratio of 1:1. The intervention arm will be offered the Inspiring Futures programme. The control group will receive services as usual. The aim is to determine the effectiveness of the Inspiring Futures programme on the primary outcome of behavioural and emotional difficulties of primary school children identified as having behavioural or emotional difficulties. Discussion This study will further enhance the evidence for early intervention parenting programmes for child behavioural and emotional problems in the UK. Trial registration Current Controlled Trials ISRCTN32083735. Retrospectively registered 28 October 2014.

  17. Evaluation and development of a novel binocular treatment (I-BiT™) system using video clips and interactive games to improve vision in children with amblyopia ('lazy eye'): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Foss, Alexander J; Gregson, Richard M; MacKeith, Daisy; Herbison, Nicola; Ash, Isabel M; Cobb, Sue V; Eastgate, Richard M; Hepburn, Trish; Vivian, Anthony; Moore, Diane; Haworth, Stephen M

    2013-05-20

    Amblyopia (lazy eye) affects the vision of approximately 2% of all children. Traditional treatment consists of wearing a patch over their 'good' eye for a number of hours daily, over several months. This treatment is unpopular and compliance is often low. Therefore results can be poor. A novel binocular treatment which uses 3D technology to present specially developed computer games and video footage (I-BiT™) has been studied in a small group of patients and has shown positive results over a short period of time. The system is therefore now being examined in a randomised clinical trial. Seventy-five patients aged between 4 and 8 years with a diagnosis of amblyopia will be randomised to one of three treatments with a ratio of 1:1:1 - I-BiT™ game, non-I-BiT™ game, and I-BiT™ DVD. They will be treated for 30 minutes once weekly for 6 weeks. Their visual acuity will be assessed independently at baseline, mid-treatment (week 3), at the end of treatment (week 6) and 4 weeks after completing treatment (week 10). The primary endpoint will be the change in visual acuity from baseline to the end of treatment. Secondary endpoints will be additional visual acuity measures, patient acceptability, compliance and the incidence of adverse events. This is the first randomised controlled trial using the I-BiT™ system. The results will determine if the I-BiT™ system is effective in the treatment of amblyopia and will also determine the optimal treatment for future development. ClinicalTrials.gov identifier: NCT01702727.

  18. The effects of the Make a Wish intervention on psychiatric symptoms and health-related quality of life of children with cancer: a randomised controlled trial.

    Science.gov (United States)

    Shoshani, Anat; Mifano, Keren; Czamanski-Cohen, Johanna

    2016-05-01

    Children with life-threatening medical conditions frequently undergo invasive medical procedures that may elicit anxiety and distress. However, there are few empirically validated interventions that reduce mental health symptoms and increase the resilience of children during the acute stages of illness. This study aimed to evaluate the efficacy of the Make a Wish intervention for children with life-threatening cancer. The design was a wait-list-controlled trial with two parallel groups. Sixty-six children aged 5-12 with an initial diagnosis of life-threatening cancer were identified and randomly assigned to the Make a Wish intervention (n = 32) or a wait-list control group (n = 34). Children completed measures of psychiatric and health-related symptoms, positive and negative affect, hope, and optimism pre-intervention and post-intervention. After baseline data collection, children were interviewed and made an authentic wish that they wanted to come true. These wishes were made possible 5-6 months after baseline data collection, to fuel anticipation and excitement over the wish-fulfillment event. The post-intervention assessment point was 5 weeks after wish fulfillment (approximately 7 months after baseline data collection). Children in the intervention group exhibited a significant reduction in general distress (d = 0.54), depression (d = 0.70), and anxiety symptoms (d = 0.41), improved health-related quality of life (d = 0.59), hope (d = 0.71), and positive affect (d = 0.80) compared to decrease in positive affect and no significant changes in the other measures in the control group. These findings emphasize the role of hope and positive emotions in fostering the well-being of children who suffer from serious illnesses.

  19. Informed consent, parental awareness, and reasons for participating in a randomised controlled study

    NARCIS (Netherlands)

    M. van Stuijvenberg (Margriet); M.H. Suur (Marja); S. de Vos (Sandra); G.C.H. Tjiang (Gilbert); E.W. Steyerberg (Ewout); G. Derksen-Lubsen (Gerarda); H.A. Moll (Henriëtte)

    1998-01-01

    textabstractBACKGROUND: The informed consent procedure plays a central role in randomised controlled trials but has only been explored in a few studies on children. AIM: To assess the quality of the informed consent process in a paediatric setting. METHODS: A

  20. Parenting Resilient Kids (PaRK), an online parenting program to prevent anxiety and depression problems in primary school-aged children: Study protocol for a randomised controlled trial.

    Science.gov (United States)

    Fernando, Luwishennadige Madhawee N; Sim, Wan Hua; Jorm, Anthony F; Rapee, Ron; Lawrence, Katherine A; Yap, Marie B H

    2018-04-19

    Preventive efforts targeting childhood anxiety and depression symptoms have the potential to alter the developmental trajectory of depression and anxiety disorders across the lifespan. Substantial previous research suggests that modifiable parenting factors such as parental aversiveness and over-involvement are associated with childhood anxiety, depressive and internalising symptoms, indicating that parents can play a critical role in prevention. The Parenting Resilient Kids study is a new evidence-based online parenting program designed to prevent anxiety and depression problems in primary school-aged children by reducing family-based risk factors and enhancing protective factors through increased positive interactions between parent and child. The current study is a parallel group superiority randomised controlled trial with parent-child dyads randomised to the intervention or active-control group in a 1:1 ratio. The intervention group will receive the Parenting Resilient Kids program consisting of a feedback report on parenting behaviours and up to 12 interactive online modules personalised based on responses to the parent survey. The active-control group will receive a standardised package of online educational materials about child development and wellbeing. The trial website is programmed to run a stratified random allocation sequence (based on parent gender) to determine group membership. We aim to recruit 340 parent-child dyads (170 dyads per group). We hypothesise that the intervention group will show greater improvement in parenting risk and protective factors from baseline to 3-month follow-up (primary outcome), which will in turn mediate changes in child depressive and anxiety symptoms from baseline to 12 and 24 months (co-primary outcomes). We also hypothesise that the intervention group will show greater benefits from baseline to 3-, 12- and 24-month follow-up, with regard to: child depressive and anxiety symptoms (co-primary outcomes); and child and

  1. Rationale, design and methods for a randomised and controlled trial of the impact of virtual reality games on motor competence, physical activity, and mental health in children with developmental coordination disorder

    Directory of Open Access Journals (Sweden)

    Straker Leon M

    2011-08-01

    Full Text Available Abstract Background A healthy start to life requires adequate motor development and physical activity participation. Currently 5-15% of children have impaired motor development without any obvious disorder. These children are at greater risk of obesity, musculoskeletal disorders, low social confidence and poor mental health. Traditional electronic game use may impact on motor development and physical activity creating a vicious cycle. However new virtual reality (VR game interfaces may provide motor experiences that enhance motor development and lead to an increase in motor coordination and better physical activity and mental health outcomes. VR games are beginning to be used for rehabilitation, however there is no reported trial of the impact of these games on motor coordination in children with developmental coordination disorder. Methods This cross-over randomised and controlled trial will examine whether motor coordination is enhanced by access to active electronic games and whether daily activity, attitudes to physical activity and mental health are also enhanced. Thirty children aged 10-12 years with poor motor coordination (≤ 15th percentile will be recruited and randomised to a balanced ordering of 'no active electronic games' and 'active electronic games'. Each child will participate in both conditions for 16 weeks, and be assessed prior to participation and at the end of each condition. The primary outcome is motor coordination, assessed by kinematic and kinetic motion analysis laboratory measures. Physical activity and sedentary behaviour will be assessed by accelerometry, coordination in daily life by parent report questionnaire and attitudes to physical activity, self-confidence, anxiety and depressed mood will be assessed by self report questionnaire. A sample of 30 will provide a power of > 0.9 for detecting a 5 point difference in motor coordination on the MABC-2 TIS scale (mean 17, sd = 5. Discussion This is the first trial to

  2. Rationale, design and methods for a randomised and controlled trial of the impact of virtual reality games on motor competence, physical activity, and mental health in children with developmental coordination disorder.

    Science.gov (United States)

    Straker, Leon M; Campbell, Amity C; Jensen, Lyn M; Metcalf, Deborah R; Smith, Anne J; Abbott, Rebecca A; Pollock, Clare M; Piek, Jan P

    2011-08-18

    A healthy start to life requires adequate motor development and physical activity participation. Currently 5-15% of children have impaired motor development without any obvious disorder. These children are at greater risk of obesity, musculoskeletal disorders, low social confidence and poor mental health. Traditional electronic game use may impact on motor development and physical activity creating a vicious cycle. However new virtual reality (VR) game interfaces may provide motor experiences that enhance motor development and lead to an increase in motor coordination and better physical activity and mental health outcomes. VR games are beginning to be used for rehabilitation, however there is no reported trial of the impact of these games on motor coordination in children with developmental coordination disorder. This cross-over randomised and controlled trial will examine whether motor coordination is enhanced by access to active electronic games and whether daily activity, attitudes to physical activity and mental health are also enhanced. Thirty children aged 10-12 years with poor motor coordination (≤ 15th percentile) will be recruited and randomised to a balanced ordering of 'no active electronic games' and 'active electronic games'. Each child will participate in both conditions for 16 weeks, and be assessed prior to participation and at the end of each condition. The primary outcome is motor coordination, assessed by kinematic and kinetic motion analysis laboratory measures. Physical activity and sedentary behaviour will be assessed by accelerometry, coordination in daily life by parent report questionnaire and attitudes to physical activity, self-confidence, anxiety and depressed mood will be assessed by self report questionnaire. A sample of 30 will provide a power of > 0.9 for detecting a 5 point difference in motor coordination on the MABC-2 TIS scale (mean 17, sd = 5). This is the first trial to examine the impact of new virtual reality games on

  3. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Nigeria.

    Science.gov (United States)

    van der Kam, Saskia; Salse-Ubach, Nuria; Roll, Stephanie; Swarthout, Todd; Gayton-Toyoshima, Sayaka; Jiya, Nma Mohammed; Matsumoto, Akiko; Shanks, Leslie

    2016-02-01

    Globally, Médecins Sans Frontières (MSF) treats more than 300,000 severely malnourished children annually. Malnutrition is not only caused by lack of food and poor infant and child feeding practices but also by illnesses. Breaking the vicious cycle of illness and malnutrition by providing ill children with nutritional supplementation is a potentially powerful strategy for preventing malnutrition that has not been adequately investigated. Therefore, MSF investigated whether incidence of malnutrition among ill children malnutrition rates. We investigated the effect of supplementation with ready-to-use therapeutic food (RUTF) and a micronutrient powder (MNP) on the incidence of malnutrition in ill children presenting at an outpatient clinic in Goronyo during February to September 2012. A three-armed, partially-blinded, randomised controlled trial was conducted in children diagnosed as having malaria, diarrhoea, or lower respiratory tract infection. Children aged 6 to 59 mo were randomised to one of three arms: one sachet/d of RUTF; two sachets/d of micronutrients or no supplement (control) for 14 d for each illness over 6 mo. The primary outcome was the incidence of first negative nutritional outcome (NNO) during the 6 mo follow-up. NNO was a study-specific measure used to indicate occurrence of malnutrition; it was defined as low weight-for-height z-score (children), mid-upper arm circumference children who were moderately malnourished compared with non-malnourished at enrollment. The average number of study illnesses for the RUTF, MNP, and control groups were 4.2 (95% CI, 4.0-4.3), 3.4 (3.2-3.6), and 3.6 (3.4-3.7). The proportion of children who died in the RUTF, MNP, and control groups were 0.8% (95% CI, 0.3-1.8), 1.8% (1.0-3.3), and 1.4% (0.7-2.8). A 2-wk supplementation with RUTF or MNP to ill children as part of routine primary medical care did not reduce the incidence of malnutrition. The lack of effect in Goronyo may be due to a high frequency of morbidity

  4. The impact of a computerised test of attention and activity (QbTest) on diagnostic decision-making in children and young people with suspected attention deficit hyperactivity disorder: single-blind randomised controlled trial.

    Science.gov (United States)

    Hollis, Chris; Hall, Charlotte L; Guo, Boliang; James, Marilyn; Boadu, Janet; Groom, Madeleine J; Brown, Nikki; Kaylor-Hughes, Catherine; Moldavsky, Maria; Valentine, Althea Z; Walker, Gemma M; Daley, David; Sayal, Kapil; Morriss, Richard

    2018-04-26

    Diagnosis of attention deficit hyperactivity disorder (ADHD) relies on subjective methods which can lead to diagnostic uncertainty and delay. This trial evaluated the impact of providing a computerised test of attention and activity (QbTest) report on the speed and accuracy of diagnostic decision-making in children with suspected ADHD. Randomised, parallel, single-blind controlled trial in mental health and community paediatric clinics in England. Participants were 6-17 years-old and referred for ADHD diagnostic assessment; all underwent assessment-as-usual, plus QbTest. Participants and their clinician were randomised to either receive the QbTest report immediately (QbOpen group) or the report was withheld (QbBlind group). The primary outcome was number of consultations until a diagnostic decision confirming/excluding ADHD within 6-months from baseline. Health economic cost-effectiveness and cost utility analysis was conducted. Assessing QbTest Utility in ADHD: A Randomised Controlled Trial was registered at ClinicalTrials.gov (https://clinicaltrials.gov/ct2/show/NCT02209116). One hundred and thirty-two participants were randomised to QbOpen group (123 analysed) and 135 to QbBlind group (127 analysed). Clinicians with access to the QbTest report (QbOpen) were more likely to reach a diagnostic decision about ADHD (hazard ratio 1.44, 95% CI 1.04-2.01). At 6-months, 76% of those with a QbTest report had received a diagnostic decision, compared with 50% without. QbTest reduced appointment length by 15% (time ratio 0.85, 95% CI 0.77-0.93), increased clinicians' confidence in their diagnostic decisions (odds ratio 1.77, 95% CI 1.09-2.89) and doubled the likelihood of excluding ADHD. There was no difference in diagnostic accuracy. Health economic analysis showed a position of strict dominance; however, cost savings were small suggesting that the impact of providing the QbTest report within this trial can best be viewed as 'cost neutral'. QbTest may increase the

  5. The effects of Nordic school meals on concentration and school performance in 8- to 11-year-old children in the OPUS School Meal Study: a cluster-randomised, controlled, cross-over trial.

    Science.gov (United States)

    Sørensen, Louise B; Dyssegaard, Camilla B; Damsgaard, Camilla T; Petersen, Rikke A; Dalskov, Stine-Mathilde; Hjorth, Mads F; Andersen, Rikke; Tetens, Inge; Ritz, Christian; Astrup, Arne; Lauritzen, Lotte; Michaelsen, Kim F; Egelund, Niels

    2015-04-28

    It is widely assumed that nutrition can improve school performance in children; however, evidence remains limited and inconclusive. In the present study, we investigated whether serving healthy school meals influenced concentration and school performance of 8- to 11-year-old Danish children. The OPUS (Optimal well-being, development and health for Danish children through a healthy New Nordic Diet) School Meal Study was a cluster-randomised, controlled, cross-over trial comparing a healthy school meal programme with the usual packed lunch from home (control) each for 3 months (NCT 01457794). The d2 test of attention, the Learning Rating Scale (LRS) and standard tests on reading and mathematics proficiency were administered at baseline and at the end of each study period. Intervention effects were evaluated using hierarchical mixed models. The school meal intervention did not influence concentration performance (CP; primary outcome, n 693) or processing speed; however, the decrease in error percentage was 0·18 points smaller (Pschool year. The percentage of correct sentences also improved (Pperformance or outcomes from the LRS. In conclusion, school meals did not affect CP, but improved reading performance, which is a complex cognitive activity that involves inference, and increased errors related to impulsivity and inattention. These findings are worth examining in future trials.

  6. Impact of the Early Start Denver Model on the cognitive level of children with autism spectrum disorder: study protocol for a randomised controlled trial using a two-stage Zelen design.

    Science.gov (United States)

    Touzet, Sandrine; Occelli, Pauline; Schröder, Carmen; Manificat, Sabine; Gicquel, Ludovic; Stanciu, Razvana; Schaer, Marie; Oreve, Marie-Joelle; Speranza, Mario; Denis, Angelique; Zelmar, Amelie; Falissard, Bruno; Georgieff, Nicolas; Bahrami, Stephane; Geoffray, Marie-Maude

    2017-03-27

    Early intervention for autism spectrum disorder (ASD) in the European French-speaking countries is heterogeneous and poorly evaluated to date. Early intervention units applying the Early Start Denver Model (ESDM) for toddlers and young children with ASD have been created in France and Belgium to improve this situation. It is essential to evaluate this intervention for the political decision-making process regarding ASD interventions in European French-speaking countries. We will evaluate the effectiveness of 12 hours per week ESDM intervention on the cognitive level of children with ASD, over a 2-year period. The study will be a multicentre, randomised controlled trial, using a two-stage Zelen design. Children aged 15-36 months, diagnosed with ASD and with a developmental quotient (DQ) of 30 or above on the Mullen Scale of Early Learning (MSEL) will be included. We will use a stratified minimisation randomisation at a ratio 1:2 in favour of the control group. The sample size required is 180 children (120 in the control and 60 in the intervention group). The experimental group will receive 12 hours per week ESDM by trained therapists 10 hours per week in the centre and 2 hours in the toddlers' natural environment (alternatively by the therapist and the parent). The control group will receive care available in the community. The primary outcome will be the change in cognitive level measured with the DQ of the MSEL scored at 2 years. Secondary outcomes will include change in autism symptoms, behavioural adaptation, communicative and productive language level, sensory profile and parents' quality of life. The primary analysis will use the intention-to-treat principle. An economic evaluation will be performed. Findings from the study will be disseminated through peer reviewed publications and meetings. NCT02608333 (clinicaltrials.gov); Pre-results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence

  7. Effect of High-Intensity Interval Training on Fitness, Fat Mass and Cardiometabolic Biomarkers in Children with Obesity: A Randomised Controlled Trial.

    Science.gov (United States)

    Dias, Katrin A; Ingul, Charlotte B; Tjønna, Arnt E; Keating, Shelley E; Gomersall, Sjaan R; Follestad, Turid; Hosseini, Mansoureh S; Hollekim-Strand, Siri M; Ro, Torstein B; Haram, Margrete; Huuse, Else Marie; Davies, Peter S W; Cain, Peter A; Leong, Gary M; Coombes, Jeff S

    2018-03-01

    Paediatric obesity significantly increases the risk of developing cardiometabolic diseases across the lifespan. Increasing cardiorespiratory fitness (CRF) could mitigate this risk. High-intensity interval training (HIIT) improves CRF in clinical adult populations but the evidence in paediatric obesity is inconsistent. The objectives of this study were to determine the efficacy of a 12-week, HIIT intervention for increasing CRF and reducing adiposity in children with obesity. Children with obesity (n = 99, 7-16 years old) were randomised into a 12-week intervention as follows: (1) HIIT [n = 33, 4 × 4-min bouts at 85-95% maximum heart rate (HR max ), interspersed with 3 min of active recovery at 50-70% HR max , 3 times/week] and nutrition advice; (2) moderate-intensity continuous training (MICT) [n = 32, 44 min at 60-70% HR max , 3 times/week] and nutrition advice; and (3) nutrition advice only (nutrition) [n = 34]. CRF was quantified through a maximal exercise test ([Formula: see text]) while adiposity was assessed using magnetic resonance imaging (MRI), dual-energy X-ray absorptiometry (DXA) and air-displacement plethysmography. HIIT stimulated significant increases in relative [Formula: see text] compared with MICT (+3.6 mL/kg/min, 95% CI 1.1-6.0, P = 0.004) and the nutrition intervention (+5.4 mL/kg/min, 95% CI 2.9-7.9, P = 0.001). However, the intervention had no significant effect on visceral and subcutaneous adipose tissue, whole body composition or cardiometabolic biomarkers (P > 0.05). A 12-week, HIIT intervention was highly effective in increasing cardiorespiratory fitness when compared with MICT and nutrition interventions. While there were no concomitant reductions in adiposity or blood biomarkers, the cardiometabolic health benefit conferred through increased CRF should be noted. Clinicaltrials.gov; NCT01991106.

  8. "Pre-schoolers in the playground" an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial.

    Science.gov (United States)

    Barber, Sally E; Jackson, Cath; Akhtar, Shaheen; Bingham, Daniel D; Ainsworth, Hannah; Hewitt, Catherine; Richardson, Gerry; Summerbell, Carolyn D; Pickett, Kate E; Moore, Helen J; Routen, Ash C; O'Malley, Claire L; Brierley, Shirley; Wright, John

    2013-10-09

    The pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood, thus establishing habitual physical activity early in life is vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children. There are few pre-school, playground-based interventions, and evaluations of these have found mixed results. A recent report published by the UK Chief Medical Officer (CMO) highlighted that new interventions to promote movement in the early years (0-5 years old) are needed. The aim of this study is to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old ("Pre-schoolers in the Playground"; PiP) and to assess the feasibility of conducting a full scale cluster RCT. The PiP intervention is grounded in behavioural theory (Social Cognitive Theory), and is in accordance with the CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. One hundred and fifty pre-school children affiliated to 10 primary schools will be recruited. Schools will be randomised to either the PiP intervention arm or the control arm (usual practice). Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks (3 school terms) at the school. Feasibility will be assessed by examining recruitment rates, attendance, attrition, acceptability of the trial and of the PiP intervention to parents, fidelity of intervention implementation, capability and capacity for schools to deliver the intervention. Health outcomes and the feasibility of outcome measurement tools will be assessed. These include physical activity via

  9. “Pre-schoolers in the playground” an outdoor physical activity intervention for children aged 18 months to 4 years old: study protocol for a pilot cluster randomised controlled trial

    Science.gov (United States)

    2013-01-01

    Background The pre-school years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood, thus establishing habitual physical activity early in life is vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school aged children. There are few pre-school, playground-based interventions, and evaluations of these have found mixed results. A recent report published by the UK Chief Medical Officer (CMO) highlighted that new interventions to promote movement in the early years (0–5 years old) are needed. The aim of this study is to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged 18 months to 4 years old (“Pre-schoolers in the Playground”; PiP) and to assess the feasibility of conducting a full scale cluster RCT. The PiP intervention is grounded in behavioural theory (Social Cognitive Theory), and is in accordance with the CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. Methods/Design One hundred and fifty pre-school children affiliated to 10 primary schools will be recruited. Schools will be randomised to either the PiP intervention arm or the control arm (usual practice). Children in the intervention arm will be invited to attend three 30 minute outdoor play sessions per week for 30 weeks (3 school terms) at the school. Feasibility will be assessed by examining recruitment rates, attendance, attrition, acceptability of the trial and of the PiP intervention to parents, fidelity of intervention implementation, capability and capacity for schools to deliver the intervention. Health outcomes and the feasibility of outcome measurement tools will be assessed. These

  10. A randomised controlled trial of multiple periods of outdoor free-play to increase moderate-to-vigorous physical activity among 3 to 6 year old children attending childcare: study protocol

    Directory of Open Access Journals (Sweden)

    Luke Wolfenden

    2016-09-01

    Full Text Available Abstract Background The implementation of physical activity interventions in centre-based childcare services has been recommended to improve child health. This study aims to evaluate the efficacy of scheduling multiple periods of outdoor free play in increasing the time children spend in moderate-to-vigorous physical activity (MVPA during childcare. Methods The study will employ a between group cluster randomised controlled trial design. Fourteen childcare services in the Hunter New England region of New South Wales, Australia, who currently implement a single session of free outdoor play between their core operational hours of 9 am to 3 pm will be recruited into the trial. Childcare services will be randomised to an intervention or a no intervention control group. Childcare services in the intervention group will be supported by an early childhood education specialist to provide three periods of outdoor free play for children between the hours of 9 am to 3 pm. Each period of outdoor free play will be at least 15 min in duration but must equate to their total usual duration of outdoor play. Services in the control group will continue to implement a single period of outdoor play. The primary trial outcome is minutes of time children spend in MVPA whilst in care assessed objectively via accelerometer over 5 days. Outcome assessment will occur at baseline and 3 months post baseline. Generalised Linear Mixed Models (GLMM under an intention to treat framework will be used to compare differences between groups in the primary trial outcome at follow-up. Sensitivity analysis will be conducted to test assumptions of missing data. Per protocol analysis will be performed using services that implemented the intervention as intended and subgroup analysis undertaken by gender and baseline physical activity levels of children. Discussion The study tests a simple ecological intervention that has the potential to increase child physical activity in care

  11. The effect of sucrose as pain relief/comfort during immunisation of 15-month-old children in health care centres: a randomised controlled trial.

    Science.gov (United States)

    Despriee, Åshild Wik; Langeland, Eva

    2016-02-01

    To investigate the effect of 30% sucrose compared with a placebo (water) as pain relief and comfort during immunisation of 15-month-old children in health care centres. Children experience different levels of pain and distress during immunisation. Sweet solutions function as pain relief during immunisation for infants up to one year of age. However, there are few studies of older children. An experimental design in which the participants (15-month-old infants) were randomly assigned to an intervention group that received a 30% sugar solution or a control group that received a placebo (water). The study was performed at three health care centres in a large Norwegian municipality. The parents of all 15-month-old infants who were recommended for vaccination (for measles, mumps and rubella) between 5 September 2013 and 31 March 2014 were invited to have their infant participate. Duration of crying was the outcome measure. A total of 114 children were included (59 in the intervention group, 55 in the control group). The intervention group infants' crying was shorter (18 seconds mean) compared with the control group infants (33 seconds mean). The difference in crying duration between the groups was both statistically and clinically significant. This trial revealed that 30% sucrose orally has a calming and pain-relieving effect on 15-month-old infants during immunisation. Public health nurses should use a 30% sucrose solution for pain relief during immunisation of 15-month-old infants. © 2016 John Wiley & Sons Ltd.

  12. A motivational interviewing intervention to PREvent PAssive Smoke Exposure (PREPASE) in children with a high risk of asthma: design of a randomised controlled trial.

    Science.gov (United States)

    Hutchinson, Sasha G; Mesters, Ilse; van Breukelen, Gerard; Muris, Jean Wm; Feron, Frans Jm; Hammond, S Katharine; van Schayck, Constant P; Dompeling, Edward

    2013-02-27

    Especially children at risk for asthma are sensitive to the detrimental health effects of passive smoke (PS) exposure, like respiratory complaints and allergic sensitisation. Therefore, effective prevention of PS exposure in this group of vulnerable children is important. Based on previous studies, we hypothesized that an effective intervention program to prevent PS exposure in children is possible by means of a motivational interviewing tailored program with repeated contacts focussing on awareness, knowledge, beliefs (pros/cons), perceived barriers and needs of parents, in combination with feedback about urine cotinine levels of the children. The aim of the PREPASE study is to test the effectiveness of such an intervention program towards eliminating or reducing of PS exposure in children at risk for asthma. This article describes the protocol of the PREPASE study. The study is a one-year follow-up randomized controlled trial. Families with children (0-13 years of age) having an asthma predisposition who experience PS exposure at home are randomized into an intervention group receiving an intervention or a control group receiving care as usual. The intervention is given by trained research assistants. The intervention starts one month after a baseline measurement and takes place once per month for an hour during six home based counselling sessions. The primary outcome measure is the percentage of families curtailing PS exposure in children (parental report verified with the urine cotinine concentrations of the children) after 6 months. The secondary outcome measures include: household nicotine level, the child's lung function, airway inflammation and oxidative stress, presence of wheezing and questionnaires on respiratory symptoms, and quality of life. A process evaluation is included. Most of the measurements take place every 3 months (baseline and after 3, 6, 9 and 12 months of study). The PREPASE study incorporates successful elements of previous interventions

  13. Relevance of randomised controlled trials in oncology.

    Science.gov (United States)

    Tannock, Ian F; Amir, Eitan; Booth, Christopher M; Niraula, Saroj; Ocana, Alberto; Seruga, Bostjan; Templeton, Arnoud J; Vera-Badillo, Francisco

    2016-12-01

    Well-designed randomised controlled trials (RCTs) can prevent bias in the comparison of treatments and provide a sound basis for changes in clinical practice. However, the design and reporting of many RCTs can render their results of little relevance to clinical practice. In this Personal View, we discuss the limitations of RCT data and suggest some ways to improve the clinical relevance of RCTs in the everyday management of patients with cancer. RCTs should ask questions of clinical rather than commercial interest, avoid non-validated surrogate endpoints in registration trials, and have entry criteria that allow inclusion of all patients who are fit to receive treatment. Furthermore, RCTs should be reported with complete accounting of frequency and management of toxicities, and with strict guidelines to ensure freedom from bias. Premature reporting of results should be avoided. The bar for clinical benefit should be raised for drug registration, which should require publication and review of mature data from RCTs, post-marketing health outcome studies, and value-based pricing. Copyright © 2016 Elsevier Ltd. All rights reserved.

  14. Rationale, design and methods for a randomised and controlled trial to evaluate "Animal Fun" - a program designed to enhance physical and mental health in young children

    Directory of Open Access Journals (Sweden)

    McLaren Sue

    2010-11-01

    Full Text Available Abstract Background Children with poor motor ability have been found to engage less in physical activities than other children, and a lack of physical activity has been linked to problems such as obesity, lowered bone mineral density and cardiovascular risk factors. Furthermore, if children are confident with their fine and gross motor skills, they are more likely to engage in physical activities such as sports, crafts, dancing and other physical activity programs outside of the school curriculum which are important activities for psychosocial development. The primary objective of this project is to comprehensively evaluate a whole of class physical activity program called Animal Fun designed for Pre-Primary children. This program was designed to improve the child's movement skills, both fine and gross, and their perceptions of their movement ability, promote appropriate social skills and improve social-emotional development. Methods The proposed randomized and controlled trial uses a multivariate nested cohort design to examine the physical (motor coordination and psychosocial (self perceptions, anxiety, social competence outcomes of the program. The Animal Fun program is a teacher delivered universal program incorporating animal actions to facilitate motor skill and social skill acquisition and practice. Pre-intervention scores on motor and psychosocial variables for six control schools and six intervention schools will be compared with post-intervention scores (end of Pre-Primary year and scores taken 12 months later after the children's transition to primary school Year 1. 520 children aged 4.5 to 6 years will be recruited and it is anticipated that 360 children will be retained to the 1 year follow-up. There will be equal numbers of boys and girls. Discussion If this program is found to improve the child's motor and psychosocial skills, this will assist in the child's transition into the first year of school. As a result of these changes

  15. Treatment reduction for children and young adults with low-risk acute lymphoblastic leukaemia defined by minimal residual disease (UKALL 2003): a randomised controlled trial.

    Science.gov (United States)

    Vora, Ajay; Goulden, Nick; Wade, Rachel; Mitchell, Chris; Hancock, Jeremy; Hough, Rachael; Rowntree, Clare; Richards, Sue

    2013-03-01

    Minimal residual disease (MRD) is the most sensitive and specific predictor of relapse risk in children with acute lymphoblastic leukaemia (ALL) during remission. We assessed whether treatment intensity could be adjusted for children and young adults according to MRD risk stratification. Between Oct 1, 2003 and June 30, 2011, consecutive children and young adults (aged 1-25 years) with ALL from the UK and Ireland were recruited. Eligible patients were categorised into clinical standard, intermediate, and high risk groups on the basis of a combination of National Cancer Institute (NCI) criteria, cytogenetics, and early response to induction therapy, which was assessed by bone marrow blast counts taken at days 8 (NCI high-risk patients) and 15 (NCI standard-risk patients) after induction began. Clinical standard-risk and intermediate-risk patients were assessed for MRD. Those classified as MRD low risk (undetectable MRD at the end of induction [day 29] or detectable MRD at day 29 that became undetectable by week 11) were randomly assigned to receive one or two delayed intensification courses. Patients had received induction, consolidation, and interim maintenance therapy before they began delayed intensification. Delayed intensification consisted of pegylated asparaginase on day 4; vincristine, dexamethasone (alternate weeks), and doxorubicin for 3 weeks; and 4 weeks of cyclophosphamide and cytarabine. Computer randomisation was done with stratification by MRD result and balancing for sex, age, and white blood cell count at diagnosis by method of minimisation. Patients, clinicians, and data analysts were not masked to treatment allocation. The primary outcome was event-free survival (EFS), which was defined as time to relapse, secondary tumour, or death. Our aim was to rule out a 7% reduction in EFS in the group given one delayed intensification course relative to that given two delayed intensification courses. Analyses were by intention to treat. This trial is

  16. TIGA-CUB - manualised psychoanalytic child psychotherapy versus treatment as usual for children aged 5-11 years with treatment-resistant conduct disorders and their primary carers: study protocol for a randomised controlled feasibility trial.

    Science.gov (United States)

    Edginton, Elizabeth; Walwyn, Rebecca; Burton, Kayleigh; Cicero, Robert; Graham, Liz; Reed, Sadie; Tubeuf, Sandy; Twiddy, Maureen; Wright-Hughes, Alex; Ellis, Lynda; Evans, Dot; Hughes, Tom; Midgley, Nick; Wallis, Paul; Cottrell, David

    2017-09-15

    The National Institute for Health and Care Excellence (NICE) recommends evidence-based parenting programmes as a first-line intervention for conduct disorders (CD) in children aged 5-11 years. As these are not effective in 25-33% of cases, NICE has requested research into second-line interventions. Child and Adolescent Psychotherapists (CAPTs) address highly complex problems where first-line treatments have failed and there have been small-scale studies of Psychoanalytic Child Psychotherapy (PCP) for CD. A feasibility trial is needed to determine whether a confirmatory trial of manualised PCP (mPCP) versus Treatment as Usual (TaU) for CD is practicable or needs refinement. The aim of this paper is to publish the abridged protocol of this feasibility trial. TIGA-CUB (Trial on improving Inter-Generational Attachment for Children Undergoing Behaviour problems) is a two-arm, pragmatic, parallel-group, multicentre, individually randomised (1:1) controlled feasibility trial (target n = 60) with blinded outcome assessment (at 4 and 8 months), which aims to develop an optimum practicable protocol for a confirmatory, pragmatic, randomised controlled trial (RCT) (primary outcome: child's behaviour; secondary outcomes: parental reflective functioning and mental health, child and parent quality of life), comparing mPCP and TaU as second-line treatments for children aged 5-11 years with treatment-resistant CD and inter-generational attachment difficulties, and for their primary carers. Child-primary carer dyads will be recruited following a referral to, or re-referral within, National Health Service (NHS) Child and Adolescent Mental Health Services (CAMHS) after an unsuccessful first-line parenting intervention. PCP will be delivered by qualified CAPTs working in routine NHS clinical practice, using a trial-specific PCP manual (a brief version of established PCP clinical practice). Outcomes are: (1) feasibility of recruitment methods, (2) uptake and follow-up rates, (3

  17. The effectiveness of the biannual application of silver nitrate solution followed by sodium fluoride varnish in arresting early childhood caries in preschool children: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Chu, Chun-Hung; Gao, Sherry Shiqian; Li, Samantha Ky; Wong, May Cm; Lo, Edward Cm

    2015-09-25

    The application of 38 % silver diamine fluoride (SDF) has been shown to be effective in arresting early childhood caries (ECC). Since SDF is not available in certain countries, some dentists use adjunctive application of 25 % silver nitrate (AgNO3) and 5 % sodium fluoride (NaF) to arrest ECC. This randomised controlled trial will systematically compare the efficacy of a 25 % AgNO3 solution followed by 5 % NaF varnish with that of a 38 % SDF solution in arresting ECC when applied at half-yearly intervals over a 30-month period. This study is a randomised, double-blinded, non-inferiority clinical trial. The hypothesis tested is that adjunctive application of 25 % AgNO3 followed by 5 % NaF is at least not appreciably worse than a 38 % SDF in arresting ECC. Approximately 3100 kindergarten children aged 3-4 years will be screened and at least 1070 children with caries will be recruited. This sample size is sufficient for an appropriate statistical analysis (power at 90 % (β = 0.10) with a 2-sided type-I error of α = 0.05), allowing for an overall 20 % drop-out rate. The children will be randomly allocated into 2 groups to treat their caries over a 30-month period: Group A - biannual adjunctive application of a 25 % AgNO3 solution and a 5 % NaF varnish, and Group B - biannual adjunctive application of a 38 % SDF solution followed by a placebo varnish. Clinical examinations will be conducted at 6-month intervals. Primary outcome measured is the number of active caries surfaces which are arrested. Information on confounding factors such as oral hygiene habits will be collected through a parental questionnaire. We expect that adjunctive application of 25 % AgNO3 solution and 5 % NaF varnish and of 38 % SDF solution can both effectively arrest ECC. Lower concentrations of silver and fluoride are contained in 25 % AgNO3 and 5 % NaF, respectively, than in 38 % SDF; therefore, AgNO3/NaF are more favourable for use in young children. Because its use for caries management is

  18. Reduction of postoperative chemotherapy in children with stage I intermediate-risk and anaplastic Wilms' tumour (SIOP 93-01 trial): a randomised controlled trial

    NARCIS (Netherlands)

    de Kraker, J.; Graf, N.; van Tinteren, H.; Pein, F.; Sandstedt, B.; Godzinski, J.; Tournade, M. F.

    2004-01-01

    Background Present treatment for Wilms' tumour is very successful. Now, efforts are aimed at reducing toxicity and burden of treatment by shortening schedules without loss of effectiveness. The objective of this randomised trial was to assess whether postoperative chemotherapy for patients with

  19. Effect of Short-Term Supplementation with Ready-to-Use Therapeutic Food or Micronutrients for Children after Illness for Prevention of Malnutrition: A Randomised Controlled Trial in Uganda.

    Directory of Open Access Journals (Sweden)

    Saskia van der Kam

    2016-02-01

    Full Text Available Globally, Médecins Sans Frontières (MSF treats more than 300,000 severely malnourished children annually. Malnutrition is not only caused by lack of food but also by illnesses and by poor infant and child feeding practices. Breaking the vicious cycle of illness and malnutrition by providing ill children with nutritional supplementation is a potentially powerful strategy for preventing malnutrition that has not been adequately investigated. Therefore, MSF investigated whether incidence of malnutrition among ill children <5 y old could be reduced by providing a fortified food product or micronutrients during their 2-wk convalescence period. Two trials, one in Nigeria and one in Uganda, were conducted; here, we report on the trial that took place in Kaabong, a poor agropastoral region of Karamoja, in east Uganda. While the region of Karamoja shows an acute malnutrition rate between 8.4% and 11.5% of which 2% to 3% severe malnutrition, more than half (58% of the population in the district of Kaabong is considered food insecure.We investigated the effect of two types of nutritional supplementation on the incidence of malnutrition in ill children presenting at outpatient clinics during March 2011 to April 2012 in Kaabong, Karamoja region, Uganda, a resource-poor region where malnutrition is a chronic problem for its seminomadic population. A three-armed, partially-blinded, randomised controlled trial was conducted in children diagnosed with malaria, diarrhoea, or lower respiratory tract infection. Non-malnourished children aged 6 to 59 mo were randomised to one of three arms: one sachet/d of ready-to-use therapeutic food (RUTF, two sachets/d of micronutrient powder (MNP, or no supplement (control for 14 d for each illness over 6 mo. The primary outcome was the incidence of first negative nutritional outcome (NNO during the 6 mo follow-up. NNO was a study-specific measure used to indicate progression to moderate or severe acute malnutrition; it was

  20. Effectiveness of a universal parental support programme to promote health behaviours and prevent overweight and obesity in 6-year-old children in disadvantaged areas, the Healthy School Start Study II, a cluster-randomised controlled trial.

    Science.gov (United States)

    Nyberg, Gisela; Norman, Åsa; Sundblom, Elinor; Zeebari, Zangin; Elinder, Liselotte Schäfer

    2016-01-21

    There is increasing evidence for the effectiveness of parental support programmes to promote healthy behaviours and prevent obesity in children, but only few studies have been conducted among groups with low socio-economic status. The aim of this study was to develop and evaluate the effectiveness of a parental support programme to promote healthy dietary and physical activity habits and to prevent overweight and obesity in six-year-old children in disadvantaged areas. A cluster-randomised controlled trial was carried out in disadvantaged areas in Stockholm. Participants were six-year-old children (n = 378) and their parents. Thirty-one school classes from 13 schools were randomly assigned to intervention (n = 16) and control groups (n = 15). The intervention lasted for 6 months and included: 1) Health information for parents, 2) Motivational Interviewing with parents and 3) Teacher-led classroom activities with children. Physical activity was measured by accelerometry, dietary intake and screen time with a questionnaire, body weight and height were measured and BMI standard deviation score was calculated. Measurements were conducted at baseline, post-intervention and at 5months follow-up. Group effects were examined using Mixed-effect Regression analyses adjusted for sex, parental education and baseline values. Fidelity to all three intervention components was satisfactory. Significant intervention effects were found regarding consumption of unhealthy foods (p = 0.01) and unhealthy drinks (p = 0.01). At follow-up, the effect on intake of unhealthy foods was sustained for boys (p = 0.03). There was no intervention effect on physical activity. Further, the intervention had no apparent effect on BMI sds for the whole sample, but a significant difference between groups was detected among children who were obese at baseline (p = 0.03) which was not sustained at follow-up. The Healthy School Start study shows that it is possible to influence

  1. Trauma-focused cognitive behaviour therapy versus treatment as usual for post traumatic stress disorder (PTSD) in young children aged 3 to 8 years: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Dalgleish, Tim; Goodall, Benjamin; Chadwick, Isobel; Werner-Seidler, Aliza; McKinnon, Anna; Morant, Nicola; Schweizer, Susanne; Panesar, Inderpal; Humphrey, Ayla; Watson, Peter; Lafortune, Louise; Smith, Patrick; Meiser-Stedman, Richard

    2015-03-25

    Following horrific or life-threatening events approximately 10 to 15% of young children develop post traumatic stress disorder (PTSD). The symptoms of this disorder are distressing - nightmares, flashbacks, anger outbursts and disturbed play. These symptoms cause major disruption to a child's functioning and, if left untreated, can persist for many years. As yet, there are no established empirically-validated treatments for PTSD in young children. Trauma-focused cognitive behaviour therapy (TF-CBT) is a psychological intervention that is effective in treating the disorder in older children (8 to 12 years), adolescents and adults. This study examines TF-CBT adapted for children aged between 3 and 8 years. This protocol describes a two-arm exploratory randomised controlled trial comparing TF-CBT to treatment as usual (TAU) in children aged 3 to 8 years with a principal diagnosis of PTSD following a single-event discrete trauma. Using a half-crossover design, 44 participants will be randomly allocated to receive the intervention or to receive TAU. Those allocated to TAU will be offered TF-CBT at the end of the 'treatment' period (approximately 12 weeks) if still indicated. The primary outcome is PTSD diagnosis according to DSM-5 criteria for children 6 years and younger at post-treatment. Secondary outcomes include effects on co-morbid diagnoses and changes in emotion and trauma symptoms at each of the follow-up points (post-treatment, 3-months, 12-months). Additionally, broader efficacy will be considered with regard to treatment feasibility, acceptability and service utilisation. The key targets of the intervention are trauma memory, the interpretation of the meaning of the event, and the management of symptoms. This is the first European trial to examine the efficacy of TF-CBT in alleviating PTSD in very young children. As well as providing much-needed data on the utility of the intervention, this exploratory trial will also allow us to gather important information

  2. Reduced inattention and hyperactivity and improved cognition after marine oil extract (PCSO-524®) supplementation in children and adolescents with clinical and subclinical symptoms of attention-deficit hyperactivity disorder (ADHD): a randomised, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Kean, James D; Sarris, Jerome; Scholey, Andrew; Silberstein, Richard; Downey, Luke A; Stough, Con

    2017-02-01

    This study investigated the effects of a marine oil extract (PCSO-524®) on inattention, hyperactivity, mood and cognition in children and adolescents. PCSO-524® is a standardised lipid extract of the New Zealand green-lipped mussel and is an inflammatory modulator that inhibits the 5'-lipoxygenase and cyclooxygenase pathways and decreases concentrations of the pro-inflammatory arachidonic acid (AA). PCSO-524® or a matched placebo was administered for 14 weeks to 144 participants (123 males/21 females; mean age 8.7 years) with high hyperactivity and inattention in a randomised, double-blind, placebo-controlled study. The primary outcome was the Conners Parent Rating Scale assessing parental reports of behavioural problems. Secondary outcomes assessed changes in cognition and mood. The results of the present study did not support the hypothesis that PCSO-524® improves parental reports of hyperactivity, inattention and impulsivity in children ages 6 to 14 years over placebo. Repeated measures ANOVA on post hoc subsample analysis indicated significant improvements in hyperactivity (p = 0.04), attention (p = 0.02), learning (p = 0.05) and probability of ADHD (p = 0.04) with a medium to large average effect size (d = 0.65) in those children who did not meet criteria for combined hyperactivity and inattention. Furthermore, significant improvements in the PCSO-524® group were indicated in a whole sample repeated measures ANCOVA on recognition memory between baseline and week 8 over placebo (p = 0.02, d = 0.56); this difference was not sustained at week 14. The results presented indicate that PCSO-524® may be beneficial in reducing levels of hyperactivity and inattention in a population of children with clinical and subclinical symptoms of ADHD.

  3. A crossover randomised and controlled trial of the impact of active video games on motor coordination and perceptions of physical ability in children at risk of Developmental Coordination Disorder.

    Science.gov (United States)

    Straker, L; Howie, E; Smith, A; Jensen, L; Piek, J; Campbell, A

    2015-08-01

    Impaired motor development can significantly affect a child's life and may result in an increased risk of a range of physical and psychological disorders. Active video game (AVG) interventions have been demonstrated to enhance motor skills in children with Developmental Coordination Disorder (DCD); however a home-based intervention has not been assessed. The primary aim of this study was to compare the changes in motor coordination between a 16 week period of AVG use, with 16 weeks of normal activities (NAG). The secondary aim was to compare the child and parent perceptions of their physical performance between the AVG and NAG conditions. Twenty-one 9-12 year olds (10 males) were confirmed to be at risk of DCD (⩽ 16th percentile Movement Assessment Battery for Children-2nd edition (MABC-2) and ⩽ 15th percentile Developmental Coordination Disorder Questionnaire (DCDQ)) and participated in this crossover randomised and controlled trial. Data was collected at study entry, after the first 16 week condition and following the final 16 week condition, including; (1) the MABC-2, (2) three-dimensional motion analysis of single leg balance and finger-nose tasks, and (3) parent perception of physical skills. Participant perception of physical skills was collected only after the first and second conditions. There was no significant difference between AVG and NAG for any of the primary variables including the MABC-2, balance centre-of-mass path distance and finger-nose path distance. There was no significant intervention effect for secondary measures of motor coordination; however the children perceived their motor skills to be significantly enhanced as a result of the AVG intervention in comparison to the period of no intervention. A 16 week home based AVG intervention did not enhance motor skills in children with DCD, although they perceived their physical skills to be significantly improved. Australia and New Zealand Clinical trials Registry (ACTRN 12611000400965

  4. Effectiveness of a universal parental support programme to promote healthy dietary habits and physical activity and to prevent overweight and obesity in 6-year-old children: the Healthy School Start Study, a cluster-randomised controlled trial.

    Science.gov (United States)

    Nyberg, Gisela; Sundblom, Elinor; Norman, Åsa; Bohman, Benjamin; Hagberg, Jan; Elinder, Liselotte Schäfer

    2015-01-01

    To develop and evaluate the effectiveness of a parental support programme to promote healthy dietary and physical activity habits and to prevent overweight and obesity in Swedish children. A cluster-randomised controlled trial was carried out in areas with low to medium socio-economic status. Participants were six-year-old children (n = 243) and their parents. Fourteen pre-school classes were randomly assigned to intervention (n = 7) and control groups (n = 7). The intervention lasted for 6 months and included: 1) Health information for parents, 2) Motivational Interviewing with parents and 3) Teacher-led classroom activities with children. Physical activity was measured by accelerometry, dietary and physical activity habits and parental self-efficacy through a questionnaire. Body weight and height were measured and BMI standard deviation score was calculated. Measurements were conducted at baseline, post-intervention and at 6-months follow-up. Group differences were examined using analysis of covariance and Poisson regression, adjusted for gender and baseline values. There was no significant intervention effect in the primary outcome physical activity. Sub-group analyses showed a significant gender-group interaction in total physical activity (TPA), with girls in the intervention group demonstrating higher TPA during weekends (p = 0.04), as well as in sedentary time, with boys showing more sedentary time in the intervention group (p = 0.03). There was a significantly higher vegetable intake (0.26 servings) in the intervention group compared to the control group (p = 0.003). At follow-up, sub-group analyses showed a sustained effect for boys. The intervention did not affect the prevalence of overweight or obesity. It is possible to influence vegetable intake in children and girls' physical activity through a parental support programme. The programme needs to be intensified in order to increase effectiveness and sustain the effects long-term. These findings are an

  5. Effectiveness of a universal parental support programme to promote healthy dietary habits and physical activity and to prevent overweight and obesity in 6-year-old children: the Healthy School Start Study, a cluster-randomised controlled trial.

    Directory of Open Access Journals (Sweden)

    Gisela Nyberg

    Full Text Available To develop and evaluate the effectiveness of a parental support programme to promote healthy dietary and physical activity habits and to prevent overweight and obesity in Swedish children.A cluster-randomised controlled trial was carried out in areas with low to medium socio-economic status. Participants were six-year-old children (n = 243 and their parents. Fourteen pre-school classes were randomly assigned to intervention (n = 7 and control groups (n = 7. The intervention lasted for 6 months and included: 1 Health information for parents, 2 Motivational Interviewing with parents and 3 Teacher-led classroom activities with children. Physical activity was measured by accelerometry, dietary and physical activity habits and parental self-efficacy through a questionnaire. Body weight and height were measured and BMI standard deviation score was calculated. Measurements were conducted at baseline, post-intervention and at 6-months follow-up. Group differences were examined using analysis of covariance and Poisson regression, adjusted for gender and baseline values.There was no significant intervention effect in the primary outcome physical activity. Sub-group analyses showed a significant gender-group interaction in total physical activity (TPA, with girls in the intervention group demonstrating higher TPA during weekends (p = 0.04, as well as in sedentary time, with boys showing more sedentary time in the intervention group (p = 0.03. There was a significantly higher vegetable intake (0.26 servings in the intervention group compared to the control group (p = 0.003. At follow-up, sub-group analyses showed a sustained effect for boys. The intervention did not affect the prevalence of overweight or obesity.It is possible to influence vegetable intake in children and girls' physical activity through a parental support programme. The programme needs to be intensified in order to increase effectiveness and sustain the effects long-term. These findings

  6. Effects of the Informed Health Choices primary school intervention on the ability of children in Uganda to assess the reliability of claims about treatment effects: a cluster-randomised controlled trial.

    Science.gov (United States)

    Nsangi, Allen; Semakula, Daniel; Oxman, Andrew D; Austvoll-Dahlgren, Astrid; Oxman, Matt; Rosenbaum, Sarah; Morelli, Angela; Glenton, Claire; Lewin, Simon; Kaseje, Margaret; Chalmers, Iain; Fretheim, Atle; Ding, Yunpeng; Sewankambo, Nelson K

    2017-07-22

    Claims about what improves or harms our health are ubiquitous. People need to be able to assess the reliability of these claims. We aimed to evaluate an intervention designed to teach primary school children to assess claims about the effects of treatments (ie, any action intended to maintain or improve health). In this cluster-randomised controlled trial, we included primary schools in the central region of Uganda that taught year-5 children (aged 10-12 years). We excluded international schools, special needs schools for children with auditory and visual impairments, schools that had participated in user-testing and piloting of the resources, infant and nursery schools, adult education schools, and schools that were difficult for us to access in terms of travel time. We randomly allocated a representative sample of eligible schools to either an intervention or control group. Intervention schools received the Informed Health Choices primary school resources (textbooks, exercise books, and a teachers' guide). Teachers attended a 2 day introductory workshop and gave nine 80 min lessons during one school term. The lessons addressed 12 concepts essential to assessing claims about treatment effects and making informed health choices. We did not intervene in the control schools. The primary outcome, measured at the end of the school term, was the mean score on a test with two multiple-choice questions for each of the 12 concepts and the proportion of children with passing scores on the same test. This trial is registered with the Pan African Clinical Trial Registry, number PACTR201606001679337. Between April 11, 2016, and June 8, 2016, 2960 schools were assessed for eligibility; 2029 were eligible, and a random sample of 170 were invited to recruitment meetings. After recruitment meetings, 120 eligible schools consented and were randomly assigned to either the intervention group (n=60, 76 teachers and 6383 children) or control group (n=60, 67 teachers and 4430 children

  7. Randomised controlled trial of mesalazine in IBS.

    Science.gov (United States)

    Barbara, Giovanni; Cremon, Cesare; Annese, Vito; Basilisco, Guido; Bazzoli, Franco; Bellini, Massimo; Benedetti, Antonio; Benini, Luigi; Bossa, Fabrizio; Buldrini, Paola; Cicala, Michele; Cuomo, Rosario; Germanà, Bastianello; Molteni, Paola; Neri, Matteo; Rodi, Marcello; Saggioro, Alfredo; Scribano, Maria Lia; Vecchi, Maurizio; Zoli, Giorgio; Corinaldesi, Roberto; Stanghellini, Vincenzo

    2016-01-01

    Low-grade intestinal inflammation plays a role in the pathophysiology of IBS. In this trial, we aimed at evaluating the efficacy and safety of mesalazine in patients with IBS. We conducted a phase 3, multicentre, tertiary setting, randomised, double-blind, placebo-controlled trial in patients with Rome III confirmed IBS. Patients were randomly assigned to either mesalazine, 800 mg, or placebo, three times daily for 12 weeks, and were followed for additional 12 weeks. The primary efficacy endpoint was satisfactory relief of abdominal pain/discomfort for at least half of the weeks of the treatment period. The key secondary endpoint was satisfactory relief of overall IBS symptoms. Supportive analyses were also performed classifying as responders patients with a percentage of affirmative answers of at least 75% or >75% of time. A total of 185 patients with IBS were enrolled from 21 centres. For the primary endpoint, the responder patients were 68.6% in the mesalazine group versus 67.4% in the placebo group (p=0.870; 95% CI -12.8 to 15.1). In explorative analyses, with the 75% rule or >75% rule, the percentage of responders was greater in the mesalazine group with a difference over placebo of 11.6% (p=0.115; 95% CI -2.7% to 26.0%) and 5.9% (p=0.404; 95% CI -7.8% to 19.4%), respectively, although these differences were not significant. For the key secondary endpoint, overall symptoms improved in the mesalazine group and reached a significant difference of 15.1% versus placebo (p=0.032; 95% CI 1.5% to 28.7%) with the >75% rule. Mesalazine treatment was not superior than placebo on the study primary endpoint. However, a subgroup of patients with IBS showed a sustained therapy response and benefits from a mesalazine therapy. ClincialTrials.gov number, NCT00626288. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  8. Effectiveness of a parental training programme in enhancing the parent-child relationship and reducing harsh parenting practices and parental stress in preparing children for their transition to primary school: a randomised controlled trial.

    Science.gov (United States)

    Li, Ho Cheung William; Chan, Sophia S C; Mak, Yim Wah; Lam, Tai Hing

    2013-11-16

    Entering primary school is an important childhood milestone, marking the beginning of a child's formal education. Yet the change creates a time of vulnerability for the child, the parents and the parent-child relationship. Failure to adjust to the transition may place the family in a psychologically devastating position. The aims of this study were to test the effectiveness of a parental training programme in enhancing the parent-child relationship and decreasing parental stress by reducing harsh parenting in preparing children for the transition to primary school. A randomised controlled trial incorporating a two-group pre-test and repeated post-test was conducted in one of the largest public housing estates in Hong Kong. A total of 142 parents were recruited, with 72 parents randomly assigned to the experimental group and 70 to the control group. Harsh parenting practices, parent-child relationships and parental stress were assessed. In comparison to parents in the control group, those in the experimental group engaged in less harsh parenting practices and reported better parent-child relationships. However, parental stress scores did not differ significantly between the two groups. This study addressed a gap in the literature by examining the effectiveness of the training programme for enhancing parent-child relationship and decreasing parental stress at the time of a child's transition to primary school. The findings from this study provide empirical evidence of the effectiveness of the parental training programme and highlight the significance of parenting in promoting a smooth transition for children from kindergarten to primary 1. ClinicalTrials.gov: NCT01845948.

  9. Classroom Promotion of Oral Language (CPOL): protocol for a cluster randomised controlled trial of a school-based intervention to improve children's literacy outcomes at grade 3, oral language and mental health.

    Science.gov (United States)

    Goldfeld, Sharon; Snow, Pamela; Eadie, Patricia; Munro, John; Gold, Lisa; Le, Ha N D; Orsini, Francesca; Shingles, Beth; Lee, Katherine; Connell, Judy; Watts, Amy

    2017-11-20

    Oral language and literacy competence are major influences on children's developmental pathways and life success. Children who do not develop the necessary language and literacy skills in the early years of school then go on to face long-term difficulties. Improving teacher effectiveness may be a critical step in lifting oral language and literacy outcomes. The Classroom Promotion of Oral Language trial aims to determine whether a specifically designed teacher professional learning programme focusing on promoting oral language can lead to improved teacher knowledge and practice, and advance outcomes in oral language and literacy for early years school children, compared with usual practice. This is a two-arm cluster multisite randomised controlled trial conducted within Catholic and Government primary schools across Victoria, Australia. The intervention comprises 4 days of face-to-face professional learning for teachers and ongoing implementation support via a specific worker. The primary outcome is reading ability of the students at grade 3, and the secondary outcomes are teacher knowledge and practice, student mental health, reading comprehension and language ability at grade 1; and literacy, writing and numeracy at grade 3. Economic evaluation will compare the incremental costs of the intervention to the measured primary and secondary outcomes. This trial was approved by the Monash University Human Research Ethics Committee #CF13/2634-2013001403 and later transferred to the University of Melbourne #1545540. The investigators (including Government and Catholic partners) will communicate trial results to stakeholders, collaborators and participating schools and teachers via appropriate presentations and publications. ISRCTN77681972; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  10. Move it to improve it (Mitii): study protocol of a randomised controlled trial of a novel web-based multimodal training program for children and adolescents with cerebral palsy

    Science.gov (United States)

    Boyd, Roslyn N; Mitchell, Louise E; James, Sarah T; Ziviani, Jenny; Sakzewski, Leanne; Smith, Anthony; Rose, Stephen; Cunnington, Ross; Whittingham, Koa; Ware, Robert S; Comans, Tracey A; Scuffham, Paul A

    2013-01-01

    Introduction Persons with cerebral palsy require a lifetime of costly and resource intensive interventions which are often limited by equity of access. With increasing burden being placed on health systems, new methods to deliver intensive rehabilitation therapies are needed. Move it to improve it (Mitii) is an internet-based multimodal programme comprising upper-limb and cognitive training with physical activity. It can be accessed in the client's home at their convenience. The proposed study aims to test the efficacy of Mitii in improving upper-limb function and motor planning. Additionally, this study hopes to further our understanding of the central neurovascular mechanisms underlying the proposed changes and determine the cost effectiveness of Mitii. Methods and analysis Children with congenital hemiplegia will be recruited to participate in this waitlist control, matched pairs, single-blind randomised trial. Children be matched at baseline and randomly allocated to receive 20 weeks of 30 min of daily Mitii training immediately, or waitlisted for 20 weeks before receiving the same Mitii training (potential total dose=70 h). Outcomes will be assessed at 20 weeks after the start of Mitii, and retention effects tested at 40 weeks. The primary outcomes will be the Assessment of Motor and Process Skills (AMPS), the Assisting Hand Assessment (AHA) and unimanual upper-limb capacity using the Jebsen-Taylor Test of Hand Function (JTTHF). Advanced brain imaging will assess use-dependant neuroplasticity. Measures of body structure and functions, activity, participation and quality of life will be used to assess Mitii efficacy across all domains of the International Classification of Functioning, Disability and Health framework. Ethics and dissemination This project has received Ethics Approval from the Medical Ethics Committee of The University of Queensland (2011000608) and the Royal Children's Hospital Brisbane (HREC/11/QRCH/35). Findings will be

  11. A multi-centre open-label randomised non-inferiority trial comparing watchful waiting to antibiotic treatment for acute otitis media without perforation in low-risk urban Aboriginal and Torres Strait Islander children (the WATCH trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Abbott, Penelope; Gunasekera, Hasantha; Leach, Amanda Jane; Askew, Deborah; Walsh, Robyn; Kong, Kelvin; Girosi, Federico; Bond, Chelsea; Morris, Peter; Lujic, Sanja; Hu, Wendy; Usherwood, Tim; Tyson, Sissy; Spurling, Geoffrey; Douglas, Markeeta; Schubert, Kira; Chapman, Shavaun; Siddiqui, Nadeem; Murray, Reeion; Rabbitt, Keitha; Porykali, Bobby; Woodall, Cheryl; Newman, Tina; Reath, Jennifer

    2016-03-03

    Treatment guidelines recommend watchful waiting for children older than 2 years with acute otitis media (AOM) without perforation, unless they are at high risk of complications. The high prevalence of chronic suppurative otitis media (CSOM) in remote Aboriginal and Torres Strait Islander communities leads these children to be classified as high risk. Urban Aboriginal and Torres Strait Islander children are at lower risk of complications, but evidence to support the subsequent recommendation for watchful waiting in this population is lacking. This non-inferiority multi-centre randomised controlled trial will determine whether watchful waiting is non-inferior to immediate antibiotics for urban Aboriginal and Torres Strait Islander children with AOM without perforation. Children aged 2 - 16 years with AOM who are considered at low risk for complications will be recruited from six participating urban primary health care services across Australia. We will obtain informed consent from each participant or their guardian. The primary outcome is clinical resolution on day 7 (no pain, no fever of at least 38 °C, no bulging eardrum and no complications of AOM such as perforation or mastoiditis) as assessed by general practitioners or nurse practitioners. Participants and outcome assessors will not be blinded to treatment. With a sample size of 198 children in each arm, we have 80 % power to detect a non-inferiority margin of up to 10 % at a significance level of 5 %, assuming clinical improvement of at least 80 % in both groups. Allowing for a 20 % dropout rate, we aim to recruit 495 children. We will analyse both by intention-to-treat and per protocol. We will assess the cost- effectiveness of watchful waiting compared to immediate antibiotic prescription. We will also report on the implementation of the trial from the perspectives of parents/carers, health professionals and researchers. The trial will provide evidence for the safety and effectiveness of watchful waiting

  12. Influence of reported study design characteristics on intervention effect estimates from randomised controlled trials

    DEFF Research Database (Denmark)

    Savović, J; Jones, He; Altman, Dg

    2012-01-01

    The design of randomised controlled trials (RCTs) should incorporate characteristics (such as concealment of randomised allocation and blinding of participants and personnel) that avoid biases resulting from lack of comparability of the intervention and control groups. Empirical evidence suggests...

  13. Cost-effectiveness analysis of a communication-focused therapy for pre-school children with autism: results from a randomised controlled trial.

    Science.gov (United States)

    Byford, Sarah; Cary, Maria; Barrett, Barbara; Aldred, Catherine R; Charman, Tony; Howlin, Patricia; Hudry, Kristelle; Leadbitter, Kathy; Le Couteur, Ann; McConachie, Helen; Pickles, Andrew; Slonims, Vicky; Temple, Kathryn J; Green, Jonathan

    2015-12-21

    Autism is associated with impairments that have life-time consequences for diagnosed individuals and a substantial impact on families. There is growing interest in early interventions for children with autism, yet despite the substantial economic burden, there is little evidence of the cost-effectiveness of such interventions with which to support resource allocation decisions. This study reports an economic evaluation of a parent-mediated, communication-focused therapy carried out within the Pre-School Autism Communication Trial (PACT). 152 pre-school children with autism were randomly assigned to treatment as usual (TAU) or PACT + TAU. Primary outcome was severity of autism symptoms at 13-month follow-up. Economic data included health, education and social services, childcare, parental productivity losses and informal care. Clinically meaningful symptom improvement was evident for 53 % of PACT + TAU versus 41 % of TAU (odds ratio 1.91, p = 0.074). Service costs were significantly higher for PACT + TAU (mean difference £4,489, p < 0.001), but the difference in societal costs was smaller and non-significant (mean difference £1,385, p = 0.788) due to lower informal care rates for PACT + TAU. Improvements in outcome generated by PACT come at a cost. Although this cost is lower when burden on parents is included, the cost and effectiveness results presented do not support the cost-effectiveness of PACT + TAU compared to TAU alone. Current Controlled Trials ISRCTN58133827.

  14. Efficacy of human rotavirus vaccine against severe gastroenteritis in Malawian children in the first two years of life: a randomised, double-blind, placebo controlled trial

    Science.gov (United States)

    Cunliffe, Nigel A; Witte, Desiree; Ngwira, Bagrey M; Todd, Stacy; Bostock, Nancy J; Turner, Ann M; Chimpeni, Philips; Victor, John C; Steele, A Duncan; Bouckenooghe, Alain; Neuzil, Kathleen M

    2014-01-01

    Rotavirus gastroenteritis is a major cause of morbidity and mortality among African infants and young children. A phase III, placebo-controlled, multi-centre clinical trial of a live, oral G1P[8] human rotavirus vaccine (RIX4414) undertaken in Malawi and South Africa significantly reduced the incidence of severe rotavirus gastroenteritis in the first year of life. We now report on vaccine efficacy in the Malawi cohort of children who were followed into the second year of life. A total of 1,773 healthy infants were enrolled in Blantyre, Malawi into three groups. Two groups received three doses of RIX4414 or placebo at age 6, 10, and 14 weeks and the third group received placebo at 6 weeks and RIX4414 at age 10 and 14 weeks. Subjects were followed by weekly home visits for episodes of gastroenteritis until 1 year of age, and were then re-consented for further follow-up to 18-24 months of age. Severity of gastroenteritis episodes was graded according to the Vesikari scoring system. Seroconversion for anti-rotavirus IgA was determined on a subset of children by using ELISA on pre- and post-vaccine blood samples. Rotavirus VP7 (G) and VP4 (P) genotypes were determined by RT-PCR. A total of 70/1030 (6.8%, 95% CI 5.3 - 8.5) subjects in the pooled (2 dose plus 3 dose) RIX4414 group compared with 53/483 (11.0%, 8.3 – 14.1) subjects in the placebo group developed severe rotavirus gastroenteritis in the entire follow-up period (Vaccine Efficacy 38.1% (9.8 – 57.3). The point estimate of efficacy in the second year of life (17.6%; −59.2 – 56.0) was lower than in the first year of life (49.4%; 19.2 – 68.3). There were non-significant trends towards a higher efficacy in the second year of life among children who received the three-dose schedule compared with the two-dose schedule, and a higher anti-rotavirus IgA seroresponse rate in the three-dose RIX4414 group. Rotavirus strains detected included genotype G12 (31%); G9 (23%); and G8 (18%); only 18% of strains belonged

  15. The maturation of randomised controlled trials in mental health ...

    African Journals Online (AJOL)

    The aims of this paper are: (i) to give an overview of the use and maturation of randomised controlled trials (RCTs) in mental health services research, (ii) to indicate areas in which mental health may present particular challenges, and (iii) to outline necessary steps to strengthen the capacity to conduct better quality ...

  16. A Randomised Controlled Trial of Two Early Intervention Programs for Young Children with Autism: Centre-Based with Parent Program and Home-Based

    Science.gov (United States)

    Roberts, Jacqueline; Williams, Katrina; Carter, Mark; Evans, David; Parmenter, Trevor; Silove, Natalie; Clark, Trevor; Warren, Anthony

    2011-01-01

    This study compares outcomes of early intervention programs for young children with autism; an individualised home-based program (HB), a small group centre-based program for children combined with a parent training and support group (CB) and a non-treatment comparison group (WL). Outcome measures of interest include social and communication skill…

  17. School Based Cognitive Behavioural Therapy Targeting Anxiety in Children with Autistic Spectrum Disorder: A Quasi-Experimental Randomised Controlled Trail Incorporating a Mixed Methods Approach

    Science.gov (United States)

    Clarke, Chris; Hill, Vivian; Charman, Tony

    2017-01-01

    Children with a diagnosis of autism are more likely to experience anxiety than their typically developing peers. Research suggests that Cognitive Behavioural Therapy (CBT) could offer a way to help children with autism manage their anxiety but most evidence is based on clinical trials. This study investigated a school-based CBT programme using a…

  18. Effect of a training and educational intervention for physicians and caregivers on antibiotic prescribing for upper respiratory tract infections in children at primary care facilities in rural China: a cluster-randomised controlled trial.

    Science.gov (United States)

    Wei, Xiaolin; Zhang, Zhitong; Walley, John D; Hicks, Joseph P; Zeng, Jun; Deng, Simin; Zhou, Yu; Yin, Jia; Newell, James N; Sun, Qiang; Zou, Guanyang; Guo, Yan; Upshur, Ross E G; Lin, Mei

    2017-12-01

    Inappropriate antibiotic prescribing contributes to the generation of drug resistance worldwide, and is particularly common in China. We assessed the effectiveness of an antimicrobial stewardship programme aiming to reduce inappropriate antibiotic prescribing in paediatric outpatients by targeting providers and caregivers in primary care hospitals in rural China. We did a pragmatic, cluster-randomised controlled trial with a 6-month intervention period. Clusters were primary care township hospitals in two counties of Guangxi province in China, which were randomly allocated to the intervention group or the control group (in a 1:1 ratio in Rong county and in a 5:6 ratio in Liujiang county). Randomisation was stratified by county. Eligible participants were children aged 2-14 years who attended a township hospital as an outpatient and were given a prescription following a primary diagnosis of an upper respiratory tract infection. The intervention included clinician guidelines and training on appropriate prescribing, monthly prescribing peer-review meetings, and brief caregiver education. In hospitals allocated to the control group, usual care was provided, with antibiotics prescribed at the individual clinician's discretion. Patients were masked to their allocated treatment group but doctors were not. The primary outcome was the antibiotic prescription rate in children attending the hospitals, defined as the cluster-level proportion of prescriptions for upper respiratory tract infections in 2-14-year-old outpatients, issued during the final 3 months of the 6-month intervention period (endline), that included one or more antibiotics. The outcome was based on prescription records and analysed by modified intention-to-treat. This study is registered with the ISRCTN registry, number ISRCTN14340536. We recruited all 25 eligible township hospitals in the two counties (14 hospitals in Rong county and 11 in Liujiang county), and randomly allocated 12 to the intervention group

  19. Can an educational podcast improve the ability of parents of primary school children to assess the reliability of claims made about the benefits and harms of treatments: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Semakula, Daniel; Nsangi, Allen; Oxman, Matt; Austvoll-Dahlgren, Astrid; Rosenbaum, Sarah; Kaseje, Margaret; Nyirazinyoye, Laetitia; Fretheim, Atle; Chalmers, Iain; Oxman, Andrew D; Sewankambo, Nelson K

    2017-01-21

    Claims made about the effects of treatments are very common in the media and in the population more generally. The ability of individuals to understand and assess such claims can affect their decisions and health outcomes. Many people in both low- and high-income countries have inadequate aptitude to assess information about the effects of treatments. As part of the Informed Healthcare Choices project, we have prepared a series of podcast episodes to help improve people's ability to assess claims made about treatment effects. We will evaluate the effect of the Informed Healthcare Choices podcast on people's ability to assess claims made about the benefits and harms of treatments. Our study population will be parents of primary school children in schools with limited educational and financial resources in Uganda. This will be a two-arm, parallel-group, individual-randomised trial. We will randomly allocate consenting participants who meet the inclusion criteria for the trial to either listen to nine episodes of the Informed Healthcare Choices podcast (intervention) or to listen to nine typical public service announcements about health issues (control). Each podcast includes a story about a treatment claim, a message about one key concept that we believe is important for people to be able to understand to assess treatment claims, an explanation of how that concept applies to the claim, and a second example illustrating the concept. We designed the Claim Evaluation Tools to measure people's ability to apply key concepts related to assessing claims made about the effects of treatments and making informed health care choices. The Claim Evaluation Tools that we will use include multiple-choice questions addressing each of the nine concepts covered by the podcast. Using the Claim Evaluation Tools, we will measure two primary outcomes: (1) the proportion that 'pass', based on an absolute standard and (2) the average score. As far as we are aware this is the first

  20. The effects of a strength and neuromuscular exercise programme for the lower extremity on knee load, pain and function in obese children and adolescents: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Horsak, Brian; Artner, David; Baca, Arnold; Pobatschnig, Barbara; Greber-Platzer, Susanne; Nehrer, Stefan; Wondrasch, Barbara

    2015-12-23

    Childhood obesity is one of the most critical and accelerating health challenges throughout the world. It is a major risk factor for developing varus/valgus misalignments of the knee joint. The combination of misalignment at the knee and excess body mass may result in increased joint stresses and damage to articular cartilage. A training programme, which aims at developing a more neutral alignment of the trunk and lower limbs during movement tasks may be able to reduce knee loading during locomotion. Despite the large number of guidelines for muscle strength training and neuromuscular exercises that exist, most are not specifically designed to target the obese children and adolescent demographic. Therefore, the aim of this study is to evaluate a training programme which combines strength and neuromuscular exercises specifically designed to the needs and limitations of obese children and adolescents and analyse the effects of the training programme from a biomechanical and clinical point of view. A single assessor-blinded, pre-test and post-test randomised controlled trial, with one control and one intervention group will be conducted with 48 boys and girls aged between 10 and 18 years. Intervention group participants will receive a 12-week neuromuscular and quadriceps/hip strength training programme. Three-dimensional (3D) gait analyses during level walking and stair climbing will be performed at baseline and follow-up sessions. The primary outcome parameters for this study will be the overall peak external frontal knee moment and impulse during walking. Secondary outcomes include the subscales of the Knee injury and Osteoarthritis Outcome Score (KOOS), frontal and sagittal kinematics and kinetics for the lower extremities during walking and stair climbing, ratings of change in knee-related well-being, pain and function and adherence to the training programme. In addition, the training programme will be evaulated from a clinical and health status perspective by

  1. Cost-effectiveness analysis of a home-based social work intervention for children and adolescents who have deliberately poisoned themselves. Results of a randomised controlled trial.

    Science.gov (United States)

    Byford, S; Harrington, R; Torgerson, D; Kerfoot, M; Dyer, E; Harrington, V; Woodham, A; Gill, J; McNiven, F

    1999-01-01

    Little evidence exists regarding the effectiveness or cost-effectiveness of alternative treatment services in the field of child and adolescent psychiatry. To assess the cost-effectiveness of a home-based social work intervention for young people who have deliberately poisoned themselves. Children aged work intervention (n = 85). Clinical and resource-use data were assessed over six months from the date of trial entry. No significant differences were found between the two groups in terms of the main outcome measures or costs. In a sub-group of children without major depression, suicidal ideation was significantly lower in the intervention group at the six-month follow-up (P = 0.01), with no significant differences in cost. A family-based social work intervention for children and adolescents who have deliberately poisoned themselves is as cost-effective as routine care alone.

  2. Protocol study for a randomised, controlled, double-blind, clinical trial involving virtual reality and anodal transcranial direct current stimulation for the improvement of upper limb motor function in children with Down syndrome.

    Science.gov (United States)

    Lopes, Jamile Benite Palma; Grecco, Luanda André Collange; Moura, Renata Calhes Franco de; Lazzari, Roberta Delasta; Duarte, Natalia de Almeida Carvalho; Miziara, Isabela; Melo, Gileno Edu Lameira de; Dumont, Arislander Jonathan Lopes; Galli, Manuela; Santos Oliveira, Claudia

    2017-08-11

    Down syndrome results in neuromotor impairment that affects selective motor control, compromising the acquisition of motor skills and functional independence. The aim of the proposed study is to evaluate and compare the effects of multiple-monopolar anodal transcranial direct current stimulation and sham stimulation over the primary motor cortex during upper limb motor training involving virtual reality on motor control, muscle activity, cerebral activity and functional independence. A randomised, controlled, double-blind, clinical trial is proposed. The calculation of the sample size will be defined based on the results of a pilot study involving the same methods. The participants will be randomly allocated to two groups. Evaluations will be conducted before and after the intervention as well as 1 month after the end of the intervention process. At each evaluation, three-dimensional analysis of upper limb movement muscle activity will be measured using electromyography, cerebral activity will be measured using an electroencephalogram system and intellectual capacity will be assessed using the Wechsler Intelligence Scale for Children. Virtual reality training will be performed three times a week (one 20 min session per day) for a total of 10 sessions. During the protocol, transcranial stimulation will be administered concomitantly to upper limb motor training. The results will be analysed statistically, with a p value≤0.05 considered indicative of statistical significance. The present study received approval from the Institutional Review Board of Universidade Nove de Julho (Sao Paulo,Brazil) under process number 1.540.113 and is registered with the Brazilian Registry of Clinical Trials (N° RBR3PHPXB). The participating institutions have presented a declaration of participation. The volunteers will be permitted to drop out of the study at any time with no negative repercussions. The results will be published and will contribute evidence regarding the use of

  3. Effect of co-trimoxazole on mortality in HIV-exposed but uninfected children in Botswana (the Mpepu Study: a double-blind, randomised, placebo-controlled trial

    Directory of Open Access Journals (Sweden)

    Shahin Lockman, MD

    2017-05-01

    Full Text Available Summary: Background: Co-trimoxazole prophylaxis reduces mortality among HIV-infected children, but efficacy in HIV-exposed but uninfected (HEU children in a non-malarial, low-breastfeeding setting with a low risk of mother-to-child transmission of HIV is unclear. Methods: HEU children in Botswana were randomly assigned to receive co-trimoxazole (100 mg/20 mg once daily until age 6 months and 200 mg/40 mg once daily thereafter or placebo from age 14–34 days to age 15 months. Mothers chose whether to breastfeed or formula feed their children. Breastfed children were randomly assigned to breastfeeding for 6 months (Botswana guidelines or 12 months (WHO guidelines. The primary outcome, analysed by a modified intention-to-treat approach, was cumulative child mortality from treatment assignment to age 18 months. We also assessed HIV-free survival by duration of breastfeeding. This trial is registered with ClinicalTrials.gov, number NCT01229761. Findings: From June 7, 2011, to April 2, 2015, 2848 HEU children were randomly assigned to receive co-trimoxazole (n=1423 or placebo (n=1425. The data and safety monitoring board stopped the study early because of a low likelihood of benefit with co-trimoxazole. Only 153 (5% children were lost to follow-up (76 in the co-trimoxazole group and 77 in the placebo group, and 2053 (72% received treatment continuously to age 15 months, death, or study closure. Mortality after the start of study treatment was similar in the two study groups: 30 children died in the co-trimoxazole group, compared with 34 in the placebo group (estimated mortality at 18 months 2·4% vs 2·6%; difference −0·2%, 95% CI −1·5 to 1·0, p=0·70. We saw no difference in hospital admissions between groups (12·5% in the co-trimoxazole group vs 17·4% in the placebo group, p=0·19 or grade 3–4 clinical adverse events (16·5% vs 18·4%, p=0·18. Grade 3–4 anaemia did not differ between groups (8·1% vs 8·3%, p=0·93, but grade 3–4

  4. Effects of a restricted elimination diet on the behaviour of children with attention-deficit hyperactivity disorder (INCA study) : a randomised controlled trial

    NARCIS (Netherlands)

    Pelsser, Lidy M.; Frankena, Klaas; Toorman, Jan; Savelkoul, Huub F.; Dubois, Anthony E.; Pereira, Rob Rodrigues; Haagen, Ton A.; Rommelse, Nanda N.; Buitelaar, Jan K.

    2011-01-01

    Background The effects of a restricted elimination diet in children with attention-deficit hyperactivity disorder (ADHD) have mainly been investigated in selected subgroups of patients. We aimed to investigate whether there is a connection between diet and behaviour in an unselected group of

  5. Managing Repetitive Behaviours in Young Children with Autism Spectrum Disorder (ASD): Pilot Randomised Controlled Trial of a New Parent Group Intervention

    Science.gov (United States)

    Grahame, Victoria; Brett, Denise; Dixon, Linda; McConachie, Helen; Lowry, Jessica; Rodgers, Jacqui; Steen, Nick; Le Couteur, Ann

    2015-01-01

    Early intervention for autism spectrum disorder (ASD) tends to focus on enhancing social-communication skills. We report the acceptability, feasibility and impact on child functioning of a new 8 weeks parent-group intervention to manage restricted and repetitive behaviours (RRB) in young children with ASD aged 3-7 years. Forty-five families took…

  6. Medium-dose riboflavin as a prophylactic agent in children with migraine: a preliminary placebo-controlled, randomised, double-blind, cross-over trial

    NARCIS (Netherlands)

    de Bruijn, J; Duivenvoorden, H.J.; Passchier, J.; Locher, H.; Dijkstra, N.; Arts, W.F.

    2010-01-01

    Background: Riboflavin seems to have a promising effect on migraine in adults. The present study examines whether riboflavin has a prophylactic effect on migraine in children. Objective: To investigate whether riboflavin in a dosage of 50 mg/day has a prophylactic effect on migraine attacks in young

  7. Medium-dose riboflavin as a prophylactic agent in children with migraine: A preliminary placebo-controlled, randomised, double-blind, cross-over trial

    NARCIS (Netherlands)

    J.K.J. Bruijn (Jacques); H.J. Duivenvoorden (Hugo); J. Passchier (Jan); H. Locher (Heiko); N. Dijkstra (Natascha); W.F.M. Arts (Willem Frans)

    2010-01-01

    textabstractBackground: Riboflavin seems to have a promising effect on migraine in adults. The present study examines whether riboflavin has a prophylactic effect on migraine in children. Objective: To investigate whether riboflavin in a dosage of 50 mg/day has a prophylactic effect on migraine

  8. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children: design of a cluster randomised controlled trial

    NARCIS (Netherlands)

    Veldhuis, L.; Struijk, M.K.; Kroeze, W.; Oenema, A.; Renders, C.M.; Bunschoten, A.M.W.; Hira Sing, R.A.; Raat, H.

    2009-01-01

    Background. The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence of

  9. 'Be active, eat right', evaluation of an overweight prevention protocol among 5-year-old children : Design of a cluster randomised controlled trial

    NARCIS (Netherlands)

    L. Veldhuis (Lydian); M.K. Struijk (Mirjam); W. Kroeze (Willemieke); A. Oenema (Anke); C.M. Renders (Carry); A.M.W. Bulk-Bunschoten (Anneke); R.A. Hirasing (Remy); H. Raat (Hein)

    2009-01-01

    textabstractBACKGROUND: The prevalence of overweight and obesity in children has at least doubled in the past 25 years with a major impact on health. In 2005 a prevention protocol was developed applicable within Youth Health Care. This study aims to assess the effects of this protocol on prevalence

  10. Neonatal ECMO Study of Temperature (NEST - a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Juszczak Edmund

    2010-04-01

    Full Text Available Abstract Background Existing evidence indicates that once mature neonates with severe cardio-respiratory failure become eligible for Extra Corporeal Membrane Oxygenation (ECMO their chances of intact survival are doubled if they actually receive ECMO. However, significant numbers survive with disability. NEST is a multi-centre randomised controlled trial designed to test whether, in neonates requiring ECMO, cooling to 34°C for the first 48 to 72 hours of their ECMO course leads to improved later health status. Infants allocated to the control group will receive ECMO at 37°C throughout their course, which is currently standard practice around the world. Health status of both groups will be assessed formally at 2 years corrected age. Methods/Design All infants recruited to the study will be cared for in one of the four United Kingdom (UK ECMO centres. Babies who are thought to be eligible will be assessed by the treating clinician who will confirm eligibility, ensure that consent has been obtained and then randomise the baby using a web based system, based at the National Perinatal Epidemiology Unit (NPEU Clinical Trials Unit. Trial registration. Babies allocated ECMO without cooling will receive ECMO at 37°C ± 0.2°C. Babies allocated ECMO with cooling will be managed at 34°C ± 0.2°C for up to 72 hours from the start of their ECMO run. The minimum duration of cooling will be 48 hours. Rewarming (to 37°C will occur at a rate of no more than 0.5°C per hour. All other aspects of ECMO management will be identical. Primary outcome: Cognitive score from the Bayley Scales of Infant and Toddler Development, 3rd edition (Bayley-III at age of 2 years (24 - 27 months. Discussion For the primary analysis, children will be analysed in the groups to which they are assigned, comparing the outcome of all babies allocated to "ECMO with cooling" with all those allocated to "ECMO" alone, regardless of deviation from the protocol or treatment received. For

  11. Serum zinc, copper and iron status of children with coeliac disease on three months of gluten-free diet with or without four weeks of zinc supplements: a randomised controlled trial.

    Science.gov (United States)

    Negi, K; Kumar, R; Sharma, L; Datta, S P; Choudhury, M; Kumar, P

    2018-04-01

    Data about the effect of zinc supplementation with gluten-free diet on normalisation of plasma zinc, copper and iron in patients with coeliac disease are scanty. We evaluated the effect of zinc supplementation on serum zinc, copper and iron levels in patients with coeliac disease, by randomising 71 children newly diagnosed with coeliac disease into two groups: Group A = gluten-free diet (GFD); and Group B = gluten-free diet with zinc supplements (GFD +Zn). The rise in iron and zinc was significantly higher in the latter, but the mean rise of copper levels was slightly higher in the former, but the difference was not significant.

  12. Randomised controlled trial of biofeedback training in persistent encopresis with anismus.

    Science.gov (United States)

    Nolan, T; Catto-Smith, T; Coffey, C; Wells, J

    1998-08-01

    Paradoxical external anal sphincter contraction during attempted defecation (anismus) is thought to be an important contributor to chronic faecal retention and encopresis in children. Biofeedback training can be used to teach children to abolish this abnormal contraction. A randomised controlled trial in medical treatment resistant and/or treatment dependent children with anismus using surface electromyographic (EMG) biofeedback training to determine whether such training produces sustained faecal continence. Up to four sessions of biofeedback training were conducted at weekly intervals for each patient. Anorectal manometry was performed before randomisation and six months later. Parents of patients completed the "child behaviour checklist" (CBCL) before randomisation and at follow up. Sixty eight children underwent anorectal manometry and EMG. Of these, 29 had anismus (ages 4-14 years) and were randomised to either EMG biofeedback training and conventional medical treatment (BFT) (n = 14) or to conventional medical treatment alone (n = 15). All but one child were able to learn relaxation of the external anal sphincter on attempted defecation. At six months' follow up, laxative free remission had been sustained in two of 14 patients in the BFT group and in two of 15 controls (95% confidence interval (CI) on difference, -24% to 26%). Remission or improvement occurred in four of 14 patients in the BFT group and six of 15 controls (95% CI on difference, -46% to 23%). Of subjects available for repeat anorectal manometry and EMG at six months, six of 13 in the BFT group still demonstrated anismus v 11 of 13 controls (95% CI on difference, -75% to -1%). Of the four patients in full remission at six months, only one (in the BFT group) did not exhibit anismus. Rectal hyposensitivity was not associated with remission or improvement in either of the groups. Mean CBCL total behaviour problem scores were not significantly different between the BFT and control groups, but there

  13. Randomised controlled trial of biofeedback training in persistent encopresis with anismus

    Science.gov (United States)

    Nolan, T.; Catto-Smith, T.; Coffey, C.; Wells, J.

    1998-01-01

    BACKGROUND—Paradoxical external anal sphincter contraction during attempted defecation (anismus) is thought to be an important contributor to chronic faecal retention and encopresis in children. Biofeedback training can be used to teach children to abolish this abnormal contraction.
METHODS—A randomised controlled trial in medical treatment resistant and/or treatment dependent children with anismus using surface electromyographic (EMG) biofeedback training to determine whether such training produces sustained faecal continence. Up to four sessions of biofeedback training were conducted at weekly intervals for each patient. Anorectal manometry was performed before randomisation and six months later. Parents of patients completed the "child behaviour checklist" (CBCL) before randomisation and at follow up.
RESULTS—Sixty eight children underwent anorectal manometry and EMG. Of these, 29 had anismus (ages 4-14 years) and were randomised to either EMG biofeedback training and conventional medical treatment (BFT) (n = 14) or to conventional medical treatment alone (n = 15). All but one child were able to learn relaxation of the external anal sphincter on attempted defecation. At six months' follow up, laxative free remission had been sustained in two of 14 patients in the BFT group and in two of 15 controls (95% confidence interval (CI) on difference, −24% to 26%). Remission or improvement occurred in four of 14 patients in the BFT group and six of 15 controls (95% CI on difference, −46% to 23%). Of subjects available for repeat anorectal manometry and EMG at six months, six of 13 in the BFT group still demonstrated anismus v 11 of 13 controls (95% CI on difference, −75% to −1%). Of the four patients in full remission at six months, only one (in the BFT group) did not exhibit anismus. Rectal hyposensitivity was not associated with remission or improvement in either of the groups. Mean CBCL total behaviour problem scores were not significantly different

  14. Binocular treatment of amblyopia using videogames (BRAVO): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Guo, Cindy X; Babu, Raiju J; Black, Joanna M; Bobier, William R; Lam, Carly S Y; Dai, Shuan; Gao, Tina Y; Hess, Robert F; Jenkins, Michelle; Jiang, Yannan; Kowal, Lionel; Parag, Varsha; South, Jayshree; Staffieri, Sandra Elfride; Walker, Natalie; Wadham, Angela; Thompson, Benjamin

    2016-10-18

    Amblyopia is a common neurodevelopmental disorder of vision that is characterised by visual impairment in one eye and compromised binocular visual function. Existing evidence-based treatments for children include patching the nonamblyopic eye to encourage use of the amblyopic eye. Currently there are no widely accepted treatments available for adults with amblyopia. The aim of this trial is to assess the efficacy of a new binocular, videogame-based treatment for amblyopia in older children and adults. We hypothesise that binocular treatment will significantly improve amblyopic eye visual acuity relative to placebo treatment. The BRAVO study is a double-blind, randomised, placebo-controlled multicentre trial to assess the effectiveness of a novel videogame-based binocular treatment for amblyopia. One hundred and eight participants aged 7 years or older with anisometropic and/or strabismic amblyopia (defined as ≥0.2 LogMAR interocular visual acuity difference, ≥0.3 LogMAR amblyopic eye visual acuity and no ocular disease) will be recruited via ophthalmologists, optometrists, clinical record searches and public advertisements at five sites in New Zealand, Canada, Hong Kong and Australia. Eligible participants will be randomised by computer in a 1:1 ratio, with stratification by age group: 7-12, 13-17 and 18 years and older. Participants will be randomised to receive 6 weeks of active or placebo home-based binocular treatment. Treatment will be in the form of a modified interactive falling-blocks game, implemented on a 5th generation iPod touch device viewed through red/green anaglyphic glasses. Participants and those assessing outcomes will be blinded to group assignment. The primary outcome is the change in best-corrected distance visual acuity in the amblyopic eye from baseline to 6 weeks post randomisation. Secondary outcomes include distance and near visual acuity, stereopsis, interocular suppression, angle of strabismus (where applicable) measured at

  15. Effect of two different house screening interventions on exposure to malaria vectors and on anaemia in children in The Gambia: a randomised controlled trial.

    OpenAIRE

    Kirby, M.J; Ameh, D; Bottomley, C; Green, C; Jawara, M; Milligan, P.J; Snell, P.C; Conway, D.J; Lindsay, S.W

    2009-01-01

    Background: House screening should protect people against malaria. We assessed whether two types of house screening—full screening of windows, doors, and closing eaves, or installation of screened ceilings—could reduce house entry of malaria vectors and frequency of anaemia in children in an area of seasonal malaria transmission. Methods: During 2006 and 2007, 500 occupied houses in and near Farafenni town in The Gambia, an area with low use of insecticide-treated bednets, were rand...

  16. Safety and immunogenicity of RTS,S/AS01 malaria vaccine in infants and children with WHO stage 1 or 2 HIV disease: a randomised, double-blind, controlled trial.

    Science.gov (United States)

    Otieno, Lucas; Oneko, Martina; Otieno, Walter; Abuodha, Joseph; Owino, Emmanuel; Odero, Chris; Mendoza, Yolanda Guerra; Andagalu, Ben; Awino, Norbert; Ivinson, Karen; Heerwegh, Dirk; Otsyula, Nekoye; Oziemkowska, Maria; Usuf, Effua Abigail; Otieno, Allan; Otieno, Kephas; Leboulleux, Didier; Leach, Amanda; Oyieko, Janet; Slutsker, Laurence; Lievens, Marc; Cowden, Jessica; Lapierre, Didier; Kariuki, Simon; Ogutu, Bernhards; Vekemans, Johan; Hamel, Mary J

    2016-10-01

    Malaria remains a major global public health concern, especially in sub-Saharan Africa. The RTS,S/AS01 malaria candidate vaccine was reviewed by the European Medicines Agency and received a positive scientific opinion; WHO subsequently recommended pilot implementation in sub-Saharan African countries. Because malaria and HIV overlap geographically, HIV-infected children should be considered for RTS,S/AS01 vaccination. We therefore aimed to assess the safety of RTS,S/AS01 in HIV-infected children at two sites in western Kenya. We did a randomised, double-blind, controlled trial at the clinical trial sites of the Kenya Medical Research Institute (KEMRI)-Walter Reed Army Institute of research in Kisumu and the KEMRI/US Centers for Disease Control and Prevention in Siaya. Eligible participants were infants and children aged from 6 weeks to 17 months with WHO stage 1 or 2 HIV disease (documented positive by DNA PCR), whether or not they were receiving antiretroviral therapy (ART). We randomly assigned participants (1:1) to receive three doses of either RTS,S/AS01 or rabies vaccine (both 0·5 mL per dose by intramuscular injection), given once per month at 0, 1, and 2 months. We did the treatment allocation using a web-based central randomisation system stratified by age (6 weeks-4 months, 5-17 months), and by baseline CD4% (vaccine recipient, their parent or carer, the funder, and investigators responsible for the assessment of endpoints were all masked to treatment allocation (only staff responsible for the preparation and administration of the vaccines were aware of the assignment and these individuals played no other role in the study). We provided ART, even if the participants were not receiving ART before the study, and daily co-trimoxazole for prevention of opportunistic infections. The primary outcome was the occurrence of serious adverse events until 14 months after dose 1 of the vaccine, assessed in the intention-to-treat population. This trial was registered

  17. Randomised controlled trial of site specific advice on school travel patterns.

    Science.gov (United States)

    Rowland, D; DiGuiseppi, C; Gross, M; Afolabi, E; Roberts, I

    2003-01-01

    To evaluate the effect of site specific advice from a school travel coordinator on school travel patterns. Cluster randomised controlled trial of children attending 21 primary schools in the London boroughs of Camden and Islington. A post-intervention survey measured the proportion of children walking, cycling, or using public transport for travel to school, and the proportion of parents/carers very or quite worried about traffic and abduction. The proportion of schools that developed and implemented travel plans was assessed. One year post-intervention, nine of 11 intervention schools and none of 10 control schools had travel plans. Proportions of children walking, cycling, or using public transport on the school journey were similar in intervention and control schools. The proportion of parents who were very or quite worried about traffic danger was similar in the intervention (85%) and control groups (87%). However, after adjusting for baseline and other potential confounding factors we could not exclude the possibility of a modest reduction in parental concern about traffic danger as a result of the intervention. Having a school travel coordinator increased the production of school travel plans but there was no evidence that this changed travel patterns or reduced parental fears. Given the uncertainty about effectiveness, the policy of providing school travel coordinators should only be implemented within the context of a randomised controlled trial.

  18. Reported challenges in nurse-led randomised controlled trials

    DEFF Research Database (Denmark)

    Wang Vedelø, Tina; Lomborg, Kirsten

    2011-01-01

    Aims: The purpose of this integrative literature review was to explore and discuss the methodological challenges nurse researchers report after conducting nurse-led randomised controlled trials in clinical hospital settings. Our research questions were (i) what are the most commonly experienced...... and the clinical nursing staff. Two lessons learned from this integrative review can be highlighted. First, we recommend researchers openly to share their experiences of barriers and challenges. They should describe factors that may have inhibited the desired outcome. Second, efforts to improve the collaboration...... between nurse researchers and clinicians, including education, training and support may increase the success rate and quality of nurse-led studies using the randomised controlled trial....

  19. A pilot, family-based randomised controlled trial to reduce screen time and unhealthy snacking in children and their parents: Kids FIRST

    Directory of Open Access Journals (Sweden)

    Natalie Pearson

    2015-10-01

    To our knowledge, Kids FIRST is the first pilot RCT to examine the effectiveness of behaviour change strategies for reducing children’s screen-time and unhealthy snacking. The integration of consistent, evidence-based and theory informed strategies and messages to children and their parents in the family and school settings are critical components of this pilot study. The results of this study will provide evidence on the feasibility and effectiveness of single versus multiple behaviour intervention strategies. If shown to be feasible and effective, the Kids FIRST study may have a significant impact on the home environment and parenting practices relating to screen time and unhealthy snacking.

  20. Psychological rehabilitation after myocardial infarction: multicentre randomised controlled trial.

    OpenAIRE

    Jones, D. A.; West, R. R.

    1996-01-01

    OBJECTIVE: To evaluate rehabilitation after myocardial infarction. DESIGN: Randomised controlled trial of rehabilitation in unselected myocardial infarction patients in six centres, baseline data being collected on admission and by structured interview (of patients and spouses) shortly after discharge and outcome being assessed by structured interview at six months and clinical examination at 12 months. SETTING: Six district general hospitals. SUBJECTS: All 2328 eligible patients admitted ove...

  1. The effect of iron-fortified complementary food and intermittent preventive treatment of malaria on anaemia in 12- to 36-month-old children: a cluster-randomised controlled trial.

    Science.gov (United States)

    Glinz, Dominik; Hurrell, Richard F; Ouattara, Mamadou; Zimmermann, Michael B; Brittenham, Gary M; Adiossan, Lukas G; Righetti, Aurélie A; Seifert, Burkhardt; Diakité, Victorine G; Utzinger, Jürg; N'Goran, Eliézer K; Wegmüller, Rita

    2015-09-17

    Iron deficiency (ID) and malaria co-exist in tropical regions and both contribute to high rates of anaemia in young children. It is unclear whether iron fortification combined with intermittent preventive treatment (IPT) of malaria would be an efficacious strategy for reducing anaemia in young children. A 9-month cluster-randomised, single-blinded, placebo-controlled intervention trial was carried out in children aged 12-36 months in south-central Côte d'Ivoire, an area of intense and perennial malaria transmission. The study groups were: group 1: normal diet and IPT-placebo (n = 125); group 2: consumption of porridge, an iron-fortified complementary food (CF) with optimised composition providing 2 mg iron as NaFeEDTA and 3.8 mg iron as ferrous fumarate 6 days per week (CF-FeFum) and IPT-placebo (n = 126); group 3: IPT of malaria at 3-month intervals, using sulfadoxine-pyrimethamine and amodiaquine and no dietary intervention (n = 127); group 4: both CF-FeFum and IPT (n = 124); and group 5: consumption of porridge, an iron-fortified CF with the composition currently on the Ivorian market providing 2 mg iron as NaFeEDTA and 3.8 mg iron as ferric pyrophosphate 6 days per week (CF-FePP) and IPT-placebo (n = 127). The primary outcome was haemoglobin (Hb) concentration. Linear and logistic regression mixed-effect models were used for the comparison of the five study groups, and a 2 × 2 factorial analysis was used to assess treatment interactions of CF-FeFum and IPT (study groups 1-4). After 9 months, the Hb concentration increased in all groups to a similar extent with no statistically significant difference between groups. In the 2 × 2 factorial analysis after 9 months, no treatment interaction was found on Hb (P = 0.89). The adjusted differences in Hb were 0.24 g/dl (95 % CI -0.10 to 0.59; P = 0.16) in children receiving IPT and -0.08 g/dl (95 % CI -0.42 to 0.26; P = 0.65) in children receiving CF-FeFum. At baseline, anaemia (Hb

  2. A randomised controlled trial of complete denture impression materials.

    Science.gov (United States)

    Hyde, T P; Craddock, H L; Gray, J C; Pavitt, S H; Hulme, C; Godfrey, M; Fernandez, C; Navarro-Coy, N; Dillon, S; Wright, J; Brown, S; Dukanovic, G; Brunton, P A

    2014-08-01

    There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7-67.3%, pUnilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. Copyright © 2014 The Authors. Published by Elsevier Ltd.. All rights reserved.

  3. Hand sanitiser provision for reducing illness absences in primary school children: a cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Patricia Priest

    2014-08-01

    Full Text Available BACKGROUND: The potential for transmission of infectious diseases offered by the school environment are likely to be an important contributor to the rates of infectious disease experienced by children. This study aimed to test whether the addition of hand sanitiser in primary school classrooms compared with usual hand hygiene would reduce illness absences in primary school children in New Zealand. METHODS AND FINDINGS: This parallel-group cluster randomised trial took place in 68 primary schools, where schools were allocated using restricted randomisation (1:1 ratio to the intervention or control group. All children (aged 5 to 11 y in attendance at participating schools received an in-class hand hygiene education session. Schools in the intervention group were provided with alcohol-based hand sanitiser dispensers in classrooms for the winter school terms (27 April to 25 September 2009. Control schools received only the hand hygiene education session. The primary outcome was the number of absence episodes due to any illness among 2,443 follow-up children whose caregivers were telephoned after each absence from school. Secondary outcomes measured among follow-up children were the number of absence episodes due to specific illness (respiratory or gastrointestinal, length of illness and illness absence episodes, and number of episodes where at least one other member of the household became ill subsequently (child or adult. We also examined whether provision of sanitiser was associated with experience of a skin reaction. The number of absences for any reason and the length of the absence episode were measured in all primary school children enrolled at the schools. Children, school administrative staff, and the school liaison research assistants were not blind to group allocation. Outcome assessors of follow-up children were blind to group allocation. Of the 1,301 and 1,142 follow-up children in the hand sanitiser and control groups, respectively, the

  4. A randomised controlled trial evaluating IGF1 titration in contrast to current GH dosing strategies in children born small for gestational age: the North European Small-for-Gestational-Age Study.

    Science.gov (United States)

    Jensen, Rikke Beck; Thankamony, Ajay; O'Connell, Susan M; Kirk, Jeremy; Donaldson, Malcolm; Ivarsson, Sten-A; Söder, Olle; Roche, Edna; Hoey, Hilary; Dunger, David B; Juul, Anders

    2014-10-01

    Short children born small for gestational age (SGA) are treated with a GH dose based on body size, but treatment may lead to high levels of IGF1. The objective was to evaluate IGF1 titration of GH dose in contrast to current dosing strategies. In the North European Small-for-Gestational-Age Study (NESGAS), 92 short pre-pubertal children born SGA were randomised after 1 year of high-dose GH treatment (67 μg/kg per day) to three different regimens: high dose (67 μg/kg per day), low dose (35 μg/kg per day) or IGF1 titration. The average dose during the second year of the randomised trial did not differ between the IGF1 titration group (38 μg/kg per day, s.d. 0.019) and the low-dose group (35 μg/kg per day, s.d. 0.002; P=0.46), but there was a wide variation in the IGF1 titration group (range 10-80 μg/kg per day). The IGF1 titration group had significantly lower height gain (0.17 SDS, s.d. 0.18) during the second year of the randomised trial compared with the high-dose group (0.46 SDS, s.d. 0.25), but not significantly lower than the low-dose group (0.23 SDS, s.d. 0.15; P=0.17). The IGF1 titration group had lower IGF1 levels after 2 years of the trial (mean 1.16, s.d. 1.24) compared with both the low-dose (mean 1.76, s.d. 1.48) and the high-dose (mean 2.97, s.d. 1.63) groups. IGF1 titration of GH dose in SGA children proved less effective than current dosing strategies. IGF1 titration resulted in physiological IGF1 levels with a wide range of GH dose and a poorer growth response, which indicates the role of IGF1 resistance and highlights the heterogeneity of short SGA children. © 2014 European Society of Endocrinology.

  5. Randomised controlled trials in educational research: Ontological ...

    African Journals Online (AJOL)

    based practice in medical and clinical settings because they are associated with a particular ontological and epistemological perspective that is situated within a positivist world view. It assumes that environments and variables can be controlled ...

  6. Structured, intensive education maximising engagement, motivation and long-term change for children and young people with diabetes: a cluster randomised controlled trial with integral process and economic evaluation - the CASCADE study.

    Science.gov (United States)

    Christie, Deborah; Thompson, Rebecca; Sawtell, Mary; Allen, Elizabeth; Cairns, John; Smith, Felicity; Jamieson, Elizabeth; Hargreaves, Katrina; Ingold, Anne; Brooks, Lucy; Wiggins, Meg; Oliver, Sandy; Jones, Rebecca; Elbourne, Diana; Santos, Andreia; Wong, Ian C K; O'Neill, Simon; Strange, Vicki; Hindmarsh, Peter; Annan, Francesca; Viner, Russell

    2014-03-01

    Type 1 diabetes (T1D) in children and young people is increasing worldwide with a particular increase in children under the age of 5 years. Fewer than one in six children and young people achieve glycosylated fraction of haemoglobin (HbA1c) values in the range identified as providing best future outcomes. There is an urgent need for clinic-based pragmatic, feasible and effective interventions that improve both glycaemic control and quality of life (QoL). The intervention offers both structured education, to ensure young people know what they need to know, and a delivery model designed to motivate self-management. To assess the feasibility of providing a clinic-based structured educational group programme incorporating psychological approaches to improve long-term glycaemic control, QoL and psychosocial functioning in a diverse range of young people. The study was a pragmatic, cluster randomised control trial with integral process and economic evaluation. Twenty-eight paediatric diabetes services across London, south-east England and the Midlands. Minimised by clinic size, age (paediatric or adolescent) and specialisation (district general hospital clinic or teaching hospital/tertiary clinic). Half of the sites were randomised to the intervention arm and half to the control arm. Allocation was concealed until after clinics had consented and the first participant was recruited. Where possible, families were blind to allocation until recruitment finished. Forty-three health-care practitioners (14 teams) were trained in the intervention. The study recruited 362 children aged 8-16 years, diagnosed with T1D for > 12 months, with a mean 12-month HbA1c level of ≥ 8.5%. Two 1-day workshops taught intervention delivery. A detailed manual and resources were provided. The intervention consists of four group education sessions led by a paediatric diabetes specialist nurse with another team member. The primary outcome was glycaemic control, assessed at the individual level

  7. Can improving working memory prevent academic difficulties? A school based randomised controlled trial.

    Science.gov (United States)

    Roberts, Gehan; Quach, Jon; Gold, Lisa; Anderson, Peter; Rickards, Field; Mensah, Fiona; Ainley, John; Gathercole, Susan; Wake, Melissa

    2011-06-20

    Low academic achievement is common and is associated with adverse outcomes such as grade repetition, behavioural disorders and unemployment. The ability to accurately identify these children and intervene before they experience academic failure would be a major advance over the current 'wait to fail' model. Recent research suggests that a possible modifiable factor for low academic achievement is working memory, the ability to temporarily store and manipulate information in a 'mental workspace'. Children with working memory difficulties are at high risk of academic failure. It has recently been demonstrated that working memory can be improved with adaptive training tasks that encourage improvements in working memory capacity. Our trial will determine whether the intervention is efficacious as a selective prevention strategy for young children at risk of academic difficulties and is cost-effective. This randomised controlled trial aims to recruit 440 children with low working memory after a school-based screening of 2880 children in Grade one. We will approach caregivers of all children from 48 participating primary schools in metropolitan Melbourne for consent. Children with low working memory will be randomised to usual care or the intervention. The intervention will consist of 25 computerised working memory training sessions, which take approximately 35 minutes each to complete. Follow-up of children will be conducted at 6, 12 and 24 months post-randomisation through child face-to-face assessment, parent and teacher surveys and data from government authorities. The primary outcome is academic achievement at 12 and 24 months, and other outcomes include child behaviour, attention, health-related quality of life, working memory, and health and educational service utilisation. A successful start to formal learning in school sets the stage for future academic, psychological and economic well-being. If this preventive intervention can be shown to be efficacious, then

  8. Can improving working memory prevent academic difficulties? a school based randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Anderson Peter

    2011-06-01

    Full Text Available Abstract Background Low academic achievement is common and is associated with adverse outcomes such as grade repetition, behavioural disorders and unemployment. The ability to accurately identify these children and intervene before they experience academic failure would be a major advance over the current 'wait to fail' model. Recent research suggests that a possible modifiable factor for low academic achievement is working memory, the ability to temporarily store and manipulate information in a 'mental workspace'. Children with working memory difficulties are at high risk of academic failure. It has recently been demonstrated that working memory can be improved with adaptive training tasks that encourage improvements in working memory capacity. Our trial will determine whether the intervention is efficacious as a selective prevention strategy for young children at risk of academic difficulties and is cost-effective. Methods/Design This randomised controlled trial aims to recruit 440 children with low working memory after a school-based screening of 2880 children in Grade one. We will approach caregivers of all children from 48 participating primary schools in metropolitan Melbourne for consent. Children with low working memory will be randomised to usual care or the intervention. The intervention will consist of 25 computerised working memory training sessions, which take approximately 35 minutes each to complete. Follow-up of children will be conducted at 6, 12 and 24 months post-randomisation through child face-to-face assessment, parent and teacher surveys and data from government authorities. The primary outcome is academic achievement at 12 and 24 months, and other outcomes include child behaviour, attention, health-related quality of life, working memory, and health and educational service utilisation. Discussion A successful start to formal learning in school sets the stage for future academic, psychological and economic well-being. If

  9. Vitamin D treatment in calcium-deficiency rickets: a randomised controlled trial.

    Science.gov (United States)

    Thacher, Tom D; Fischer, Philip R; Pettifor, John M

    2014-09-01

    To determine whether children with calcium-deficiency rickets have a better response to treatment with vitamin D and calcium than with calcium alone. Randomised controlled trial. Jos University Teaching Hospital, Jos, Nigeria. Nigerian children with active rickets treated with calcium carbonate as limestone (approximately 938 mg elemental calcium twice daily) were, in addition, randomised to receive either oral vitamin D2 50,000 IU (Ca+D, n=44) or placebo (Ca, n=28) monthly for 24 weeks. Achievement of a 10-point radiographic severity score ≤1.5 and serum alkaline phosphatase ≤350 U/L. The median (range) age of enrolled children was 46 (15-102) months, and baseline characteristics were similar in the two groups. Mean (±SD) 25-hydroxyvitamin D (25(OH)D) was 30.2±13.2 nmol/L at baseline, and 29 (43%) had values rickets, there is a trend for vitamin D to improve the response to treatment with calcium carbonate as limestone, independent of baseline 25(OH)D concentrations. ClinicalTrials.gov NCT00949832. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  10. A Randomised Controlled Trial of complete denture impression materials

    Science.gov (United States)

    Hyde, T.P.; Craddock, H.L.; Gray, J.C.; Pavitt, S.H.; Hulme, C.; Godfrey, M.; Fernandez, C.; Navarro-Coy, N.; Dillon, S.; Wright, J.; Brown, S.; Dukanovic, G.; Brunton, P.A.

    2014-01-01

    Objectives There is continuing demand for non-implant prosthodontic treatment and yet there is a paucity of high quality Randomised Controlled Trial (RCT) evidence for best practice. The aim of this research was to provide evidence for best practice in prosthodontic impressions by comparing two impression materials in a double-blind, randomised, crossover, controlled, clinical trial. Methods Eighty-five patients were recruited, using published eligibility criteria, to the trial at Leeds Dental Institute, UK. Each patient received two sets of dentures; made using either alginate or silicone impressions. Randomisations determined the order of assessment and order of impressions. The primary outcome was patient blinded preference for unadjusted dentures. Secondary outcomes were patient preference for the adjusted dentures, rating of comfort, stability and chewing efficiency, experience of each impression, and an OHIP-EDENT questionnaire. Results Seventy-eight (91.8%) patients completed the primary assessment. 53(67.9%) patients preferred dentures made from silicone impressions while 14(17.9%) preferred alginate impressions. 4(5.1%) patients found both dentures equally satisfactory and 7 (9.0%) found both equally unsatisfactory. There was a 50% difference in preference rates (in favour of silicone) (95%CI 32.7–67.3%, p alginate as their material of choice for secondary impressions for complete dentures. Trial Registration: ISRCTN 01528038.

 This article forms part of a project for which the author (TPH) won the Senior Clinical Unilever Hatton Award of the International Assocation for Dental Research, Capetown, South Africa, June 2014. PMID:24995473

  11. A randomised trial of enteral glutamine supplementation for very preterm children showed no beneficial or adverse long-term neurodevelopmental outcomes

    NARCIS (Netherlands)

    Twilhaar, E.S.; de Kieviet, J.F.; Oosterlaan, J.; van Elburg, R.M.

    2017-01-01

    Aim This study evaluated the long-term effects of enteral glutamine supplementation on neurodevelopmental outcomes of a Dutch cohort of very preterm children at 13 years of age. Methods The cohort was enrolled in a randomised placebo-controlled trial between 2001 and 2003 in which infants received

  12. A randomised trial of enteral glutamine supplementation for very preterm children showed no beneficial or adverse long-term neurodevelopmental outcomes

    NARCIS (Netherlands)

    Twilhaar, E. Sabrina; de Kieviet, Jorrit F.; Oosterlaan, Jaap; van Elburg, Ruurd M.

    2017-01-01

    This study evaluated the long-term effects of enteral glutamine supplementation on neurodevelopmental outcomes of a Dutch cohort of very preterm children at 13 years of age. The cohort was enrolled in a randomised placebo-controlled trial between 2001-2003 in which infants received glutamine- or

  13. Choosing a control intervention for a randomised clinical trial

    Directory of Open Access Journals (Sweden)

    Djulbegovic Benjamin

    2003-04-01

    Full Text Available Abstract Background Randomised controlled clinical trials are performed to resolve uncertainty concerning comparator interventions. Appropriate acknowledgment of uncertainty enables the concurrent achievement of two goals : the acquisition of valuable scientific knowledge and an optimum treatment choice for the patient-participant. The ethical recruitment of patients requires the presence of clinical equipoise. This involves the appropriate choice of a control intervention, particularly when unapproved drugs or innovative interventions are being evaluated. Discussion We argue that the choice of a control intervention should be supported by a systematic review of the relevant literature and, where necessary, solicitation of the informed beliefs of clinical experts through formal surveys and publication of the proposed trial's protocol. Summary When clinical equipoise is present, physicians may confidently propose trial enrollment to their eligible patients as an act of therapeutic beneficence.

  14. Group art therapy as an adjunctive treatment for people with schizophrenia: a randomised controlled trial (MATISSE).

    OpenAIRE

    Crawford, MJ; Killaspy, H; Barnes, TR; Barrett, B; Byford, S; Clayton, K; Dinsmore, J; Floyd, S; Hoadley, A; Johnson, T; Kalaitzaki, E; King, M; Leurent, B; Maratos, A; O'Neill, FA

    2012-01-01

    OBJECTIVE To examine the clinical effectiveness and cost-effectiveness of referral to group art therapy plus standard care, compared with referral to an activity group plus standard care and standard care alone, among people with schizophrenia. DESIGN A three-arm, parallel group, single-blind, pragmatic, randomised controlled trial. Participants were randomised via an independent and remote telephone randomisation service using permuted blocks, stratified by study centre. SETTING Study partic...

  15. Moxibustion for cephalic version: a feasibility randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Bisits Andrew

    2011-09-01

    Full Text Available Abstract Background Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin has been used to correct a breech presentation. Evidence of effectiveness and safety from systematic reviews is encouraging although significant heterogeneity has been found among trials. We assessed the feasibility of conducting a randomised controlled trial of moxibustion plus usual care compared with usual care to promote cephalic version in women with a breech presentation, and examined the views of women and health care providers towards implementing a trial within an Australian context. Methods The study was undertaken at a public hospital in Newcastle, New South Wales, Australia. Women at 34-36.5 weeks of gestation with a singleton breech presentation (confirmed by ultrasound, were randomised to moxibustion plus usual care or usual care alone. The intervention was administered over 10 days. Clinical outcomes included cephalic presentation at birth, the need for ECV, mode of birth; perinatal morbidity and mortality, and maternal complications. Feasibility outcomes included: recruitment rate, acceptability, compliance and a sample size for a future study. Interviews were conducted with 19 midwives and obstetricians to examine the acceptability of moxibustion, and views on the trial. Results Twenty women were randomised to the trial. Fifty one percent of women approached accepted randomisation to the trial. A trend towards an increase in cephalic version at delivery (RR 5.0; 95% CI 0.7-35.5 was found for women receiving moxibustion compared with usual care. There was also a trend towards greater success with version following ECV. Two babies were admitted to the neonatal unit from the moxibustion group. Compliance with the moxibustion protocol was acceptable with no reported side effects. Clinicians expressed the need for research to establish the safety and efficacy of moxibustion, and support for the intervention was given to

  16. Randomised controlled trial of reflexology for menopausal symptoms.

    Science.gov (United States)

    Williamson, Jan; White, Adrian; Hart, Anna; Ernst, Edzard

    2002-09-01

    Clinical experience suggests that reflexology may have beneficial effects on the symptoms occurring in menopausal women, particularly psychological symptoms. This study aims to examine that effect rigorously. Randomised controlled trial with two parallel arms. School of Complementary Health in Exeter, Devon, UK. Seventy-six women, aged between 45 and 60 years, reporting menopausal symptoms. Women were randomised to receive nine sessions of either reflexology or nonspecific foot massage (control) by four qualified reflexologists given over a period of 19 weeks. The Women's Health Questionnaire (WHQ), the primary measures being the subscores for anxiety and depression. Severity (visual analogue scale, VAS) and frequency of flushes and night sweats. Mean (SD) scores for anxiety fell from 0.43 (0.29) to 0.22 (0.25) in the reflexology group and from 0.37 (0.27) to 0.27 (0.29) in the control group over the course of treatment. Mean (SD) scores for depression fell from 0.37 (0.25) to 0.20 (0.24) in the reflexology group and from 0.36 (0.23) to 0.20 (0.21) in the control (foot massage) group over the same period. For both scores there was strong evidence of a time effect (P 0.2). Similar changes were found for severity of hot flushes and night sweats. In the control group, 14/37 believed they had not received true reflexology. Foot reflexology was not shown to be more effective than non-specific foot massage in the treatment of psychological symptoms occurring during the menopause.

  17. Topical tranexamic acid as a novel treatment for bleeding peptic ulcer: A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Mandana Rafeey

    2016-01-01

    Full Text Available Background: Peptic ulcers are among the most common causes of upper gastrointestinal (GI bleeding in children. The standard care for GI bleeding is endoscopy for diagnostic and therapeutic purposes. We aimed to assess the effect of topical tranexamic acid (TXA via endoscopic procedures in children with GI bleeding caused by bleeding ulcers. Procedure: In this randomised controlled trial, 120 children were evaluated by diagnostic procedures for GI bleeding, of which 63 (30 girls, 33 boys aged 1-month to 15 years were recruited. The patients were randomly divided into case and control groups. In the case group, TXA was administered directly under endoscopic therapy. In the control group, epinephrine (1/10,000 was submucosally injected to the four quadrants of ulcer margins as the routine endoscopic therapy. In both groups, the patients received supportive medical therapy with intravenous fluids and proton pump inhibitor drugs. Results: The mean ± standard deviation age of the children was 5 ± 2.03 years. Rebleeding occurred in 15 (11.4% and 21 (9.8% patients in the case and control groups, respectively (P = 0.50. The frequency of blood transfusion episodes (P = 0.06 and duration of hospital stay (P = 0.07 were not statistically different between the groups. Conclusion: Using topical TXA via endoscopic procedures may be effective in cases of GI bleedings caused by active bleeding ulcers. In order to establish this therapeutic effect, a large number of clinical studies are needed.

  18. Parent-focused treatment for adolescent anorexia nervosa: a study protocol of a randomised controlled trial.

    Science.gov (United States)

    Hughes, Elizabeth K; Le Grange, Daniel; Court, Andrew; Yeo, Michele S M; Campbell, Stephanie; Allan, Erica; Crosby, Ross D; Loeb, Katharine L; Sawyer, Susan M

    2014-04-08

    Family-based treatment is an efficacious outpatient intervention for medically stable adolescents with anorexia nervosa. Previous research suggests family-based treatment may be more effective for some families when parents and adolescents attend separate therapy sessions compared to conjoint sessions. Our service developed a novel separated model of family-based treatment, parent-focused treatment, and is undertaking a randomised controlled trial to compare parent-focused treatment to conjoint family-based treatment. This randomised controlled trial will recruit 100 adolescents aged 12-18 years with DSM-IV anorexia nervosa or eating disorder not otherwise specified (anorexia nervosa type). The trial commenced in 2010 and is expected to be completed in 2015. Participants are recruited from the Royal Children's Hospital Eating Disorders Program, Melbourne, Australia. Following a multidisciplinary intake assessment, eligible families who provide written informed consent are randomly allocated to either parent-focused treatment or conjoint family-based treatment. In parent-focused treatment, the adolescent sees a clinical nurse consultant and the parents see a trained mental health clinician. In conjoint family-based treatment, the whole family attends sessions with the mental health clinician. Both groups receive 18 treatment sessions over 6 months and regular medical monitoring by a paediatrician. The primary outcome is remission at end of treatment and 6 and 12 month follow up, with remission defined as being ≥ 95% expected body weight and having an eating disorder symptom score within one standard deviation of community norms. The secondary outcomes include partial remission and changes in eating pathology, depressive symptoms and self-esteem. Moderating and mediating factors will also be explored. This will be first randomised controlled trial of a parent-focused model of family-based treatment of adolescent anorexia nervosa. If found to be efficacious, parent

  19. Health effects of freshwater bathing among primary school children; Design for a randomised exposure study

    NARCIS (Netherlands)

    Asperen IA van; Medema GJ; Havelaar AH; Borgdorff MW; CIE; MGB

    1997-01-01

    To study the health effects of bathing in freshwaters that meet current water quality standard, large epidemiological studies are needed. A design is presented of a study among primary school children, that aims to evaluate current water quality standard. The study concerns a randomised exposure

  20. Evaluation of biases present in the cohort multiple randomised controlled trial design : a simulation study

    NARCIS (Netherlands)

    Candlish, Jane; Pate, Alexander; Sperrin, Matthew; Staa, Tjeerd P van

    2017-01-01

    BACKGROUND: The cohort multiple randomised controlled trial (cmRCT) design provides an opportunity to incorporate the benefits of randomisation within clinical practice; thus reducing costs, integrating electronic healthcare records, and improving external validity. This study aims to address a key

  1. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Multicentre randomised controlled equivalence trial. 15 hospitals in the Netherlands. Women with an intermediate to high obstetric risk with an

  2. Labour pain with remifentanil patient-controlled analgesia versus epidural analgesia : a randomised equivalence trial

    NARCIS (Netherlands)

    Logtenberg, Slm; Oude Rengerink, K; Verhoeven, C J; Freeman, L M; van den Akker, Esa; Godfried, M B; van Beek, E; Borchert, Owhm; Schuitemaker, N; van Woerkens, Ecsm; Hostijn, I; Middeldorp, J M; van der Post, J A; Mol, B W

    OBJECTIVE: To distinguish satisfaction with pain relief using remifentanil patient-controlled analgesia (RPCA) compared with epidural analgesia (EA) in low-risk labouring women. DESIGN: Randomised controlled equivalence trial. SETTING: Eighteen midwifery practices and six hospitals in the

  3. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M; Bloemenkamp, Kitty W; Franssen, Maureen T; Papatsonis, Dimitri N; Hajenius, Petra J; Hollmann, Markus W; Woiski, Mallory D; Porath, Martina; van den Berg, Hans J; van Beek, Erik; Borchert, Odette W H M; Schuitemaker, Nico; Sikkema, J Marko; Kuipers, A H M; Logtenberg, Sabine L M; van der Salm, Paulien C M; Oude Rengerink, Katrien; Lopriore, Enrico; van den Akker-van Marle, M Elske; le Cessie, Saskia; van Lith, Jan M; Struys, Michel M; Mol, Ben Willem J; Dahan, Albert; Middeldorp, Johanna M; Oude Rengerink, K

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  4. Patient controlled analgesia with remifentanil versus epidural analgesia in labour : randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, Liv M.; Bloemenkamp, Kitty W.; Franssen, Maureen T.; Papatsonis, Dimitri N.; Hajenius, Petra J.; Hollmann, Markus W.; Woiski, Mallory D.; Porath, Martina; van den Berg, Hans J.; van Beek, Erik; Borchert, Odette W. H. M.; Schuitemaker, Nico; Sikkema, J. Marko; Kuipers, A. H. M.; Logtenberg, Sabine L. M.; van der Salm, Paulien C. M.; Rengerink, Katrien Oude; Lopriore, Enrico; van den Akker-van Marle, M. Elske; le Cessie, Saskia; van Lith, Jan M.; Struys, Michel M.; Mol, Ben Willem J.; Dahan, Albert; Middeldorp, Johanna M.

    2015-01-01

    Objective To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. Design Multicentre randomised controlled equivalence trial. Setting 15 hospitals in the Netherlands. Participants Women with an

  5. Patient controlled analgesia with remifentanil versus epidural analgesia in labour: randomised multicentre equivalence trial

    NARCIS (Netherlands)

    Freeman, L.M.; Bloemenkamp, K.W.; Franssen, M.T.; Papatsonis, D.N.; Hajenius, P.J.; Hollmann, M.W.; Woiski, M.D.; Porath, M.; Berg, H.J. van den; Beek, E. van; Borchert, O.W.; Schuitemaker, N.; Sikkema, J.M.; Kuipers, A.H.; Logtenberg, S.L.; Salm, P.C. van der; Oude Rengerink, K.; Lopriore, E.; Akker-van Marle, M.E. van den; Cessie, S. le; Lith, J.M. van; Struys, M.M.; Mol, B.W.; Dahan, A; Middeldorp, J.M.

    2015-01-01

    OBJECTIVE: To determine women's satisfaction with pain relief using patient controlled analgesia with remifentanil compared with epidural analgesia during labour. DESIGN: Multicentre randomised controlled equivalence trial. SETTING: 15 hospitals in the Netherlands. PARTICIPANTS: Women with an

  6. Impact of a deferred recruitment model in a randomised controlled trial in primary care (CREAM study).

    Science.gov (United States)

    Shepherd, Victoria; Thomas-Jones, Emma; Ridd, Matthew J; Hood, Kerenza; Addison, Katy; Francis, Nick A

    2017-11-10

    Recruitment of participants is particularly challenging in primary care, with less than a third of randomised controlled trials (RCT) achieving their target within the original time frame. Participant identification, consent, randomisation and data collection can all be time-consuming. Trials recruiting an incident, as opposed to a prevalent, population may be particularly affected. This paper describes the impact of a deferred recruitment model in a RCT of antibiotics for children with infected eczema in primary care, which required the recruitment of cases presenting acutely. Eligible children were identified by participating general practitioners (GPs) and referred to a study research nurse, who then visited them at home. This allowed the consent and recruitment processes to take place outside the general practice setting. Information was recorded about patients who were referred and recruited, or if not, the reasons for non-recruitment. Data on recruitment challenges were collected through semi-structured interviews and questionnaires with a sample of participating GPs. Data were thematically analysed to identify key themes. Of the children referred to the study 34% (58/171) were not recruited - 48% (28/58) because of difficulties arranging a baseline visit within the defined time frame, 31% (18/58) did not meet the study inclusion criteria at the time of nurse assessment, and 21% (12/58) declined participation. GPs had positive views about the recruitment process, reporting that parents valued and benefitted from additional contact with a nurse. GPs felt that the deferred recruitment model did not negatively impact on the study. GPs and parents recognised the benefits of deferred recruitment, but these did not translate into enhanced recruitment of participants. The model resulted in the loss of a third of children who were identified by the GP as eligible, but not subsequently recruited to the study. If the potential for improving outcomes in primary care

  7. Efficacy of RTS,S/AS01E malaria vaccine and exploratory analysis on anti-circumsporozoite antibody titres and protection in children aged 5–17 months in Kenya and Tanzania: a randomised controlled trial

    Science.gov (United States)

    Olotu, Ally; Lusingu, John; Leach, Amanda; Lievens, Marc; Vekemans, Johan; Msham, Salum; Lang, Trudie; Gould, Jayne; Dubois, Marie-Claude; Jongert, Erik; Vansadia, Preeti; Carter, Terrell; Njuguna, Patricia; Awuondo, Ken O; Malabeja, Anangisye; Abdul, Omar; Gesase, Samwel; Mturi, Neema; Drakeley, Chris J; Savarese, Barbara; Villafana, Tonya; Lapierre, Didier; Ballou, W Ripley; Cohen, Joe; Lemnge, Martha M; Peshu, Norbert; Marsh, Kevin; Riley, Eleanor M; von Seidlein, Lorenz; Bejon, Philip

    2011-01-01

    Summary Background RTS,S/AS01E is the lead candidate malaria vaccine. We recently showed efficacy against clinical falciparum malaria in 5–17 month old children, during an average of 8 months follow-up. We aimed to assess the efficacy of RTS,S/AS01E during 15 months of follow-up. Methods Between March, 2007, and October, 2008, we enrolled healthy children aged 5–17 months in Kilifi, Kenya, and Korogwe, Tanzania. Computer-generated block randomisation was used to randomly assign participants (1:1) to receive three doses (at month 0, 1, and 2) of either RTS,S/AS01E or human diploid-cell rabies vaccine. The primary endpoint was time to first clinical malaria episode, defined as the presence of fever (temperature ≥37·5°C) and a Plasmodium falciparum density of 2500/μL or more. Follow-up was 12 months for children from Korogwe and 15 months for children from Kilifi. Primary analysis was per protocol. In a post-hoc modelling analysis we characterised the associations between anti-circumsporozoite antibodies and protection against clinical malaria episodes. This study is registered with ClinicalTrials.gov, number NCT00380393. Findings 894 children were assigned, 447 in each treatment group. In the per-protocol analysis, 82 of 415 children in the RTS,S/AS01E group and 125 of 420 in the rabies vaccine group had first or only clinical malaria episode by 12 months, vaccine efficacy 39·2% (95% CI 19·5–54·1, p=0·0005). At 15 months follow-up, 58 of 209 children in the RTS,S/AS01E group and 85 of 206 in the rabies vaccine group had first or only clinical malaria episode, vaccine efficacy 45·8% (24·1–61·3, p=0·0004). At 12 months after the third dose, anti-circumsporozoite antibody titre data were available for 390 children in the RTS,S/AS01E group and 391 in the rabies group. A mean of 15 months (range 12–18 months) data were available for 172 children in the RTS,S/AS01E group and 155 in the rabies group. These titres at 1 month after the third dose were

  8. Effect of community based management in failure to thrive: randomised controlled trial

    Science.gov (United States)

    Wright, Charlotte M; Callum, Jane; Birks, Eileen; Jarvis, Stephen

    1998-01-01

    Objective: To evaluate the effectiveness of a health visitor led intervention for failure to thrive in children under 2 years old. Design: Controlled trial, randomised by primary care practice. Setting: Newcastle upon Tyne health district. Intervention: Structured health visitor management, with dietetic, paediatric, and social work input as required. Subjects: 229 children (120 in intervention practices and 109 in control practices) were identified as failing to thrive by population screening during the first 2 years of life. Follow up was by home visit of a research nurse and review of the childrens’ records at age 3 years. Main outcome measures: Follow up weight and height and number of routinely collected weights. Results: 95 of the 97 families offered intervention completed at least the initial assessment. At follow up, 187 (82%) records were reviewed, and these suggested that 15 (16%) controls were lost to follow up immediately after the screening weight was taken compared with only one child in the intervention group. In the 134 (58%) families who consented to home visits, children in the intervention group were significantly heavier and taller and were reported to have better appetites than childen in the control group, although both groups were equally satisfied by the services they had received. When the children were last weighed, 91 (76%) in the intervention group had recovered from their failure to thrive compared with 60 (55%) in the control group (Pfailure to thrive, health visitor intervention, with limited specialist support, can significantly improve growth compared with conventional management. Key messages Supporting health visitors in the recognition and management of children under 2 years of age with failure to thrive resulted in closer follow up and significantly better long term weight and height gain than conventional hospital based management In the control group, 15-30% of cases of failure to thrive remained unrecognised by the

  9. Randomised controlled trials and changing public health practice

    Directory of Open Access Journals (Sweden)

    Anne Cockcroft

    2017-05-01

    Full Text Available Abstract One reason for doing randomised controlled trials (RCTs is that experiments can be convincing. Early epidemiological experimenters, such as Jenner and the smallpox vaccine and Snow and his famous Broad Street pump handle, already knew the answer they were demonstrating; they used the experiments as knowledge translation devices to convince others. More sophisticated modern experiments include cluster randomised controlled trials (CRCTs for experiments in the public health setting. The knowledge translation value remains: RCTs and CRCTs can potentially stimulate changes of practice among stakeholders. Capitalising on the knowledge translation value of RCTs requires more than the standard reporting of trials. Those who are convinced by a trial and want to act, need to know how the trial relates to their own context, what contributed to success, and what might make it even more effective. Implementation research unpacks the back-story, examining how and why an intervention worked. The Camino Verde trial of community mobilisation for control of dengue reported a significant impact on entomological indices of the Aedes aegypti vector, and on serological dengue virus infection and self-reported dengue cases. This important study should lead to studies of similar interventions in other contexts, and ultimately to changes in dengue control practices. This supplement is the back-story of the trial, providing information to help researchers and planners to make use of the trial findings. Background articles include the full protocol, a systematic review of CRCTs of approaches for Aedes aegypti control, epidemiological and entomological findings from the baseline survey, and how baseline findings were used to set up the intervention. Secondary analyses of the entomological findings examine associations with the use of the larvicide temephos, and the impact of the intervention in different conditions of water supply and seasons. Other articles

  10. Paediatric asthma outpatient care by asthma nurse, paediatrician or general practitioner: randomised controlled trial with two-year follow-up

    NARCIS (Netherlands)

    Kuethe, Maarten; Vaessen-Verberne, Anja; Mulder, Paul; Bindels, Patrick; van Aalderen, Wim

    2011-01-01

    For children with stable asthma, to test non-inferiority of care provided by a hospital-based specialised asthma nurse versus a general practitioner (GP) or paediatrician. Randomised controlled trial evaluating standard care by a GP, paediatrician or an asthma nurse, with two-year follow-up. 107

  11. Paediatric asthma outpatient care by asthma nurse, paediatrician or general practitioner: Randomised controlled trial with two-year follow-up

    NARCIS (Netherlands)

    M.C. Kuethe (Maarten ); A.A.P.H. Vaessen-Verberne (Anja); P.G.H. Mulder (Paul); P.J.E. Bindels (Patrick); W.M.C. van Aalderen (Willem)

    2011-01-01

    textabstractAims: For children with stable asthma, to test non-inferiority of care provided by a hospital-based specialised asthma nurse versus a general practitioner (GP) or paediatrician. Methods: Randomised controlled trial evaluating standard care by a GP, paediatrician or an asthma nurse, with

  12. Cognitive Behaviour Therapy versus a Counselling Intervention for Anxiety in Young People with High-Functioning Autism Spectrum Disorders: A Pilot Randomised Controlled Trial

    Science.gov (United States)

    Murphy, Suzanne M.; Chowdhury, Uttom; White, Susan W.; Reynolds, Laura; Donald, Louisa; Gahan, Hilary; Iqbal, Zeinab; Kulkarni, Mahesh; Scrivener, Louise; Shaker-Naeeni, Hadi; Press, Dee A.

    2017-01-01

    The use of cognitive-behavioural therapy (CBT) as a treatment for children and adolescents with autism spectrum disorder (ASD) has been explored in a number of trials. Whilst CBT appears superior to no treatment or treatment as usual, few studies have assessed CBT against a control group receiving an alternative therapy. Our randomised controlled…

  13. Safety and immunogenicity of one versus two doses of Takeda's tetravalent dengue vaccine in children in Asia and Latin America: interim results from a phase 2, randomised, placebo-controlled study.

    Science.gov (United States)

    Sáez-Llorens, Xavier; Tricou, Vianney; Yu, Delia; Rivera, Luis; Tuboi, Suely; Garbes, Pedro; Borkowski, Astrid; Wallace, Derek

    2017-06-01

    Dengue is the most common mosquito-borne viral disease in human beings, and vector control has not halted its spread worldwide. A dengue vaccine for individuals aged 9 years and older has been licensed, but there remains urgent medical need for a vaccine that is safe and effective against all four dengue virus serotypes (DENV-1-4) in recipients of all ages. Here, we present the preplanned interim analyses at 6 months of a tetravalent dengue vaccine candidate (TDV), which is comprised of an attenuated DENV-2 virus strain (TDV-2) and three chimeric viruses containing the premembrane and envelope protein genes of DENV-1, DENV-3, and DENV-4 genetically engineered into the attenuated TDV-2 genome backbone (TDV-1, TDV-3, and TDV-4). An ongoing phase 2, randomised, double-blind, placebo-controlled trial of a TDV is being done at three sites in dengue-endemic countries (Dominican Republic, Panama, and the Philippines) to determine its safety and immunogenicity over 48 months in healthy participants aged 2-17 years who were randomly assigned (1:2:5:1) using an interactive web response system (stratified by age) to subcutaneous TDV injection (one 0·5 mL dose containing 2·5 × 10 4 plaque-forming units [PFU] of TDV-1; 6·3 × 10 3 PFU of TDV-2; 3·2 × 10 4 PFU of TDV-3; and 4·0 × 10 5 PFU of TDV-4) in different dose schedules (two-dose regimen at 0 and 3 months, one dose at 0 months, or one dose at 0 months and a booster at 12 months) or placebo. The primary endpoint of this 6 month interim analysis was geometric mean titres (GMTs) of neutralising antibodies against DENV-1-4 in the per-protocol immunogenicity subset at 1 month, 3 months, and 6 months after the first injection. Safety was assessed as a secondary outcome as percentage of participants with serious adverse events in all participants who were injected (safety set), and solicited and unsolicited adverse events (immunogenicity subset). This trial is registered with ClinicalTrials.gov, number NCT

  14. Randomised controlled trial of the efficacy of misoprostol used as a ...

    African Journals Online (AJOL)

    Randomised controlled trial of the efficacy of misoprostol used as a cervical ripening agent prior to termination of pregnancy in the first trimester. Eric T M de Jonge, Rachel Jewkes, Jonathan Levin, Helen Rees ...

  15. Medical prescription of heroin to treatment resistant heroin addicts: two randomised controlled trials

    NARCIS (Netherlands)

    van den Brink, Wim; Hendriks, Vincent M.; Blanken, Peter; Koeter, Maarten W. J.; van Zwieten, Barbara J.; van Ree, Jan M.

    2003-01-01

    OBJECTIVE: To determine whether supervised medical prescription of heroin can successfully treat addicts who do not sufficiently benefit from methadone maintenance treatment. DESIGN: Two open label randomised controlled trials. SETTING: Methadone maintenance programmes in six cities in the

  16. Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A.F.; Ven, van de J.; Merién, A.E.R.; Wit-Zuurendonk, de L.D.; Houterman, S.; Mol, B.W.J.; Oei, S.G.

    2012-01-01

    Objective To determine whether obstetric team training in a medical simulation centre improves the team performance and utilisation of appropriate medical technical skills of healthcare professionals. Design Cluster randomised controlled trial. Setting The Netherlands. Sample The obstetric

  17. Randomised Controlled Trial Study of the Effect of TENS and NSAID ...

    African Journals Online (AJOL)

    Randomised Controlled Trial Study of the Effect of TENS and NSAID (Opoid) Drug in the Management of Post Operative Gynaecological Pain. AAG Jimoh, LO Omokanye, GA Salaudeen, ZA Suleiman, K Durowade, EO Adewara ...

  18. A randomised controlled trial of early initiation of oral feeding after ...

    African Journals Online (AJOL)

    A randomised controlled trial of early initiation of oral feeding after Caesarean ... The outcome measures were rate of ileus symptoms, post operative presence of ... more rapid recovery and expressed their interest in earlier hospital discharge.

  19. Methylphenidate for attention deficit hyperactivity disorder (ADHD) in children and adolescents - assessment of harmful effects in non-randomised studies

    DEFF Research Database (Denmark)

    Jakob, Storebø Ole; Nadia, Pedersen; Erica, Ramstad

    2016-01-01

    This is the protocol for a review and there is no abstract. The objectives are as follows:To assess the harmful effects of methylphenidate treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD) in non-randomised studies.......This is the protocol for a review and there is no abstract. The objectives are as follows:To assess the harmful effects of methylphenidate treatment for children and adolescents with attention deficit hyperactivity disorder (ADHD) in non-randomised studies....

  20. The REFANI-N study protocol: a cluster-randomised controlled trial of the effectiveness and cost-effectiveness of early initiation and longer duration of emergency/seasonal unconditional cash transfers for the prevention of acute malnutrition among children, 6-59 months, in Tahoua, Niger.

    Science.gov (United States)

    Sibson, Victoria L; Grijalva-Eternod, Carlos S; Bourahla, Leila; Haghparast-Bidgoli, Hassan; Morrison, Joanna; Puett, Chloe; Trenouth, Lani; Seal, Andrew

    2015-12-23

    The global burden of acute malnutrition among children remains high, and prevalence rates are highest in humanitarian contexts such as Niger. Unconditional cash transfers are increasingly used to prevent acute malnutrition in emergencies but lack a strong evidence base. In Niger, non-governmental organisations give unconditional cash transfers to the poorest households from June to September; the 'hunger gap'. However, rising admissions to feeding programmes from March/April suggest the intervention may be late. This cluster-randomised controlled trial will compare two types of unconditional cash transfer for 'very poor' households in 'vulnerable' villages defined and identified by the implementing organisation. 3,500 children (6-59 months) and 2,500 women (15-49 years) will be recruited exhaustively from households targeted for cash and from a random sample of non-recipient households in 40 villages in Tahoua district. Clusters of villages with a common cash distribution point will be assigned to either a control group which will receive the standard intervention (n = 10), or a modified intervention group (n = 10). The standard intervention is 32,500 FCFA/month for 4 months, June to September, given cash-in-hand to female representatives of 'very poor' households. The modified intervention is 21,500 FCFA/month for 5 months, April, May, July, August, September, and 22,500 FCFA in June, providing the same total amount. In both arms the recipient women attend an education session, women and children are screened and referred for acute malnutrition treatment, and the households receive nutrition supplements for children 6-23 months and pregnant and lactating women. The trial will evaluate whether the modified unconditional cash transfer leads to a reduction in acute malnutrition among children 6-59 months old compared to the standard intervention. The sample size provides power to detect a 5 percentage point difference in prevalence of acute malnutrition between trial

  1. How do parents experience being asked to enter a child in a randomised controlled trial?

    Directory of Open Access Journals (Sweden)

    Young Bridget

    2009-02-01

    Full Text Available Abstract Background As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enrol their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Discussion Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfilment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual pants will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Summary Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future

  2. How do parents experience being asked to enter a child in a randomised controlled trial?

    Science.gov (United States)

    Shilling, Valerie; Young, Bridget

    2009-02-16

    As the number of randomised controlled trials of medicines for children increases, it becomes progressively more important to understand the experiences of parents who are asked to enroll their child in a trial. This paper presents a narrative review of research evidence on parents' experiences of trial recruitment focussing on qualitative research, which allows them to articulate their views in their own words. Parents want to do their best for their children, and socially and legally their role is to care for and protect them yet the complexities of the medical and research context can challenge their fulfillment of this role. Parents are simultaneously responsible for their child and cherish this role yet they are dependent on others when their child becomes sick. They are keen to exercise responsibility for deciding to enter a child in a trial yet can be fearful of making the 'wrong' decision. They make judgements about the threat of the child's condition as well as the risks of the trial yet their interpretations often differ from those of medical and research experts. Individual parents will experience these and other complexities to a greater or lesser degree depending on their personal experiences and values, the medical situation of their child and the nature of the trial. Interactions at the time of trial recruitment offer scope for negotiating these complexities if practitioners have the flexibility to tailor discussions to the needs and situation of individual parents. In this way, parents may be helped to retain a sense that they have acted as good parents to their child whatever decision they make. Discussing randomised controlled trials and gaining and providing informed consent is challenging. The unique position of parents in giving proxy consent for their child adds to this challenge. Recognition of the complexities parents face in making decisions about trials suggests lines for future research on the conduct of trials, and ultimately, may help

  3. Exploring the effects of a universal classroom management training programme on teacher and child behaviour: A group randomised controlled trial and cost analysis

    OpenAIRE

    O'Neill, Donal

    2017-01-01

    Teachers frequently struggle to cope with conduct problems in the classroom. The aim of this study was to assess the effectiveness of the Incredible Years Teacher Classroom Management Training Programme for improving teacher competencies and child adjustment. The study involved a group randomised controlled trial which included 22 teachers and 217 children (102 boys and 115 girls). The average age of children included in the study was 5.3 years (standard deviation = 0.89). Teacher...

  4. Paediatric asthma outpatient care by asthma nurse, paediatrician or general practitioner: Randomised controlled trial with two-year follow-up

    OpenAIRE

    Kuethe, Maarten; Vaessen-Verberne, Anja; Mulder, Paul; Bindels, Patrick; Aalderen, Willem

    2011-01-01

    textabstractAims: For children with stable asthma, to test non-inferiority of care provided by a hospital-based specialised asthma nurse versus a general practitioner (GP) or paediatrician. Methods: Randomised controlled trial evaluating standard care by a GP, paediatrician or an asthma nurse, with two-year follow-up. Results: 107 children were recruited, 45 from general practice and 62 from hospital. After two years, no significant differences between groups were found for airway responsiven...

  5. The psychological profile of parents who volunteer their children for clinical research: a controlled study.

    OpenAIRE

    Harth, S C; Johnstone, R R; Thong, Y H

    1992-01-01

    Three standard psychometric tests were administered to parents who volunteered their children for a randomised, double-blind placebo-controlled trial of a new asthma drug and to a control group of parents whose children were eligible for the trial but had declined the invitation. The trial took place at a children's hospital in Australia. The subjects comprised 68 parents who had volunteered their children and 42 who had not, a participation rate of 94 per cent and 70 per cent, respectively. ...

  6. A Feasibility Randomised Controlled Trial of the New Orleans Intervention for Infant Mental Health: A Study Protocol

    Directory of Open Access Journals (Sweden)

    Rachel Pritchett

    2013-01-01

    Full Text Available Child maltreatment is associated with life-long social, physical, and mental health problems. Intervening early to provide maltreated children with safe, nurturing care can improve outcomes. The need for prompt decisions about permanent placement (i.e., regarding adoption or return home is internationally recognised. However, a recent Glasgow audit showed that many maltreated children “revolve” between birth families and foster carers. This paper describes the protocol of the first exploratory randomised controlled trial of a mental health intervention aimed at improving placement permanency decisions for maltreated children. This trial compares an infant's mental health intervention with the new enhanced service as usual for maltreated children entering care in Glasgow. As both are new services, the trial is being conducted from a position of equipoise. The outcome assessment covers various fields of a child’s neurodevelopment to identify problems in any ESSENCE domain. The feasibility, reliability, and developmental appropriateness of all outcome measures are examined. Additionally, the potential for linkage with routinely collected data on health and social care and, in the future, education is explored. The results will inform a definitive randomised controlled trial that could potentially lead to long lasting benefits for the Scottish population and which may be applicable to other areas of the world. This trial is registered with ClinicalTrials.gov (NC01485510.

  7. Prenatal vitamin d supplementation and child respiratory health: a randomised controlled trial.

    Science.gov (United States)

    Goldring, Stephen T; Griffiths, Chris J; Martineau, Adrian R; Robinson, Stephen; Yu, Christina; Poulton, Sheree; Kirkby, Jane C; Stocks, Janet; Hooper, Richard; Shaheen, Seif O; Warner, John O; Boyle, Robert J

    2013-01-01

    Observational studies suggest high prenatal vitamin D intake may be associated with reduced childhood wheezing. We examined the effect of prenatal vitamin D on childhood wheezing in an interventional study. We randomised 180 pregnant women at 27 weeks gestation to either no vitamin D, 800 IU ergocalciferol daily until delivery or single oral bolus of 200,000 IU cholecalciferol, in an ethnically stratified, randomised controlled trial. Supplementation improved but did not optimise vitamin D status. Researchers blind to allocation assessed offspring at 3 years. Primary outcome was any history of wheeze assessed by validated questionnaire. Secondary outcomes included atopy, respiratory infection, impulse oscillometry and exhaled nitric oxide. Primary analyses used logistic and linear regression. We evaluated 158 of 180 (88%) offspring at age 3 years for the primary outcome. Atopy was assessed by skin test for 95 children (53%), serum IgE for 86 (48%), exhaled nitric oxide for 62 (34%) and impulse oscillometry of acceptable quality for 51 (28%). We found no difference between supplemented and control groups in risk of wheeze [no vitamin D: 14/50 (28%); any vitamin D: 26/108 (24%) (risk ratio 0.86; 95% confidence interval 0.49, 1.50; P = 0.69)]. There was no significant difference in atopy, eczema risk, lung function or exhaled nitric oxide between supplemented groups and controls. Prenatal vitamin D supplementation in late pregnancy that had a modest effect on cord blood vitamin D level, was not associated with decreased wheezing in offspring at age three years. Controlled-Trials.com ISRCTN68645785.

  8. Should desperate volunteers be included in randomised controlled trials?

    Science.gov (United States)

    Allmark, P; Mason, S

    2006-09-01

    Randomised controlled trials (RCTs) sometimes recruit participants who are desperate to receive the experimental treatment. This paper defends the practice against three arguments that suggest it is unethical first, desperate volunteers are not in equipoise. Second clinicians, entering patients onto trials are disavowing their therapeutic obligation to deliver the best treatment; they are following trial protocols rather than delivering individualised care. Research is not treatment; its ethical justification is different. Consent is crucial. Third, desperate volunteers do not give proper consent: effectively, they are coerced. This paper responds by advocating a notion of equipoise based on expert knowledge and widely shared values. Where such collective, expert equipoise exists there is a prima facie case for an RCT. Next the paper argues that trial entry does not involve clinicians disavowing their therapeutic obligation; individualised care based on insufficient evidence is not in patients best interest. Finally, it argues that where equipoise exists it is acceptable to limit access to experimental agents; desperate volunteers are not coerced because their desperation does not translate into a right to receive what they desire.

  9. Parenting for Autism, Language, And Communication Evaluation Study (PALACES): protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Williams, Margiad Elen; Hastings, Richard; Charles, Joanna Mary; Evans, Sue; Hutchings, Judy

    2017-02-16

    Children with autistic spectrum disorder (ASD) often have associated behavioural difficulties that can present a challenge for parents and parenting. There are several effective social learning theory-based parenting programmes for dealing with behavioural difficulties, including the Incredible Years (IY) parent programmes. However, these programmes typically do not specifically target parents of children with ASD. Recently, a new addition to the IY suite of programmes known as the IY Autistic Spectrum and Language Delays (IY-ASLD) parent programme was developed. The main aims of the present study are to examine the feasibility of delivering this programme within child health services and to provide initial evidence for effectiveness and economic costs. The Parenting for Autism, Language, And Communication Evaluation Study (PALACES) trial is a pragmatic, multicentre, pilot randomised controlled trial comparing the IY-ASLD programme with a wait-list control condition. 72 parents of children with ASD (aged 3-8 years) will be randomly allocated to either the intervention or control condition. Data will be collected prior to randomisation and 6 months postrandomisation for all families. Families in the intervention condition only will also be followed up at 12 and 18 months postrandomisation. This study will provide initial evidence of effectiveness for the newly developed IY-ASLD parenting programme. It will also add to the limited economic evidence for an intervention targeting parents of children with ASD and provide longer term data, an important component for evaluations of parenting programmes. Approval for the study was granted by the Research Ethics Committee at the School of Psychology, Bangor University (reference number: 2016-15768) and the North Wales Research Ethics Committee, UK (reference number: 16/WA/0224). The findings will be disseminated through research conferences and peer-reviewed journals. ISRCTN57070414; Pre-results. Published by the BMJ

  10. Evaluation of muscle activity, bite force and salivary cortisol in children with bruxism before and after low level laser applied to acupoints: study protocol for a randomised controlled trial.

    Science.gov (United States)

    Salgueiro, Mônica da Consolação Canuto; Bortoletto, Carolina Carvalho; Horliana, Anna Carolina RattoTempestini; Mota, Ana Carolina Costa; Motta, Lara Jansiski; Motta, Pamella de Barros; MesquitaFerrari, Raquel Agnelli; Fernandes, Kristianne Porta Santos; Bussadori, Sandra Kalil

    2017-08-08

    Bruxism is a repetitive activity that causes tooth wear, audible sounds, and discomfort. Preventive measures have been studied for conditions that can exert a negative influence on physiological development in children. Low-level laser therapy administered over acupoints is an effective, painless, low-cost treatment option that has achieved good results. Thus, the aim of the proposed study is to evaluate changes in muscle activity, bite force and salivary cortisol in children with bruxism after the application of low-level laser to accupoints. The children will be randomly allocated to four groups of 19 individuals: G1 - low-level laser; G2 - occlusal splint; G3 - placebo laser; and G4 - control (without bruxism). The BTS TMJOINT electromyography will be used to determine muscle activity and a digital gnathodynamometer will be used to measure bite force. Salivary cortisol will be analysed at baseline as well as one and six months after treatment. Two-way ANOVA will be employed and complemented by Tukey's test. Bruxism is a repetitive activity of the masticatory muscles that can have negative consequences if not treated, such as tooth wear, noises, discomfort and anxiety. Thus, control and treatment measures should be taken. Although low-level laser therapy over acupoints has been indicated for children, the effects of this treatment modality have not yet been studied. NCT02757261 on 8 April 2016. This study protocol received a grant from the Brazilian fostering agency São Paulo Research Foundation (FAPESP: #2015/24731-0).

  11. The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6-7 years.

    Science.gov (United States)

    Adab, Peymane; Barrett, Timothy; Bhopal, Raj; Cade, Janet E; Canaway, Alastair; Cheng, Kar Keung; Clarke, Joanne; Daley, Amanda; Deeks, Jonathan; Duda, Joan; Ekelund, Ulf; Frew, Emma; Gill, Paramjit; Griffin, Tania; Hemming, Karla; Hurley, Kiya; Lancashire, Emma R; Martin, James; McGee, Eleanor; Pallan, Miranda J; Parry, Jayne; Passmore, Sandra

    2018-02-01

    Systematic reviews suggest that school-based interventions can be effective in preventing childhood obesity, but better-designed trials are needed that consider costs, process, equity, potential harms and longer-term outcomes. To assess the clinical effectiveness and cost-effectiveness of the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) study intervention, compared with usual practice, in preventing obesity among primary school children. A cluster randomised controlled trial, split across two groups, which were randomised using a blocked balancing algorithm. Schools/participants could not be blinded to trial arm. Measurement staff were blind to allocation arm as far as possible. Primary schools, West Midlands, UK. Schools within a 35-mile radius of the study centre and all year 1 pupils (aged 5-6 years) were eligible. Schools with a higher proportion of pupils from minority ethnic populations were oversampled to enable subgroup analyses. The 12-month intervention encouraged healthy eating/physical activity (PA) by (1) helping teachers to provide 30 minutes of additional daily PA, (2) promoting 'Villa Vitality' (interactive healthy lifestyles learning, in an inspirational setting), (3) running school-based healthy cooking skills/education workshops for parents and children and (4) highlighting information to families with regard to local PA opportunities. The primary outcomes were the difference in body mass index z-scores (BMI-zs) between arms (adjusted for baseline body mass index) at 3 and 18 months post intervention (clinical outcome), and cost per quality-adjusted life-year (QALY) (cost-effectiveness outcome). The secondary outcomes were further anthropometric, dietary, PA and psychological measurements, and the difference in BMI-z between arms at 27 months post intervention in a subset of schools. Two groups of schools were randomised: 27 in 2011 ( n  = 650 pupils) [group 1 (G1)] and another 27 in 2012 ( n  = 817 pupils

  12. Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder - The SOSTRA trial protocol

    Directory of Open Access Journals (Sweden)

    Thomsen Per

    2011-01-01

    Full Text Available Abstract Background Children with attention deficit hyperactivity disorder (ADHD are hyperactive and impulsive, cannot maintain attention, and have difficulties with social interactions. Medical treatment may alleviate symptoms of ADHD, but seldom solves difficulties with social interactions. Social-skills training may benefit ADHD children in their social interactions. We want to examine the effects of social-skills training on difficulties related to the children's ADHD symptoms and social interactions. Methods/Design The design is randomised two-armed, parallel group, assessor-blinded trial. Children aged 8-12 years with a diagnosis of ADHD are randomised to social-skills training and parental training plus standard treatment versus standard treatment alone. A sample size calculation estimated that at least 52 children must be included to show a 4-point difference in the primary outcome on the Conners 3rd Edition subscale for 'hyperactivity-impulsivity' between the intervention group and the control group. The outcomes will be assessed 3 and 6 months after randomisation. The primary outcome measure is ADHD symptoms. The secondary outcome is social skills. Tertiary outcomes include the relationship between social skills and symptoms of ADHD, the ability to form attachment, and parents' ADHD symptoms. Discussion We hope that the results from this trial will show that the social-skills training together with medication may have a greater general effect on ADHD symptoms and social and emotional competencies than medication alone. Trial registration ClinicalTrials (NCT: NCT00937469

  13. Randomised social-skills training and parental training plus standard treatment versus standard treatment of children with attention deficit hyperactivity disorder

    DEFF Research Database (Denmark)

    Storebo, Ole Jakob; Pedersen, Jesper; Skoog, Maria

    2011-01-01

    Background: Children with attention deficit hyperactivity disorder (ADHD) are hyperactive and impulsive, cannot maintain attention, and have difficulties with social interactions. Medical treatment may alleviate symptoms of ADHD, but seldom solves difficulties with social interactions. Social...... on the Conners 3(rd) Edition subscale for 'hyperactivity-impulsivity' between the intervention group and the control group. The outcomes will be assessed 3 and 6 months after randomisation. The primary outcome measure is ADHD symptoms. The secondary outcome is social skills. Tertiary outcomes include...

  14. Asthma control in children

    DEFF Research Database (Denmark)

    Pedersen, Søren

    2016-01-01

    The goal of asthma management is to achieve disease control. Poorly controlled asthma is associated with an increased number of days lost from school, exacerbations and days in hospital. Furthermore, children with uncontrolled asthma have more frequent contacts with the health-care system. Recent...... studies have added new information about the effects of poorly controlled asthma on a range of important, but less studied outcomes, including risk of obesity, daily physical activity, cardiovascular fitness, stress, concentration and focused attention, learning disabilities and risk of depression. From...... these studies it seems that poor asthma control may have a greater impact on the child than previously thought. This may have important long-term consequences for the child such as an increased risk of life-style associated diseases and poorer school performance. The level of control seems to be the most...

  15. Subgroup analyses in randomised controlled trials: cohort study on trial protocols and journal publications.

    Science.gov (United States)

    Kasenda, Benjamin; Schandelmaier, Stefan; Sun, Xin; von Elm, Erik; You, John; Blümle, Anette; Tomonaga, Yuki; Saccilotto, Ramon; Amstutz, Alain; Bengough, Theresa; Meerpohl, Joerg J; Stegert, Mihaela; Olu, Kelechi K; Tikkinen, Kari A O; Neumann, Ignacio; Carrasco-Labra, Alonso; Faulhaber, Markus; Mulla, Sohail M; Mertz, Dominik; Akl, Elie A; Bassler, Dirk; Busse, Jason W; Ferreira-González, Ignacio; Lamontagne, Francois; Nordmann, Alain; Gloy, Viktoria; Raatz, Heike; Moja, Lorenzo; Rosenthal, Rachel; Ebrahim, Shanil; Vandvik, Per O; Johnston, Bradley C; Walter, Martin A; Burnand, Bernard; Schwenkglenks, Matthias; Hemkens, Lars G; Bucher, Heiner C; Guyatt, Gordon H; Briel, Matthias

    2014-07-16

    To investigate the planning of subgroup analyses in protocols of randomised controlled trials and the agreement with corresponding full journal publications. Cohort of protocols of randomised controlled trial and subsequent full journal publications. Six research ethics committees in Switzerland, Germany, and Canada. 894 protocols of randomised controlled trial involving patients approved by participating research ethics committees between 2000 and 2003 and 515 subsequent full journal publications. Of 894 protocols of randomised controlled trials, 252 (28.2%) included one or more planned subgroup analyses. Of those, 17 (6.7%) provided a clear hypothesis for at least one subgroup analysis, 10 (4.0%) anticipated the direction of a subgroup effect, and 87 (34.5%) planned a statistical test for interaction. Industry sponsored trials more often planned subgroup analyses compared with investigator sponsored trials (195/551 (35.4%) v 57/343 (16.6%), P<0.001). Of 515 identified journal publications, 246 (47.8%) reported at least one subgroup analysis. In 81 (32.9%) of the 246 publications reporting subgroup analyses, authors stated that subgroup analyses were prespecified, but this was not supported by 28 (34.6%) corresponding protocols. In 86 publications, authors claimed a subgroup effect, but only 36 (41.9%) corresponding protocols reported a planned subgroup analysis. Subgroup analyses are insufficiently described in the protocols of randomised controlled trials submitted to research ethics committees, and investigators rarely specify the anticipated direction of subgroup effects. More than one third of statements in publications of randomised controlled trials about subgroup prespecification had no documentation in the corresponding protocols. Definitive judgments regarding credibility of claimed subgroup effects are not possible without access to protocols and analysis plans of randomised controlled trials. © The DISCO study group 2014.

  16. Generalisability of an online randomised controlled trial: an empirical analysis.

    Science.gov (United States)

    Wang, Cheng; Mollan, Katie R; Hudgens, Michael G; Tucker, Joseph D; Zheng, Heping; Tang, Weiming; Ling, Li

    2018-02-01

    Investigators increasingly use online methods to recruit participants for randomised controlled trials (RCTs). However, the extent to which participants recruited online represent populations of interest is unknown. We evaluated how generalisable an online RCT sample is to men who have sex with men in China. Inverse probability of sampling weights (IPSW) and the G-formula were used to examine the generalisability of an online RCT using model-based approaches. Online RCT data and national cross-sectional study data from China were analysed to illustrate the process of quantitatively assessing generalisability. The RCT (identifier NCT02248558) randomly assigned participants to a crowdsourced or health marketing video for promotion of HIV testing. The primary outcome was self-reported HIV testing within 4 weeks, with a non-inferiority margin of -3%. In the original online RCT analysis, the estimated difference in proportions of HIV tested between the two arms (crowdsourcing and health marketing) was 2.1% (95% CI, -5.4% to 9.7%). The hypothesis that the crowdsourced video was not inferior to the health marketing video to promote HIV testing was not demonstrated. The IPSW and G-formula estimated differences were -2.6% (95% CI, -14.2 to 8.9) and 2.7% (95% CI, -10.7 to 16.2), with both approaches also not establishing non-inferiority. Conducting generalisability analysis of an online RCT is feasible. Examining the generalisability of online RCTs is an important step before an intervention is scaled up. NCT02248558. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. Publication status of contemporary oncology randomised controlled trials worldwide.

    Science.gov (United States)

    Chen, Yu-Pei; Liu, Xu; Lv, Jia-Wei; Li, Wen-Fei; Zhang, Yuan; Guo, Ying; Lin, Ai-Hua; Sun, Ying; Mao, Yan-Ping; Ma, Jun

    2016-10-01

    Little is known about the extent of selective publication in contemporary oncology randomised controlled trials (RCTs) worldwide. This study aimed to evaluate the rates of publication and timely publication (within 24 months) for contemporary oncology RCTs from all over the world. We also investigated the trial characteristics associated with publication and timely publication. We identified all phase III oncology RCTs registered on ClinicalTrials.gov with a primary completion date between January 2008 and December 2012. We searched PubMed and EMBASE to identify publications. The final search date was 31 December 2015. Our primary outcome measure was the time to publication from the primary completion date to the date of primary publication in a peer-reviewed journal. We identified 598 completed oncology RCTs; overall, 398 (66.6%) had been published. For published trials, the median time to publication was 25 months (interquartile range, 16-37 months). Only 192 trials (32.1%) were published within 24 months. Timely publication was independently associated with trials completed late in 2012. Trials conducted in Asia and other regions were less likely to have timely publication, but trials conducted in different locations were all equally likely to be published. Industry- and NIH-funded trials were equally likely to be published timely or at any time after trial completion. Among 391 published trials with clear primary outcomes, there was a trend for timely publication of positive trials compared with negative trials. Despite the ethical obligations and societal expectations of disclosing findings promptly, oncology RCTs performed poorly. Copyright © 2016 Elsevier Ltd. All rights reserved.

  18. Acupuncture for dry eye: a randomised controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Kim Ae-Ran

    2009-12-01

    Full Text Available Abstract Background Dry eye is usually managed by conventional medical interventions such as artificial tears, anti-inflammatory drugs and surgical treatment. However, since dry eye is one of the most frequent ophthalmologic disorders, safer and more effective methods for its treatment are necessary, especially for vulnerable patients. Acupuncture has been widely used to treat patients with dry eye. Our aim is to evaluate the effectiveness and safety of acupuncture for this condition. Methods/Design A randomised, patient-assessor blinded, sham (non-acupuncture point, shallow acupuncture controlled study was established. Participants allocated to verum acupuncture and sham acupuncture groups will be treated three times weekly for three weeks for a total of nine sessions per participant. Seventeen points (GV23; bilateral BL2, GB4, TE23, Ex1 (Taiyang, ST1 and GB20; and left SP3, LU9, LU10 and HT8 for men, right for women have been selected for the verum acupuncture; for the sham acupuncture, points have been selected that do not coincide with a classical acupuncture point and that are located close to the verum points, except in the case of the rim of the eye. Ocular surface disease index, tear film breakup time, the Schirmer I test, medication quantification scale and general assessment of improvement will be used as outcome variables for evaluating the effectiveness of acupuncture. Safety will also be assessed at every visit. Primary and secondary outcomes will be assessed four weeks after screening. All statistical analyses will be performed using analysis of covariance. Discussion The results of this trial will be used as a basis for clarifying the efficacy of acupuncture for dry eye. Trial registration ClinicalTrials.gov NCT00969280.

  19. Design, analysis and presentation of factorial randomised controlled trials

    Directory of Open Access Journals (Sweden)

    Little Paul

    2003-11-01

    Full Text Available Abstract Background The evaluation of more than one intervention in the same randomised controlled trial can be achieved using a parallel group design. However this requires increased sample size and can be inefficient, especially if there is also interest in considering combinations of the interventions. An alternative may be a factorial trial, where for two interventions participants are allocated to receive neither intervention, one or the other, or both. Factorial trials require special considerations, however, particularly at the design and analysis stages. Discussion Using a 2 × 2 factorial trial as an example, we present a number of issues that should be considered when planning a factorial trial. The main design issue is that of sample size. Factorial trials are most often powered to detect the main effects of interventions, since adequate power to detect plausible interactions requires greatly increased sample sizes. The main analytical issues relate to the investigation of main effects and the interaction between the interventions in appropriate regression models. Presentation of results should reflect the analytical strategy with an emphasis on the principal research questions. We also give an example of how baseline and follow-up data should be presented. Lastly, we discuss the implications of the design, analytical and presentational issues covered. Summary Difficulties in interpreting the results of factorial trials if an influential interaction is observed is the cost of the potential for efficient, simultaneous consideration of two or more interventions. Factorial trials can in principle be designed to have adequate power to detect realistic interactions, and in any case they are the only design that allows such effects to be investigated.

  20. The Cool Little Kids randomised controlled trial: population-level early prevention for anxiety disorders.

    Science.gov (United States)

    Bayer, Jordana K; Rapee, Ronald M; Hiscock, Harriet; Ukoumunne, Obioha C; Mihalopoulos, Cathrine; Clifford, Susan; Wake, Melissa

    2011-01-05

    The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety) will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500) with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework) will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively) to compare outcomes between the trial arms. This trial addresses gaps

  1. The Cool Little Kids randomised controlled trial: Population-level early prevention for anxiety disorders

    Directory of Open Access Journals (Sweden)

    Hiscock Harriet

    2011-01-01

    Full Text Available Abstract Background The World Health Organization predicts that by 2030 internalising problems (e.g. depression and anxiety will be second only to HIV/AIDS in international burden of disease. Internalising problems affect 1 in 7 school aged children, impacting on peer relations, school engagement, and later mental health, relationships and employment. The development of early childhood prevention for internalising problems is in its infancy. The current study follows two successful 'efficacy' trials of a parenting group intervention to reduce internalising disorders in temperamentally inhibited preschool children. Cool Little Kids is a population-level randomised trial to determine the impacts of systematically screening preschoolers for inhibition then offering a parenting group intervention, on child internalising problems and economic costs at school entry. Methods/Design This randomised trial will be conducted within the preschool service system, attended by more than 95% of Australian children in the year before starting school. In early 2011, preschool services in four local government areas in Melbourne, Australia, will distribute the screening tool. The ≈16% (n≈500 with temperamental inhibition will enter the trial. Intervention parents will be offered Cool Little Kids, a 6-session group program in the local community, focusing on ways to develop their child's bravery skills by reducing overprotective parenting interactions. Outcomes one and two years post-baseline will comprise child internalising diagnoses and symptoms, parenting interactions, and parent wellbeing. An economic evaluation (cost-consequences framework will compare incremental differences in costs of the intervention versus control children to incremental differences in outcomes, from a societal perspective. Analyses will use the intention-to-treat principle, using logistic and linear regression models (binary and continuous outcomes respectively to compare outcomes

  2. A randomised controlled trial of cardiac rehabilitation after revascularisation

    NARCIS (Netherlands)

    Brugemann, Johan; Poels, Bas J. J.; Oosterwijk, Mieke H.; van der Schans, Cees P.; Postema, Klaas; van Veldhuisen, Dirk J.

    Background: It is unclear if psycho- education on top of physical training is of additional value regarding quality of life in revascularised patients. Design: Prospective randomised study comparing two types of cardiac rehabilitation: exercise based versus a more comprehensive approach including

  3. Radiotherapy for Graves' orbitopathy : randomised placebo-controlled study

    NARCIS (Netherlands)

    Mourits, MP; van Kempen-Harteveld, ML; Garcia, MBG; Koppeschaar, HPF; Tick, L; Terwee, CB

    2000-01-01

    Background The best treatment (steroids, irradiation, or both) for moderately severe Graves' orbitopathy, a self-limiting disease is not known. We tested the efficacy of external beam irradiation compared with sham-irradiation. Methods In a double-blind randomised clinical trial, 30 patients with

  4. Evaluation of the COPING parent online universal programme: study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Owen, Dawn Adele; Griffith, Nia; Hutchings, Judy

    2017-04-26

    Bangor University, Brigantia Building, College Road, Bangor, LL57 2AS, UK INTRODUCTION: The COPING parent online universal programme is a web-based parenting intervention for parents of children aged 3-8 years with an interest in positive parenting. The programme focuses on strengthening parent-child relationships and encouraging positive child behaviour. This trial will evaluate whether the intervention is effective in increasing the use of positive parenting strategies outlined in the programme using parent report and blind observation measures. This is a pilot randomised controlled trial with intervention and wait-list control conditions. The intervention is a 10-week online parenting programme to promote positive parent-child relations by teaching core social learning theory principles that encourage positive child behaviour, primarily through the use of praise and rewards. Health visitors and school nurses will circulate a recruitment poster to parents of children aged 3-8 years on their current caseloads. Recruitment posters will also be distributed via local primary schools and nurseries. Parents recruited to the trial will be randomised on a 2:1 ratio to intervention or wait-list control conditions (stratified according to child gender and age). The primary outcome measure is positive parenting as measured by a behavioural observation of parent-child interactions using the Dyadic Parent-Child Interaction Coding System. Secondary outcomes include parent report of child behaviour, and self-reported parental sense of competence, parenting behaviour and parental mental health. Data will be collected at baseline and 3 months later (postintervention) for all participants and 6 months postbaseline for the intervention group only. Analysis of covariance will be the main statistical method used. The trial has received ethical approval from the NHS Betsi Cadwaladr University Health Board Ethics Committee (REC) and the School of Psychology, Bangor University REC (15

  5. The REFANI-S study protocol: a non-randomised cluster controlled trial to assess the role of an unconditional cash transfer, a non-food item kit, and free piped water in reducing the risk of acute malnutrition among children aged 6-59 months living in camps for internally displaced persons in the Afgooye corridor, Somalia.

    Science.gov (United States)

    Jelle, Mohamed; Grijalva-Eternod, Carlos S; Haghparast-Bidgoli, Hassan; King, Sarah; Cox, Cassy L; Skordis-Worrall, Jolene; Morrison, Joanna; Colbourn, Timothy; Fottrell, Edward; Seal, Andrew J

    2017-07-06

    The prevalence of acute malnutrition is often high in emergency-affected populations and is associated with elevated mortality risk and long-term health consequences. Increasingly, cash transfer programmes (CTP) are used instead of direct food aid as a nutritional intervention, but there is sparse evidence on their nutritional impact. We aim to understand whether CTP reduces acute malnutrition and its known risk factors. A non-randomised, cluster-controlled trial will assess the impact of an unconditional cash transfer of US$84 per month for 5 months, a single non-food items kit, and free piped water on the risk of acute malnutrition in children, aged 6-59 months. The study will take place in camps for internally displaced persons (IDP) in peri-urban Mogadishu, Somalia. A cluster will consist of one IDP camp and 10 camps will be allocated to receive the intervention based on vulnerability targeting criteria. The control camps will then be selected from the same geographical area. Needs assessment data indicates small differences in vulnerability between camps. In each trial arm, 120 households will be randomly sampled and two detailed household surveys will be implemented at baseline and 3 months after the initiation of the cash transfer. The survey questionnaire will cover risk factors for malnutrition including household expenditure, assets, food security, diet diversity, coping strategies, morbidity, WASH, and access to health care. A community surveillance system will collect monthly mid-upper arm circumference measurements from all children aged 6-59 months in the study clusters to assess the incidence of acute malnutrition over the duration of the intervention. Process evaluation data will be compiled from routine quantitative programme data and primary qualitative data collected using key informant interviews and focus group discussions. The UK Department for International Development will provide funding for this study. The European Civil Protection and

  6. The REFANI-S study protocol: a non-randomised cluster controlled trial to assess the role of an unconditional cash transfer, a non-food item kit, and free piped water in reducing the risk of acute malnutrition among children aged 6–59 months living in camps for internally displaced persons in the Afgooye corridor, Somalia

    Directory of Open Access Journals (Sweden)

    Mohamed Jelle

    2017-07-01

    Full Text Available Abstract Background The prevalence of acute malnutrition is often high in emergency-affected populations and is associated with elevated mortality risk and long-term health consequences. Increasingly, cash transfer programmes (CTP are used instead of direct food aid as a nutritional intervention, but there is sparse evidence on their nutritional impact. We aim to understand whether CTP reduces acute malnutrition and its known risk factors. Methods/design A non-randomised, cluster-controlled trial will assess the impact of an unconditional cash transfer of US$84 per month for 5 months, a single non-food items kit, and free piped water on the risk of acute malnutrition in children, aged 6–59 months. The study will take place in camps for internally displaced persons (IDP in peri-urban Mogadishu, Somalia. A cluster will consist of one IDP camp and 10 camps will be allocated to receive the intervention based on vulnerability targeting criteria. The control camps will then be selected from the same geographical area. Needs assessment data indicates small differences in vulnerability between camps. In each trial arm, 120 households will be randomly sampled and two detailed household surveys will be implemented at baseline and 3 months after the initiation of the cash transfer. The survey questionnaire will cover risk factors for malnutrition including household expenditure, assets, food security, diet diversity, coping strategies, morbidity, WASH, and access to health care. A community surveillance system will collect monthly mid-upper arm circumference measurements from all children aged 6–59 months in the study clusters to assess the incidence of acute malnutrition over the duration of the intervention. Process evaluation data will be compiled from routine quantitative programme data and primary qualitative data collected using key informant interviews and focus group discussions. The UK Department for International Development will provide

  7. Testing the activitystat hypothesis: a randomised controlled trial protocol.

    Science.gov (United States)

    Gomersall, Sjaan; Maher, Carol; Norton, Kevin; Dollman, Jim; Tomkinson, Grant; Esterman, Adrian; English, Coralie; Lewis, Nicole; Olds, Tim

    2012-10-08

    The activitystat hypothesis proposes that when physical activity or energy expenditure is increased or decreased in one domain, there will be a compensatory change in another domain to maintain an overall, stable level of physical activity or energy expenditure. To date, there has been no experimental study primarily designed to test the activitystat hypothesis in adults. The aim of this trial is to determine the effect of two different imposed exercise loads on total daily energy expenditure and physical activity levels. This study will be a randomised, multi-arm, parallel controlled trial. Insufficiently active adults (as determined by the Active Australia survey) aged 18-60 years old will be recruited for this study (n=146). Participants must also satisfy the Sports Medicine Australia Pre-Exercise Screening System and must weigh less than 150 kg. Participants will be randomly assigned to one of three groups using a computer-generated allocation sequence. Participants in the Moderate exercise group will receive an additional 150 minutes of moderate to vigorous physical activity per week for six weeks, and those in the Extensive exercise group will receive an additional 300 minutes of moderate to vigorous physical activity per week for six weeks. Exercise targets will be accumulated through both group and individual exercise sessions monitored by heart rate telemetry. Control participants will not be given any instructions regarding lifestyle. The primary outcome measures are activity energy expenditure (doubly labeled water) and physical activity (accelerometry). Secondary measures will include resting metabolic rate via indirect calorimetry, use of time, maximal oxygen consumption and several anthropometric and physiological measures. Outcome measures will be conducted at baseline (zero weeks), mid- and end-intervention (three and six weeks) with three (12 weeks) and six month (24 week) follow-up. All assessors will be blinded to group allocation. This protocol

  8. Researching Effective Strategies to Improve Insulin Sensitivity in Children and Teenagers - RESIST. A randomised control trial investigating the effects of two different diets on insulin sensitivity in young people with insulin resistance and/or pre-diabetes.

    Directory of Open Access Journals (Sweden)

    De Sukanya

    2010-09-01

    Full Text Available Abstract Background Concomitant with the rise in childhood obesity there has been a significant increase in the number of adolescents with clinical features of insulin resistance and prediabetes. Clinical insulin resistance and prediabetes are likely to progress to type 2 diabetes and early atherosclerosis if not targeted for early intervention. There are no efficacy trials of lifestyle intervention in this group to inform clinical practice. The primary aim of this randomised control trial (RCT is to determine the efficacy and effectiveness of two different structured lifestyle interventions differing in diet composition on insulin sensitivity, in adolescents with clinical insulin resistance and/or prediabetes treated with metformin. Methods/design This study protocol describes the design of an ongoing RCT. We are recruiting 108 (54 each treatment arm 10 to 17 year olds with clinical features of insulin resistance and/or prediabetes, through physician referral, into a multi-centred RCT. All participants are prescribed metformin and participate in a diet and exercise program. The lifestyle program is the same for all participants except for diet composition. The diets are a high carbohydrate, low fat diet and a moderate carbohydrate, increased protein diet. The program commences with an intensive 3 month dietary intervention, implemented by trained dietitians, followed by a 3 month intensive gym and home based exercise program, supervised by certified physical trainers. To measure the longer term effectiveness, after the intensive intervention trial participants are managed by either their usual physician or study physician and followed up by the study dietitians for an additional 6 months. The primary outcome measure, change in insulin sensitivity, is measured at 3, 6 and 12 months. Discussion Clinical insulin resistance and prediabetes in the paediatric population are rapidly emerging clinical problems with serious health outcomes. With

  9. Lessons learned from a double-blind randomised placebo-controlled study with a iota-carrageenan nasal spray as medical device in children with acute symptoms of common cold

    Directory of Open Access Journals (Sweden)

    Fazekas Tamas

    2012-09-01

    Full Text Available Abstract Background Common cold is caused by a variety of respiratory viruses. The prevalence in children is high, and it potentially contributes to significant morbidity. Iota-carragenan, a polymer derived from red seaweed, has reduced viral load in nasal secretions and alleviated symptoms in adults with common cold. Methods We have assessed the antiviral and therapeutic activity of a nasal spray containing iota-carrageenan in children with acute symptoms of common cold. A cohort of 153 children between 1–18 years (mean age 5 years, displaying acute symptoms of common cold were randomly assigned to treatment with a nasal spray containing iota-carrageenan (0.12% as verum or 0.9% sodium chloride solution as placebo for seven days. Symptoms of common cold were recorded and the viral load of respiratory viruses in nasal secretions was determined at two consecutive visits. Results The results of the present study showed no significant difference between the iota carrageenan and the placebo group on the mean of TSS between study days 2–7. Secondary endpoints, such as reduced time to clearance of disease (7.6 vs 9.4 days; p = 0.038, reduction of viral load (p = 0.026, and lower incidence of secondary infections with other respiratory viruses (p = 0.046 indicated beneficial effects of iota-carrageenan in this population. The treatment was safe and well tolerated, with less side effects observed in the verum group compared to placebo. Conclusion In this study iota-carrageenan did not alleviate symptoms in children with acute symptoms of common cold, but significantly reduced viral load in nasal secretions that may have important implications for future studies. Trial registration ISRCTN52519535, http://www.controlled-trials.com/ISRCTN52519535/

  10. Lessons learned from a double-blind randomised placebo-controlled study with a iota-carrageenan nasal spray as medical device in children with acute symptoms of common cold.

    Science.gov (United States)

    Fazekas, Tamas; Eickhoff, Philipp; Pruckner, Nathalie; Vollnhofer, Georg; Fischmeister, Gustav; Diakos, Christopher; Rauch, Margit; Verdianz, Maria; Zoubek, Andreas; Gadner, Helmut; Lion, Thomas

    2012-09-05

    Common cold is caused by a variety of respiratory viruses. The prevalence in children is high, and it potentially contributes to significant morbidity. Iota-carragenan, a polymer derived from red seaweed, has reduced viral load in nasal secretions and alleviated symptoms in adults with common cold. We have assessed the antiviral and therapeutic activity of a nasal spray containing iota-carrageenan in children with acute symptoms of common cold. A cohort of 153 children between 1-18 years (mean age 5 years), displaying acute symptoms of common cold were randomly assigned to treatment with a nasal spray containing iota-carrageenan (0.12%) as verum or 0.9% sodium chloride solution as placebo for seven days. Symptoms of common cold were recorded and the viral load of respiratory viruses in nasal secretions was determined at two consecutive visits. The results of the present study showed no significant difference between the iota carrageenan and the placebo group on the mean of TSS between study days 2-7. Secondary endpoints, such as reduced time to clearance of disease (7.6 vs 9.4 days; p = 0.038), reduction of viral load (p = 0.026), and lower incidence of secondary infections with other respiratory viruses (p = 0.046) indicated beneficial effects of iota-carrageenan in this population. The treatment was safe and well tolerated, with less side effects observed in the verum group compared to placebo. In this study iota-carrageenan did not alleviate symptoms in children with acute symptoms of common cold, but significantly reduced viral load in nasal secretions that may have important implications for future studies. ISRCTN52519535, http://www.controlled-trials.com/ISRCTN52519535/

  11. Developing an Australian-first recovery model for parents in Victorian mental health and family services: a study protocol for a randomised controlled trial.

    Science.gov (United States)

    Maybery, Darryl; Goodyear, Melinda; Reupert, Andrea; Sheen, Jade; Cann, Warren; Dalziel, Kim; Tchernagovski, Phillip; O'Hanlon, Brendan; von Doussa, Henry

    2017-05-26

    A considerable number of people with a mental illness are parents caring for dependent children. For those with a mental illness, parenting can provide a sense of competence, belonging, identity and hope and hence is well aligned to the concept of personal recovery. However, little research has focused on the recovery journey of those who are parents and have a mental illness. This randomised controlled trial aims to (i) evaluate the effectiveness of an intervention model of recovery for parents (Let's Talk about Children) in three different mental health service sectors and (ii) examine the economic value of a larger roll out (longer term) of the parent recovery model. A two arm parallel randomised controlled trial will be used with participants, who are being treated for their mental illness in adult mental health, non-government community mental health or family welfare services. The study will involve 192 parents, who are considered by their treating practitioner to be sufficiently well to provide informed consent and participate in an intervention (Let's Talk about Children) or control group (treatment as usual). Participant randomisation will occur at the level of the treating practitioner and will be based on whether the randomised practitioner is trained in the intervention. Outcomes are compared at pre, post intervention and six-month follow-up. Recovery, parenting and family functioning, and quality of life questionnaires will be used to measure parent wellbeing and the economic benefits of the intervention. This is the first randomised controlled trial to investigate the efficacy of a parenting intervention on recovery outcomes and the first to provide an economic evaluation of an intervention for parents with a mental illness. An implementation model is required to embed the intervention in different sectors. The trial was retrospectively registered: ACTRN12616000460404 on the 8/4/2016.

  12. Feather bedding and childhood asthma associated with house dust mite sensitisation: a randomised controlled trial.

    Science.gov (United States)

    Glasgow, Nicholas J; Ponsonby, Anne-Louise; Kemp, Andrew; Tovey, Euan; van Asperen, Peter; McKay, Karen; Forbes, Samantha

    2011-06-01

    Observational studies report inverse associations between the use of feather upper bedding (pillow and/or quilt) and asthma symptoms but there is no randomised controlled trial (RCT) evidence assessing the role of feather upper bedding as a secondary prevention measure. To determine whether, among children not using feather upper bedding, a new feather pillow and feather quilt reduces asthma severity among house dust mite (HDM) sensitised children with asthma over a 1-year period compared with standard dust mite avoidance advice, and giving children a new mite-occlusive mattress cover. RCT. The Calvary Hospital in the Australian Capital Territory and the Children's Hospital at Westmead, Sydney, New South Wales. 197 children with HDM sensitisation and moderate to severe asthma. Intervention New upper bedding duck feather pillow and quilt and a mite-occlusive mattress cover (feather) versus standard care and a mite-occlusive mattress cover (standard). The proportion of children reporting four or more episodes of wheeze in the past year; an episode of speech-limiting wheeze; or one or more episodes of sleep disturbance caused by wheezing; and spirometry with challenge testing. Statistical analysis included multiple logistic and linear regression. No differences between groups were found for primary end points--frequent wheeze (OR 1.51, 95% CI 0.83 to 2.76, p=0.17), speech-limiting wheeze (OR 0.70, 95% CI 0.32 to 1.48, p=0.35), sleep disturbed because of wheezing (OR 1.17, 95% CI 0.64 to 2.13, p=0.61) or for any secondary end points. Secondary analyses indicated the intervention reduced the risk of sleep being disturbed because of wheezing and severe wheeze to a greater extent for children who slept supine. No differences in respiratory symptoms or lung function were observed 1 year after children with moderate-severe asthma and HDM sensitisation were given a mite-occlusive mattress cover and then received either feather upper bedding (pillow and quilt) or standard

  13. Healthcare costs in the Danish randomised controlled lung cancer CT-screening trial

    DEFF Research Database (Denmark)

    Rasmussen, J.F.; Siersma, V.; Pedersen, Jesper H.

    2014-01-01

    : This registry study was nested in a randomised controlled trial (DLCST). 4104 participants, current or former heavy smokers, aged 50-70 years were randomised to five annual low dose CT scans or usual care during 2004-2010. Total healthcare costs and healthcare utilisation data for both the primary...... and the secondary healthcare sector were retrieved from public registries from randomisation - September 2011 and compared between (1) the CT-screening group and the control group and, (2) the control group and each of the true-positive, false-positive and true-negative groups. RESULTS: The median annual costs per...... participant were significantly higher in the CT-screening group (Euros [EUR] 1342, interquartile range [IQR] 750-2980) compared with the control group (EUR 1190, IQR 590-2692) (pcost of the CT-screening programme was excluded, there was no longer a statistically significant difference...

  14. Effect of women’s groups and volunteer peer counselling on rates of mortality, morbidity, and health behaviours in mothers and children in rural Malawi (MaiMwana): a factorial, cluster-randomised controlled trial

    Science.gov (United States)

    Lewycka, Sonia; Mwansambo, Charles; Rosato, Mikey; Kazembe, Peter; Phiri, Tambosi; Mganga, Andrew; Chapota, Hilda; Malamba, Florida; Kainja, Esther; Newell, Marie-Louise; Greco, Giulia; Pulkki-Brännström, Anni-Maria; Skordis-Worrall, Jolene; Vergnano, Stefania; Osrin, David; Costello, Anthony

    2013-01-01

    Summary Background Women’s groups and health education by peer counsellors can improve the health of mothers and children. We assessed their effects on mortality and breastfeeding rates in rural Malawi. Methods We did a 2×2 factorial, cluster-randomised trial in 185 888 people in Mchinji district. 48 equal-sized clusters were randomly allocated to four groups with a computer-generated number sequence. 24 facilitators guided groups through a community action cycle to tackle maternal and child health problems. 72 trained volunteer peer counsellors made home visits at five timepoints during pregnancy and after birth to support breastfeeding and infant care. Primary outcomes for the women’s group intervention were maternal, perinatal, neonatal, and infant mortality rates (MMR, PMR, NMR, and IMR, respectively); and for the peer counselling were IMR and exclusive breastfeeding (EBF) rates. Analysis was by intention to treat. The trial is registered as ISRCTN06477126. Findings We monitored outcomes of 26 262 births between 2005 and 2009. In a factorial model adjusted only for clustering and the volunteer peer counselling intervention, in women’s group areas, for years 2 and 3, we noted non-significant decreases in NMR (odds ratio 0·93, 0·64–1·35) and MMR (0·54, 0·28–1·04). After adjustment for parity, socioeconomic quintile, and baseline measures, effects were larger for NMR (0·85, 0·59–1·22) and MMR (0·48, 0·26–0·91). Because of the interaction between the two interventions, a stratified analysis was done. For women’s groups, in adjusted analyses, MMR fell by 74% (0·26, 0·10–0·70), and NMR by 41% (0·59, 0·40–0·86) in areas with no peer counsellors, but there was no effect in areas with counsellors (1·09, 0·40–2·98, and 1·38, 0·75–2·54). Factorial analysis for the peer counselling intervention for years 1–3 showed a fall in IMR of 18% (0·82, 0·67–1·00) and an improvement in EBF rates (2·42, 1·48–3·96). The

  15. Design of the OPUS School Meal Study: A randomised controlled trial assessing the impact of serving school meals based on the New Nordic Diet

    DEFF Research Database (Denmark)

    Damsgaard, Camilla T.; Dalskov, Stine-Mathilde; Petersen, Rikke A.

    2012-01-01

    Introduction: Danish children consume too much sugar and not enough whole grain, fish, fruit, and vegetables. The Nordic region is rich in such foods with a strong health-promoting potential. We lack randomised controlled trials that investigate the developmental and health impact of serving school...... meals based on Nordic foods. Aim: This paper describes the rationale, design, study population, and potential implications of the Optimal well-being, development and health for Danish children through a healthy New Nordic Diet (OPUS) School Meal Study. Methods: In a cluster-randomised cross-over design...... activity, cardiorespiratory fitness, sleep, growth, body composition, early metabolic and cardiovascular risk markers, illness, absence from school, wellbeing, cognitive function, social and cultural features, food acceptance, waste, and cost were assessed. Results: In total, 834 children (82% of those...

  16. Maternal fish oil supplementation in pregnancy: a 12 year follow-up of a randomised controlled trial.

    Science.gov (United States)

    Meldrum, Suzanne; Dunstan, Janet A; Foster, Jonathan K; Simmer, Karen; Prescott, Susan L

    2015-03-20

    A number of trials have been undertaken to assess whether the intake of omega-3 long-chain polyunsaturated fatty acids (n-3 LCPUFA) during pregnancy can influence the neurological development of the offspring, yet no consensus from these trials has been reached. We aimed to investigate the long-term effects (12 years) of fish oil supplementation in pregnancy on neurodevelopment, including cognition, language and fine motor skills. In a follow up of a previously published randomised controlled trial of 98 pregnant women, their children were assessed at 12 years of age using a battery of neurodevelopmental assessments. Fifty participants were assessed at 12 years, with 25 participant's mothers receiving fish oil supplementation, and 25 receiving control capsules. There were no significant differences for any of the assessment measures completed. Our data indicate that fish oil supplementation during pregnancy does not influence the cognition, language or fine motor skills of children in late primary school (12 years of age).

  17. Protocol investigating the clinical utility of an objective measure of attention, impulsivity and activity (QbTest) for optimising medication management in children and young people with ADHD 'QbTest Utility for Optimising Treatment in ADHD' (QUOTA): a feasibility randomised controlled trial.

    Science.gov (United States)

    Hall, Charlotte L; James, Marilyn; Brown, Sue; Martin, Jennifer L; Brown, Nikki; Selby, Kim; Clarke, Julie; Vijayan, Hena; Guo, Boliang; Sayal, Kapil; Hollis, Chris; Groom, Madeleine J

    2018-02-15

    Attention-deficit hyperactivity disorder (ADHD) is characterised by symptoms of inattention, hyperactivity and impulsivity. To improve outcomes, the National Institute for Health and Care Excellence ADHD guidelines recommend regular monitoring of symptoms when children commence medication. However, research suggests that routine monitoring rarely happens, and clinicians often rely on subjective information such as reports from parents and teachers to ascertain improvement. These sources can be unreliable and difficult to obtain. The addition of an objective test of attention and activity (QbTest) may improve the objectivity, reliability and speed of clinical decision-making and so reduce the time to identify the optimal medication dose. This study aims to assess the feasibility and acceptability of a QbTest medication management protocol delivered in routine healthcare services for children with ADHD. This multisite feasibility randomised controlled trial (RCT) will recruit 60 young people (aged 6-17 years old), diagnosed with ADHD, and starting stimulant medication who are seen by Child and Adolescent Mental Health Services or Community Paediatric services. Participants will be randomised into one of two arms. In the experimental arm (QbTest protocol), the participant will complete a QbTest at baseline (prior to medication initiation), and two follow-up QbTests on medication (2-4 weeks and 8-10 weeks later). In the control arm, participants will receive treatment as usual, with at least two follow-up consultations. Measures of parent-, teacher- and clinician-rated symptoms and global functioning will be completed at each time point. Health economic measures will be completed. Clinicians will record treatment decision-making. Acceptability and feasibility of the protocol will be assessed alongside outcome measure completion rates. Qualitative interviews will be conducted. The findings will be used to inform the development of a fully powered RCT. The results will

  18. Development and Evaluation of a Psychosocial Intervention for Children and Teenagers Experiencing Diabetes (DEPICTED: a protocol for a cluster randomised controlled trial of the effectiveness of a communication skills training programme for healthcare professionals working with young people with type 1 diabetes

    Directory of Open Access Journals (Sweden)

    Lowes Lesley

    2010-02-01

    Full Text Available Abstract Background Diabetes is the third most common chronic condition in childhood and poor glycaemic control leads to serious short-term and life-limiting long-term complications. In addition to optimal medical management, it is widely recognised that psychosocial and educational factors play a key role in improving outcomes for young people with diabetes. Recent systematic reviews of psycho-educational interventions recognise the need for new methods to be developed in consultation with key stakeholders including patients, their families and the multidisciplinary diabetes healthcare team. Methods/design Following a development phase involving key stakeholders, a psychosocial intervention for use by paediatric diabetes staff and not requiring input from trained psychologists has been developed, incorporating a communication skills training programme for health professionals and a shared agenda-setting tool. The effectiveness of the intervention will be evaluated in a cluster-randomised controlled trial (RCT. The primary outcome, to be measured in children aged 4-15 years diagnosed with type 1 diabetes for at least one year, is the effect on glycaemic control (HbA1c during the year after training of the healthcare team is completed. Secondary outcomes include quality of life for patients and carers and cost-effectiveness. Patient and carer preferences for service delivery will also be assessed. Twenty-six paediatric diabetes teams are participating in the trial, recruiting a total of 700 patients for evaluation of outcome measures. Half the participating teams will be randomised to receive the intervention at the beginning of the trial and remaining centres offered the training package at the end of the one year trial period. Discussion The primary aim of the trial is to determine whether a communication skills training intervention for specialist paediatric diabetes teams will improve clinical and psychological outcomes for young people with

  19. Compliance with the CONSORT checklist in obstetric anaesthesia randomised controlled trials.

    Science.gov (United States)

    Halpern, S H; Darani, R; Douglas, M J; Wight, W; Yee, J

    2004-10-01

    The Consolidated Standards for Reporting of Trials (CONSORT) checklist is an evidence-based approach to help improve the quality of reporting randomised controlled trials. The purpose of this study was to determine how closely randomised controlled trials in obstetric anaesthesia adhere to the CONSORT checklist. We retrieved all randomised controlled trials pertaining to the practice of obstetric anaesthesia and summarised in Obstetric Anesthesia Digest between March 2001 and December 2002 and compared the quality of reporting to the CONSORT checklist. The median number of correctly described CONSORT items was 65% (range 36% to 100%). Information pertaining to randomisation, blinding of the assessors, sample size calculation, reliability of measurements and reporting of the analysis were often omitted. It is difficult to determine the value and quality of many obstetric anaesthesia clinical trials because journal editors do not insist that this important information is made available to readers. Both clinicians and clinical researchers would benefit from uniform reporting of randomised trials in a manner that allows rapid data retrieval and easy assessment for relevance and quality.

  20. Effect of steroids on inflammatory markers and clinical parameters in congenital open heart surgery: a randomised controlled trial.

    Science.gov (United States)

    Amanullah, Muhammad M; Hamid, Mohammad; Hanif, Hashim M; Muzaffar, Marium; Siddiqui, Maria T; Adhi, Fatima; Ahmad, Khabir; Khan, Shahjahan; Hasan, Zahra

    2016-03-01

    Cardiopulmonary bypass is associated with systemic inflammatory response. Steroids suppress this response, although the therapeutic evidence remains controversial. We hypothesised that intravenous steroids in children undergoing open-heart surgery would decrease inflammation leading to better early post-operative outcomes. We conducted a randomised controlled trial to evaluate the trends in the levels of immunomodulators and their effects on clinical parameters. To assess the effects of intravenous steroids on early post-operative inflammatory markers and clinical parameters in children undergoing open-heart surgery. A randomised controlled trial involving 152 patients, from one month up to 18 years of age, who underwent open-heart surgery for congenital heart disease from April 2010-2012 was carried out. Patients were randomised and administered either three scheduled intravenous pulse doses of dexamethasone (1 mg/kg) or placebo. Blood samples were drawn at four time intervals and serum levels of inflammatory cytokines - Interleukin-6, 8, 10, 18, and tumour necrosis factor-alpha - were measured. Clinical parameters were also assessed. Blood cytokine levels were compared between the dexamethasone (n=65) and placebo (n=64) groups. Interleukin-6 levels were lower at 6 and 24 hours post-operatively (p<0.001), and Interleukin-10 levels were higher 6 hours post-operatively (p<0.001) in the steroid group. Interleukin-8, 18, and tumour necrosis factor-alpha levels did not differ between the groups at any time intervals. The clinical parameters were similar in both the groups. Dexamethasone caused quantitative suppression of Interleukin-6 and increased Interleukin-10 activation, contributing to reduced immunopathology, but it did not translate into clinical benefit in the short term.

  1. Health promotion and the randomised controlled trial: a square peg in a round hole?

    Directory of Open Access Journals (Sweden)

    Freeman Ruth

    2009-01-01

    Full Text Available Abstract In their paper published in BMC Oral Health in March, Barker and Horton present qualitative data which explored Latino parents' main concerns regarding accessing dental care for their pre-school children. In the radical discourse of health promotion the use of participant narratives is a first and essential step in community development interventions. While there is agreement regarding the development and implementation of health promotion, the means by which it is evaluated or the type of evaluation design used, is hotly debated. This commentary outlines the rationale of adopting a randomised controlled trial methodology, contrasts it with realistic evaluation and considers design evaluation in the light of the Medical Research Council's (MRC guidance of 2000 and 2008. It is at this juncture that the commentary suggests that, despite the MRC's acknowledgement of the limitations of its 2000 guidance, there remains, in the 2008 guidance, an underlying insistence to use design evaluations which control for selection bias and confounding extraneous factors. For the evaluation of health promotion interventions it may remain a case of fitting a square peg into a round hole.

  2. An assessment of early Child Life Therapy pain and anxiety management: A prospective randomised controlled trial.

    Science.gov (United States)

    Hyland, Ela J; D'Cruz, Rachel; Harvey, John G; Moir, Jordyn; Parkinson, Christina; Holland, Andrew J A

    2015-12-01

    Burns remain extremely painful and distressing in young children. The consequences of poorly managed pain and anxiety can be life-long. Whilst Child Life Therapy (CLT) has been shown to be effective in many situations, few studies have looked at the effectiveness of CLT in regard to reducing pain and anxiety in children undergoing burn dressing changes. A prospective, randomised controlled trial was conducted, comparing CLT versus standard care in relation to pain and anxiety scores of children undergoing their initial burn dressing change. Pain and anxiety were assessed by an independent observer and questionnaires completed by the child, parent/caregiver and nursing staff. 50 subjects were recruited in each treatment group; median age 2.3 years (CLT) and 2.2 years (standard care). The median total body surface area (TBSA) burnt was 0.8% (CLT) and 0.5% (standard care). The majority were partial thickness dermal burns (88% CLT, 94% standard care). Rates of parent anxiety and pre-procedural child pain and anxiety were similar. Combined and scaled pain and anxiety scores in the CLT group were significantly less than in the standard treatment group (p=0.03). Whilst pain was significantly better in the CLT group (p=0.02), fear scores, wound outcomes and the need for skin grafting were not statistically different in either group. The presence of a Child Life Therapist, with their ability to adapt to the environment, the child and their family, significantly reduced the experience of pain during paediatric burn dressings. Copyright © 2015 Elsevier Ltd and ISBI. All rights reserved.

  3. Influence of vitamin E supplementation on glycaemic control: a meta-analysis of randomised controlled trials.

    Directory of Open Access Journals (Sweden)

    Renfan Xu

    Full Text Available Observational studies have revealed that higher serum vitamin E concentrations and increased vitamin E intake and vitamin E supplementation are associated with beneficial effects on glycaemic control in type 2 diabetes mellitus (T2DM. However, whether vitamin E supplementation exerts a definitive effect on glycaemic control remains unclear. This article involves a meta-analysis of randomised controlled trials of vitamin E to better characterise its impact on HbA1c, fasting glucose and fasting insulin. PubMed, EMBASE and the Cochrane Library were electronically searched from the earliest possible date through April 2013 for all relevant studies. Weighted mean difference (WMD was calculated for net changes using fixed-effects or random-effects models. Standard methods for assessing statistical heterogeneity and publication bias were used. Fourteen randomised controlled trials involving individual data on 714 subjects were collected in this meta-analysis. Increased vitamin E supplementation did not result in significant benefits in glycaemic control as measured by reductions in HbA1c, fasting glucose and fasting insulin. Subgroup analyses revealed a significant reduction in HbA1c (-0.58%, 95% CI -0.83 to -0.34 and fasting insulin (-9.0 pmol/l, 95% CI -15.90 to -2.10 compared with controls in patients with low baseline vitamin E status. Subgroup analyses also demonstrated that the outcomes may have been influenced by the vitamin E dosage, study duration, ethnic group, serum HbA1c concentration, and fasting glucose control status. In conclusion, there is currently insufficient evidence to support a potential beneficial effect of vitamin E supplementation on improvements of HbA1c and fasting glucose and insulin concentrations in subjects with T2DM.

  4. Influence of vitamin E supplementation on glycaemic control: a meta-analysis of randomised controlled trials.

    Science.gov (United States)

    Xu, Renfan; Zhang, Shasha; Tao, Anyu; Chen, Guangzhi; Zhang, Muxun

    2014-01-01

    Observational studies have revealed that higher serum vitamin E concentrations and increased vitamin E intake and vitamin E supplementation are associated with beneficial effects on glycaemic control in type 2 diabetes mellitus (T2DM). However, whether vitamin E supplementation exerts a definitive effect on glycaemic control remains unclear. This article involves a meta-analysis of randomised controlled trials of vitamin E to better characterise its impact on HbA1c, fasting glucose and fasting insulin. PubMed, EMBASE and the Cochrane Library were electronically searched from the earliest possible date through April 2013 for all relevant studies. Weighted mean difference (WMD) was calculated for net changes using fixed-effects or random-effects models. Standard methods for assessing statistical heterogeneity and publication bias were used. Fourteen randomised controlled trials involving individual data on 714 subjects were collected in this meta-analysis. Increased vitamin E supplementation did not result in significant benefits in glycaemic control as measured by reductions in HbA1c, fasting glucose and fasting insulin. Subgroup analyses revealed a significant reduction in HbA1c (-0.58%, 95% CI -0.83 to -0.34) and fasting insulin (-9.0 pmol/l, 95% CI -15.90 to -2.10) compared with controls in patients with low baseline vitamin E status. Subgroup analyses also demonstrated that the outcomes may have been influenced by the vitamin E dosage, study duration, ethnic group, serum HbA1c concentration, and fasting glucose control status. In conclusion, there is currently insufficient evidence to support a potential beneficial effect of vitamin E supplementation on improvements of HbA1c and fasting glucose and insulin concentrations in subjects with T2DM.

  5. Improving immunisation coverage in rural India: clustered randomised controlled evaluation of immunisation campaigns with and without incentives.

    Science.gov (United States)

    Banerjee, Abhijit Vinayak; Duflo, Esther; Glennerster, Rachel; Kothari, Dhruva

    2010-05-17

    To assess the efficacy of modest non-financial incentives on immunisation rates in children aged 1-3 and to compare it with the effect of only improving the reliability of the supply of services. Clustered randomised controlled study. Rural Rajasthan, India. 1640 children aged 1-3 at end point. 134 villages were randomised to one of three groups: a once monthly reliable immunisation camp (intervention A; 379 children from 30 villages); a once monthly reliable immunisation camp with small incentives (raw lentils and metal plates for completed immunisation; intervention B; 382 children from 30 villages), or control (no intervention, 860 children in 74 villages). Surveys were undertaken in randomly selected households at baseline and about 18 months after the interventions started (end point). Proportion of children aged 1-3 at the end point who were partially or fully immunised. Among children aged 1-3 in the end point survey, rates of full immunisation were 39% (148/382, 95% confidence interval 30% to 47%) for intervention B villages (reliable immunisation with incentives), 18% (68/379, 11% to 23%) for intervention A villages (reliable immunisation without incentives), and 6% (50/860, 3% to 9%) for control villages. The relative risk of complete immunisation for intervention B versus control was 6.7 (4.5 to 8.8) and for intervention B versus intervention A was 2.2 (1.5 to 2.8). Children in areas neighbouring intervention B villages were also more likely to be fully immunised than those from areas neighbouring intervention A villages (1.9, 1.1 to 2.8). The average cost per immunisation was $56 (2202 rupees) in intervention A and $28 (1102 rupees, about pound16 or euro19) in intervention B. Improving reliability of services improves immunisation rates, but the effect remains modest. Small incentives have large positive impacts on the uptake of immunisation services in resource poor areas and are more cost effective than purely improving supply. IRSCTN87759937.

  6. The effectiveness of Stepping stones Triple P: the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual

    OpenAIRE

    Kleefman, Marijke; Jansen, Daniëlle EMC; Reijneveld, Sijmen A

    2011-01-01

    Abstract Background Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems in children with a (intellectual) disability by enhancing parenting knowledge and skills, and the self-confidence of parents. This paper aims to describe the design of a study of the effecti...

  7. The gait and balance of patients with diabetes can be improved: a randomised controlled trial.

    NARCIS (Netherlands)

    Allet, L.; Armand, S.; Bie, R.A. de; Golay, A.; Monnin, D.; Aminian, K.; Staal, J.B.; Bruin, E.D. de

    2010-01-01

    AIMS/HYPOTHESIS: Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. METHODS: This was a randomised controlled trial (n=71)

  8. Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial

    NARCIS (Netherlands)

    Fransen, A. F.; van de Ven, J.; Merién, A. E. R.; de Wit-Zuurendonk, L. D.; Houterman, S.; Mol, B. W.; Oei, S. G.

    2012-01-01

    Please cite this paper as: Fransen A, van de Ven J, Merien A, de Wit-Zuurendonk L, Houterman S, Mol B, Oei S. Effect of obstetric team training on team performance and medical technical skills: a randomised controlled trial. BJOG 2012;119:13871393. Objective To determine whether obstetric team

  9. Internet cognitive behavioural treatment for obsessive compulsive disorder : A randomised controlled trial

    NARCIS (Netherlands)

    Mahoney, Alison E J; Mackenzie, Anna; Williams, Alishia D; Smith, Jessica; Andrews, Gavin

    2014-01-01

    Internet-based cognitive behaviour therapy (iCBT) is becoming increasing accepted as an efficacious and effective treatment for the anxiety and depressive disorders. However few studies have examined the efficacy of iCBT for obsessive compulsive disorder (OCD). This randomised controlled trial

  10. Effects of circuit training as alternative to usual physiotherapy after stroke: randomised controlled trial

    NARCIS (Netherlands)

    van de Port, I.G.L.; Wevers, L.E.G.; Lindeman, E.; Kwakkel, G.

    2012-01-01

    Objective: To analyse the effect of task oriented circuit training compared with usual physiotherapy in terms of self reported walking competency for patients with stroke discharged from a rehabilitation centre to their own home. Design: Randomised controlled trial with follow-up to 24 weeks.

  11. Low sodium diet and pregnancy-induced hypertension: a multi-centre randomised controlled trial

    NARCIS (Netherlands)

    Knuist, M.; Bonsel, G. J.; Zondervan, H. A.; Treffers, P. E.

    1998-01-01

    To examine the effectiveness of the standard policy in the Netherlands to prescribe a sodium restricted diet to prevent or to treat mild pregnancy-induced hypertension. Multi-centre randomised controlled trial between April 1992 and April 1994. Seven practices of independent midwives and one

  12. Skills Training to Avoid Inadvertent Plagiarism: Results from a Randomised Control Study

    Science.gov (United States)

    Newton, Fiona J.; Wright, Jill D.; Newton, Joshua D.

    2014-01-01

    Plagiarism continues to be a concern within academic institutions. The current study utilised a randomised control trial of 137 new entry tertiary students to assess the efficacy of a scalable short training session on paraphrasing, patch writing and plagiarism. The results indicate that the training significantly enhanced students' overall…

  13. Melatonin for chronic whiplash syndrome with delayed melatonin onset randomised, placebo-controlled trial

    NARCIS (Netherlands)

    Wieringen, S. van; Jansen, T.; Smits, M.G.; Nagtegaal, J.E.; Coenen, A.M.L.

    2001-01-01

    Objective: To assess the influence of melatonin in patients with chronic whiplash syndrome and delayed melatonin onset. Design: Randomised, double-blind, placebo-controlled, parallel-group trial. One-week baseline was followed by a 4-week treatment period with either melatonin or placebo. In the

  14. Effectiveness of physiotherapy in Parkinson's disease: the feasibility of a randomised controlled trial.

    NARCIS (Netherlands)

    Keus, S.H.J.; Bloem, B.R.; Hilten, J.J. van; Ashburn, A.; Munneke, M.

    2007-01-01

    To study the feasibility of a large randomised controlled trial (RCT) evaluating the effectiveness of physiotherapy in Parkinson's disease (PD), 173 patients were asked to participate in a study with random allocation to best practice physiotherapy, or to no physiotherapy. The primary outcome

  15. Timing of insertion of levonorgestrel-releasing intrauterine system : a randomised controlled trial

    NARCIS (Netherlands)

    van der Heijden, Pahh; Geomini, Pmaj; Herman, M C; Veersema, S; Bongers, M Y

    OBJECTIVE: The objective was to assess whether patient-perceived pain during the insertion of the levonorgestrel-releasing intrauterine system (LNG-IUS) depends on the timing during the menstrual cycle. DESIGN: A stratified two-armed non-inferiority randomised controlled trial. SETTING: Large

  16. Prophylactic antibiotic regimens in tumour surgery (PARITY) : a pilot multicentre randomised controlled trial

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

  17. Fracture fixation in the operative management of hip fractures (FAITH) : an international, multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Nauth, Aaron; Creek, Aaron T.; Zellar, Abby; Lawendy, Abdel Rahman; Dowrick, Adam; Gupta, Ajay; Dadi, Akhil; van Kampen, Albert; Yee, Albert; de Vries, Alexander C.; de Mol van Otterloo, Alexander; Garibaldi, Alisha; Liew, Allen; McIntyre, Allison W.; Prasad, Amal Shankar; Romero, Amanda W.; Rangan, Amar; Oatt, Amber; Sanghavi, Amir; Foley, Amy L.; Karlsten, Anders; Dolenc, Andrea; Bucknill, Andrew; Chia, Andrew; Evans, Andrew; Gong, Andrew; Schmidt, Andrew H.; Marcantonio, Andrew J.; Jennings, Andrew; Ward, Angela; Khanna, Angshuman; Rai, Anil; Smits, Anke B; Horan, Annamarie D.; Brekke, Anne Christine; Flynn, Annette; Duraikannan, Aravin; Stødle, Are; van Vugt, Arie B.; Luther, Arlene; Zurcher, Arthur W.; Jain, Arvind; Amundsen, Asgeir; Moaveni, Ash; Carr, Ashley; Sharma, Ateet; Hill, Austin D.; Trommer, Axel; Rai, B. Sachidananda; Hileman, Barbara; Schreurs, Bart; Verhoeven, Bart A N; Barden, Benjamin B.; Flatøy, Bernhard; Cleffken, Berry I.; Bøe, Berthe; Perey, Bertrand; Hanusch, Birgit C.; Weening, Brad; Fioole, Bram; Rijbroek, Bram; Crist, Brett D.; Halliday, Brett; Peterson, Brett; Mullis, Brian; Richardson, C. Glen; Clark, Callum; Sagebien, Carlos A.; van der Pol, Carmen C.; Bowler, Carol; Humphrey, Catherine A.; Coady, Catherine; Koppert, Cees L.; Coles, Chad; Tannoury, Chadi; DePaolo, Charles J.; Gayton, Chris; Herriott, Chris; Reeves, Christina; Tieszer, Christina; Dobb, Christine; Anderson, Christopher G.; Sage, Claire; Cuento, Claudine; Jones, Clifford B.; Bosman, Coks H.R.; Linehan, Colleen; van der Hart, Cor P.; Henderson, Corey; Lewis, Courtland G.; Davis, Craig A.; Donohue, Craig; Mauffrey, Cyril; Sundaresh, D. C.; Farrell, Dana J.; Whelan, Daniel B.; Horwitz, Daniel; Stinner, Daniel; Viskontas, Darius; Roffey, Darren M.; Alexander, David; Karges, David E.; Hak, David; Johnston, David; Love, David; Wright, David M.; Zamorano, David P.; Goetz, David R.; Sanders, David; Stephen, David; Yen, David; Bardana, Davide; Olakkengil, Davy J.; Lawson, Deanna; Maddock, Deborah; Sietsema, Debra L.; Pourmand, Deeba; Den Hartog, Dennis; Donegan, Derek; Heels-Ansdell, Diane; Nam, Diane; Inman, Dominic; Boyer, Dory; Li, Doug; Gibula, Douglas; Price, Dustin M.; Watson, Dylan J.; Hammerberg, E. Mark; Tan, Edward C T H; de Graaf, Eelco J.R.; Vesterhus, Elise Berg; Roper, Elizabeth; Edwards, Elton; Schemitsch, Emil H.; Hammacher, Eric R.; Henderson, Eric R.; Whatley, Erica; Torres, Erick T.; Vermeulen, Erik G.J.; Finn, Erin; Van Lieshout, Esther M M; Wai, Eugene K.; Bannister, Evan R.; Kile, Evelyn; Theunissen, Evert B.M.; Ritchie, Ewan D.; Khan, Farah; Moola, Farhad; Howells, Fiona; de Nies, Frank; van der Heijden, Frank H.W.M.; de Meulemeester, Frank R.A.J.; Frihagen, Frede; Nilsen, Fredrik; Schmidt, G. Ben; Albers, G. H.Robert; Gudger, Garland K.; Johnson, Garth; Gruen, Gary; Zohman, Gary; Sharma, Gaurav; Wood, Gavin; Tetteroo, Geert W.M.; Hjorthaug, Geir; Jomaas, Geir; Donald, Geoff; Rieser, Geoffrey Ryan; Reardon, Gerald; Slobogean, Gerard P.; Roukema, Gert R.; Visser, Gijs A.; Moatshe, Gilbert; Horner, Gillian; Rose, Glynis; Guyatt, Gordon; Chuter, Graham; Etherington, Greg; Rocca, Gregory J.Della; Ekås, Guri; Dobbin, Gwendolyn; Lemke, H. Michael; Curry, Hamish; Boxma, Han; Gissel, Hannah; Kreder, Hans; Kuiken, Hans; Brom, Hans L.F.; Pape, Hans Christoph; van der Vis, Harm M.; Bedi, Harvinder; Vallier, Heather A.; Brien, Heather; Silva, Heather; Newman, Heike; Viveiros, Helena; van der Hoeven, Henk; Ahn, Henry; Johal, Herman; Rijna, Herman; Stockmann, Heyn; Josaputra, Hong A.; Carlisle, Hope; van der Brand, Igor; Dawson, Imro; Tarkin, Ivan; Wong, Ivan; Parr, J. Andrew; Trenholm, J. Andrew; Goslings, J Carel; Amirault, J. David; Broderick, J. Scott; Snellen, Jaap P.; Zijl, Jacco A.C.; Ahn, Jaimo; Ficke, James; Irrgang, James; Powell, James; Ringler, James R.; Shaer, James; Monica, James T.; Biert, Jan; Bosma, Jan; Brattgjerd, Jan Egil; Frölke, Jan Paul M.; Wille, Jan; Rajakumar, Janakiraman; Walker, Jane E.; Baker, Janell K.; Ertl, Janos P.; De Vries, Jean-Paul P. M.; Gardeniers, Jean W.M.; May, Jedediah; Yach, Jeff; Hidy, Jennifer T.; Westberg, Jerald R.; Hall, Jeremy A.; van Mulken, Jeroen; McBeth, Jessica Cooper; Hoogendoorn, Jochem M; Hoffman, Jodi M.; Cherian, Joe Joseph; Tanksley, John A.; Clarke-Jenssen, John; Adams, John D.; Esterhai, John; Tilzey, John F.; Murnaghan, John; Ketz, John P.; Garfi, John S.; Schwappach, John; Gorczyca, John T.; Wyrick, John; Rydinge, Jonas; Foret, Jonathan L.; Gross, Jonathan M.; Keeve, Jonathan P.; Meijer, Joost; Scheepers, Joris J.G.; Baele, Joseph; O'Neil, Joseph; Cass, Joseph R.; Hsu, Joseph R.; Dumais, Jules; Lee, Julia; Switzer, Julie A.; Agel, Julie; Richards, Justin E.; Langan, Justin W.; Turckan, Kahn; Pecorella, Kaili; Rai, Kamal; Aurang, Kamran; Shively, Karl; van Wessem, Karlijn; Moon, Karyn; Eke, Kate; Erwin, Katie; Milner, Katrine; Ponsen, Kees Jan; Mills, Kelli; Apostle, Kelly; Johnston, Kelly; Trask, Kelly; Strohecker, Kent; Stringfellow, Kenya; Kruse, Kevin K.; Tetsworth, Kevin; Mitchell, Khalis; Browner, Kieran; Hemlock, Kim; Carcary, Kimberly; Jørgen Haug, Knut; Noble, Krista; Robbins, Kristin; Payton, Krystal; Jeray, Kyle J.; Rubino, L. Joseph; Nastoff, Lauren A.; Leffler, Lauren C.; Stassen, Laurents P.S.; O'Malley, Lawrence K.; Specht, Lawrence M.; Thabane, Lehana; Geeraedts, Leo M.G.; Shell, Leslie E.; Anderson, Linda K.; Eickhoff, Linda S.; Lyle, Lindsey; Pilling, Lindsey; Buckingham, Lisa; Cannada, Lisa K.; Wild, Lisa M.; Dulaney-Cripe, Liz; Poelhekke, Lodewijk M.S.J.; Govaert, Lonneke; Ton, Lu; Kottam, Lucksy; Leenen, Luke P.H.; Clipper, Lydia; Jackson, Lyle T.; Hampton, Lynne; de Waal Malefijt, Maarten C.; Simons, Maarten P.; van der Elst, Maarten; Bronkhorst, Maarten W.G.A.; Bhatia, Mahesh; Swiontkowski, Marc; Lobo, Margaret J.; Swinton, Marilyn; Pirpiris, Marinis; Molund, Marius; Gichuru, Mark; Glazebrook, Mark; Harrison, Mark; Jenkins, Mark; MacLeod, Mark; de Vries, Mark R.; Butler, Mark S.; Nousiainen, Markku; van ‘t Riet, Martijne; Tynan, Martin C.; Campo, Martin; Eversdijk, Martin G.; Heetveld, Martin J.; Richardson, Martin; Breslin, Mary; Fan, Mary; Edison, Matt; Napierala, Matthew; Knobe, Matthias; Russ, Matthias; Zomar, Mauri; de Brauw, Maurits; Esser, Max; Hurley, Meghan; Peters, Melissa E.; Lorenzo, Melissa; Li, Mengnai; Archdeacon, Michael; Biddulph, Michael; Charlton, Michael R; McDonald, Michael D.; McKee, Michael D.; Dunbar, Michael; Torchia, Michael E.; Gross, Michael; Hewitt, Michael; Holt, Michael; Prayson, Michael J.; Edwards, Michael J R; Beckish, Michael L.; Brennan, Michael L.; Dohm, Michael P.; Kain, Michael S.H.; Vogt, Michelle; Yu, Michelle; Verhofstad, Michiel H J; Segers, Michiel J M; Segers, Michiel J M; Siroen, Michiel P.C.; Reed, Mike; Vicente, Milena R.; Bruijninckx, Milko M.M.; Trivedi, Mittal; Bhandari, Mohit; Moore, Molly M.; Kunz, Monica; Smedsrud, Morten; Palla, Naveen; Jain, Neeraj; Out, Nico J.M.; Simunovic, Nicole; Simunovic, Nicole; Schep, Niels W. L.; Müller, Oliver; Guicherit, Onno R.; Van Waes, Oscar J.F.; Wang, Otis; Doornebosch, Pascal G.; Seuffert, Patricia; Hesketh, Patrick J.; Weinrauch, Patrick; Duffy, Paul; Keller, Paul; Lafferty, Paul M.; Pincus, Paul; Tornetta, Paul; Zalzal, Paul; McKay, Paula; Cole, Peter A.; de Rooij, Peter D.; Hull, Peter; Go, Peter M.N.Y.M.; Patka, Peter; Siska, Peter; Weingarten, Peter; Kregor, Philip; Stahel, Philip; Stull, Philip; Wittich, Philippe; de Rijcke, Piet A.R.; Oprel, Pim; Devereaux, P. J.; Zhou, Qi; Lee Murphy, R.; Alosky, Rachel; Clarkson, Rachel; Moon, Raely; Logishetty, Rajanikanth; Nanda, Rajesh; Sullivan, Raymond J.; Snider, Rebecca G.; Buckley, Richard E.; Iorio, Richard; Farrugia, Richard J.; Jenkinson, Richard; Laughlin, Richard; Groenendijk, Richard P R; Gurich, Richard W.; Worman, Ripley; Silvis, Rob; Haverlag, Robert; Teasdall, Robert J.; Korley, Robert; McCormack, Robert; Probe, Robert; Cantu, Robert V.; Huff, Roger B.; Simmermacher, Rogier K J; Peters, Rolf; Pfeifer, Roman; Liem, Ronald; Wessel, Ronald N.; Verhagen, Ronald; Vuylsteke, Ronald J C L M; Leighton, Ross; McKercher, Ross; Poolman, Rudolf W; Miller, Russell; Bicknell, Ryan; Finnan, Ryan; Khan, Ryan M.; Mehta, Samir; Vang, Sandy; Singh, Sanjay; Anand, Sanjeev; Anderson, Sarah A.; Dawson, Sarah A.; Marston, Scott B.; Porter, Scott E.; Watson, Scott T.; Festen, Sebastiaan; Lieberman, Shane; Puloski, Shannon; Bielby, Shea A.; Sprague, Sheila; Hess, Shelley; MacDonald, Shelley; Evans, Simone; Bzovsky, Sofia; Hasselund, Sondre; Lewis, Sophie; Ugland, Stein; Caminiti, Stephanie; Tanner, Stephanie L.; Zielinski, Stephanie M.; Shepard, Stephanie; Sems, Stephen A.; Walter, Stephen D.; Doig, Stephen; Finley, Stephen H.; Kates, Stephen; Lindenbaum, Stephen; Kingwell, Stephen P.; Csongvay, Steve; Papp, Steve; Buijk, Steven E.; Rhemrev, Steven J.; Hollenbeck, Steven M.; van Gaalen, Steven M.; Yang, Steven; Weinerman, Stuart; Lambert, Sue; Liew, Susan; Meylaerts, Sven A.G.; Blokhuis, Taco J.; de Vries Reilingh, Tammo S.; Lona, Tarjei; Scott, Taryn; Swenson, Teresa K.; Endres, Terrence J.; Axelrod, Terry; van Egmond, Teun; Pace, Thomas B.; Kibsgård, Thomas; Schaller, Thomas M.; Ly, Thuan V.; Miller, Timothy J.; Weber, Timothy; Le, Toan; Oliver, Todd M.; Karsten, Tom M.; Borch, Tor; Hoseth, Tor Magne; Nicolaisen, Tor; Ianssen, Torben; Rutherford, Tori; Nanney, Tracy; Gervais, Trevor; Stone, Trevor; Schrickel, Tyson; Scrabeck, Tyson; Ganguly, Utsav; Naumetz, V.; Frizzell, Valda; Wadey, Veronica; Jones, Vicki; Avram, Victoria; Mishra, Vimlesh; Yadav, Vineet; Arora, Vinod; Tyagi, Vivek; Borsella, Vivian; Willems, W. Jaap; Hoffman, W. H.; Gofton, Wade T.; Lackey, Wesley G.; Ghent, Wesley; Obremskey, William; Oxner, William; Cross, William W.; Murtha, Yvonne M.; Murdoch, Zoe

    2017-01-01

    Background Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled trial, we

  18. Fracture fixation in the operative management of hip fractures (FAITH): an international, multicentre, randomised controlled trial

    NARCIS (Netherlands)

    Nauth, A. (Aaron); Creek, A.T. (Aaron T.); Zellar, A. (Abby); Lawendy, A.-R. (Abdel-Rahman); Dowrick, A. (Adam); Gupta, A. (Ajay); Dadi, A. (Akhil); A. van Kampen (A.); Yee, A. (Albert); A.C. de Vries (Alexander); de Mol van Otterloo, A. (Alexander); Garibaldi, A. (Alisha); Liew, A. (Allen); McIntyre, A.W. (Allison W.); Prasad, A.S. (Amal Shankar); Romero, A.W. (Amanda W.); Rangan, A. (Amar); Oatt, A. (Amber); Sanghavi, A. (Amir); Foley, A.L. (Amy L.); Karlsten, A. (Anders); Dolenc, A. (Andrea); Bucknill, A. (Andrew); Chia, A. (Andrew); Evans, A. (Andrew); Gong, A. (Andrew); Schmidt, A.H. (Andrew H.); Marcantonio, A.J. (Andrew J.); Jennings, A. (Andrew); Ward, A. (Angela); Khanna, A. (Angshuman); Rai, A. (Anil); Smits, A.B. (Anke B.); Horan, A.D. (Annamarie D.); Brekke, A.C. (Anne Christine); Flynn, A. (Annette); Duraikannan, A. (Aravin); Stødle, A. (Are); van Vugt, A.B. (Arie B.); Luther, A. (Arlene); Zurcher, A.W. (Arthur W.); Jain, A. (Arvind); Amundsen, A. (Asgeir); Moaveni, A. (Ash); Carr, A. (Ashley); Sharma, A. (Ateet); Hill, A.D. (Austin D.); Trommer, A. (Axel); Rai, B.S. (B. Sachidananda); Hileman, B. (Barbara); Schreurs, B. (Bart); Verhoeven, B. (Bart); Barden, B.B. (Benjamin B.); Flatøy, B. (Bernhard); B.I. Cleffken (Berry); Bøe, B. (Berthe); Perey, B. (Bertrand); Hanusch, B.C. (Birgit C.); Weening, B. (Brad); B. Fioole (Bram); Rijbroek, B. (Bram); Crist, B.D. (Brett D.); Halliday, B. (Brett); Peterson, B. (Brett); Mullis, B. (Brian); Richardson, C.G. (C. Glen); Clark, C. (Callum); Sagebien, C.A. (Carlos A.); C. van der Pol (Carmen); Bowler, C. (Carol); Humphrey, C.A. (Catherine A.); Coady, C. (Catherine); Koppert, C.L. (Cees L.); Coles, C. (Chad); Tannoury, C. (Chadi); DePaolo, C.J. (Charles J.); Gayton, C. (Chris); Herriott, C. (Chris); Reeves, C. (Christina); Tieszer, C. (Christina); Dobb, C. (Christine); Anderson, C.G. (Christopher G.); Sage, C. (Claire); Cuento, C. (Claudine); Jones, C.B. (Clifford B.); Bosman, C.H.R. (Coks H.R.); Linehan, C. (Colleen); C.P. van der Hart (Cor P.); Henderson, C. (Corey); Lewis, C.G. (Courtland G.); Davis, C.A. (Craig A.); Donohue, C. (Craig); Mauffrey, C. (Cyril); Sundaresh, D.C. (D. C.); Farrell, D.J. (Dana J.); Whelan, D.B. (Daniel B.); Horwitz, D. (Daniel); Stinner, D. (Daniel); Viskontas, D. (Darius); Roffey, D.M. (Darren M.); Alexander, D. (David); Karges, D.E. (David E.); Hak, D. (David); Johnston, D. (David); Love, D. (David); Wright, D.M. (David M.); Zamorano, D.P. (David P.); Goetz, D.R. (David R.); Sanders, D. (David); Stephen, D. (David); Yen, D. (David); Bardana, D. (Davide); Olakkengil, D.J. (Davy J); Lawson, D. (Deanna); Maddock, D. (Deborah); Sietsema, D.L. (Debra L.); Pourmand, D. (Deeba); D. den Hartog (Dennis); Donegan, D. (Derek); D. Heels-Ansdell (Diane); Nam, D. (Diane); Inman, D. (Dominic); Boyer, D. (Dory); Li, D. (Doug); Gibula, D. (Douglas); Price, D.M. (Dustin M.); Watson, D.J. (Dylan J.); Hammerberg, E.M. (E. Mark); Tan, E.T.C.H. (Edward T.C.H.); E.J.R. de Graaf (Eelco); Vesterhus, E.B. (Elise Berg); Roper, E. (Elizabeth); Edwards, E. (Elton); E.H. Schemitsch (Emil); E.R. Hammacher (Eric); Henderson, E.R. (Eric R.); Whatley, E. (Erica); Torres, E.T. (Erick T.); Vermeulen, E.G.J. (Erik G.J.); Finn, E. (Erin); E.M.M. van Lieshout (Esther); Wai, E.K. (Eugene K.); Bannister, E.R. (Evan R.); Kile, E. (Evelyn); Theunissen, E.B.M. (Evert B.M.); Ritchie, E.D. (Ewan D.); Khan, F. (Farah); Moola, F. (Farhad); Howells, F. (Fiona); F. de Nies (Frank); F.H.W.M. van der Heijden (Frank); de Meulemeester, F.R.A.J. (Frank R.A.J.); F. Frihagen (Frede); Nilsen, F. (Fredrik); Schmidt, G.B. (G. Ben); Albers, G.H.R. (G.H. Robert); Gudger, G.K. (Garland K.); Johnson, G. (Garth); Gruen, G. (Gary); Zohman, G. (Gary); Sharma, G. (Gaurav); Wood, G. (Gavin); G.W.M. Tetteroo (Geert); Hjorthaug, G. (Geir); Jomaas, G. (Geir); Donald, G. (Geoff); Rieser, G.R. (Geoffrey Ryan); Reardon, G. (Gerald); Slobogean, G.P. (Gerard P.); G.R. Roukema (Gert); Visser, G.A. (Gijs A.); Moatshe, G. (Gilbert); Horner, G. (Gillian); Rose, G. (Glynis); Guyatt, G. (Gordon); Chuter, G. (Graham); Etherington, G. (Greg); Rocca, G.J.D. (Gregory J. Della); Ekås, G. (Guri); Dobbin, G. (Gwendolyn); Lemke, H.M. (H. Michael); Curry, H. (Hamish); H. Boxma (Han); Gissel, H. (Hannah); Kreder, H. (Hans); Kuiken, H. (Hans); H.L.F. Brom; Pape, H.-C. (Hans-Christoph); H.M. van der Vis (Harm); Bedi, H. (Harvinder); Vallier, H.A. (Heather A.); Brien, H. (Heather); Silva, H. (Heather); Newman, H. (Heike); H. Viveiros (Helena); van der Hoeven, H. (Henk); Ahn, H. (Henry); Johal, H. (Herman); H. Rijna; Stockmann, H. (Heyn); Josaputra, H.A. (Hong A.); Carlisle, H. (Hope); van der Brand, I. (Igor); I. Dawson (Imro); Tarkin, I. (Ivan); Wong, I. (Ivan); Parr, J.A. (J. Andrew); Trenholm, J.A. (J. Andrew); J.C. Goslings (Carel); Amirault, J.D. (J. David); Broderick, J.S. (J. Scott); Snellen, J.P. (Jaap P.); Zijl, J.A.C. (Jacco A.C.); Ahn, J. (Jaimo); Ficke, J. (James); Irrgang, J. (James); Powell, J. (James); Ringler, J.R. (James R.); Shaer, J. (James); Monica, J.T. (James T.); J. Biert (Jan); Bosma, J. (Jan); Brattgjerd, J.E. (Jan Egil); J.P.M. Frölke (Jan Paul); J.C. Wille (Jan); Rajakumar, J. (Janakiraman); Walker, J.E. (Jane E.); Baker, J.K. (Janell K.); Ertl, J.P. (Janos P.); de Vries, J.P.P.M. (Jean Paul P.M.); Gardeniers, J.W.M. (Jean W.M.); May, J. (Jedediah); Yach, J. (Jeff); Hidy, J.T. (Jennifer T.); Westberg, J.R. (Jerald R.); Hall, J.A. (Jeremy A.); van Mulken, J. (Jeroen); McBeth, J.C. (Jessica Cooper); Hoogendoorn, J. (Jochem); Hoffman, J.M. (Jodi M.); Cherian, J.J. (Joe Joseph); Tanksley, J.A. (John A.); Clarke-Jenssen, J. (John); Adams, J.D. (John D.); Esterhai, J. (John); Tilzey, J.F. (John F.); Murnaghan, J. (John); Ketz, J.P. (John P.); Garfi, J.S. (John S.); Schwappach, J. (John); Gorczyca, J.T. (John T.); Wyrick, J. (John); Rydinge, J. (Jonas); Foret, J.L. (Jonathan L.); Gross, J.M. (Jonathan M.); Keeve, J.P. (Jonathan P.); Meijer, J. (Joost); J.J. Scheepers (Joris J.); Baele, J. (Joseph); O'Neil, J. (Joseph); Cass, J.R. (Joseph R.); Hsu, J.R. (Joseph R.); Dumais, J. (Jules); Lee, J. (Julia); Switzer, J.A. (Julie A.); Agel, J. (Julie); Richards, J.E. (Justin E.); Langan, J.W. (Justin W.); Turckan, K. (Kahn); Pecorella, K. (Kaili); Rai, K. (Kamal); Aurang, K. (Kamran); Shively, K. (Karl); K.J.P. van Wessem; Moon, K. (Karyn); Eke, K. (Kate); Erwin, K. (Katie); Milner, K. (Katrine); K.J. Ponsen (Kees-jan); Mills, K. (Kelli); Apostle, K. (Kelly); Johnston, K. (Kelly); Trask, K. (Kelly); Strohecker, K. (Kent); Stringfellow, K. (Kenya); Kruse, K.K. (Kevin K.); Tetsworth, K. (Kevin); Mitchell, K. (Khalis); Browner, K. (Kieran); Hemlock, K. (Kim); Carcary, K. (Kimberly); Jørgen Haug, K. (Knut); Noble, K. (Krista); Robbins, K. (Kristin); Payton, K. (Krystal); Jeray, K.J. (Kyle J.); Rubino, L.J. (L. Joseph); Nastoff, L.A. (Lauren A.); Leffler, L.C. (Lauren C.); L.P. Stassen (Laurents); O'Malley, L.K. (Lawrence K.); Specht, L.M. (Lawrence M.); L. Thabane (Lehana); Geeraedts, L.M.G. (Leo M.G.); Shell, L.E. (Leslie E.); Anderson, L.K. (Linda K.); Eickhoff, L.S. (Linda S.); Lyle, L. (Lindsey); Pilling, L. (Lindsey); Buckingham, L. (Lisa); Cannada, L.K. (Lisa K.); Wild, L.M. (Lisa M.); Dulaney-Cripe, L. (Liz); L.M.S.J. Poelhekke; Govaert, L. (Lonneke); Ton, L. (Lu); Kottam, L. (Lucksy); L.P.H. Leenen (Luke); Clipper, L. (Lydia); Jackson, L.T. (Lyle T.); Hampton, L. (Lynne); de Waal Malefijt, M.C. (Maarten C.); M.P. Simons; M. van der Elst (Maarten); M.W.G.A. Bronkhorst (Maarten); Bhatia, M. (Mahesh); M.F. Swiontkowski (Marc ); Lobo, M.J. (Margaret J.); Swinton, M. (Marilyn); Pirpiris, M. (Marinis); Molund, M. (Marius); Gichuru, M. (Mark); Glazebrook, M. (Mark); Harrison, M. (Mark); Jenkins, M. (Mark); MacLeod, M. (Mark); M.R. de Vries (Mark); Butler, M.S. (Mark S.); Nousiainen, M. (Markku); van ‘t Riet, M. (Martijne); Tynan, M.C. (Martin C.); Campo, M. (Martin); M.G. Eversdijk (Martin); M.J. Heetveld (Martin); Richardson, M. (Martin); Breslin, M. (Mary); Fan, M. (Mary); Edison, M. (Matt); Napierala, M. (Matthew); Knobe, M. (Matthias); Russ, M. (Matthias); Zomar, M. (Mauri); de Brauw, M. (Maurits); Esser, M. (Max); Hurley, M. (Meghan); Peters, M.E. (Melissa E.); Lorenzo, M. (Melissa); Li, M. (Mengnai); Archdeacon, M. (Michael); Biddulph, M. (Michael); Charlton, M. (Michael); McDonald, M.D. (Michael D.); McKee, M.D. (Michael D.); Dunbar, M. (Michael); Torchia, M.E. (Michael E.); Gross, M. (Michael); Hewitt, M. (Michael); Holt, M. (Michael); Prayson, M.J. (Michael J.); M.J.R. Edwards (Michael); Beckish, M.L. (Michael L.); Brennan, M.L. (Michael L.); Dohm, M.P. (Michael P.); Kain, M.S.H. (Michael S.H.); Vogt, M. (Michelle); Yu, M. (Michelle); M.H.J. Verhofstad (Michiel); Segers, M.J.M. (Michiel J.M.); M.J.M. Segers (Michiel); Siroen, M.P.C. (Michiel P.C.); M.R. Reed (Mike); Vicente, M.R. (Milena R.); M.M.M. Bruijninckx (Milko); Trivedi, M. (Mittal); M. Bhandari (Mohit); Moore, M.M. (Molly M.); Kunz, M. (Monica); Smedsrud, M. (Morten); Palla, N. (Naveen); Jain, N. (Neeraj); Out, N.J.M. (Nico J.M.); Simunovic, N. (Nicole); Simunovic, N. (Nicole); N.W.L. Schep (Niels); Müller, O. (Oliver); Guicherit, O.R. (Onno R.); O.J.F. van Waes (Oscar); Wang, O. (Otis); P. Doornebosch (Pascal); Seuffert, P. (Patricia); Hesketh, P.J. (Patrick J.); Weinrauch, P. (Patrick); Duffy, P. (Paul); Keller, P. (Paul); Lafferty, P.M. (Paul M.); Pincus, P. (Paul); P. Tornetta III (Paul); Zalzal, P. (Paul); McKay, P. (Paula); Cole, P.A. (Peter A.); de Rooij, P.D. (Peter D.); Hull, P. (Peter); Go, P.M.N.Y.M. (Peter M.N.Y.M.); P. Patka (Peter); Siska, P. (Peter); Weingarten, P. (Peter); Kregor, P. (Philip); Stahel, P. (Philip); Stull, P. (Philip); P. Wittich (Philippe); P.A.R. Rijcke (Piet); P.P. Oprel (Pim); Devereaux, P.J. (P. J.); Zhou, Q. (Qi); Lee Murphy, R. (R.); Alosky, R. (Rachel); Clarkson, R. (Rachel); Moon, R. (Raely); Logishetty, R. (Rajanikanth); Nanda, R. (Rajesh); Sullivan, R.J. (Raymond J.); Snider, R.G. (Rebecca G.); Buckley, R.E. (Richard E.); Iorio, R. (Richard); Farrugia, R.J. (Richard J); Jenkinson, R. (Richard); Laughlin, R. (Richard); R.P.R. Groenendijk (Richard); Gurich, R.W. (Richard W.); Worman, R. (Ripley); Silvis, R. (Rob); R. Haverlag (Robert); Teasdall, R.J. (Robert J.); Korley, R. (Robert); McCormack, R. (Robert); Probe, R. (Robert); Cantu, R.V. (Robert V.); Huff, R.B. (Roger B.); R.K.J. Simmermacher; Peters, R. (Rolf); Pfeifer, R. (Roman); Liem, R. (Ronald); Wessel, R.N. (Ronald N.); Verhagen, R. (Ronald); Vuylsteke, R. (Ronald); Leighton, R. (Ross); McKercher, R. (Ross); R.W. Poolman (Rudolf); Miller, R. (Russell); Bicknell, R. (Ryan); Finnan, R. (Ryan); Khan, R.M. (Ryan M.); Mehta, S. (Samir); Vang, S. (Sandy); Singh, S. (Sanjay); Anand, S. (Sanjeev); Anderson, S.A. (Sarah A.); Dawson, S.A. (Sarah A.); Marston, S.B. (Scott B.); Porter, S.E. (Scott E.); Watson, S.T. (Scott T.); S. Festen (Sebastiaan); Lieberman, S. (Shane); Puloski, S. (Shannon); Bielby, S.A. (Shea A.); Sprague, S. (Sheila); Hess, S. (Shelley); MacDonald, S. (Shelley); Evans, S. (Simone); Bzovsky, S. (Sofia); Hasselund, S. (Sondre); Lewis, S. (Sophie); Ugland, S. (Stein); Caminiti, S. (Stephanie); Tanner, S.L. (Stephanie L.); S.M. Zielinski (Stephanie); Shepard, S. (Stephanie); Sems, S.A. (Stephen A.); Walter, S.D. (Stephen D.); Doig, S. (Stephen); Finley, S.H. (Stephen H.); Kates, S. (Stephen); Lindenbaum, S. (Stephen); Kingwell, S.P. (Stephen P.); Csongvay, S. (Steve); Papp, S. (Steve); Buijk, S.E. (Steven E.); S. Rhemrev (Steven); Hollenbeck, S.M. (Steven M.); van Gaalen, S.M. (Steven M.); Yang, S. (Steven); Weinerman, S. (Stuart); Subash, (); Lambert, S. (Sue); Liew, S. (Susan); S.A.G. Meylaerts (Sven); Blokhuis, T.J. (Taco J.); de Vries Reilingh, T.S. (Tammo S.); Lona, T. (Tarjei); Scott, T. (Taryn); Swenson, T.K. (Teresa K.); Endres, T.J. (Terrence J.); Axelrod, T. (Terry); van Egmond, T. (Teun); Pace, T.B. (Thomas B.); Kibsgård, T. (Thomas); Schaller, T.M. (Thomas M.); Ly, T.V. (Thuan V.); Miller, T.J. (Timothy J.); Weber, T. (Timothy); Le, T. (Toan); Oliver, T.M. (Todd M.); T.M. Karsten (Thomas); Borch, T. (Tor); Hoseth, T.M. (Tor Magne); Nicolaisen, T. (Tor); Ianssen, T. (Torben); Rutherford, T. (Tori); Nanney, T. (Tracy); Gervais, T. (Trevor); Stone, T. (Trevor); Schrickel, T. (Tyson); Scrabeck, T. (Tyson); Ganguly, U. (Utsav); Naumetz, V. (V.); Frizzell, V. (Valda); Wadey, V. (Veronica); Jones, V. (Vicki); Avram, V. (Victoria); Mishra, V. (Vimlesh); Yadav, V. (Vineet); Arora, V. (Vinod); Tyagi, V. (Vivek); Borsella, V. (Vivian); W.J. Willems (Jaap); Hoffman, W.H. (W. H.); Gofton, W.T. (Wade T.); Lackey, W.G. (Wesley G.); Ghent, W. (Wesley); Obremskey, W. (William); Oxner, W. (William); Cross, W.W. (William W.); Murtha, Y.M. (Yvonne M.); Murdoch, Z. (Zoe)

    2017-01-01

    textabstractBackground Reoperation rates are high after surgery for hip fractures. We investigated the effect of a sliding hip screw versus cancellous screws on the risk of reoperation and other key outcomes. Methods For this international, multicentre, allocation concealed randomised controlled

  19. Maximising the impact of qualitative research in feasibility studies for randomised controlled trials: guidance for researchers

    NARCIS (Netherlands)

    O’Cathain, A.; Hoddinott, P.; Lewin, S.; Thomas, K.J.; Young, B.; Adamson, J.; Jansen, J.F.M.; Mills, N.; Moore, G.; Donovan, J.L.

    2015-01-01

    Feasibility studies are increasingly undertaken in preparation for randomised controlled trials in order to explore uncertainties and enable trialists to optimise the intervention or the conduct of the trial. Qualitative research can be used to examine and address key uncertainties prior to a full

  20. A randomised, controlled clinical study on total hip arthroplasty using 4 different bearings

    DEFF Research Database (Denmark)

    Borgwardt, Arne; Zerahn, Bo; Fabricius, Sandra D

    2017-01-01

    PURPOSE: To compare 4 different bearings in total hip arthroplasty (THA) in a randomised controlled clinical study on clinical performance. METHODS: 393 patients with osteoarthritis of the hip or avascular necrosis were included and allocated to 1 of the head-and-cup couples zirconia...

  1. Occupational therapy for elderly : evidence mapping of randomised controlled trials from 2004-2012

    NARCIS (Netherlands)

    Voigt-Radloff, S; Ruf, G.; Vogel, A.; van Nes, F.; Hüll, M.

    OBJECTIVE: Previous systematic reviews on occupational therapy for elderly included studies until 2003. The present evidence mapping summarizes recent evidence for the efficacy of occupational therapy with older persons based on randomised controlled trials from 2004-2012. METHOD: An electronic

  2. Psychosocial consequences in the Danish randomised controlled lung cancer screening trial (DLCST)

    DEFF Research Database (Denmark)

    F. Rasmussen, Jakob; Siersma, V.; H. Pedersen, J.

    2015-01-01

    on Airway Symptoms, Stigmatisation, Introvert, and Harm of Smoking. Results: 4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5% and 73.6%, respectively. There was a significant increase in negative psychosocial consequences from...

  3. A randomised, controlled trial of circumpatellar electrocautery in total knee replacement without patellar resurfacing

    NARCIS (Netherlands)

    Jonbergen, H.P. van; Scholtes, V.A.; Kampen, A. van; Poolman, R.W.

    2011-01-01

    The efficacy of circumpatellar electrocautery in reducing the incidence of post-operative anterior knee pain is unknown. We conducted a single-centre, outcome-assessor and patient-blinded, parallel-group, randomised, controlled trial to compare circumpatellar electrocautery with no electrocautery in

  4. Feather bedding and childhood asthma associated with house dust mite sensitisation : a randomised controlled trial

    NARCIS (Netherlands)

    Glasgow, Nicholas J.; Ponsonby, Anne-Louise; Kemp, Andrew; Tovey, Euan; van Asperen, Peter; McKay, Karen; Forbes, Samantha

    Introduction Observational studies report inverse associations between the use of feather upper bedding (pillow and/or quilt) and asthma symptoms but there is no randomised controlled trial (RCT) evidence assessing the role of feather upper bedding as a secondary prevention measure. Objective To

  5. The effect of reflexology upon spasticity and function among children with cerebral palsy who received physiotherapy: Three group randomised trial.

    Science.gov (United States)

    Özkan, Filiz; Zincir, Handan

    2017-08-01

    To assess the effectiveness of reflexology method upon spasticity and function among children with cerebral palsy who received physiotherapy. A three group, randomised trial with blinded evaluator. Randomization was made sealed and opaque envelopes. 45 children with cerebral palsy who were trained at a Special Education and Rehabilitation Centre. In the reflexology and placebo group; a 20min reflexology was performed twice a week in a total 24 sessions. In the control group; no intervention was done. Before and after the implementation; measurements of the participants were obtained. The data were collected using Gross Motor Function Measure, Modified Ashworth Scale (MAS), Modified Tardieu Scale, Pediatric Functional Independence Scale, Pediatric Quality of Life Scale (PedsQL) and demographic data. A total of 45 children completed the study. The groups were homogeneous at baseline. Between right MAS Gastrocnemius muscle was a difference and right and left Soleus muscles was significant among the groups (p0.05). Reflexology with physiotherapy reduced spasticity in legs, improved gross motor functions, decreased dependency but led to no change in quality of life. Copyright © 2017 Elsevier Inc. All rights reserved.

  6. The effectiveness of Stepping stones Triple P : the design of a randomised controlled trial on a parenting programme regarding children with mild intellectual disability and psychosocial problems versus care as usual

    NARCIS (Netherlands)

    Kleefman, Marijke; Jansen, Danielle E. M. C.; Reijneveld, Sijmen A.

    2011-01-01

    Background: Children with an intellectual disability are at increased risk of psychosocial problems. This leads to serious restrictions in the daily functioning of the children and to parental stress. Stepping Stones Triple P aims to prevent severe behavioural, emotional and developmental problems

  7. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Buck Deborah

    2012-10-01

    Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

  8. Prescribed computer games in addition to occlusion versus standard occlusion treatment for childhood amblyopia: a pilot randomised controlled trial.

    Science.gov (United States)

    Tailor, Vijay K; Glaze, Selina; Khandelwal, Payal; Davis, Alison; Adams, Gillian G W; Xing, Wen; Bunce, Catey; Dahlmann-Noor, Annegret

    2015-01-01

    Amblyopia ("lazy eye") is the commonest vision deficit in children. If not fully corrected by glasses, amblyopia is treated by patching or blurring the better-seeing eye. Compliance with patching is often poor. Computer-based activities are increasingly topical, both as an adjunct to standard treatment and as a platform for novel treatments. Acceptability by families has not been explored, and feasibility of a randomised controlled trial (RCT) using computer games in terms of recruitment and treatment acceptability is uncertain. We carried out a pilot RCT to test whether computer-based activities are acceptable and accessible to families and to test trial methods such as recruitment and retention rates, randomisation, trial-specific data collection tools and analysis. The trial had three arms: standard near activity advice, Eye Five, a package developed for children with amblyopia, and an off-the-shelf handheld games console with pre-installed games. We enrolled 60 children age 3-8 years with moderate or severe amblyopia after completion of optical treatment. This trial was registered as UKCRN-ID 11074. Pre-screening of 3600 medical notes identified 189 potentially eligible children, of whom 60 remained eligible after optical treatment, and were enrolled between April 2012 and March 2013. One participant was randomised twice and withdrawn from the study. Of the 58 remaining, 37 were boys. The mean (SD) age was 4.6 (1.7) years. Thirty-seven had moderate and 21 severe amblyopia. Three participants were withdrawn at week 6, and in total, four were lost to follow-up at week 12. Most children and parents/carers found the study procedures, i.e. occlusion treatment, usage of the allocated near activity and completion of a study diary, easy. The prescribed cumulative dose of near activity was 84 h at 12 weeks. Reported near activity usage numbers were close to prescribed numbers in moderate amblyopes (94 % of prescribed) but markedly less in severe amblyopes (64

  9. Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

    Science.gov (United States)

    Macedo, Luciana G; Latimer, Jane; Maher, Chris G; Hodges, Paul W; Nicholas, Michael; Tonkin, Lois; McAuley, James H; Stafford, Ryan

    2008-01-01

    Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week) and function (patient-specific functional scale) at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415 PMID:18454877

  10. Motor control or graded activity exercises for chronic low back pain? A randomised controlled trial

    Directory of Open Access Journals (Sweden)

    McAuley James H

    2008-05-01

    Full Text Available Abstract Background Chronic low back pain remains a major health problem in Australia and around the world. Unfortunately the majority of treatments for this condition produce small effects because not all patients respond to each treatment. It appears that only 25–50% of patients respond to exercise. The two most popular types of exercise for low back pain are graded activity and motor control exercises. At present however, there are no guidelines to help clinicians select the best treatment for a patient. As a result, time and money are wasted on treatments which ultimately fail to help the patient. Methods This paper describes the protocol of a randomised clinical trial comparing the effects of motor control exercises with a graded activity program in the treatment of chronic non specific low back pain. Further analysis will identify clinical features that may predict a patient's response to each treatment. One hundred and seventy two participants will be randomly allocated to receive either a program of motor control exercises or graded activity. Measures of outcome will be obtained at 2, 6 and 12 months after randomisation. The primary outcomes are: pain (average pain intensity over the last week and function (patient-specific functional scale at 2 and 6 months. Potential treatment effect modifiers will be measured at baseline. Discussion This trial will not only evaluate which exercise approach is more effective in general for patients will chronic low back pain, but will also determine which exercise approach is best for an individual patient. Trial registration number ACTRN12607000432415

  11. Study protocol: a cluster randomised controlled trial of a school based fruit and vegetable intervention - Project Tomato.

    Science.gov (United States)

    Kitchen, Meaghan S; Ransley, Joan K; Greenwood, Darren C; Clarke, Graham P; Conner, Mark T; Jupp, Jennifer; Cade, Janet E

    2009-06-16

    The School Fruit and Vegetable Scheme (SFVS) is an important public health intervention. The aim of this scheme is to provide a free piece of fruit and/or vegetable every day for children in Reception to Year 2. When children are no longer eligible for the scheme (from Year 3) their overall fruit and vegetable consumption decreases back to baseline levels. This proposed study aims to design a flexible multi-component intervention for schools to support the maintenance of fruit and vegetable consumption for Year 3 children who are no longer eligible for the scheme. This study is a cluster randomised controlled trial of Year 2 classes from 54 primary schools across England. The schools will be randomly allocated into two groups to receive either an active intervention called Project Tomato, to support maintenance of fruit intake in Year 3 children, or a less active intervention (control group), consisting of a 5 A DAY booklet. Children's diets will be analysed using the Child And Diet Evaluation Tool (CADET), and height and weight measurements collected, at baseline (Year 2) and 18 month follow-up (Year 4). The primary outcome will be the ability of the intervention (Project Tomato) to maintain consumption of fruit and vegetable portions compared to the control group. A positive result will identify how fruit and vegetable consumption can be maintained in young children, and will be useful for policies supporting the SFVS. A negative result would be used to inform the research agenda and contribute to redefining future strategies for increasing children's fruit and vegetable consumption. Medical Research Council Registry code G0501297.

  12. Study protocol: a cluster randomised controlled trial of a school based fruit and vegetable intervention – Project Tomato

    Science.gov (United States)

    Kitchen, Meaghan S; Ransley, Joan K; Greenwood, Darren C; Clarke, Graham P; Conner, Mark T; Jupp, Jennifer; Cade, Janet E

    2009-01-01

    Background The School Fruit and Vegetable Scheme (SFVS) is an important public health intervention. The aim of this scheme is to provide a free piece of fruit and/or vegetable every day for children in Reception to Year 2. When children are no longer eligible for the scheme (from Year 3) their overall fruit and vegetable consumption decreases back to baseline levels. This proposed study aims to design a flexible multi-component intervention for schools to support the maintenance of fruit and vegetable consumption for Year 3 children who are no longer eligible for the scheme. Method This study is a cluster randomised controlled trial of Year 2 classes from 54 primary schools across England. The schools will be randomly allocated into two groups to receive either an active intervention called Project Tomato, to support maintenance of fruit intake in Year 3 children, or a less active intervention (control group), consisting of a 5 A DAY booklet. Children's diets will be analysed using the Child And Diet Evaluation Tool (CADET), and height and weight measurements collected, at baseline (Year 2) and 18 month follow-up (Year 4). The primary outcome will be the ability of the intervention (Project Tomato) to maintain consumption of fruit and vegetable portions compared to the control group. Discussion A positive result will identify how fruit and vegetable consumption can be maintained in young children, and will be useful for policies supporting the SFVS. A negative result would be used to inform the research agenda and contribute to redefining future strategies for increasing children's fruit and vegetable consumption. Trial registration Medical Research Council Registry code G0501297 PMID:19531246

  13. Study protocol: a cluster randomised controlled trial of a school based fruit and vegetable intervention – Project Tomato

    Directory of Open Access Journals (Sweden)

    Conner Mark T

    2009-06-01

    Full Text Available Abstract Background The School Fruit and Vegetable Scheme (SFVS is an important public health intervention. The aim of this scheme is to provide a free piece of fruit and/or vegetable every day for children in Reception to Year 2. When children are no longer eligible for the scheme (from Year 3 their overall fruit and vegetable consumption decreases back to baseline levels. This proposed study aims to design a flexible multi-component intervention for schools to support the maintenance of fruit and vegetable consumption for Year 3 children who are no longer eligible for the scheme. Method This study is a cluster randomised controlled trial of Year 2 classes from 54 primary schools across England. The schools will be randomly allocated into two groups to receive either an active intervention called Project Tomato, to support maintenance of fruit intake in Year 3 children, or a less active intervention (control group, consisting of a 5 A DAY booklet. Children's diets will be analysed using the Child And Diet Evaluation Tool (CADET, and height and weight measurements collected, at baseline (Year 2 and 18 month follow-up (Year 4. The primary outcome will be the ability of the intervention (Project Tomato to maintain consumption of fruit and vegetable portions compared to the control group. Discussion A positive result will identify how fruit and vegetable consumption can be maintained in young children, and will be useful for policies supporting the SFVS. A negative result would be used to inform the research agenda and contribute to redefining future strategies for increasing children's fruit and vegetable consumption. Trial registration Medical Research Council Registry code G0501297

  14. A follow-up of a randomised study of metformin and insulin in gestational diabetes mellitus: growth and development of the children at the age of 18 months.

    Science.gov (United States)

    Ijäs, H; Vääräsmäki, M; Saarela, T; Keravuo, R; Raudaskoski, T

    2015-06-01

    To compare the growth and development of children born to mothers with gestational diabetes mellitus (GDM) requiring pharmacological treatment, and randomised to treatment with metformin or insulin. Follow-up of a randomised controlled trial (RCT) comparing metformin and insulin treatment of GDM. Data were gathered during routine visits to child welfare clinics at the ages of 6, 12, and 18 months, including weight and height measurements, and assessment of motor, social, and linguistic development. The children of mothers with GDM randomised to metformin (n = 47) or insulin (n = 50) treatment during pregnancy. Data were collected from the structured questionnaire filled in at the child welfare clinics. The growth and development of the children until the age of 18 months. Children exposed to metformin were significantly heavier (10.47 versus 9.85 kg, 95% CI 0.04-1.20) at the age of 12 months and taller and heavier (83.9 vs 82.2 cm, 95% CI 0.23-3.03, 12.05 vs 11.32 kg, 95% CI 0.04-1.43) at the age of 18 months. The mean ponderal index (PI) did not differ significantly. The motor, social, or linguistic development evaluated at the age of 18 months did not differ between the groups. Children prenatally exposed to metformin were heavier at the 12 months measurements and taller and heavier at the 18 months measurements than those exposed to insulin, but their body composition defined by PI did not differ. Over the short term, metformin does not seem to be harmful with regards to early motor, linguistic, or social development. © 2014 Royal College of Obstetricians and Gynaecologists.

  15. THE SCANDCLEFT RANDOMISED CONTROLLED TRIALS: SPEECH OUTCOMES IN 5-YEAR-OLDS WITH UCLP – consonant proficiency and errors

    DEFF Research Database (Denmark)

    Willadsen, Elisabeth; Persson, Christina; Lohmander, Anette

    2017-01-01

    Background and aim: Normal articulation before school start is a main objective in cleft palate treatment. The aim was to investigate if differences exist in consonant proficiency at age 5 years between children with unilateral cleft lip and palate (UCLP) randomised to different surgical protocol...... in terms of secondary pharyngeal surgeries, number of fistulae, and speech therapy visits differed. Trial registration: ISRCTN29932826. Keywords: Primary palatal repair, unilateral cleft lip and palate, consonant proficiency, cleft speech characteristics, randomised clinical trial...

  16. When is a randomised controlled trial health equity relevant? Development and validation of a conceptual framework.

    Science.gov (United States)

    Jull, J; Whitehead, M; Petticrew, M; Kristjansson, E; Gough, D; Petkovic, J; Volmink, J; Weijer, C; Taljaard, M; Edwards, S; Mbuagbaw, L; Cookson, R; McGowan, J; Lyddiatt, A; Boyer, Y; Cuervo, L G; Armstrong, R; White, H; Yoganathan, M; Pantoja, T; Shea, B; Pottie, K; Norheim, O; Baird, S; Robberstad, B; Sommerfelt, H; Asada, Y; Wells, G; Tugwell, P; Welch, V

    2017-09-25

    Randomised controlled trials can provide evidence relevant to assessing the equity impact of an intervention, but such information is often poorly reported. We describe a conceptual framework to identify health equity-relevant randomised trials with the aim of improving the design and reporting of such trials. An interdisciplinary and international research team engaged in an iterative consensus building process to develop and refine the conceptual framework via face-to-face meetings, teleconferences and email correspondence, including findings from a validation exercise whereby two independent reviewers used the emerging framework to classify a sample of randomised trials. A randomised trial can usefully be classified as 'health equity relevant' if it assesses the effects of an intervention on the health or its determinants of either individuals or a population who experience ill health due to disadvantage defined across one or more social determinants of health. Health equity-relevant randomised trials can either exclusively focus on a single population or collect data potentially useful for assessing differential effects of the intervention across multiple populations experiencing different levels or types of social disadvantage. Trials that are not classified as 'health equity relevant' may nevertheless provide information that is indirectly relevant to assessing equity impact, including information about individual level variation unrelated to social disadvantage and potentially useful in secondary modelling studies. The conceptual framework may be used to design and report randomised trials. The framework could also be used for other study designs to contribute to the evidence base for improved health equity. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  17. Conductive Education as a Method of Stroke Rehabilitation: A Single Blinded Randomised Controlled Feasibility Study

    Directory of Open Access Journals (Sweden)

    Judith Bek

    2016-01-01

    Full Text Available Background. Conductive Education for stroke survivors has shown promise but randomised evidence is unavailable. This study assessed the feasibility of a definitive randomised controlled trial to evaluate efficacy. Methods. Adult stroke survivors were recruited through local community notices. Those completing the baseline assessment were randomised using an online program and group allocation was independent. Intervention group participants received 10 weekly 1.5-hour sessions of Conductive Education at the National Institute of Conductive Education in Birmingham, UK. The control group participants attended two group meetings. The study evaluated the feasibility of recruitment procedures, delivery of the intervention, retention of participants, and appropriateness of outcome measures and data collection methods. Independent assessments included the Barthel Index, the Stroke Impact Scale, the Timed Up and Go test, and the Hospital Anxiety and Depression Scale. Results. Eighty-two patients were enrolled; 77 completed the baseline assessment (46 men, mean age 62.1 yrs. and were randomised. 70 commenced the intervention (n=37 or an equivalent waiting period (n=33. 32/37 completed the 10-week training and 32/33 the waiting period. There were no missing items from completed questionnaires and no adverse events. Discussion. Recruitment, intervention, and assessment methods worked well. Transport issues for intervention and assessment appointments require review. Conclusion. A definitive trial is feasible. This trial is registered with ISRCTN84064492.

  18. Randomised controlled trial of an iPad based early intervention for autism: TOBY playpad study protocol.

    Science.gov (United States)

    Granich, Joanna; Dass, Alena; Busacca, Margherita; Moore, Dennis; Anderson, Angelika; Venkatesh, Svetha; Duong, Thi; Vellanki, Pratibha; Richdale, Amanda; Trembath, David; Cairns, Darin; Marshall, Wendy; Rodwell, Tania; Rayner, Madeleine; Whitehouse, Andrew J O

    2016-10-19

    Evidence for early intensive behavioural interventions (EIBI) by therapists as an effective treatment for children with an Autism Spectrum Disorder (ASD) is growing. High-intensity and sustained delivery of quality EIBI is expensive. The TOBY (Therapy Outcomes by You) Playpad is an App-based platform delivering EIBI to facilitate learning for young children with ASD, while enabling parents to become co-therapists. Intervention targets include increasing joint attention, imitation and communication of children with ASD. The primary aim of the study presented in this protocol is to determine the effectiveness of the TOBY App in reducing ASD symptoms when used as a complement to conventional EIBI. The secondary aim is to examine parental attributes as a result of TOBY App use. Children aged less than 4;3 years diagnosed with ASD and parents will be recruited into this single-blind, randomised controlled trial using a pragmatic approach. Eligible participants will be randomised to the treatment group 'TOBY therapy + therapy as usual' or, the control group 'therapy as usual' for six months. The treatment will be provided by the TOBY App and parent where a combination of learning environments such as on-iPad child only (solo), partner (with parent) and off-iPad - Natural Environment (with parent) Tasks will be implemented. Parents in the treatment group will participate in a TOBY training workshop. Treatment fidelity will be monitored via an App-based reporting system and parent diaries. The primary outcome measure is the Autism Treatment Evaluation Checklist. The secondary outcome measures involve diagnostics, functional and developmental assessments, including parent questionnaires at baseline (T0), three months (T1) and six months (T2). This trial will determine the effectiveness of the TOBY App as a therapeutic complement to other early interventions children with ASD receive. The trial will also determine the feasibility of a parent delivered early intervention

  19. Psychosocial consequences of allocation to lung cancer screening: a randomised controlled trial.

    Science.gov (United States)

    Aggestrup, Louise Mosborg; Hestbech, Mie Sara; Siersma, Volkert; Pedersen, Jesper Holst; Brodersen, John

    2012-01-01

    To examine the psychosocial consequences of being allocated to the control group as compared with the screen group in a randomised lung cancer screening trial. The Danish Lung Cancer Screening Trial, a randomised controlled trial, ran from 2004 to 2010 with the purpose of investigating the benefits and harms of lung cancer screening. The participants in Danish Lung Cancer Screening Trial were randomised to either the control group or the screen group and were asked to complete the questionnaires Consequences Of Screening and Consequences Of Screening in Lung Cancer (COS-LC). The Consequences Of Screening and the COS-LC were used to examine the psychosocial consequences of participating in the study, by comparing the control and the screen groups' responses at the prevalence and at the incidence round. There was no statistically significant difference in socio-demographic characteristics or smoking habits between the two groups. Responses to the COS-LC collected before the incidence round were statistically significantly different on the scales 'anxiety', 'behaviour', 'dejection', 'self-blame', 'focus on airway symptoms' and 'introvert', with the control group reporting higher negative psychosocial consequences. Furthermore, the participants in both the control and the screen groups exhibited a mean increase in negative psychosocial consequences when their responses from the prevalence round were compared with their responses from the first incidence round. Participation in a randomised controlled trial on lung cancer screening has negative psychosocial consequences for the apparently healthy participants-both the participants in the screen group and the control group. This negative impact was greatest for the control group.

  20. The Incredible Years Parent-Toddler Programme and parental language: a randomised controlled trial.

    Science.gov (United States)

    Gridley, N; Hutchings, J; Baker-Henningham, H

    2015-01-01

    Parental language is associated with children's later language development. Parenting programmes, based on social learning theory, enhance a range of parenting behaviours, yet there is limited evidence for their effect on parental language. To assess the benefits of a behavioural-based parenting programme, which features components of language and communication, to enhance parental language. Parents of toddlers, aged 12 to 36 months, were recruited from eight Flying Start early intervention centres across Wales. Participants were randomised 2:1 either to a parenting programme (n = 60) or to a wait-list control group (n = 29). Researchers were blind to participant allocation throughout the trial. Fifteen-minute video-recorded observations of parents and children interacting during free-play, both at a pre-intervention and at 6-month follow-up, provided the data for the study. Five observed measures of parental language were assessed; quantity and variety, encouraging, critical, child-led and parent led interactions. The Incredible Years Parent-Toddler Programme (IYPTP) is a 12-week group-based behavioural intervention that teaches effective relationship and behavioural management skills including social, emotional and persistence coaching to enable parents to better support their children's development. Of 89 dyads that completed pre-intervention assessments 81 (54 intervention and 27 control) met the criteria for the current study. Intention to treat analysis indicated that child-led language interactions significantly benefited from the intervention [regression coefficient (B) = -1.44, 95% confidence intervals (CI) = -2.59 to -0.29, P = 0.015, effect size (ES) = 0.47] and a positive trend for encouraging language in favour of the intervention sample was evident. Per-protocol sample analysis replicated these findings with encouraging language reaching statistical significance (B = 1.07, 95% CI = 0.11 to 2.03, P = 0.03, ES = 0.52). No further benefits were evident

  1. Healthy eating and obesity prevention for preschoolers: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Swinburn Boyd

    2010-04-01

    Full Text Available Abstract Background Developing effective prevention and intervention programs for the formative preschool years is seen as an essential step in combating the obesity epidemic across the lifespan. The overall goal of the current project is to measure the effectiveness of a healthy eating and childhood obesity prevention intervention, the MEND (Mind Exercise Nutrition Do It! program that is delivered to parents of children aged 2-4 years. Methods/Design This randomised controlled trial will be conducted with 200 parents and their 2-4 year old children who attend the MEND 2-4 program in metropolitan and regional Victoria. Parent-child dyads will attend ten 90-minute group workshops. These workshops focus on general nutrition, as well as physical activity and behaviours. They are typically held at community or maternal and child health centres and run by a MEND 2-4 trained program leader. Child eating habits, physical activity levels and parental behaviours and cognitions pertaining to nutrition and physical activity will be assessed at baseline, the end of the intervention, and at 6 and 12 months post the intervention. Informed consent will be obtained from all parents, who will then be randomly allocated to the intervention or wait-list control group. Discussion Our study is the first RCT of a healthy eating and childhood obesity prevention intervention targeted specifically to Australian parents and their preschool children aged 2-4 years. It responds to the call by experts in the area of childhood obesity and child health that prevention of overweight in the formative preschool years should focus on parents, given that parental beliefs, attitudes, perceptions and behaviours appear to impact significantly on the development of early overweight. This is 'solution-oriented' rather than 'problem-oriented' research, with its focus being on prevention rather than intervention. If this is a positive trial, the MEND2-4 program can be implemented as a

  2. Cognition, behaviour and academic skills after cognitive rehabilitation in Ugandan children surviving severe malaria: a randomised trial

    Directory of Open Access Journals (Sweden)

    John Chandy C

    2011-08-01

    Full Text Available Abstract Background Infection with severe malaria in African children is associated with not only a high mortality but also a high risk of cognitive deficits. There is evidence that interventions done a few years after the illness are effective but nothing is known about those done immediately after the illness. We designed a study in which children who had suffered from severe malaria three months earlier were enrolled into a cognitive intervention program and assessed for the immediate benefit in cognitive, academic and behavioral outcomes. Methods This parallel group randomised study was carried out in Kampala City, Uganda between February 2008 and October 2010. Sixty-one Ugandan children aged 5 to 12 years with severe malaria were assessed for cognition (using the Kaufman Assessment Battery for Children, second edition and the Test of Variables of Attention, academic skills (Wide Range Achievement Test, third edition and psychopathologic behaviour (Child Behaviour Checklist three months after an episode of severe malaria. Twenty-eight were randomised to sixteen sessions of computerised cognitive rehabilitation training lasting eight weeks and 33 to a non-treatment group. Post-intervention assessments were done a month after conclusion of the intervention. Analysis of covariance was used to detect any differences between the two groups after post-intervention assessment, adjusting for age, sex, weight for age z score, quality of the home environment, time between admission and post-intervention testing and pre-intervention score. The primary outcome was improvement in attention scores for the intervention group. This trial is registered with Current Controlled Trials, number ISRCTN53183087. Results Significant intervention effects were observed in the intervention group for learning mean score (SE, [93.89 (4.00 vs 106.38 (4.32, P = 0.04] but for working memory the intervention group performed poorly [27.42 (0.66 vs 25.34 (0.73, P = 0.04]. No

  3. Impact of intermittent screening and treatment for malaria among school children in Kenya: a cluster randomised trial.

    Directory of Open Access Journals (Sweden)

    Katherine E Halliday

    2014-01-01

    Full Text Available Improving the health of school-aged children can yield substantial benefits for cognitive development and educational achievement. However, there is limited experimental evidence of the benefits of alternative school-based malaria interventions or how the impacts of interventions vary according to intensity of malaria transmission. We investigated the effect of intermittent screening and treatment (IST for malaria on the health and education of school children in an area of low to moderate malaria transmission.A cluster randomised trial was implemented with 5,233 children in 101 government primary schools on the south coast of Kenya in 2010-2012. The intervention was delivered to children randomly selected from classes 1 and 5 who were followed up for 24 months. Once a school term, children were screened by public health workers using malaria rapid diagnostic tests (RDTs, and children (with or without malaria symptoms found to be RDT-positive were treated with a six dose regimen of artemether-lumefantrine (AL. Given the nature of the intervention, the trial was not blinded. The primary outcomes were anaemia and sustained attention. Secondary outcomes were malaria parasitaemia and educational achievement. Data were analysed on an intention-to-treat basis. During the intervention period, an average of 88.3% children in intervention schools were screened at each round, of whom 17.5% were RDT-positive. 80.3% of children in the control and 80.2% in the intervention group were followed-up at 24 months. No impact of the malaria IST intervention was observed for prevalence of anaemia at either 12 or 24 months (adjusted risk ratio [Adj.RR]: 1.03, 95% CI 0.93-1.13, p = 0.621 and Adj.RR: 1.00, 95% CI 0.90-1.11, p = 0.953 respectively, or on prevalence of P. falciparum infection or scores of classroom attention. No effect of IST was observed on educational achievement in the older class, but an apparent negative effect was seen on spelling scores in

  4. Effect and process evaluation of a kindergarten-based, family-involved cluster randomised controlled trial in six European countries on four- to six-year-old children's steps per day: the ToyBox-study.

    Science.gov (United States)

    De Craemer, Marieke; Verloigne, Maïté; De Bourdeaudhuij, Ilse; Androutsos, Odysseas; Iotova, Violeta; Moreno, Luis; Koletzko, Berthold; Socha, Piotr; Manios, Yannis; Cardon, Greet

    2017-08-29

    The ToyBox-intervention is a theory- and evidence-based intervention delivered in kindergartens to improve four- to six-year-old children's energy balance-related behaviours and prevent obesity. The current study aimed to (1) examine the effect of the ToyBox-intervention on increasing European four- to six-year-old children' steps per day, and (2) examine if a higher process evaluation score from teachers and parents was related to a more favourable effect on steps per day. A sample of 2438 four- to six-year-old children (51.9% boys, mean age 4.75 ± 0.43 years) from 6 European countries (Belgium, Bulgaria, Germany, Greece, Poland and Spain) wore a motion sensor (pedometer or accelerometer) for a minimum of two weekdays and one weekend day both at baseline and follow-up to objectively measure their steps per day. Kindergarten teachers implemented the physical activity component of the ToyBox-intervention for 6 weeks in total, with a focus on (1) environmental changes in the classroom, (2) the child performing the actual behaviour and (3) classroom activities. Children's parents received newsletters, tip cards and posters. To assess intervention effects, multilevel repeated measures analyses were conducted for the total sample and the six intervention countries separately. In addition, process evaluation questionnaires were used to calculate a total process evaluation score (with implementation and satisfaction as a part of the overall score) for teachers and parents which was then linked with the physical activity outcomes. No significant intervention effects on four- to six-year-old children' steps per weekday, steps per weekend day and steps per average day were found, both in the total sample and in the country-specific samples (all p > 0.05). In general, the intervention effects on steps per day were least favourable in four- to six-year-old children with a low teachers process evaluation score and most favourable in four- to six-year-old children with a

  5. Comprehensive geriatric assessment for older adults admitted to hospital: meta-analysis of randomised controlled trials

    OpenAIRE

    Ellis, G.; Whitehead, M.A.; Robinson, D.; O'Neill, D.; Langhorne, P.

    2011-01-01

    Objective - To evaluate the effectiveness of comprehensive geriatric assessment in hospital for older adults admitted as an emergency.\\ud \\ud Search strategy - We searched the EPOC Register, Cochrane’s Controlled Trials Register, the Database of Abstracts of Reviews of Effects (DARE), Medline, Embase, CINAHL, AARP Ageline, and handsearched high yield journals.\\ud \\ud Selection criteria - Randomised controlled trials of comprehensive geriatric assessment (whether by mobile teams or in designat...

  6. The gait and balance of patients with diabetes can be improved: a randomised controlled trial

    OpenAIRE

    Allet, L.; Armand, S.; de Bie, R. A.; Golay, A.; Monnin, D.; Aminian, K.; Staal, J. B.; de Bruin, E. D.

    2009-01-01

    Aims/hypothesis Gait characteristics and balance are altered in diabetic patients. Little is known about possible treatment strategies. This study evaluates the effect of a specific training programme on gait and balance of diabetic patients. Methods This was a randomised controlled trial (n?=?71) with an intervention (n?=?35) and control group (n?=?36). The intervention consisted of physiotherapeutic group training including gait and balance exercises with function-orientated strengthening (...

  7. Efficacy of RTS,S/AS01E malaria vaccine and exploratory analysis on anti-circumsporozoite antibody titres and protection in children aged 5-17 months in Kenya and Tanzania: a randomised controlled trial

    DEFF Research Database (Denmark)

    Olotu, Ally; Lusingu, John; Leach, Amanda

    2011-01-01

    RTS,S/AS01E is the lead candidate malaria vaccine. We recently showed efficacy against clinical falciparum malaria in 5-17 month old children, during an average of 8 months follow-up. We aimed to assess the efficacy of RTS,S/AS01E during 15 months of follow-up.......RTS,S/AS01E is the lead candidate malaria vaccine. We recently showed efficacy against clinical falciparum malaria in 5-17 month old children, during an average of 8 months follow-up. We aimed to assess the efficacy of RTS,S/AS01E during 15 months of follow-up....

  8. Does hospital at home for palliative care facilitate death at home? Randomised controlled trial

    Science.gov (United States)

    Grande, Gunn E; Todd, Chris J; Barclay, Stephen I G; Farquhar, Morag C

    1999-01-01

    Objective To evaluate the impact on place of death of a hospital at home service for palliative care. Design Pragmatic randomised controlled trial. Setting Former Cambridge health district. Participants 229 patients referred to the hospital at home service; 43 randomised to control group (standard care), 186 randomised to hospital at home. Intervention Hospital at home versus standard care. Main outcome measures Place of death. Results Twenty five (58%) control patients died at home compared with 124 (67%) patients allocated to hospital at home. This difference was not significant; intention to treat analysis did not show that hospital at home increased the number of deaths at home. Seventy three patients randomised to hospital at home were not admitted to the service. Patients admitted to hospital at home were significantly more likely to die at home (88/113; 78%) than control patients. It is not possible to determine whether this was due to hospital at home itself or other characteristics of the patients admitted to the service. The study attained less statistical power than initially planned. Conclusion In a locality with good provision of standard community care we could not show that hospital at home allowed more patients to die at home, although neither does the study refute this. Problems relating to recruitment, attrition, and the vulnerability of the patient group make randomised controlled trials in palliative care difficult. While these difficulties have to be recognised they are not insurmountable with the appropriate resourcing and setting. Key messagesTerminally ill patients allocated to hospital at home were no more likely to die at home than patients receiving standard careAlthough the subsample of patients actually admitted to hospital at home did show a significant increase in likelihood of dying at home, whether this was due to the service itself or the characteristics of patients admitted to hospital at home could not be determinedThe need to

  9. Metacognitive training for schizophrenia: a multicentre randomised controlled trial.

    Science.gov (United States)

    Briki, Malick; Monnin, Julie; Haffen, Emmanuel; Sechter, Daniel; Favrod, Jérôme; Netillard, Christian; Cheraitia, Elisabeth; Marin, Karine; Govyadovskaya, Svetlana; Tio, Grégory; Bonin, Bernard; Chauvet-Gelinier, Jean-Christophe; Leclerc, Stéphanie; Hodé, Yann; Vidailhet, Pierre; Berna, Fabrice; Bertschy, Anna Zinetti; Vandel, Pierre

    2014-08-01

    A psychotherapeutic approach for schizophrenia is now recommended as an adjuvant for psychopharmacology, since antipsychotic medications only have a partial impact especially as regards positive symptoms and insight. In addition, cognitive distortions and the lack of metacognitive skills might increase positive symptoms leading to poor social functioning. This underlines the need for specific approaches which target cognitive processes relevant for insight, and abilities in metacognition. Metacognitive training (MCT) is a structured group intervention, which enhances a patient's reflection on cognitive biases and improves problem-solving. The aim of our study was to assess MCTs' short term impact on insight, symptoms and quality of life. Fifty patients with schizophrenia or schizoaffective disorders and persistent positive symptoms (delusions or hallucinations) were enrolled in the study. After baseline assessment participants were randomised either to supportive therapy or MCT. Both groups used the same design (1h-session twice a week during 8weeks) although the basic knowledge given to participants was different between interventions. Participants were assessed at eight weeks based on the Scale to Assess Unawareness of Mental Disorder, Positive and Negative Syndrome Scale (PANSS), Psychotic Symptom Rating Scales, the Calgary Depression Scale for Schizophrenia and the Quality of Life Scale. Between-group differences were significant in favour of MCT on the PANSS positive scale. Between-group differences in post- and pre-test values showed a trend in favour of MCT for insight on hallucinations. Results of our study indicate that the MCT has an effect on reducing positive symptomatology, and a trend impact on insight and social functioning. Copyright © 2014 Elsevier B.V. All rights reserved.

  10. Chinese Obstetrics & Gynecology journal club: a randomised controlled trial.

    Science.gov (United States)

    Tsui, Ilene K; Dodson, William C; Kunselman, Allen R; Kuang, Hongying; Han, Feng-Juan; Legro, Richard S; Wu, Xiao-Ke

    2016-01-28

    To assess whether a journal club model could improve comprehension and written and spoken medical English in a population of Chinese medical professionals. The study population consisted of 52 medical professionals who were residents or postgraduate master or PhD students in the Department of Obstetrics and Gynecology, Heilongjiang University of Chinese Medicine, China. After a three-part baseline examination to assess medical English comprehension, participants were randomised to either (1) an intensive journal club treatment arm or (2) a self-study group. At the conclusion of the 8-week intervention participants (n=52) were re-tested with new questions. The primary outcome was the change in score on a multiple choice examination. Secondary outcomes included change in scores on written and oral examinations which were modelled on the Test of English as a Foreign Language (TOEFL). Both groups had improved scores on the multiple choice examination without a statistically significant difference between them (90% power). However, there was a statistically significant difference between the groups in mean improvement in scores for both written (95% CI 1.1 to 5.0; p=0.003) and spoken English (95% CI 0.06 to 3.7; p=0.04) favouring the journal club intervention. Interacting with colleagues and an English-speaking facilitator in a journal club improved both written and spoken medical English in Chinese medical professionals. Journal clubs may be suitable for use as a self-sustainable teaching model to improve fluency in medical English in foreign medical professionals. NCT01844609. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  11. Reduced inattention and hyperactivity and improved cognition after marine oil extract (PCSO-524?) supplementation in children and adolescents with clinical and subclinical symptoms of attention-deficit hyperactivity disorder (ADHD): a randomised, double-blind, placebo-controlled trial

    OpenAIRE

    Kean, James D.; Sarris, Jerome; Scholey, Andrew; Silberstein, Richard; Downey, Luke A.; Stough, Con

    2016-01-01

    Introduction This study investigated the effects of a marine oil extract (PCSO-524?) on inattention, hyperactivity, mood and cognition in children and adolescents. PCSO-524? is a standardised lipid extract of the New Zealand green-lipped mussel and is an inflammatory modulator that inhibits the 5?-lipoxygenase and cyclooxygenase pathways and decreases concentrations of the pro-inflammatory arachidonic acid (AA). Methods PCSO-524? or a matched placebo was administered for 14?weeks to 144 parti...

  12. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial

    OpenAIRE

    Voskuijl, W; de Lorijn, F; Verwijs, W; Hogeman, P; Heijmans, J; Mäkel, W; Taminiau, J; Benninga, M

    2004-01-01

    Background: Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exist evaluating the efficacy of either laxative.

  13. Early assisted discharge with generic community nursing for chronic obstructive pulmonary disease exacerbations: Results of a randomised controlled trial

    NARCIS (Netherlands)

    C.M.A. Utens (Cecile); L.M.A. Goossens (Lucas); F.W.J.M. Smeenk (Frank); M.P.M.H. Rutten-van Mölken (Maureen); M. van Vliet (Monique); M.W. Braken (Maria); L. van Eijsden (Loes); O.C.P. Schayck (Onno)

    2012-01-01

    textabstractObjectives: To determine the effectiveness of early assisted discharge for chronic obstructive pulmonary disease (COPD) exacerbations, with home care provided by generic community nurses, compared with usual hospital care. Design: Prospective, randomised controlled and multicentre trial

  14. Using an electrocautery strategy or recombinant follicle stimulating hormone to induce ovulation in polycystic ovary syndrome: randomised controlled trial

    NARCIS (Netherlands)

    Bayram, Neriman; van Wely, Madelon; Kaaijk, Eugenie M.; Bossuyt, Patrick M. M.; van der Veen, Fulco

    2004-01-01

    Objective To compare the effectiveness of an electrocautery strategy with ovulation induction using recombinant follicle stimulating hormone in patients with clomiphene resistant polycystic ovary syndrome. Design Randomised controlled trial. Setting Secondary and tertiary hospitals in the

  15. Misoprostol for cervical priming prior to hysteroscopy in postmenopausal and premenopausal nulliparous women; a multicentre randomised placebo controlled trial

    NARCIS (Netherlands)

    Tasma, M L; Louwerse, M D; Hehenkamp, W J; Geomini, P M; Bongers, M Y; Veersema, S; van Kesteren, P J; Tromp, E; Huirne, J A; Graziosi, G C

    OBJECTIVE: To evaluate the reduction of pain by misoprostol compared with placebo prior to hysteroscopy in postmenopausal and premenopausal nulliparous women. DESIGN: Randomised multicentre double-blind placebo controlled trial. SETTING: Two Dutch teaching hospitals and one Dutch university medical

  16. The Infant Feeding Activity and Nutrition Trial (INFANT an early intervention to prevent childhood obesity: Cluster-randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Campbell Karen

    2008-03-01

    Full Text Available Abstract Background Multiple factors combine to support a compelling case for interventions that target the development of obesity-promoting behaviours (poor diet, low physical activity and high sedentary behaviour from their inception. These factors include the rapidly increasing prevalence of fatness throughout childhood, the instigation of obesity-promoting behaviours in infancy, and the tracking of these behaviours from childhood through to adolescence and adulthood. The Infant Feeding Activity and Nutrition Trial (INFANT aims to determine the effectiveness of an early childhood obesity prevention intervention delivered to first-time parents. The intervention, conducted with parents over the infant's first 18 months of life, will use existing social networks (first-time parent's groups and an anticipatory guidance framework focusing on parenting skills which support the development of positive diet and physical activity behaviours, and reduced sedentary behaviours in infancy. Methods/Design This cluster-randomised controlled trial, with first-time parent groups as the unit of randomisation, will be conducted with a sample of 600 first-time parents and their newborn children who attend the first-time parents' group at Maternal and Child Health Centres. Using a two-stage sampling process, local government areas in Victoria, Australia will be randomly selected at the first stage. At the second stage, a proportional sample of first-time parent groups within selected local government areas will be randomly selected and invited to participate. Informed consent will be obtained and groups will then be randomly allocated to the intervention or control group. Discussion The early years hold promise as a time in which obesity prevention may be most effective. To our knowledge this will be the first randomised trial internationally to demonstrate whether an early health promotion program delivered to first-time parents in their existing social groups

  17. PEG 3350 (Transipeg) versus lactulose in the treatment of childhood functional constipation: a double blind, randomised, controlled, multicentre trial.

    Science.gov (United States)

    Voskuijl, W; de Lorijn, F; Verwijs, W; Hogeman, P; Heijmans, J; Mäkel, W; Taminiau, J; Benninga, M

    2004-11-01

    Recently, polyethylene glycol (PEG 3350) has been suggested as a good alternative laxative to lactulose as a treatment option in paediatric constipation. However, no large randomised controlled trials exist evaluating the efficacy of either laxative. To compare PEG 3350 (Transipeg: polyethylene glycol with electrolytes) with lactulose in paediatric constipation and evaluate clinical efficacy/side effects. One hundred patients (aged 6 months-15 years) with paediatric constipation were included in an eight week double blinded, randomised, controlled trial. After faecal disimpaction, patients PEG 3350 (2.95 g/sachet) or lactulose (6 g/sachet) while children > or =6 years started with 2 sachets/day. Primary outcome measures were: defecation and encopresis frequency/week and successful treatment after eight weeks. Success was defined as a defecation frequency > or =3/week and encopresis PEG 3350: 3 pre v 7 post treatment/week; lactulose: 3 pre v 6 post/week) and a significant decrease in encopresis frequency (PEG 3350: 10 pre v 3 post/week; lactulose: 8 pre v 3 post/week) was found in both groups (NS). However, success was significantly higher in the PEG group (56%) compared with the lactulose group (29%). PEG 3350 patients reported less abdominal pain, straining, and pain at defecation than children using lactulose. However, bad taste was reported significantly more often in the PEG group. PEG 3350 (0.26 (0.11) g/kg), compared with lactulose (0.66 (0.32) g/kg), provided a higher success rate with fewer side effects. PEG 3350 should be the laxative of first choice in childhood constipation.

  18. Timing of birth for women with a twin pregnancy at term: a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Haslam Ross R

    2010-10-01

    is a protocol for a randomised trial, the findings of which will contribute information about the optimal time of birth for women with an uncomplicated multiple pregnancy at and beyond 37 weeks gestation. Clinical Trial Registration Current Controlled Trials ISRCTN15761056

  19. Changing cluster composition in cluster randomised controlled trials: design and analysis considerations

    Science.gov (United States)

    2014-01-01

    Background There are many methodological challenges in the conduct and analysis of cluster randomised controlled trials, but one that has received little attention is that of post-randomisation changes to cluster composition. To illustrate this, we focus on the issue of cluster merging, considering the impact on the design, analysis and interpretation of trial outcomes. Methods We explored the effects of merging clusters on study power using standard methods of power calculation. We assessed the potential impacts on study findings of both homogeneous cluster merges (involving clusters randomised to the same arm of a trial) and heterogeneous merges (involving clusters randomised to different arms of a trial) by simulation. To determine the impact on bias and precision of treatment effect estimates, we applied standard methods of analysis to different populations under analysis. Results Cluster merging produced a systematic reduction in study power. This effect depended on the number of merges and was most pronounced when variability in cluster size was at its greatest. Simulations demonstrate that the impact on analysis was minimal when cluster merges were homogeneous, with impact on study power being balanced by a change in observed intracluster correlation coefficient (ICC). We found a decrease in study power when cluster merges were heterogeneous, and the estimate of treatment effect was attenuated. Conclusions Examples of cluster merges found in previously published reports of cluster randomised trials were typically homogeneous rather than heterogeneous. Simulations demonstrated that trial findings in such cases would be unbiased. However, simulations also showed that any heterogeneous cluster merges would introduce bias that would be hard to quantify, as well as having negative impacts on the precision of estimates obtained. Further methodological development is warranted to better determine how to analyse such trials appropriately. Interim recommendations

  20. Modelling variable dropout in randomised controlled trials with longitudinal outcomes: application to the MAGNETIC study.

    Science.gov (United States)

    Kolamunnage-Dona, Ruwanthi; Powell, Colin; Williamson, Paula Ruth

    2016-04-28

    Clinical trials with longitudinally measured outcomes are often plagued by missing data due to patients withdrawing or dropping out from the trial before completing the measurement schedule. The reasons for dropout are sometimes clearly known and recorded during the trial, but in many instances these reasons are unknown or unclear. Often such reasons for dropout are non-ignorable. However, the standard methods for analysing longitudinal outcome data assume that missingness is non-informative and ignore the reasons for dropout, which could result in a biased comparison between the treatment groups. In this article, as a post hoc analysis, we explore the impact of informative dropout due to competing reasons on the evaluation of treatment effect in the MAGNETIC trial, the largest randomised placebo-controlled study to date comparing the addition of nebulised magnesium sulphate to standard treatment in acute severe asthma in children. We jointly model longitudinal outcome and informative dropout process to incorporate the information regarding the reasons for dropout by treatment group. The effect of nebulised magnesium sulphate compared with standard treatment is evaluated more accurately using a joint longitudinal-competing risk model by taking account of such complexities. The corresponding estimates indicate that the rate of dropout due to good prognosis is about twice as high in the magnesium group compared with standard treatment. We emphasise the importance of identifying reasons for dropout and undertaking an appropriate statistical analysis accounting for such dropout. The joint modelling approach accounting for competing reasons for dropout is proposed as a general approach for evaluating the sensitivity of conclusions to assumptions regarding missing data in clinical trials with longitudinal outcomes. EudraCT number 2007-006227-12 . Registration date 18 Mar 2008.

  1. HElmet therapy Assessment in infants with Deformed Skulls (HEADS: protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    van Wijk Renske M

    2012-07-01

    Full Text Available Abstract Background In The Netherlands, helmet therapy is a commonly used treatment in infants with skull deformation (deformational plagiocephaly or deformational brachycephaly. However, evidence of the effectiveness of this treatment remains lacking. The HEADS study (HElmet therapy Assessment in Deformed Skulls aims to determine the effects and costs of helmet therapy compared to no helmet therapy in infants with moderate to severe skull deformation. Methods/design Pragmatic randomised controlled trial (RCT nested in a cohort study. The cohort study included infants with a positional preference and/or skull deformation at two to four months (first assessment. At 5 months of age, all children were assessed again and infants meeting the criteria for helmet therapy were asked to participate in the RCT. Participants were randomly allocated to either helmet therapy or no helmet therapy. Parents of eligible infants that do not agree with enrolment in the RCT were invited to stay enrolled for follow up in a non-randomisedrandomised controlled trial (nRCT; they were then free to make the decision to start helmet therapy or not. Follow-up assessments took place at 8, 12 and 24 months of age. The main outcome will be head shape at 24 months that is measured using plagiocephalometry. Secondary outcomes will be satisfaction of parents and professionals with the appearance of the child, parental concerns about the future, anxiety level and satisfaction with the treatment, motor development and quality of life of the infant. Finally, complian