Mohr, David C; Schueller, Stephen M; Riley, William T; Brown, C Hendricks; Cuijpers, Pim; Duan, Naihua; Kwasny, Mary J; Stiles-Shields, Colleen; Cheung, Ken
In recent years, there has been increasing discussion of the limitations of traditional randomized controlled trial (RCT) methodologies for the evaluation of eHealth and mHealth interventions, and in particular, the requirement that these interventions be locked down during evaluation. Locking down these interventions locks in defects and eliminates the opportunities for quality improvement and adaptation to the changing technological environment, often leading to validation of tools that are outdated by the time that trial results are published. Furthermore, because behavioral intervention technologies change frequently during real-world deployment, even if a tested intervention were deployed in the real world, its shelf life would be limited. We argue that RCTs will have greater scientific and public health value if they focus on the evaluation of intervention principles (rather than a specific locked-down version of the intervention), allowing for ongoing quality improvement modifications to the behavioral intervention technology based on the core intervention principles, while continuously improving the functionality and maintaining technological currency. This paper is an initial proposal of a framework and methodology for the conduct of trials of intervention principles (TIPs) aimed at minimizing the risks of in-trial changes to intervention technologies and maximizing the potential for knowledge acquisition. The focus on evaluation of intervention principles using clinical and usage outcomes has the potential to provide more generalizable and durable information than trials focused on a single intervention technology.
Forster, Martin; Sundell, Knut; Morris, Richard J.; Karlberg, Martin; Melin, Lennart
This study reports the results from a Swedish randomized controlled trial of a standardized behavior management intervention. The intervention targeted students with externalizing behavior in a regular education setting. First- and second-grade students (N = 100) from 38 schools were randomly assigned to either the intervention or an active…
Durand, V. Mark; Hieneman, Meme; Clarke, Shelley; Wang, Mo; Rinaldi, Melissa L.
The present study was a multisite randomized clinical trial assessing the effects of adding a cognitive-behavioral intervention to positive behavior support (PBS). Fifty-four families who met the criteria of (a) having a child with a developmental disability, (b) whose child displayed serious challenging behavior (e.g., aggression, self-injury,…
Shire, Stephanie Yoshiko; Kasari, Connie
This systematic review examines train the trainer (TTT) effectiveness trials of behavioral interventions for individuals with autism spectrum disorder (ASD). Published methodological quality scales were used to assess studies including participant description, research design, intervention, outcomes, and analysis. Twelve studies including 9 weak…
Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; Hardcastle, Emily; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole; Roland, Erin; Sterba, Sonya K.; Cole, David A.
A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9-15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at post-intervention (2 months), after completion of 4 monthly booster sessions (6…
Betancourt, Theresa S.; McBain, Ryan; Newnham, Elizabeth A.; Akinsulure-Smith, Adeyinka M.; Brennan, Robert T.; Weisz, John R.; Hansen, Nathan B.
Objective Youth in war-affected regions are at risk for poor psychological, social, and educational outcomes. Effective interventions are needed to improve mental health, social behavior, and school functioning. This randomized controlled trial tested the effectiveness of a 10-session cognitive-behavioral therapy (CBT)–based group mental health intervention for multisymptomatic war-affected youth (aged 15–24 years) in Sierra Leone. Method War-affected youth identified by elevated distress and impairment via community screening were randomized (stratified by sex and age) to the Youth Readiness Intervention (YRI) (n = 222) or to a control condition (n = 214). After treatment, youth were again randomized and offered an education subsidy immediately (n = 220) or waitlisted (n = 216). Emotion regulation, psychological distress, prosocial attitudes/behaviors, social support, functional impairment, and posttraumatic stress disorder (PTSD) symptoms were assessed at pre- and postintervention and at 6-month follow-up. For youth in school, enrollment, attendance, and classroom performance were assessed after 8 months. Linear mixed-effects regressions evaluated outcomes. Results The YRI showed significant postintervention effects on emotion regulation, prosocial attitudes/behaviors, social support, and reduced functional impairment, and significant follow-up effects on school enrollment, school attendance, and classroom behavior. In contrast, education subsidy was associated with better attendance but had no effect on mental health or functioning, school retention, or classroom behavior. Interactions between education subsidy and YRI were not significant. Conclusion YRI produced acute improvements in mental health and functioning as well as longer-term effects on school engagement and behavior, suggesting potential to prepare war-affected youth for educational and other opportunities. Clinical trial registration information-Trial of the Youth Readiness Intervention (YRI
Compas, Bruce E.; Forehand, Rex; Keller, Gary; Champion, Jennifer E.; Rakow, Aaron; Reeslund, Kristen L.; McKee, Laura; Fear, Jessica M.; Colletti, Christina J. M.; HARDCASTLE, EMILY; Merchant, Mary Jane; Roberts, Lori; Potts, Jennifer; Garai, Emily; Coffelt, Nicole
A family cognitive-behavioral preventive intervention for parents with a history of depression and their 9–15-year-old children was compared with a self-study written information condition in a randomized clinical trial (n = 111 families). Outcomes were assessed at postintervention (2 months), after completion of 4 monthly booster sessions (6 months), and at 12-month follow-up. Children were assessed by child reports on depressive symptoms, internalizing problems, and externalizing problems; ...
Khary K. Rigg
Full Text Available An overemphasis on clinical trials and behavior change models has narrowed the knowledge base that can be used to design interventions. The overarching point is that the process of overanalyzing variables is impeding the process of gaining insight into the everyday experiences that shape how people define health and seek treatment. This claim is especially important to health decision-making and behavior change because subtle interpretations often influence the decisions that people make. This manuscript provides a critique of traditional approaches to developing health interventions, and theoretically justifies what and why changes are warranted. The limited scope of these models is also discussed, and an argument is made to adopt a strategy that includes the perceptions of people as necessary for understanding health and health-related decision-making. Three practical strategies are suggested to be used with the more standard approaches to assessing the effectiveness and relevance of health interventions.
Doyle, Orla; McGlanaghy, Edel; O’Farrelly, Christine; Tremblay, Richard E.
This study examined the impact of a targeted Irish early intervention program on children’s emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally. Trial Registration: ISRCTN Registry ISRCTN04631728 PMID:27253184
Pieper, M.J.C.; Francke, A.L.; Steen, J.T. van der; Scherder, E.J.A.; Twisk, J.W.R.; Kovach, C.R.; Achterberg, W.P.
Objectives: To assess whether implementation of a stepwise multicomponent intervention (STA OP!) is effective in reducing challenging behavior and depression in nursing home residents with advanced dementia. Design: Cluster randomized controlled trial. Setting: Twenty-one clusters (single independe
Full Text Available This study examined the impact of a targeted Irish early intervention program on children's emotional and behavioral development using multiple methods to test the robustness of the results. Data on 164 Preparing for Life participants who were randomly assigned into an intervention group, involving home visits from pregnancy onwards, or a control group, was used to test the impact of the intervention on Child Behavior Checklist scores at 24-months. Using inverse probability weighting to account for differential attrition, permutation testing to address small sample size, and quantile regression to characterize the distributional impact of the intervention, we found that the few treatment effects were largely concentrated among boys most at risk of developing emotional and behavioral problems. The average treatment effect identified a 13% reduction in the likelihood of falling into the borderline clinical threshold for Total Problems. The interaction and subgroup analysis found that this main effect was driven by boys. The distributional analysis identified a 10-point reduction in the Externalizing Problems score for boys at the 90th percentile. No effects were observed for girls or for the continuous measures of Total, Internalizing, and Externalizing problems. These findings suggest that the impact of this prenatally commencing home visiting program may be limited to boys experiencing the most difficulties. Further adoption of the statistical methods applied here may help to improve the internal validity of randomized controlled trials and contribute to the field of evaluation science more generally.ISRCTN Registry ISRCTN04631728.
Davidson, Karina W; Peacock, James; Kronish, Ian M; Edmondson, Donald
Behavioral interventions are typically studied with the use of a conventional between-subject randomized controlled trial (RCT) design. In this design, the effect of an intervention on one group of patients is compared with the effect of a control condition on another group of patients, such that a between-subject change is tested. A between-subject design has an underlying assumption that there is a homogenous treatment effect for a behavioral intervention, drug or psychotherapy, and that the way the intervention operates in the study that will tend to operate in the same way in many other patients. We review some of the philosophical and practical problems with the use of this design when a clinician is attempting to decide on a course of behavioral treatment aimed at within-subject change in patients who are likely to have heterogeneous or unique responses to behavioral treatment. We also review the biases inherent in our current clinical practice model, which does not use any empirical data collection or design for testing if a treatment is useful, and also in the conventional between-subject personalized medicine RCT designs. We propose increased use of single-patient (also known as N-of-1) trials that employ within-subject designs, in cases where treatment response is heterogeneous-as is the case for most psychological and behavioral treatments. Limitations of such designs include that they can only be used when the treatment is potentially reversible, the patient can act as their own control, and the outcome can be measured repeatedly. Increased use of within-subject trials may address in many more instances the more clinically relevant question of how a specific patient will respond to a specific treatment, and could introduce a more harmonious scientific approach into the way we treat our patients. We have incorporated a case presentation that illustrates the complexities of applying evidence drawn from these different designs to selecting and evaluating
Full Text Available Abstract Background Medically unexplained symptoms are an important mental health problem in primary care and generate a high cost in health services. Cognitive behavioral therapy and psychodynamic therapy have proven effective in these patients. However, there are few studies on the effectiveness of psychosocial interventions by primary health care. The project aims to determine whether a cognitive-behavioral group intervention in patients with medically unexplained symptoms, is more effective than routine clinical practice to improve the quality of life measured by the SF-12 questionary at 12 month. Methods/design This study involves a community based cluster randomized trial in primary healthcare centres in Madrid (Spain. The number of patients required is 242 (121 in each arm, all between 18 and 65 of age with medically unexplained symptoms that had seeked medical attention in primary care at least 10 times during the previous year. The main outcome variable is the quality of life measured by the SF-12 questionnaire on Mental Healthcare. Secondary outcome variables include number of consultations, number of drug (prescriptions and number of days of sick leave together with other prognosis and descriptive variables. Main effectiveness will be analyzed by comparing the percentage of patients that improve at least 4 points on the SF-12 questionnaire between intervention and control groups at 12 months. All statistical tests will be performed with intention to treat. Logistic regression with random effects will be used to adjust for prognostic factors. Confounding factors or factors that might alter the effect recorded will be taken into account in this analysis. Discussion This study aims to provide more insight to address medically unexplained symptoms, highly prevalent in primary care, from a quantitative methodology. It involves intervention group conducted by previously trained nursing staff to diminish the progression to the chronicity
Nugent, Chris D; McClean, Sally I; Cleland, Ian; Tschanz, JoAnn T; Clark, Christine J; Norton, Maria C
Background Health education and behavior change programs targeting specific risk factors have demonstrated their effectiveness in reducing the development of future diseases. Alzheimer disease (AD) shares many of the same risk factors, most of which can be addressed via behavior change. It is therefore theorized that a behavior change intervention targeting these risk factors would likely result in favorable rates of AD prevention. Objective The objective of this study was to reduce the future risk of developing AD, while in the short term promoting vascular health, through behavior change. Methods The study was an interventional randomized controlled trial consisting of subjects who were randomly assigned into either treatment (n=102) or control group (n=42). Outcome measures included various blood-based biomarkers, anthropometric measures, and behaviors related to AD risk. The treatment group was provided with a bespoke “Gray Matters” mobile phone app designed to encourage and facilitate behavior change. The app presented evidence-based educational material relating to AD risk and prevention strategies, facilitated self-reporting of behaviors across 6 behavioral domains, and presented feedback on the user’s performance, calculated from reported behaviors against recommended guidelines. Results This paper explores the rationale for a mobile phone–led intervention and details the app’s effect on behavior change and subsequent clinical outcomes. Via the app, the average participant submitted 7.3 (SD 3.2) behavioral logs/day (n=122,719). Analysis of these logs against primary outcome measures revealed that participants who improved their high-density lipoprotein cholesterol levels during the study duration answered a statistically significant higher number of questions per day (mean 8.30, SD 2.29) than those with no improvement (mean 6.52, SD 3.612), t97.74=−3.051, P=.003. Participants who decreased their body mass index (BMI) performed significantly
Full Text Available We investigated the effects of group music intervention on aggression and self-esteem in children with highly aggressive behavior. Forty-eight children were allocated to either a music intervention group or an untreated control group. The music intervention group received 50 min of music intervention twice weekly for 15 consecutive weeks. The outcome measures were Child Behavior Checklist Aggression Problems Scale (Parents, Child Aggression Assessment Inventory (Teachers and Rosenberg Self-esteem Scale. After 15 weeks, the music intervention group showed significant reduction of aggression and improvement of self-esteem compared with the control group. All outcome measures were significantly lower in the music intervention group than prior to treatment, while there was no change in the control group. These findings suggest that music can reduce aggressive behavior and improve self-esteem in children with highly aggressive behavior. Music intervention is an easily accessible therapy for children and as such may be an effective intervention for aggressive behavior. Further more, objective and replicable measures are required from a randomized controlled trial with a larger sample size and active comparable control.
Full Text Available Abstract Background Coping with a chronic illness (CI challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the intervention program may enhance the use of learned coping strategies in daily life, especially on the long-term. The primary aim of the present study is to examine the effectiveness of a cognitive behavioral based group intervention (called 'Op Koers' 1 for children with CI and of a parallel intervention for their parents. A secondary objective is to investigate why and for whom this intervention works, in order to understand the underlying mechanisms of the intervention effect. Methods/design This study is a multicentre randomized controlled trial. Participants are children (8 to 18 years of age with a chronic illness, and their parents, recruited from seven participating hospitals in the Netherlands. Participants are randomly allocated to two intervention groups (the child intervention group and the child intervention combined with a parent program and a wait-list control group. Primary outcomes are child psychosocial functioning, wellbeing and child disease related coping skills. Secondary outcomes are child quality of life, child general coping skills, child self-perception, parental stress, quality of parent-child interaction, and parental perceived vulnerability. Outcomes are evaluated at baseline, after 6 weeks of treatment, and at a 6 and 12-month follow-up period. The analyses will be performed on the basis of an intention-to-treat population. Discussion This study evaluates the effectiveness of a group intervention improving psychosocial functioning in children with CI and their parents. If proven effective, the intervention will be implemented in clinical practice. Strengths and limitations of the study design are discussed
Roll, Lona; Stegenga, Kristin; Hendricks-Ferguson, Verna; Barnes, Yvonne J; Cherven, Brooke; Docherty, Sharron L; Robb, Sheri L; Haase, Joan E
Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses) include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA) undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings. PMID:24102024
Full Text Available Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.
Rost, Kathryn M.; Marshall, Donna; Xu, Stanley
Background Employers can purchase high quality depression products that provide the type, intensity and duration of depression care management shown to improve work outcomes sufficiently for many employers to achieve a return on investment. The purpose of this randomized controlled trial was to test an intervention to encourage employers to purchase a high quality depression product for their workforce. Methods Twenty nine organizations recruited senior health benefit professional members rep...
Quinn, Charlene C.; Shardell, Michelle D; Terrin, Michael L.; Barr, Erik A.; Ballew, Shoshana H.; Gruber-Baldini, Ann L.
OBJECTIVE To test whether adding mobile application coaching and patient/provider web portals to community primary care compared with standard diabetes management would reduce glycated hemoglobin levels in patients with type 2 diabetes. RESEARCH DESIGN AND METHODS A cluster-randomized clinical trial, the Mobile Diabetes Intervention Study, randomly assigned 26 primary care practices to one of three stepped treatment groups or a control group (usual care). A total of 163 patients were enrolled...
Robb, Sheri L.; Burns, Debra S.; Docherty, Sharron L.; Haase, Joan E.
The Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study (R01NR008583; U10CA098543; U10CA095861) is an ongoing multi-site Children’s Oncology Group randomized clinical trial testing the efficacy of a therapeutic music video intervention for adolescents/young adults (11–24 years of age) with cancer undergoing stem cell transplant. Treatment fidelity strategies from our trial are consistent with the NIH Behavior Change Consortium Treatment Fidelity Workgroup (...
Forman, Evan M.; Butryn, Meghan L.; Hoffman, Kimberly L.; Herbert, James D.
Innovative approaches are urgently needed to improve behavioral treatment for weight loss. The weight regain that is so common after treatment may be a result of an environment that makes it challenging to adhere, long-term, to a dietary and physical activity regimen. This study was designed to test, via a 12-week open trial, the preliminary…
Prick, A.J.C.; Lange, J. de; Scherder, E.; Twisk, J.; Pot, A.M.
Purpose: The effects of a multicomponent dyadic intervention on the mood, behavior, and physical health of people with dementia living in the community were evaluated in a randomized controlled trial. This multicomponent dyadic intervention is a translated and adapted version of an intervention that
Albert, Dustin; Belsky, Daniel W; Crowley, D Max; Latendresse, Shawn J; Aliev, Fazil; Riley, Brien; Sun, Cuie; Dick, Danielle M; Dodge, Kenneth A
Early interventions are a preferred method for addressing behavioral problems in high-risk children, but often have only modest effects. Identifying sources of variation in intervention effects can suggest means to improve efficiency. One potential source of such variation is the genome. We conducted a genetic analysis of the Fast Track randomized control trial, a 10-year-long intervention to prevent high-risk kindergarteners from developing adult externalizing problems including substance abuse and antisocial behavior. We tested whether variants of the glucocorticoid receptor gene NR3C1 were associated with differences in response to the Fast Track intervention. We found that in European-American children, a variant of NR3C1 identified by the single-nucleotide polymorphism rs10482672 was associated with increased risk for externalizing psychopathology in control group children and decreased risk for externalizing psychopathology in intervention group children. Variation in NR3C1 measured in this study was not associated with differential intervention response in African-American children. We discuss implications for efforts to prevent externalizing problems in high-risk children and for public policy in the genomic era.
Full Text Available Abstract Background Frailty is a term commonly used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However, despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. The criteria Fried and colleagues used to define the frailty syndrome will be used in this study (i.e. weight loss, fatigue, decreased grip strength, slow gait speed, and low physical activity. Previous studies have shown that clinical outcomes for frail older people can be improved using multi-factorial interventions such as comprehensive geriatric assessment, and single interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. We have developed a multidisciplinary intervention that specifically targets frailty as defined by Fried et al. We aim to establish the effects of this intervention on frailty, mobility, hospitalisation and institutionalisation in frail older people. Methods and Design A single centre randomised controlled trial comparing a multidisciplinary intervention with usual care. The intervention will target identified characteristics of frailty, functional limitations, nutritional status, falls risk, psychological issues and management of chronic health conditions. Two hundred and thirty people aged 70 and over who meet the Fried definition of frailty will be recruited from clients of the aged care service of a metropolitan hospital. Participants will be followed for a 12-month period. Discussion This research is an important step in the examination of specifically targeted frailty interventions. This project will assess whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If successful, the study will establish a
Siller, Michael; Hutman, Ted; Sigman, Marian
Longitudinal research has demonstrated that responsive parental behaviors reliably predict subsequent language gains in children with autism spectrum disorder. To investigate the underlying causal mechanisms, we conducted a randomized clinical trial of an experimental intervention (Focused Playtime Intervention, FPI) that aims to enhance…
Davison, Kirsten; Bowling, April; Garcia, Jeanette; Wood, Brian; Hermesch, Robert; Prince, James; Hayes, Amanda; Kow, Richard; Newlan, Sami; Slavet, James
While positive and clinically meaningful effects of exercise on cognition and behavior in children have been demonstrated in controlled experimental settings, they have rarely been translated and rigorously evaluated in real-world environments. In particular, there is a lack of research on school-based approaches to sustainable physical activity and exercise interventions targeting children with behavioral health disorders. Manville Moves is an exercise intervention designed to improve behavioral regulation and classroom functioning among children with neurodevelopmental and affective disorders within a therapeutic day-school environment. The curriculum is built around virtual-reality exergaming bicycles (cybercycles) and integrated into physical education (PE) classes. Manville Moves was developed using community based participatory research (CBPR) and implemented as a pragmatic trial. In this paper, we describe (a) the background, theoretical framework and intervention setting, (b) the Manville Moves curriculum, (c) the study design and outcome and process measures, and (d) the strategies used to support implementation compliance and intervention uptake by a population with a variety of behavioral challenges. We conclude with a detailed description of the participatory process by which the intervention was developed and integrated into school programming and a review of the program's key innovations and approaches to addressing threats to internal and external validity. PMID:27261171
Experimental Evidence for Differential Susceptibility: Dopamine D4 Receptor Polymorphism (DRD4 VNTR) Moderates Intervention Effects on Toddlers' Externalizing Behavior in a Randomized Controlled Trial
Bakermans-Kranenburg, Marian J.; Van Ijzendoorn, Marinus H.; Pijlman, Femke T. A.; Mesman, Judi; Juffer, Femmie
In a randomized controlled trial we tested the role of genetic differences in explaining variability in intervention effects on child externalizing behavior. One hundred fifty-seven families with 1- to 3-year-old children screened for their relatively high levels of externalizing behavior participated in a study implementing Video-feedback…
Ae-Na Choi; Myeong Soo Lee; Jung-Sook Lee
We investigated the effects of group music intervention on aggression and self-esteem in children with highly aggressive behavior. Forty-eight children were allocated to either a music intervention group or an untreated control group. The music intervention group received 50 min of music intervention twice weekly for 15 consecutive weeks. The outcome measures were Child Behavior Checklist Aggression Problems Scale (Parents), Child Aggression Assessment Inventory (Teachers) and Rosenberg Self-...
Thomas, Evan A; Tellez-Sanchez, Sarita; Wick, Carson; Kirby, Miles; Zambrano, Laura; Abadie Rosa, Ghislaine; Clasen, Thomas F; Nagel, Corey
Subject reactivity--when research participants change their behavior in response to being observed--has been documented showing the effect of human observers. Electronics sensors are increasingly used to monitor environmental health interventions, but the effect of sensors on behavior has not been assessed. We conducted a cluster randomized controlled trial in Rwanda among 170 households (70 blinded to the presence of the sensor, 100 open) testing whether awareness of an electronic monitor would result in a difference in weekly use of household water filters and improved cookstoves over a four-week surveillance period. A 63% increase in number of uses of the water filter per week between the groups was observed in week 1, an average of 4.4 times in the open group and 2.83 times in the blind group, declining in week 4 to an insignificant 55% difference of 2.82 uses in the open, and 1.93 in the blind. There were no significant differences in the number of stove uses per week between the two groups. For both filters and stoves, use decreased in both groups over four-week installation periods. This study suggests behavioral monitoring should attempt to account for reactivity to awareness of electronic monitors that persists for weeks or more. PMID:26986617
Cancer-Related Fatigue and Rehabilitation: A Randomized Controlled Multicenter Trial Comparing Physical Training Combined With Cognitive-Behavioral Therapy With Physical Training Only and With No Intervention
van Weert, E; May, A M; Korstjens, I.; Post, W.J.; van der Schans, C P; van den Borne, B; Mesters, I.; Ros, W J G; Hoekstra-Weebers, J.E.H.M.
textabstractBackground. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancerrelated fatigue of physical training combined with cognitive behavioral therapy with physical training alone and with no intervention. Design. In this multicenter randomized controlled trial, 147 survivors of cancer were randomly assigned to a ...
Full Text Available "n Objective: "n "nThe main objective of this study is to evaluate the effect of psychological therapies and art/sport supportive interventions separately,and in combination on post traumatic stress symptoms in children and compare them with a control group . "nMethods: In a field trial, we evaluated the efficacy of group behavioral therapy, art and sport supportive interventions in Bam earthquake children survivors with PTSD symptoms and compared it with a control group. Before and after interventions we evaluated the PTSD symptoms using K-SADS-PL semi-structural interview for each group and compared them using appropriate statistical methods. "nResults: The participants were 200 individuals who were randomized in four groups according to an intervention program including: Group behavioral therapy; Group behavioral therapy plus art and sport interventions; Art and sport interventions; and control group. During the interventions, 39 individuals were excluded. None of the participants had severed PTSD or other psychiatry disorders that needed pharmacological interventions. In interventional groups, the reduction of total PTSD symptoms and the symptoms of re-experience, avoidance and hyper arousal was not statistically significant. However, in the control group, the PTSD symptoms increased during the study which was statistically significant. "nConclusion: Group behavior therapy and supportive interventions (art and sport may have preventive effects on PTSD symptoms.
Full Text Available BACKGROUND: Substance use during sex is associated with sexual risk behavior among men who have sex with men (MSM, and MSM continue to be the group at highest risk for incident HIV in the United States. The objective of this study is to test the efficacy of a group-based, cognitive-behavioral intervention to reduce risk behavior of substance-using MSM, compared to a randomized attention-control group and a nonrandomized standard HIV-testing group. METHODS AND FINDINGS: Participants (n = 1,686 were enrolled in Chicago, Los Angeles, New York City, and San Francisco and randomized to a cognitive-behavioral intervention or attention-control comparison. The nonrandomized group received standard HIV counseling and testing. Intervention group participants received six 2-h group sessions focused on reducing substance use and sexual risk behavior. Attention-control group participants received six 2-h group sessions of videos and discussion of MSM community issues unrelated to substance use, sexual risk, and HIV/AIDS. All three groups received HIV counseling and testing at baseline. The sample reported high-risk behavior during the past 3 mo prior to their baseline visit: 67% reported unprotected anal sex, and 77% reported substance use during their most recent anal sex encounter with a nonprimary partner. The three groups significantly (p0.05 from each other at 3-, 6-, and 12-mo follow-up. Outcomes for the 2-arm comparisons were not significantly different at 12-mo follow-up (e.g., unprotected anal sex, odds ratio = 1.14, confidence interval = 0.86-1.51, nor at earlier time points. Similar results were found for each outcome variable in both 2- and 3-arm comparisons. CONCLUSIONS: These results for reducing sexual risk behavior of substance-using MSM are consistent with results of intervention trials for other populations, which collectively suggest critical challenges for the field of HIV behavioral interventions. Several mechanisms may contribute to
Chan, Ko-Ling; Chow, Chun-Bong; Lam, Tai-Hing; Ho, Sai-Yin; Wong, Wilfred Hing-Sang; Wong, Margaret Fung-Yee
Background Underage drinking is a prevalent risk behavior and common public health problem. Research shows that alcohol abuse not only affects the quality of life of drinkers themselves. The problems resulting from underage drinking pose substantial costs to society as well. The proposed study will address underage drinking with the use of an Internet campaign, which is a cost-effective way of tackling the problem. Objective The aims of this study are to test the effectiveness of an online quiz competition in changing adolescents’ alcohol-related attitudes and behavior and to explore the feasibility of using Internet viral marketing to reach a significant number of adolescents. Methods The study will constitute a cluster randomized controlled trial for 20 secondary schools (6720 Grade 7-9 students). Schools will be randomized to intervention or control arm with equal likelihood. Students in intervention schools will be invited to take part in the Internet campaign, whereas those in control schools will receive relevant promotional leaflets. Results Alcohol-related attitude and behavior will be the primary outcome measures. The results of the proposed study will provide evidence on the efficacy of an Internet intervention in modifying adolescents’ attitudes and behavior and guide further investigation into the prevention of and intervention in such risk behaviors as underage drinking. The project was funded July 2015, enrollment started September 2015, and results are expected July 2017. Conclusions With the Internet increasingly being recognized as a practical and cost-effective platform for health information delivery, the proposed Internet-based intervention is expected to be more effective in altering adolescents’ alcohol-related attitudes and behaviors than traditional health promotion. ClinicalTrial ClinicalTrials.gov NCT02450344; https://clinicaltrials.gov/ct2/show/NCT02450344 (Archived by WebCite at http://www.webcitation.org/6heB2zMBD) PMID:27252072
Spindler, Helle; Staugaard, Søren Risløv; Nicolaisen, Camilla;
The objective of this study was to examine the effect of a brief cognitive-behavioral intervention for patients with dental fear in a private dental clinic. Patients presenting with subjectively reported dental fear were randomly assigned to either an immediate intervention (n = 53) or a waiting...... list (n = 51) group. Both groups received an identical intervention, but delayed by 4-6 weeks in the waiting list group. Participants were asked to fill out two self-report questionnaires of dental fear at pre- and post-intervention, and again at a 2-year follow-up assessment. Analysis of variance...... showed that dental fear was significantly reduced in the immediate intervention group (d = 1.5-2.2), compared with the waiting list group (d = 0.3-0.4). Additionally, all participants showed a significant reduction of dental fear following the brief intervention, and in the subgroup available for follow...
Siller, Michael; Swanson, Meghan; Gerber, Alan; Hutman, Ted; Sigman, Marian
The current study is a randomized clinical trial evaluating the efficacy of Focused Playtime Intervention (FPI) in a sample of 70 children with Autism Spectrum Disorder. This parent-mediated intervention has previously been shown to significantly increase responsive parental communication (Siller et al. in "J Autism Dev Disord"…
Full Text Available Abstract Background Executive function is critical for children's healthy development. We propose an intervention program to enhance children's executive function using the game, GO. Many neuroimaging studies have revealed that playing GO is related to executive function. In addition, previous studies also revealed that executive function can be enhanced by training. We will perform a randomized controlled trial to investigate the effectiveness of a GO intervention group and a control group without intervention. Methods/Design 35 elementary school children aged 8 to 10 were recruited from Edogawa elementary school in Tokyo, Japan. They will be randomized into two groups; either the 5-week GO intervention group or no-intervention control group. We will ask the participants of the intervention group to join the GO course which will be held once every week for five weeks (total: six times. In the GO course, the children will be taught GO by the GO masters of the Nihon Ki-in and enjoy it for an hour. Besides the course, the participants will perform GO problems about twenty minutes a day, three times a week during the intervention period. We will use the Stroop task, the digit span, the Raven's colored progressive matrices, the Span-board task, and the Behavioral inhibition/behavioral activation scale for the outcome measures. Outcomes will be measured at a baseline (Assessment 1 and 5 weeks after the intervention program started (Assessment 2. The intervention group will be compared with the control group using one-way analyses of covariance with the difference between Assessment 1 and Assessment 2 measures as dependent variables and pretest scores as covariates. Discussion To our knowledge, this study will be the first RCT to investigate the efficacy of a GO intervention program for elementary school children. If this intervention is effective, we will be able to take the next steps in making an educational program to enhance children's executive
D. Daley; S. van der Oord; M. Ferrin; M. Danckaerts; M. Doepfner; S. Cortese; E.J.S. Sonuga-Barke
OBJECTIVE: Behavioral interventions are recommended as attention-deficit/hyperactivity disorder (ADHD) treatments. However, a recent meta-analysis found no effects on core ADHD symptoms when raters were probably blind to treatment allocation. The present analysis is extended to a broader range of ch
L. Scholten; A.M. Willemen; M.A. Grootenhuis; H. Maurice-Stam; C. Schuengel; B.F. Last
Coping with a chronic illness (CI) challenges children's psychosocial functioning and wellbeing. Cognitive-behavioral intervention programs that focus on teaching the active use of coping strategies may prevent children with CI from developing psychosocial problems. Involvement of parents in the int
Patrick, Kevin; Ybarra, Michele L; Reback, Cathy J; Rawson, Richard A; Chokron Garneau, Helene; Chavez, Kathryn; Venegas, Alexandra
Background Evidence-based psychosocial interventions for addictions and related conditions such as cognitive behavioral therapy (CBT) are underutilized. Obstacles to implementation of CBT in clinical settings include limited availability of quality training, supervision, and certification in CBT for clinicians; high rates of clinician turnover and high caseloads; and limited qualifications of the workforce to facilitate CBT expertise. Objective Mobile phone–based delivery of CBT, if demonstrated to be feasible and effective, could be transformative in broadening its application and improving the quality of addiction treatment. No experimental interventions that deliver CBT targeting both drug use and medication adherence using text messaging have been previously reported; as such, the objective of this study is to develop and test an SMS-based treatment program for HIV-positive adults with comorbid substance use disorders. Methods With user input, we developed a 12-week CBT-based text messaging intervention (TXT-CBT) targeting antiretroviral (ART) adherence, risk behaviors, and drug use in a population of HIV-infected substance users. Results The intervention has been developed and is presently being tested in a pilot randomized clinical trial. Results will be reported later this year. Conclusions This investigation will yield valuable knowledge about the utility of a cost-effective, readily deployable text messaging behavioral intervention for HIV-infected drug users. PMID:27341852
George, Steven Z.; Zeppieri, Giorgio; Cere, Anthony L.; Cere, Melissa R.; Borut, Michael S.; Hodges, Michael J.; Reed, Dalton M.; Valencia, Carolina; Robinson, Michael E.
Psychological factors consistent with fear-avoidance models are associated with the development of chronic low back pain (LBP). As a result, graded activity (GA) and graded exposure (GX) have been suggested as behavioral treatment options. This clinical trial compared the effectiveness of treatment based classification (TBC) physical therapy alone, to TBC augmented with GA or GX for patients with acute and sub-acute LBP. Our primary hypothesis was that GX would be most effective for those wit...
Bunge, Eduardo L; Barrera, Alinne Z; Wickham, Robert E; Lee, Jessica
Background The Institute for International Internet Interventions for Health at Palo Alto University proposes to develop digital tools specifically to help low-income English- and Spanish-speaking smokers to quit. Individuals from lower-income countries and those with lower social status quit at lower rates than those from high-income countries and those with higher social status. Objective We plan to launch a project designed to test whether a mobile-based digital intervention designed with systematic input from low-income English- and Spanish-speaking smokers from a public-sector health care system can significantly improve its acceptability, utilization, and effectiveness. Methods Using human-centered development methods, we will involve low-income patients in the design of a Web app/text messaging tool. We will also use their input to improve our recruitment and dissemination strategies. We will iteratively develop versions of the digital interventions informed by our human-centered approach. The project involves three specific aims: (1) human-centered development of an English/Spanish smoking cessation web app, (2) improvement of dissemination strategies, and (3) evaluation of resulting smoking cessation web app. We will develop iterative versions of a digital smoking cessation tool that is highly responsive to the needs and preferences of the users. Input from participants will identify effective ways of reaching and encouraging low-income English- and Spanish-speaking smokers to use the digital smoking cessation interventions to be developed. This information will support ongoing dissemination and implementation efforts beyond the grant period. We will evaluate the effectiveness of the successive versions of the resulting stop smoking Web app by an online randomized controlled trial. Increased effectiveness will be defined as increased utilization of the Web app and higher abstinence rates than those obtained by a baseline usual care Web app. Results
A Randomized Clinical Trial Comparison between Pivotal Response Treatment (PRT) and Adult-Driven Applied Behavior Analysis (ABA) Intervention on Disruptive Behaviors in Public School Children with Autism
Mohammadzaheri, Fereshteh; Koegel, Lynn Kern; Rezaei, Mohammad; Bakhshi, Enayatolah
Children with autism often demonstrate disruptive behaviors during demanding teaching tasks. Language intervention can be particularly difficult as it involves social and communicative areas, which are challenging for this population. The purpose of this study was to compare two intervention conditions, a naturalistic approach, Pivotal Response…
Lewis, Gary; Yu, Catherine; Rotondi, Michael; Seto, Emily; Cafazzo, Joseph A
Background Patients with type 2 diabetes mellitus (T2DM) struggle with the management of their condition due to difficulty relating lifestyle behaviors with glycemic control. While self-monitoring of blood glucose (SMBG) has proven to be effective for those treated with insulin, it has been shown to be less beneficial for those only treated with oral medications or lifestyle modification. We hypothesized that the effective self-management of non-insulin treated T2DM requires a behavioral intervention that empowers patients with the ability to self-monitor, understand the impact of lifestyle behaviors on glycemic control, and adjust their self-care based on contextualized SMBG data. Objective The primary objective of this randomized controlled trial (RCT) is to determine the impact of bant2, an evidence-based, patient-centered, behavioral mobile app intervention, on the self-management of T2DM. Our second postulation is that automated feedback delivered through the mobile app will be as effective, less resource intensive, and more scalable than interventions involving additional health care provider feedback. Methods This study is a 12-month, prospective, multicenter RCT in which 150 participants will be randomly assigned to one of two groups: the control group will receive current standard of care, and the intervention group will receive the mobile phone app system in addition to standard of care. The primary outcome measure is change in glycated hemoglobin A1c from baseline to 12 months. Results The first patient was enrolled on July 28, 2015, and we anticipate completing this study by September, 2018. Conclusions This RCT is one of the first to evaluate an evidence-based mobile app that focuses on facilitating lifestyle behavior change driven by contextualized and structured SMBG. The results of this trial will provide insights regarding the usage of mobile tools and consumer-grade devices for diabetes self-care, the economic model of using incentives to motivate
Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia
Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…
Full Text Available Anna-Eva Prick,1 Jacomine de Lange,2 Erik Scherder,3 Jos Twisk,4 Anne Margriet Pot1,5,6 1Department of Clinical Psychology and the EMGO+ Institute for Health and Care Research, Faculty of Psychology and Education, VU University, Amsterdam, the Netherlands; 2Research Centre Innovations in Care, Rotterdam University of Applied Sciences, Rotterdam, the Netherlands; 3Department of Clinical Neuropsychology, Faculty of Psychology and Education, VU University, Amsterdam, the Netherlands; 4Department of Epidemiology and Biostatistics and the EMGO+ Institute for Health and Care Research, VU University Medical Center, Amsterdam, the Netherlands; 5Program on Ageing, Institute of Mental Health and Addiction, Utrecht, the Netherlands; 6School of Psychology, University of Queensland, Brisbane, QLD, Australia Purpose: The effects of a multicomponent dyadic intervention on the mood, behavior, and physical health of people with dementia living in the community were evaluated in a randomized controlled trial. This multicomponent dyadic intervention is a translated and adapted version of an intervention that has been shown to be effective for people with dementia in the US. Patients and methods: People with dementia living in the community and their family caregivers (N=111 caregiver-care recipient dyads were randomly assigned to the intervention and comparison group. The intervention group received home-based physical exercise training, psycho-education, communication skills training, and pleasant activities training during 3 months directed at both the person with dementia and the caregiver. Mood, behavior, and physical health were measured at baseline, 3 months, and 6 months. The effects of the study were determined by using generalized estimating equations based on an intention-to-treat analysis. Results: Analyses showed no beneficial effects over time on any of the outcome measures. Conclusion: This study showed no effects. The negative results in this study
Full Text Available Abstract Background To examine the effects of a 6 month lifestyle intervention on quality of life, depression, self-efficacy and eating behavior changes in overweight and obese endometrial cancer survivors. Methods Early stage endometrial cancer survivors were randomized to intervention (n = 23 or usual care (n = 22 groups. Chi-square, Student's t-test and repeated measures analysis of variance were used in intent-to-treat analyses. Outcomes were also examined according to weight loss. Results Morbidly obese patients had significantly lower self-efficacy, specifically when feeling physical discomfort. There was a significant improvement for self-efficacy related to social pressure (p = .03 and restraint (p = .02 in the LI group. There was a significant difference for emotional well-being quality of life (p = .02, self-efficacy related to negative emotions (p Conclusion This pilot lifestyle intervention had no effect on quality of life or depression but did improve self-efficacy and some eating behaviors. Trial Registration http://www.clinicaltrials.gov; NCT00420979
Pigeon, Wilfred R; Heffner, Kathi L; Crean, Hugh; Gallegos, Autumn M; Walsh, Patrick; Seehuus, Martin; Cerulli, Catherine
Sleep disturbance is a common feature of posttraumatic stress disorder (PTSD), but is not a focus of standard PTSD treatments. Psychological trauma exposure is associated with considerable physical and mental health morbidity, possibly due to the alterations in neuroendocrine function and inflammation observed in trauma exposed individuals. Although PTSD treatments are efficacious, they are associated with high drop-out rates in clinical trials and clinical practice. Finally, individuals with PTSD stemming from exposure to interpersonal violence represent an especially under-treated population with significant sleep disturbance. Community-based participatory research was utilized to design and prepare a clinical trial that randomizes recent survivors of interpersonal violence who have PTSD, depression, and insomnia to receive either: (1) Cognitive Behavioral Therapy for Insomnia (CBTi) followed by Cognitive Processing Therapy (CPT) for trauma, or (2) attention control followed by CPT. Outcome measures include subjective and objective measures of sleep, clinician-administered PTSD and depression scales, inflammatory cytokines, and salivary cortisol. Assessments are conducted at baseline, following the sleep or control intervention, and again following CPT. The design allows for: (1) the first test of a sleep intervention in this population; (2) the comparison of sequenced CBTi and CPT to attention control followed by CPT, and (3) assessing the roles of neuroendocrine function, inflammatory processes, and objective sleep markers in mediating treatment outcomes. The study's overarching hypothesis is that treating insomnia will produce reduction in insomnia, PTSD, and depression severity, allowing patients to more fully engage in, and derive optimal benefits from, cognitive processing therapy.
Cunningham, Michael R.; van Zyl, Michiel A.; Antle, Becky F.; Langley, Cheri N.
Objectives. To test the efficacy of Reducing the Risk (RTR) and Love Notes (LN) on reducing risky sexual behavior among youths yet to experience or cause a pregnancy. Methods. The four dependent variables were ever had sex, condom use, birth control use, and number of sexual partners at 3- and 6-month follow-up in a 3-arm cluster randomized controlled trial of 1448 impoverished youths, aged 14 to 19 years, in 23 community-based organizations in Louisville, Kentucky, from September 2011 through March 2014. Results. At 3 and 6 months, compared with the control condition, youths in RTR reported fewer sexual partners and greater use of birth control. At 6 months, LN participants reported greater use of birth control and condoms, fewer sexual partners, and were less likely to have ever had sex compared with the control condition. Conclusions. We provided additional evidence for the continued efficacy of RTR and the first rigorous study of LN, which embeds sex education into a larger curriculum on healthy relationships and violence prevention. PMID:27689500
Esther C Gallegos
Full Text Available OBJETIVO: Determinar la eficacia de una intervención conductual-educativa diseñada para disminuir las conductas sexuales de riesgo de VIH/SIDA y embarazos no planeados de adolescentes mexicanos. MATERIAL Y MÉTODOS: Ensayo controlado aleatorizado con cuatro seguimientos en un año; 832 adolescentes reclutados de escuelas preparatorias, entre 14 y 17 años, se asignaron aleatoriamente al grupo experimental o al control. La intervención, de seis hrs. de duración, aplicó estrategias de aprendizaje activo. El estudio se realizó en Monterrey, México, de 2002 a 2005. RESULTADOS: De acuerdo al análisis GEE, no hubo diferencia en las intenciones de tener relaciones sexuales, pero sí mayor nivel de intenciones de usar condón y anticonceptivos (diferencia de medias 0.15 y 0.16, IC 95% en el grupo experimental comparado con el control. Variables teoréticas como creencias sobre control fueron mediadoras de la intervención. CONCLUSIONES: La intervención conductual representa un importante esfuerzo en la promoción de conductas sexuales seguras en adolescentes mexicanos.OBJECTIVE: To test the efficacy of a behavioral intervention designed to decrease risk sexual behaviors for HIV/AIDS and unplanned pregnancies in Mexican adolescents. MATERIAL AND METHODS: Randomized controlled trial with four follow ups; 832 adolescents recruited from high schools, age 14-17, were randomly assigned to the experimental or control group. The six hour intervention used active learning strategies, and was delivered in two sessions on two consecutive Saturdays. The study was carried out in Monterrey, Mexico, 2002-2005. RESULTS: GEE analysis indicated no differences in sexual relationships’ intentions between the two conditions, however, the experimental group had higher intentions to use condoms and contraceptives (mean differences 0.15 and 0.16, CI 95% in the next three months, as compared with the control group. Theoretical variables, such as control beliefs, were
Steege, Mark W.; Mace, F. Charles; Perry, Lora; Longenecker, Harold
We discuss the problem of autism-specific special education programs representing themselves as Applied Behavior Analysis (ABA) programs when the only ABA intervention employed is Discrete Trial Teaching (DTT), and often for limited portions of the school day. Although DTT has many advantages to recommend its use, it is not well suited to teach…
Waring, Molly E; May, Christine N; Ding, Eric Y; Kunz, Werner H; Hayes, Rashelle; Oleski, Jessica L
Patients are increasingly using online social networks (ie, social media) to connect with other patients and health care professionals—a trend called peer-to-peer health care. Because online social networks provide a means for health care professionals to communicate with patients, and for patients to communicate with each other, an opportunity exists to use social media as a modality to deliver behavioral interventions. Social media-delivered behavioral interventions have the potential to reduce the expense of behavioral interventions by eliminating visits, as well as increase our access to patients by becoming embedded in their social media feeds. Trials of online social network-delivered behavioral interventions have shown promise, but much is unknown about intervention development and methodology. In this paper, we discuss the process by which investigators can translate behavioral interventions for social media delivery. We present a model that describes the steps and decision points in this process, including the necessary training and reporting requirements. We also discuss issues pertinent to social media-delivered interventions, including cost, scalability, and privacy. Finally, we identify areas of research that are needed to optimize this emerging behavioral intervention modality. PMID:26825969
Pagoto, Sherry; Waring, Molly E; May, Christine N; Ding, Eric Y; Kunz, Werner H; Hayes, Rashelle; Oleski, Jessica L
Patients are increasingly using online social networks (ie, social media) to connect with other patients and health care professionals--a trend called peer-to-peer health care. Because online social networks provide a means for health care professionals to communicate with patients, and for patients to communicate with each other, an opportunity exists to use social media as a modality to deliver behavioral interventions. Social media-delivered behavioral interventions have the potential to reduce the expense of behavioral interventions by eliminating visits, as well as increase our access to patients by becoming embedded in their social media feeds. Trials of online social network-delivered behavioral interventions have shown promise, but much is unknown about intervention development and methodology. In this paper, we discuss the process by which investigators can translate behavioral interventions for social media delivery. We present a model that describes the steps and decision points in this process, including the necessary training and reporting requirements. We also discuss issues pertinent to social media-delivered interventions, including cost, scalability, and privacy. Finally, we identify areas of research that are needed to optimize this emerging behavioral intervention modality.
Pagoto, Sherry; Waring, Molly E; May, Christine N; Ding, Eric Y; Kunz, Werner H; Hayes, Rashelle; Oleski, Jessica L
Patients are increasingly using online social networks (ie, social media) to connect with other patients and health care professionals--a trend called peer-to-peer health care. Because online social networks provide a means for health care professionals to communicate with patients, and for patients to communicate with each other, an opportunity exists to use social media as a modality to deliver behavioral interventions. Social media-delivered behavioral interventions have the potential to reduce the expense of behavioral interventions by eliminating visits, as well as increase our access to patients by becoming embedded in their social media feeds. Trials of online social network-delivered behavioral interventions have shown promise, but much is unknown about intervention development and methodology. In this paper, we discuss the process by which investigators can translate behavioral interventions for social media delivery. We present a model that describes the steps and decision points in this process, including the necessary training and reporting requirements. We also discuss issues pertinent to social media-delivered interventions, including cost, scalability, and privacy. Finally, we identify areas of research that are needed to optimize this emerging behavioral intervention modality. PMID:26825969
Thurman, T R; Kidman, R; Carton, T W; Chiroro, P
Evidence-based approaches are needed to address the high levels of sexual risk behavior and associated HIV infection among orphaned and vulnerable adolescents. This study recruited adolescents from a support program for HIV-affected families and randomly assigned them by cluster to receive one of the following: (1) a structured group-based behavioral health intervention; (2) interpersonal psychotherapy group sessions; (3) both interventions; or (4) no new interventions. With 95% retention, 1014 adolescents were interviewed three times over a 22-month period. Intent-to-treat analyses, applying multivariate difference-in-difference probit regressions, were performed separately for boys and girls to assess intervention impacts on sexual risk behaviors. Exposure to a single intervention did not impact behaviors. Exposure to both interventions was associated with risk-reduction behaviors, but the outcomes varied by gender: boys reported fewer risky sexual partnerships (β = -.48, p = .05) and girls reported more consistent condom (β = 1.37, p = .02). There was no difference in the likelihood of sexual debut for either gender. Providing both psychological and behavioral interventions resulted in long-term changes in sexual behavior that were not present when either intervention was provided in isolation. Multifaceted approaches for reducing sexual risk behaviors among vulnerable adolescents hold significant promise for mitigating the HIV epidemic among this priority population. PMID:26886261
Knowler, William C.; Bahnson, Judy L.; Bantle, John P.; Bertoni, Alain G.; Bray, George A.; Chen, Haiying; Cheskin, Lawrence; Clark, Jeanne M.; Egan, Caitlin; Evans, Mary; Foreyt, John P.; Glasser, Stephen P.; Greenway, Frank L.; Gregg, Edward W.; Hazuda, Helen P.; Hill, James O.; Horton, Edward S.; Hubbard, Van S.; Jakicic, John M.; Jeffery, Robert W.; Johnson, Karen C.; Kahn, Steven E.; Kitabchi, Abbas E.; Korytkowski, Mary; Krakoff, Jonathan; Kure, Anne; Lewis, Cora E.; Maschak-Carey, Barbara J.; Michaels, Sara; Montez, Maria G.; Nathan, David M.; Nyenwe, Ebenezer; Patricio, Jennifer; Peters, Anne; Pi-Sunyer, Xavier; Pownall, Henry; Wadden, Thomas A.; Wagenknecht, Lynne E.; Williamson, David F.; Wing, Rena R.; Wyatt, Holly; Yanovski, Susan Z.
Background Long-term effects of behavioral weight loss interventions on diabetes complications are unknown. We assessed whether an intensive lifestyle intervention (ILI) affects the development of nephropathy in Look AHEAD, a multicenter randomized clinical trial in type 2 diabetes. Methods 5145 overweight or obese persons aged 45–76 years with type 2 diabetes were randomized to ILI designed to achieve and maintain weight loss through reduced caloric consumption and increased physical activity or to a diabetes support and education (DSE) group. Randomization to ILI or DSE, in a 1:1 ratio, was implemented in a central web-based data management system, stratified by clinical center, and blocked with random block sizes. Outcomes assessors and laboratory staff were masked to treatment. The interventions ended early because of lack of effect on the primary outcome of cardiovascular disease events. Albuminuria and estimated glomerular filtration rate were prespecified “other” outcomes and were assessed from baseline through 9.6 years (median) of follow-up until the interventions ended. They were combined post-hoc to define the main outcome for this report: very-high-risk chronic kidney disease (CKD) based on the 2013 Kidney Disease Improving Global Outcomes classification. Data were analyzed by intention to treat. The trial is registered as Clinicaltrials.gov NCT00017953. Findings The incidence rate of very-high-risk CKD was 31% lower in ILI than DSE with hazard rates of 0.90 cases/100 person-years in DSE and 0.63 in ILI (difference=0.27 cases/100 person-years, hazard ratio and 95% confidence interval: HR=0.69, 0.55 to 0.87). This effect was partly attributable to reductions in weight, HbA1c, and blood pressure. Interpretation Weight loss should be considered as an adjunct to medical therapies to prevent or delay progression of CKD in overweight or obese persons with type 2 diabetes. Primary Funding National Institute of Diabetes and Digestive and Kidney Diseases
Bradshaw, Catherine P.; Mitchell, Mary M.; Leaf, Philip J.
Schoolwide Positive Behavioral Interventions and Supports (SWPBIS) is a universal, schoolwide prevention strategy that is currently implemented in over 9,000 schools across the nation to reduce disruptive behavior problems through the application of behavioral, social learning, and organizational behavioral principles. SWPBIS aims to alter school…
Randomized controlled trials were launched in 1985 to test the effects of multiple vitamin and mineral interventions on total mortality and total and cause-specific cancer mortality in a rural Chinese population
Price, Joseph M.; Roesch, Scott; Walsh, Natalia E.; LANDSVERK, JOHN
Children in foster care are at risk for externalizing behavior problems, which can in turn increase the risk of changes in foster care placement. The KEEP (Keeping Foster Parents Trained and Supported) foster parent training intervention was designed to equip foster parents with strategies for managing externalizing behavior problems. The primary goals of this investigation were to (a) examine the effectiveness of the KEEP intervention in reducing child behavior problems, as delivered by a co...
O'Carroll Bantum, Erin; Albright, Cheryl L.; White, Kami K.; Berenberg, Jeffrey L.; Layi, Gabriela; Ritter, Phillip L; Laurent, Diana; Plant, Katy; Lorig, Kate
Background Given the substantial improvements in cancer screening and cancer treatment in the United States, millions of adult cancer survivors live for years following their initial cancer diagnosis and treatment. However, latent side effects can occur and some symptoms can be alleviated or managed effectively via changes in lifestyle behaviors. Objective The purpose of this study was to test the effectiveness of a six-week Web-based multiple health behavior change program for adult survivor...
Kahlert, Daniela; Unyi-Reicherz, Annelie; Stratton, Gareth;
and feasible to evaluate. PREMIT is part of an intervention trial, which aims to prevent the onset of type-2 diabetes in pre-diabetics in eight clinical centers across the world by guiding them in changing their physical activity and dietary behavior through a group counseling approach. METHODS: The program...... development took five progressive steps, in line with the Public Health Action Cycle: (1) Summing-up the intervention goal(s), target group and the setting, (2) uncovering the generative psychological mechanisms, (3) identifying behavior change techniques and tools, (4) preparing for evaluation and (5...
Mohammadzaheri, Fereshteh; Koegel, Lynn Kern; Rezaee, Mohammad; Rafiee, Seyed Majid
Accumulating studies are documenting specific motivational variables that, when combined into a naturalistic teaching paradigm, can positively influence the effectiveness of interventions for children with autism spectrum disorder (ASD). The purpose of this study was to compare two applied behavior analysis (ABA) intervention procedures, a…
Harvey, S. Marie; Kraft, Joan Marie; West, Stephen G.; Taylor, Aaron B.; Pappas-DeLuca, Katina A.; Beckman, Linda J.
This study examines an intervention for heterosexual couples to prevent human immunodeficiency virus/sexually transmitted infections. It also evaluates the effect of the intervention, which is based on current models of health behavior change, on intermediate outcomes (individual and relationship factors) and consistency of condom use. Eligible…
Downs, Julie S; Bruine de Bruin, Wändi; Fischhoff, Baruch; Murray, Pamela J
Although adolescents are at disproportionate risk for sexually transmitted infections, most sex education programs have shown little effect on sexual behavior. An interactive video intervention developed by our team has been identified as one of a few programs that have been documented to reduce sexually transmitted infections in this population. Building on behavioral decision research, we used a mental models approach to interview young women about their sexual decisions, finding, among other things, the strong role of perceived social norms. We based our intervention on these results, aiming to help young women identify and implement personally and socially acceptable decision strategies. A randomized controlled trial found that the video reduced risky sexual behavior and the acquisition of chlamydia infection. We recently revised the video to suit more diverse audiences, and upgraded it to modern standards of cinematography and interactivity. It is now in field trial. PMID:26149165
Sorensen, G; Emmons, K; Hunt, M K; Johnston, D
This paper examines the results of population-level interventions conducted in three settings: entire communities, worksites, and schools. Four major conclusions are discussed: (a) Directions for the next generation of community-based interventions include targeting multiple levels of influence; addressing social inequalities in disease risk; involving communities in program planning and implementation; incorporating approaches for "tailoring" interventions; and utilizing rigorous process evaluation. (b) In addition to randomized controlled trials, it is time to use the full range of research phases available, from hypothesis generation and methods development to dissemination research. (c) The public health research agenda may have contributed to observed secular trends by placing behavioral risk factors on the social and media agendas. (d) The magnitude of the results of community intervention trials must be judged according to their potential public health or population-level effects. Small changes at the individual level may result in large benefits at the population level. PMID:9611625
Joseph, Natalie Pierre; Bernstein, Judith; Pelton, Steve; Belizaire, Myrdell; Goff, Ginette; Horanieh, Nour; Freund, Karen M
Objective To evaluate the impact of a client-centered behavioral intervention (Brief Negotiated Interviewing) on mothers' human papillomavirus (HPV) vaccine knowledge and vaccination initiation for their adolescent daughters. Methods We randomized mothers to intervention (n = 100) and control (n = 100) groups, and followed them over 12 months. Electronic medical records were reviewed to determine vaccination status. The primary outcome was receipt of the first vaccine. The secondary outcome was HPV vaccine knowledge among mothers. Results Brief Negotiated Interviewing intervention mothers demonstrated increased knowledge about HPV (pre/post mean score of 5 to 10 out of a possible 11; P < .001) and significantly higher mean knowledge scores (10 vs 6, P < .001) than control mothers. However, initiation and completion rates of the vaccine were not significantly different between groups. Conclusions Increasing HPV vaccine knowledge did not translate into increased vaccine uptake or completion of vaccination series. Future intervention must explore vaccine reminders to increase HPV vaccination rates.
Joseph, Natalie Pierre; Bernstein, Judith; Pelton, Steve; Belizaire, Myrdell; Goff, Ginette; Horanieh, Nour; Freund, Karen M
Objective To evaluate the impact of a client-centered behavioral intervention (Brief Negotiated Interviewing) on mothers' human papillomavirus (HPV) vaccine knowledge and vaccination initiation for their adolescent daughters. Methods We randomized mothers to intervention (n = 100) and control (n = 100) groups, and followed them over 12 months. Electronic medical records were reviewed to determine vaccination status. The primary outcome was receipt of the first vaccine. The secondary outcome was HPV vaccine knowledge among mothers. Results Brief Negotiated Interviewing intervention mothers demonstrated increased knowledge about HPV (pre/post mean score of 5 to 10 out of a possible 11; P vaccine were not significantly different between groups. Conclusions Increasing HPV vaccine knowledge did not translate into increased vaccine uptake or completion of vaccination series. Future intervention must explore vaccine reminders to increase HPV vaccination rates. PMID:26968631
Full Text Available Purpose: This article informs readers about the theoretical and practical origins of the behaviorally informed interventions (BIPI, analyzes examples of the BIPI from different policy sectors and strategies they offer for policy and regulatory design, and discusses applications and implications of BIPI for public interventions Methodology: This paper is based on a review of literature, as well as an inspection of administrative practices in OECD countries. It encompasses a systematic analysis of scientific papers fromthe SCOPUS database and a query carried out at the library of George Washington University. Findings: The traditional approach to public policy research is based on rational choice theory. It offers limited support, because by assuming perfect rationality of policy decisions, it overlooks existence of systematic errors and biases of human decision-making. The authors argue that behaviorally informed public interventions (BIPI might contribute to improving the effectiveness of a number of public measures – regulation, projects, programs, and even entire policies. Practical implications: The behavioral approach allows decision-makers to better understand the decisions and behaviors of citizens, as well as to design more effective interventions with minimum effort by adapting the existing solutions to real decision mechanisms of citizens. Originality: By combining the concepts of traditional approach with the growing behavioral approach, the authors aim to propose a new theoretical framework (BIPI to be used as a tool for policy design, delivery and evaluation.
Diet, physical exercise and cognitive behavioral training as a combined workplace based intervention to reduce body weight and increase physical capacity in health care workers - a randomized controlled trial
Full Text Available Abstract Background Health care workers comprise a high-risk workgroup with respect to deterioration and early retirement. There is high prevalence of obesity and many of the workers are overweight. Together, these factors play a significant role in the health-related problems within this sector. The present study evaluates the effects of the first 3-months of a cluster randomized controlled lifestyle intervention among health care workers. The intervention addresses body weight, general health variables, physical capacity and musculoskeletal pain. Methods 98 female, overweight health care workers were cluster-randomized to an intervention group or a reference group. The intervention consisted of an individually dietary plan with an energy deficit of 1200 kcal/day (15 min/hour, strengthening exercises (15 min/hour and cognitive behavioral training (30 min/hour during working hours 1 hour/week. Leisure time aerobic fitness was planned for 2 hour/week. The reference group was offered monthly oral presentations. Body weight, BMI, body fat percentage (bioimpedance, waist circumference, blood pressure, musculoskeletal pain, maximal oxygen uptake (maximal bicycle test, and isometric maximal muscle strength of 3 body regions were measured before and after the intervention period. Results In an intention-to-treat analysis from pre to post tests, the intervention group significantly reduced body weight with 3.6 kg (p Conclusion The significantly reduced body weight, body fat, waist circumference and blood pressure as well as increased aerobic fitness in the intervention group show the great potential of workplace health promotion among this high-risk workgroup. Long-term effects of the intervention remain to be investigated. Trial registration ClinicalTrials.gov: NCT01015716
Dermen, Kurt H.; Thomas, Sherilyn N.
The present study tested the proposition that an intervention to reduce alcohol use among college students will also reduce their risky sexual behavior. In a randomized, controlled trial, 154 heavy-drinking, predominantly White, heterosexual college students at behavioral risk for infection with HIV and other STDs were assigned to receive no intervention or a two-session, in-person, motivational interviewing-based intervention focused on either: (a) reducing alcohol risk behavior, (b) reducin...
Full Text Available Abstract Background Total knee replacement (TKR is a common and effective surgical procedure to relieve advanced knee arthritis that persists despite comprehensive medical treatment. Although TKR has excellent technical outcomes, significant variation in patient-reported functional improvement post-TKR exists. Evidence suggests that consistent post-TKR exercise and physical activity is associated with functional gain, and that this relationship is influenced by emotional health. The increasing use of TKR in the aging US population makes it critical to find strategies that maximize functional outcomes. Methods/Design This randomized clinical trial (RCT will test the efficacy of a theory-based telephone-delivered Patient Self-Management Support intervention that seeks to enhance adherence to independent exercise and activity among post- TKR patients. The intervention consists of 12 sessions, which begin prior to surgery and continue for approximately 9 weeks post-TKR. The intervention condition will be compared to a usual care control condition using a randomized design and a probabilistic sample of men and women. Assessments are conducted at baseline, eight weeks, and six- and twelve- months. The project is being conducted at a large healthcare system in Massachusetts. The study was designed to provide greater than 80% power for detecting a difference of 4 points in physical function (SF36/Physical Component Score between conditions (standard deviation of 10 at six months with secondary outcomes collected at one year, assuming a loss to follow up rate of no more than 15%. Discussion As TKR use expands, it is important to develop methods to identify patients at risk for sub-optimal functional outcome and to effectively intervene with the goal of optimizing functional outcomes. If shown efficacious, this peri-TKR intervention has the potential to change the paradigm for successful post-TKR care. We hypothesize that Patient Self-Management Support
Go, Vivian F; Frangakis, Constantine; Le Minh, Nguyen; Latkin, Carl A; Ha, Tran Viet; Mo, Tran Thi; Sripaipan, Teerada; Davis, Wendy; Zelaya, Carla; Vu, Pham The; Chen, Yong; Celentano, David D; Quan, Vu Minh
Globally, 30% of new HIV infections outside sub-Saharan Africa involve injecting drug users (IDU) and in many countries, including Vietnam, HIV epidemics are concentrated among IDU. We conducted a randomized controlled trial in Thai Nguyen, Vietnam, to evaluate whether a peer oriented behavioral intervention could reduce injecting and sexual HIV risk behaviors among IDU and their network members. 419 HIV-negative index IDU aged 18 years or older and 516 injecting and sexual network members were enrolled. Each index participant was randomly assigned to receive a series of six small group peer educator-training sessions and three booster sessions in addition to HIV testing and counseling (HTC) (intervention; n = 210) or HTC only (control; n = 209). Follow-up, including HTC, was conducted at 3, 6, 9 and 12 months post-intervention. The proportion of unprotected sex dropped significantly from 49% to 27% (SE (difference) = 3%, p sex relative to control participants (Wald test = 10.8, df = 4, p = 0.03). This intervention effect is explained by trial participants assigned to the control arm who missed at least one standardized HTC session during follow-up and subsequently reported increased unprotected sex. The proportion of observed needle/syringe sharing dropped significantly between baseline and the 3-month visit (14% vs. 3%, SE (difference) = 2%, p < 0.01) and persisted until 12 months, but there was no difference across trial arms (Wald test = 3.74, df = 3, p = 0.44).
Bergh Ingunn H
Full Text Available Abstract Background There is limited knowledge as to whether obesity prevention interventions are able to produce change in the determinants hypothesized to precede change in energy balance-related behaviors in young people. The aim of this study was to evaluate the effect of a multi-component intervention on a wide range of theoretically informed determinants of physical activity (PA and sedentary behavior (SB. Moderation effects of gender, weight status and parental education level and whether the perceived intervention dose received influenced the effects were also explored. Methods The HEIA study was a 20-month school-based, randomized controlled trial to promote healthy weight development. In total, 1418 11-year-olds participated at baseline and post-intervention assessment. Enjoyment, self-efficacy, perceived social support from parents, teachers and friends related to PA, perceived parental regulation of TV-viewing and computer/game-use and perceived social inclusion at schools were examined by covariance analyses to assess overall effects and moderation by gender, weight status and parental education, mid-way and post-intervention. Covariance analyses were also used to examine the role of intervention dose received on change in the determinants. Results At mid-way enjoyment (p = .03, perceived social support from teachers (p = .003 and self-efficacy (p = .05 were higher in the intervention group. Weight status moderated the effect on self-efficacy, with a positive effect observed among the normal weight only. At post-intervention results were sustained for social support from teachers (p = .001, while a negative effect was found for self-efficacy (p = .02. Weight status moderated the effect on enjoyment, with reduced enjoyment observed among the overweight. Moderation effects for parental education level were detected for perceived social support from parents and teachers. Finally, positive effects on several
Gale, E A M; Bingley, P J; Emmett, C L;
BACKGROUND: Results of studies in animals and human beings suggest that type 1 diabetes is preventable. Nicotinamide prevents autoimmune diabetes in animal models, possibly through inhibition of the DNA repair enzyme poly-ADP-ribose polymerase and prevention of beta-cell NAD depletion. We aimed...... to assess whether high dose nicotinamide prevents or delays clinical onset of diabetes in people with a first-degree family history of type 1 diabetes. METHOD: We did a randomised double-blind placebo-controlled trial of nicotinamide in 552 relatives with confirmed islet cell antibody (ICA) levels of 20...... secretion. INTERPRETATION: Large-scale controlled trials of interventions designed to prevent the onset of type 1 diabetes are feasible, but nicotinamide was ineffective at the dose we used....
Ritz, Thomas; Meuret, Alicia E.; Trueba, Ana F.; Fritzsche, Anja; von Leupoldt, Andreas
Objective: This review examines the evidence for psychosocial influences in asthma and behavioral medicine approaches to its treatment. Method: We conducted a systematic review of the literature on psychosocial influences and the evidence for behavioral interventions in asthma with a focus on research in the past 10 years and clinical trials.…
Huisjes Anjoke JM
Full Text Available Abstract Background Around 80% of intrauterine growth restricted (IUGR infants are born at term. They have an increase in perinatal mortality and morbidity including behavioral problems, minor developmental delay and spastic cerebral palsy. Management is controversial, in particular the decision whether to induce labour or await spontaneous delivery with strict fetal and maternal surveillance. We propose a randomised trial to compare effectiveness, costs and maternal quality of life for induction of labour versus expectant management in women with a suspected IUGR fetus at term. Methods/design The proposed trial is a multi-centre randomised study in pregnant women who are suspected on clinical grounds of having an IUGR child at a gestational age between 36+0 and 41+0 weeks. After informed consent women will be randomly allocated to either induction of labour or expectant management with maternal and fetal monitoring. Randomisation will be web-based. The primary outcome measure will be a composite neonatal morbidity and mortality. Secondary outcomes will be severe maternal morbidity, maternal quality of life and costs. Moreover, we aim to assess neurodevelopmental and neurobehavioral outcome at two years as assessed by a postal enquiry (Child Behavioral Check List-CBCL and Ages and Stages Questionnaire-ASQ. Analysis will be by intention to treat. Quality of life analysis and a preference study will also be performed in the same study population. Health technology assessment with an economic analysis is part of this so called Digitat trial (Disproportionate Intrauterine Growth Intervention Trial At Term. The study aims to include 325 patients per arm. Discussion This trial will provide evidence for which strategy is superior in terms of neonatal and maternal morbidity and mortality, costs and maternal quality of life aspects. This will be the first randomised trial for IUGR at term. Trial registration Dutch Trial Register and ISRCTN
Rationale and Baseline Characteristics of PREVENT: A Second-Generation Intervention Trial in Subjects At-Risk (Prodromal) of Developing First-Episode Psychosis Evaluating Cognitive Behavior Therapy, Aripiprazole, and Placebo for the Prevention of Psychosis
Bechdolf, Andreas; Müller, Hendrik; Stützer, Hartmut; Wagner, Michael; Maier, Wolfgang; Lautenschlager, Marion; Heinz, Andreas; de Millas, Walter; Janssen, Birgit; Gaebel, Wolfgang; Michel, Tanja Maria; Schneider, Frank; Lambert, Martin; Naber, Dieter; Brüne, Martin; Krüger-Özgürdal, Seza; Wobrock, Thomas; Riedel, Michael; Klosterkötter, Joachim
Antipsychotics, cognitive behavioral therapy (CBT), and omega-3-fatty acids have been found superior to control conditions as regards prevention of psychosis in people at-risk of first-episode psychosis. However, no large-scale trial evaluating the differential efficacy of CBT and antipsychotics has been performed yet. In PREVENT, we evaluate CBT, aripiprazole, and clinical management (CM) as well as placebo and CM for the prevention of psychosis in a randomized, double-blind, placebo-controlled trial with regard to the antipsychotic intervention and a randomized controlled trial with regard to the CBT intervention with blinded ratings. The hypotheses are first that CBT and aripiprazole and CM are superior to placebo and CM and second that CBT is not inferior to aripiprazole and CM combined. The primary outcome is transition to psychosis. By November 2010, 156 patients were recruited into the trial. The subjects were substantially functionally compromised (Social and Occupational Functioning Assessment Scale mean score 52.5) and 78.3% presented with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition axis I comorbid diagnosis. Prior to randomization, 51.5% of the participants preferred to be randomized into the CBT arm, whereas only 12.9% preferred pharmacological treatment. First, assessments of audiotaped treatment sessions confirmed the application of CBT-specific skills in the CBT condition and the absence of those in CM. The overall quality rating of the CBT techniques applied in the CBT condition was good. When the final results of the trial are available, PREVENT will substantially expand the current limited evidence base for best clinical practice in people at-risk (prodromal) of first-episode psychosis. PMID:21860040
Vivian F Go
Full Text Available Injecting drug use is a primary driver of HIV epidemics in many countries. People who inject drugs (PWID and are HIV infected are often doubly stigmatized and many encounter difficulties reducing risk behaviors. Prevention interventions for HIV-infected PWID that provide enhanced support at the individual, family, and community level to facilitate risk-reduction are needed.455 HIV-infected PWID and 355 of their HIV negative injecting network members living in 32 sub-districts in Thai Nguyen Province were enrolled. We conducted a two-stage randomization: First, sub-districts were randomized to either a community video screening and house-to-house visits or standard of care educational pamphlets. Second, within each sub-district, participants were randomized to receive either enhanced individual level post-test counseling and group support sessions or standard of care HIV testing and counseling. This resulted in four arms: 1 standard of care; 2 community level intervention; 3 individual level intervention; and 4 community plus individual intervention. Follow-up was conducted at 6, 12, 18, and 24 months. Primary outcomes were self-reported HIV injecting and sexual risk behaviors. Secondary outcomes included HIV incidence among HIV negative network members.Fewer participants reported sharing injecting equipment and unprotected sex from baseline to 24 months in all arms (77% to 4% and 24% to 5% respectively. There were no significant differences at the 24-month visit among the 4 arms (Wald = 3.40 (3 df; p = 0.33; Wald = 6.73 (3 df; p = 0.08. There were a total of 4 HIV seroconversions over 24 months with no significant difference between intervention and control arms.Understanding the mechanisms through which all arms, particularly the control arm, demonstrated both low risk behaviors and low HIV incidence has important implications for policy and prevention programming.ClinicalTrials.gov NCT01689545.
Stice, Eric; Rohde, Paul; Seeley, John R.; Gau, Jeff M.
Objective: Evaluate a new 5-step method for testing mediators hypothesized to account for the effects of depression prevention programs. Method: In this indicated prevention trial, at-risk teens with elevated depressive symptoms were randomized to a group cognitive-behavioral (CB) intervention, group supportive expressive intervention, CB…
Yardley, Lucy; Miller, Sascha; Schlotz, Wolff; Little, Paul
Background Hand-washing is regarded as a potentially important behavior for preventing transmission of respiratory infection, particularly during a pandemic. Objective The objective of our study was to evaluate whether a Web-based intervention can encourage more frequent hand-washing in the home, and to examine potential mediators and moderators of outcomes, as a necessary first step before testing effects of the intervention on infection rates in the PRIMIT trial (PRimary care trial of a web...
Testing Brief Intervention and Phone Contact among Subjects with Suicidal Behavior: A Randomized Controlled Trial in French Polynesia in the Frames of the World Health Organization/Suicide Trends in At-Risk Territories Study.
Amadéo, Stéphane; Rereao, Moerani; Malogne, Aurelia; Favro, Patrick; Nguyen, Ngoc Lam; Jehel, Louis; Milner, Allison; Kolves, Kairi; De Leo, Diego
The World Health Organization Suicide trends in at-risk territories study is a multi-site regional research program operating first in French Polynesia and countries of the Western Pacific, then extended to the world. The aims of the study were to establish a monitoring system for suicidal behaviors and to conduct a randomised control trial intervention for non-fatal suicidal behaviors. The latter part is the purpose of the present article. Over the period 2008-2010, 515 patients were admitted at the Emergency Department of the Centre Hospitalier de Polynésie Française for suicidal behavior. Those then hospitalized in the Psychiatry Emergency Unit were asked to be involved in the study and randomly allocated to either Treatment As Usual (TAU) or TAU plus Brief Intervention and Contact (BIC), which provides a psycho-education session and a follow-up of 9 phone contacts over an 18-months period. One hundred persons were assigned to TAU, while 100 participants were allocated to the BIC group. At the end of the follow-up there were no significant differences between the two groups in terms of number of presentations to the hospital for repeated suicidal behaviors. Although the study could not demonstrate the superiority of a treatment over the other, nevertheless - given its importance - the investigation captured public attention and was able to contribute to the awareness of the need of suicide prevention in French Polynesia. The BIC model of intervention seemed to particularly suit the geographical and health care context of the country. PMID:26605034
Testing brief intervention and phone contact among subjects with suicidal behavior: a randomized controlled trial in French Polynesia in the frames of the World Health Organization/Suicide Trends in At-Risk Territories study
Full Text Available The World Health Organization Suicide trends in at-risk territories study is a multi-site regional research program operating first in French Polynesia and countries of the Western Pacific, then extended to the world. The aims of the study were to establish a monitoring system for suicidal behaviors and to conduct a randomised control trial intervention for non-fatal suicidal behaviors. The latter part is the purpose of the present article. Over the period 2008-2010, 515 patients were admitted at the Emergency Department of the Centre Hospitalier de Polynésie Française for suicidal behavior. Those then hospitalized in the Psychiatry Emergency Unit were asked to be involved in the study and randomly allocated to either Treatment As Usual (TAU or TAU plus Brief Intervention and Contact (BIC, which provides a psycho-education session and a follow-up of 9 phone contacts over an 18-months period. One hundred persons were assigned to TAU, while 100 participants were allocated to the BIC group. At the end of the follow-up there were no significant differences between the two groups in terms of number of presentations to the hospital for repeated suicidal behaviors. Although the study could not demonstrate the superiority of a treatment over the other, nevertheless – given its importance – the investigation captured public attention and was able to contribute to the awareness of the need of suicide prevention in French Polynesia. The BIC model of intervention seemed to particularly suit the geographical and health care context of the country.
Tyson, M.; Covey, J.; Rosenthal, H. E. S.
Objective: The meta-analysis reported here examined interventions informed by the theory of planned behavior (TPB) or theory of reasoned action (TRA) aimed at reducing heterosexual risk behaviors (prevention of STDs and unwanted pregnancy). Methods: Studies were eligible for inclusion if they were either randomized control trials or quasi-experimental studies that compared the TPB-based intervention against a control group. Search strategy consisted of articles identified in previous reviews,...
Garbutt Jane M
Full Text Available Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes the protocol for a randomized controlled trial (RCT to evaluate a 12-month telephone-coaching program designed to support primary care management of children with persistent asthma and subsequently to improve asthma control and disease-related quality of life and reduce urgent care events for asthma care. Randomization occurred at the practice level with eligible families within a practice having access to the coaching program or to usual care. The coaching intervention was based on the transtheoretical model of behavior change. Targeted behaviors included 1 effective use of controller medications, 2 effective use of rescue medications and 3 monitoring to ensure optimal control. Trained lay coaches provided parents with education and support for asthma care, tailoring the information provided and frequency of contact to the parent's readiness to change their child's day-to-day asthma management. Coaching calls varied in frequency from weekly to monthly. For each participating family, follow-up measurements were obtained at 12- and 24-months after enrollment in the study during a telephone interview. The primary outcomes were the mean change in 1 the child's asthma control score, 2 the parent's quality of life score, and 3 the number of urgent care events assessed at 12 and 24 months. Secondary outcomes reflected adherence to guideline recommendations by the primary care pediatricians and included the proportion of children prescribed controller medications
Freuler, Ashley C.; Baranek, Grace T.; Tashjian, Christene; Watson, Linda R.; Crais, Elizabeth R.; Turner-Brown, Lauren M.
Background: Despite the mounting evidence of efficacy of early intervention for children with autism spectrum disorders, there is little research that considers the various perceptions and resources with which parents respond to the pressures and opportunities associated with participation in early intervention. Research is particularly lacking…
Full Text Available Abstract Background The registration of clinical trials has been promoted to prevent publication bias and increase research transparency. Despite general agreement about the minimum amount of information needed for trial registration, we lack clear guidance on descriptions of non-pharmacologic interventions in trial registries. We aimed to evaluate the quality of registry descriptions of non-pharmacologic interventions assessed in ongoing randomized controlled trials (RCTs of patient education. Methods On 6 May 2009, we searched for all ongoing RCTs registered in the 10 trial registries accessible through the World Health Organization International Clinical Trials Registry Platform. We included trials evaluating an educational intervention (that is, designed to teach or train patients about their own health and dedicated to participants, their family members or home caregivers. We used a standardized data extraction form to collect data related to the description of the experimental intervention, the centers, and the caregivers. Results We selected 268 of 642 potentially eligible studies and appraised a random sample of 150 records. All selected trials were registered in 4 registers, mainly ClinicalTrials.gov (61%. The median [interquartile range] target sample size was 205 [100 to 400] patients. The comparator was mainly usual care (47% or active treatment (47%. A minority of records (17%, 95% CI 11 to 23% reported an overall adequate description of the intervention (that is, description that reported the content, mode of delivery, number, frequency, duration of sessions and overall duration of the intervention. Further, for most reports (59%, important information about the content of the intervention was missing. The description of the mode of delivery of the intervention was reported for 52% of studies, the number of sessions for 74%, the frequency of sessions for 58%, the duration of each session for 45% and the overall duration for 63
Cancer-related fatigue and rehabilitation: A randomized controlled multicenter trial comparing physical training combined with cognitive-behavioral therapy with physical training only and with no intervention
E. van Weert (Ellen); A.M. May (Anne); I. Korstjens (Irene); W.J. Post (Wendy); C.P. van der Schans (Cees); B. van den Borne (Bart); I. Mesters (Ilse); W.J.G. Ros (Wynand); J.E.H.M. Hoekstra-Weebers (Josette)
textabstractBackground. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancerrelated fatigue of physical training combined w
Cancer-Related Fatigue and Rehabilitation : A Randomized Controlled Multicenter Trial Comparing Physical Training Combined With Cognitive-Behavioral Therapy With Physical Training Only and With No Intervention
van Weert, E.; May, A.M.; Korstjens, I.; Post, W.J.; van der Schans, C.P.; van den Borne, B.; Mesters, I.; Ros, W.J.G.; Hoekstra-Weebers, J.E.H.M.
Background. Research suggests that cancer rehabilitation reduces fatigue in survivors of cancer. To date, it is unclear what type of rehabilitation is most beneficial. Objective. This randomized controlled trial compared the effect on cancer-related fatigue of physical training combined with cogniti
Dopp, C.M.E.; Graff, M.J.L.; Teerenstra, S.; Sanden, M.W.; Olde Rikkert, M.G.M.; Vernooij-Dassen, M.J.F.J.
BACKGROUND: To evaluate the effectiveness of a multifaceted implementation strategy on physicians' referral rate to and knowledge on the community occupational therapy in dementia program (COTiD program). METHODS: A cluster randomized controlled trial with 28 experimental and 17 control clusters was
Naidoo, Saloshni; Satorius, Benn K.; de Vries, Hein; Taylor, Myra
Background: Bullying behavior in schools can lead to psychosocial problems. School-based interventions are important in raising student awareness, developing their skills and in planning to reduce bullying behavior. Methods: A randomized controlled trial, using a school-based educational intervention to reduce verbal bullying, was conducted among…
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.
Habibović, Mirela; Burg, Matthew M; Pedersen, Susanne S.
The implantable cardioverter defibrillator (ICD) is the first-line treatment for primary and secondary prevention of sudden cardiac death. A subgroup of patients experience psychological distress postimplant, and no clear evidence base exists regarding how best to address patients' needs. The aim...... of this critical review is to provide an overview of behavioral interventions in ICD patients to date, and to delineate directions for future research using lessons learned from the ongoing RISTA and WEBCARE trials....
Le, Huynh-Nhu; Perry, Deborah F.; Stuart, Elizabeth A.
Objective: A randomized controlled trial was conducted to evaluate the efficacy of a cognitive-behavioral (CBT) intervention to prevent perinatal depression in high-risk Latinas. Method: A sample of 217 participants, predominantly low-income Central American immigrants who met demographic and depression risk criteria, were randomized into usual…
HIV Prevention Counseling Intervention Delivered During Routine Clinical Care Reduces HIV Risk Behavior in HIV-Infected South Africans Receiving Antiretroviral Therapy: The Izindlela Zokuphila/Options for Health Randomized Trial
Fisher, Jeffrey D.; Cornman, Deborah H.; Shuper, Paul A.; Christie, Sarah; Pillay, Sandy; Macdonald, Susan; Ngcobo, Ntombenhle; Amico, K. Rivet; Lalloo, Umesh; Friedland, Gerald; Fisher, William A.
Context Sustainable interventions are needed to minimize HIV risk behavior among people living with HIV (PLWH) in South Africa on antiretroviral therapy (ART), a significant proportion of whom do not achieve viral suppression. Objective To determine whether a brief lay counselor delivered intervention implemented during routine care can reduce risky sex among PLWH on ART. Design Cluster randomized 16 HIV clinical care sites in KwaZulu Natal, South Africa, to intervention or standard-of-care. Setting Publicly funded HIV clinical care sites. Patients 1891 PLWH on ART received the HIV prevention counseling intervention (n = 967) or standard-of-care counseling (n = 924). Intervention Lay counselors delivered a brief intervention using motivational interviewing strategies based on the Information—Motivation—Behavioral Skills (IMB) model during routine clinical care. Main Outcome Measures Number of sexual events without a condom in the past four weeks with partners of any HIV status, and with partners perceived to be HIV-negative or HIV-status unknown, assessed at baseline, 6, 12, and 18 months. Results Intervention participants reported significantly greater reductions in HIV risk behavior on both primary outcomes, compared to standard-of-care participants. Differences in STI incidence between arms were not observed. Conclusion Effective behavioral interventions, delivered by lay counselors within the clinical care setting, are consistent with the strategy of linking HIV care and HIV prevention and integrating biomedical and behavioral approaches to stemming the HIV epidemic. PMID:25230288
Sharma, Mahendra P; Andrade, Chittaranjan
Insomnia is a general clinical term that refers to a difficulty in initiating or maintaining sleep. Insomnia is widely prevalent in the general population, especially in the elderly and in those with medical and psychiatric disorders. Hypnotic drug treatments of insomnia are effective but are associated with potential disadvantages. This article presents an overview of behavioral interventions for insomnia. Behavioral interventions for insomnia include relaxation training, stimulus control th...
Fjeldsoe Brianna S
Full Text Available Abstract Background With an increasing research focus on multiple health behaviour change interventions, a methodological issue requiring further investigation is whether or not to employ pre-trial behavioural screening to exclude participants who are achieving a pre-specified level of one or more behaviours. Behavioural screening can be used to direct limited resources to participants most in need of a behaviour change intervention; but may reduce the representativeness of the sample and limit comparability with trials that do not employ pre-trial behavioural screening. Furthermore, the impact of this type of screening on intervention participation and intervention effects is unknown. Methods Data for this study come from the Logan Healthy Living Program, a randomised, controlled telephone counselling lifestyle intervention trial which did not employ behavioural screening prior to randomisation. Screening for physical activity, diet or the combination was simulated using baseline trial data. To examine the impact of behavioural screening on intervention participation (in terms of participant characteristics, intervention dose received and retention, characteristics of participants included an excluded under the various screening scenarios were compared. To examine the impact of behavioural screening on intervention effects, results from the main trial analysis were compared with results obtained from the same analyses performed separately for each of the screened groups. Results Simulated pre-trial behavioural screening impacted minimally on intervention dose received and trial retention rate. Beyond the anticipated effect of reducing baseline levels of the behaviours being screened for, behavioural screening affected baseline levels of behaviours not targeted by screening, and participants' demographic and health-related characteristics. Behavioural screening impacted on intervention effects in ways that were anticipated and positive, but also
Dekker, K.; Benjamins, J.S; Straten, van, FE; Hofman, W.F.; Someren, van, E.J.W.
BACKGROUND: DSM-V criteria for insomnia disorder are met by 6 to 10 % of the adult population. Insomnia has severe consequences for health and society. One of the most common treatments provided by primary caregivers is pharmacological treatment, which is far from optimal and has not been recommended since a 2005 consensus report of the National Institutes of Health. The recommended treatment is Cognitive Behavioral Therapy for Insomnia. Effectiveness, however, is still limited. Only a few st...
Crichton Georgina E
Full Text Available Abstract Background There are many challenges involved in running randomised controlled dietary intervention trials that investigate health outcomes. The aim of this paper was to evaluate the recruitment process, retention of participants and challenges faced in our dairy intervention trial, and to provide strategies to combat the difficulties of running long-term dietary intervention trials. Methods A 12-month, randomised, two-way crossover study was conducted in overweight adults with habitually low dairy food consumption to assess the effects of a high dairy intake (4 servings of reduced-fat dairy per day compared with a low dairy intake (1 serving of reduced-fat dairy per day on measures of cardiometabolic and cognitive health. On completion of the high dairy intake phase, each participant was interviewed about their experience in the trial and responses were used to evaluate the key issues for study participants. Results Although the recruitment target was achieved, high rates of attrition (49.3% and difficulties maintaining participant compliance (reported by 37.8% of participants were major threats to the viability of the study. Factors that contributed to the high attrition included inability to comply with the dietary requirements of the study protocol (27.0%, health problems or medication changes (24.3% and time commitment (10.8%. Conclusion Attrition and adherence to study requirements present challenges to trials requiring longer-term dietary change. Including a run-in period to further assess the motivation, commitment and availability of participants, maintaining regular contact with participants during control phases, minimising time commitment, providing flexibility with dietary requirements, facilitating positive experiences, and stringent monitoring of diet are some key recommendations for future dietary intervention trials. Trial registration Australia and New Zealand Clinical Trials Registry (ACTRN 12608000538347
Venditti, EM; Elliot, DL; Faith, MS; Firrell, LS; Giles, CM; Goldberg, L.; Marcus, MD; Schneider, M; Solomon, S.; Thompson, D.; Yin, Z.
HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physical education, behavior change and communications and promotion. The conceptual rationale as well as the design and development of the behavior intervention component are described. Pilot study data...
Grant, Sean; Montgomery, Paul; Hopewell, Sally; Macdonald, Geraldine; Moher, David; Mayo-Wilson, Evan
Social and psychological interventions are often complex. Understanding randomized controlled trials (RCTs) of these complex interventions requires a detailed description of the interventions tested and the methods used to evaluate them; however, RCT reports often omit, or inadequately report, this information. Incomplete and inaccurate reporting hinders the optimal use of research, wastes resources, and fails to meet ethical obligations to research participants and consumers. In this article, we explain how reporting guidelines have improved the quality of reports in medicine and describe the ongoing development of a new reporting guideline for RCTs: Consolidated Standards of Reporting Trials-SPI (an extension for social and psychological interventions). We invite readers to participate in the project by visiting our website, in order to help us reach the best-informed consensus on these guidelines (http://tinyurl.com/CONSORT-study).
Marston, John R.
The Individuals with Disabilities Education Act (IDEA) Amendments of 1997 mandated a shift from reactive strategies toward proactive interventions with students who experience both disability and behavioral challenges. The author describes how the methodology of Life Space Crisis Intervention can provide a source of data for functional assessment…
Dawson, Geraldine; Rogers, Sally; Munson, Jeffrey; Smith, Milani; Winter, Jamie; Greenson, Jessica; Donaldson, Amy; Varley, Jennifer
OBJECTIVE To conduct a randomized, controlled trial to evaluate the efficacy of the Early Start Denver Model (ESDM), a comprehensive developmental behavioral intervention, for improving outcomes of toddlers diagnosed with autism spectrum disorder (ASD). METHODS Forty-eight children diagnosed with ASD between 18 and 30 months of age were randomly assigned to 1 of 2 groups: (1) ESDM intervention, which is based on developmental and applied behavioral analytic principles and delivered by trained therapists and parents for 2 years; or (2) referral to community providers for intervention commonly available in the community. RESULTS Compared with children who received community-intervention, children who received ESDM showed significant improvements in IQ, adaptive behavior, and autism diagnosis. Two years after entering intervention, the ESDM group on average improved 17.6 standard score points (1 SD:15 points) compared with 7.0 points in the comparison group relative to baseline scores. The ESDM group maintained its rate of grow thin adaptive behavior compared with a normative sample of typically developing children. In contrast, over the 2-year span, the comparison group showed greater delays in adaptive behavior. Children who received ESDM also were more likely to experience a change in diagnosis from autism to pervasive developmental disorder, not otherwise specified, than the comparison group. CONCLUSIONS This is the first randomized, controlled trial to demonstrate the efficacy of a comprehensive developmental behavioral intervention for toddlers with ASD for improving cognitive and adaptive behavior and reducing severity of ASD diagnosis. Results of this study underscore the importance of early detection of and intervention in autism. PMID:19948568
EMMELKAMP, PMG; VANOPPEN, P
In this report an overview is given of the contribution of cognitive approaches to behavioral medicine. The (possible) contribution of cognitive therapy is reviewed in the area of coronary heart disease, obesity, bulimia nervosa, chronic pain, benign headache, cancer, acquired immunodeficiency syndr
Kalichman, Seth C.; Rompa, David; Cage, Marjorie
Results of a randomized controlled trial show that a behavioral intervention grounded in social cognitive theory reduces unprotected sexual behaviors among men and women living with HIV infection, with the greatest reductions in HIV transmission risk behaviors occurring with non-HIV-positive sex partners. In this article, the authors describe the…
Fricke, Nicola; Griesche, Stefan; Schieben, Anna; Hesse, Tobias; Baumann, Martin
The study investigated driver behavior toward an automatic steering intervention of a collision mitigation system. Forty participants were tested in a driving simulator and confronted with an inevitable collision. They performed a naïve drive and afterwards a repeated exposure in which they were told to hold the steering wheel loosely. In a third drive they experienced a false alarm situation. Data on driving behavior, i.e. steering and braking behavior as well as subjective data was assessed in the scenarios. Results showed that most participants held on to the steering wheel strongly or counter-steered during the system intervention during the first encounter. Moreover, subjective data collected after the first drive showed that the majority of drivers was not aware of the system intervention. Data from the repeated drive in which participants were instructed to hold the steering wheel loosely, led to significantly more participants holding the steering wheel loosely and thus complying with the instruction. This study seems to imply that without knowledge and information of the system about an upcoming intervention, the most prevalent driving behavior is a strong reaction with the steering wheel similar to an automatic steering reflex which decreases the system's effectiveness. Results of the second drive show some potential for countermeasures, such as informing drivers shortly before a system intervention in order to prevent inhibiting reactions. PMID:26310799
Volkova, Ekaterina; Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona
Background There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. Objective The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled...
Fleming, Padraic; Mooney, Therese; Wilson, Linda; Fitzpatrick, Patricia
BreastCheck, the National Breast Screening Programme in the Republic of Ireland, invites women aged between 50 and 64 years biennially. A pilot intervention trial of invitation for screening of women not attending the previous appointment [previous nonattender (PNA)] was carried out that aimed at maximizing the efficiency of resources in terms of radiographer workload and scheduled appointment slots. The trial was conducted during screening round 5 at two of the regional units. The intervention arm implemented an alternative process for inviting PNA women, in which they were sent a letter inviting them to phone their screening unit to make an appointment at a convenient date/time. The control arm continued usual practice - that is, all PNA women were sent a single invitation letter with a scheduled appointment slot at a predetermined date/time. In the intervention arm, fewer PNAs took up their appointments (15.5%) compared with the control arm (18.3%; P<0.001). Uptake among PNAs fell in both arms between screening rounds 4 and 5 (intervention arm: 22.0% OSR 4, 15.5% OSR 5; control arm: 21.4% OSR 4, 18.3% OSR 5). There was a significant increase in mobile unit screening days saved because of the intervention and a significant improvement in the percentage of women reinvited for screening within 27 months in the intervention arm (85.5%). PNA recall and cancer detection rates were significantly higher compared with the general screened population. This trial showed an improvement in the efficiency of resource use. However, there was a higher cancer detection rate in PNA women. This trial provides important evidence for invitation policy for screening. PMID:26642321
Kelly, J A; St Lawrence, J S; Hood, H V; Brasfield, T L
Behavior change can curtail the spread of acquired immune deficiency syndrome (AIDS). In this study, 104 gay men with a history of frequent AIDS high-risk behavior completed self-report, self-monitoring, and behavioral measures related to AIDS risk. The sample was randomly divided into experimental and waiting-list control groups. The experimental intervention provided AIDS risk education, cognitive-behavioral self-management training, sexual assertion training, and attention to the development of steady and self-affirming social supports. Experimental group participants greatly reduced their frequency of high-risk sexual practices and increased behavioral skills for refusing sexual coercions, AIDS risk knowledge, and adoption of "safer sex" practices. Change was maintained at the 8-month follow-up. PMID:2925974
Hops, Hyman; Ozechowski, Timothy J.; Waldron, Holly B.; Davis, Betsy; Turner, Charles W.; Brody, Janet L.; Barrera, Manuel
Adolescents who abuse substances are more likely to engage in health-risking sexual behavior (HRSB) and are at particularly high risk for HIV/AIDS. Thus, substance abuse treatment presents a prime opportunity to target HIV-risk behaviors. The present study evaluated a one-session HIV-risk intervention embedded in a controlled clinical trial for drug-abusing adolescents. The trial was conducted in New Mexico and Oregon with Hispanic and Anglo adolescents. Youths were randomly assigned to indiv...
Delfino, Matthew; Larzelere, Michele McCarthy
Family physicians play an important role in identifying and treating the behavioral etiologies of morbidity and mortality. Changing behavior is a challenging process that begins with identifying a patient's readiness to change. Interventions, such as motivational interviewing, are used to increase a patient's desire to change, and cognitive behavioral therapy can be initiated to increase a patient's likelihood of change, particularly if barriers are identified. After patients embark on change, family physicians are uniquely positioned to connect them to self-help programs, more intensive psychotherapy, and newer technology-based support programs, and to provide repeated, brief, positive reinforcement. Specific behavioral interventions that can be effective include computerized smoking cessation programs; electronic reminders and support delivered by family physicians or other clinicians for weight loss; linkage to community-based programs for seniors; increased length and demands of in-school programs to support exercise participation by children; and access reduction education to prevent firearm injury. PMID:24628011
Najdowski, Adel C.; Chilingaryan, Vardui; Bergstrom, Ryan; Granpeesheh, Doreen; Balasanyan, Susie; Aguilar, Barbara; Tarbox, Jonathan
Cummings and Carr (2009) compared two methods of data collection in a behavioral intervention program for children with pervasive developmental disorders: collecting data on all trials versus only the first trial in a session. Results showed that basing a child's progress on first-trial data resulted in identifying mastery-level responding…
Crawford, Mike J; Barnicot, Kirsten; Patterson, Sue; Gold, Christian
Not all interventions that show promise in exploratory trials will be supported in phase III studies. But the high failure rate in recent trials of complex mental health interventions is a concern. Proper consideration of trial processes and greater use of adaptive trial designs could ensure better use of available resources. PMID:27369475
Olson, Christine M
e- and m-Health communication technologies are now common approaches to improving population health. The efficacy of behavioral nutrition interventions using e-health technologies to decrease fat intake and increase fruit and vegetable intake was demonstrated in studies conducted from 2005 to 2009, with approximately 75% of trials showing positive effects. By 2010, an increasing number of behavioral nutrition interventions were focusing on body weight. The early emphasis on interventions that were highly computer tailored shifted to personalized electronic interventions that included weight and behavioral self-monitoring as key features. More diverse target audiences began to participate, and mobile components were added to interventions. Little progress has been made on using objective measures rather than self-reported measures of dietary behavior. A challenge for nutritionists is to link with the private sector in the design, use, and evaluation of the many electronic devices that are now available in the marketplace for nutrition monitoring and behavioral change. PMID:27022772
Narme, Pauline; Clément, Sylvain; Ehrlé, Nathalie; Schiaratura, Loris; Vachez, Sylvie; Courtaigne, Bruno; Munsch, Frédéric; Samson, Séverine
Although musical interventions have recently gained popularity as a non-pharmacological treatment in dementia, there is still insufficient evidence of their effectiveness. To investigate this issue, a single-center randomized controlled trial was conducted with forty-eight patients with Alzheimer's disease or mixed dementia to compare the effects of music versus cooking interventions in the emotional, cognitive, and behavioral domain, as well as on professional caregiver distress. Each intervention lasted four weeks (two one-hour sessions a week). Multi-component evaluations (with blind assessors) were conducted before, during, and after the interventions to assess their short and long-term effects (up to four weeks post interventions). Analyses revealed that both music and cooking interventions led to positive changes in the patients' emotional state and decreased the severity of their behavioral disorders, as well as reduced caregiver distress. However, no benefit on the cognitive status of the patients was seen. While results did not demonstrate a specific benefit of music on any of the considered measures, the present study suggests the efficacy of two pleasant non-pharmacological treatments in patients with moderate to severe dementia. Our findings highlight the potential of such interventions in improving the well-being of patients living in residential care, as well as reducing caregiver distress. PMID:23969994
The National Institute of Mental Health Multisite HIV Prevention Trial was a trial of an intervention to reduce sexual HIV risk behaviors among 3,706 low-income at-risk men and women at 7 U.S. research sites. The intervention, based on social-cognitive theory and designed to influence behavior change by improving expected outcomes of condom use and increasing knowledge, skills, and self-efficacy to execute safer sex behaviors, was effective relative to a control condition in reducing sexual risk behavior. At 3 months after completion of the intervention, measures of these potential mediators were higher in the intervention than in the control condition. Although the effect of the intervention on sexual risk behavior was significantly reduced when the variables were controlled statistically, supporting the hypothesis of their mediation of the intervention effect, most of the effect remained unexplained, indicating the influence of unmeasured factors on outcome.
Full Text Available Abstract Background Lifestyle risk factors, in particular smoking, nutrition, alcohol consumption and physical inactivity (SNAP are the main behavioural risk factors for chronic disease. Primary health care (PHC has been shown to be an effective setting to address lifestyle risk factors at the individual level. However much of the focus of research to date has been in general practice. Relatively little attention has been paid to the role of nurses working in the PHC setting. Community health nurses are well placed to provide lifestyle intervention as they often see clients in their own homes over an extended period of time, providing the opportunity to offer intervention and enhance motivation through repeated contacts. The overall aim of this study is to evaluate the impact of a brief lifestyle intervention delivered by community nurses in routine practice on changes in clients' SNAP risk factors. Methods/Design The trial uses a quasi-experimental design involving four generalist community nursing services in NSW Australia. Services have been randomly allocated to an 'early intervention' group or 'late intervention' (comparison group. 'Early intervention' sites are provided with training and support for nurses in identifying and offering brief lifestyle intervention for clients during routine consultations. 'Late intervention site' provide usual care and will be offered the study intervention following the final data collection point. A total of 720 generalist community nursing clients will be recruited at the time of referral from participating sites. Data collection consists of 1 telephone surveys with clients at baseline, three months and six months to examine change in SNAP risk factors and readiness to change 2 nurse survey at baseline, six and 12 months to examine changes in nurse confidence, attitudes and practices in the assessment and management of SNAP risk factors 3 semi-structured interviews/focus with nurses, managers and clients
Gambrill, E D
The range of factors identified as related to child maltreatment has expanded over the years. The literature clearly calls for an ecological approach in which individual, family, community, and societal factors are considered. The behavioral literature to date reflects an unevenness in terms of acceptance of such an approach. Studies are also uneven concerning the faithfulness with which hallmarks of a behavioral approach have been applied. These include individually tailored assessment and intervention based on empirical data and planning for generalization and maintenance. Most intervention programs do attend to positive as well as negative parent behaviors. Little attention is devoted to environmental characteristics, such as poverty level incomes and impoverished social support systems that may contribute to maltreatment. Lack of comprehensive assessment and intervention programs is no doubt responsible for the modest changes described in many reports. Behavioral studies suffer from uncritical acceptance of the term "abuse" or "at risk" in a number of ways, one of which is a failure to clearly describe the nature of the alleged maltreatment and the immediate situational context. Another is in the assumption that one particular factor is responsible for the maltreatment, such as ineffective parenting skills. Too often a label identifies only one characteristic of a person, ignoring other attributes and related factors. Like all deviant labels, the poor and minority groups are more likely to receive negative labels (Newberger et al., 1976). Investigaters have not taken advantage of relevant literature in the area of child welfare. Familiarity with this material would be helpful in avoiding myths in the field to which many have fallen prey, such as the myth of classlessness of child maltreatment. Acceptance of this myth interferes with the development of programs that deal with difficult environmental problems. Reports suggest that a behavioral approach is
Burke, Jeffrey D; Loeber, Rolf
Evidence for effective treatment for behavioral problems continues to grow, yet evidence about the effective mechanisms underlying those interventions has lagged behind. The Stop Now and Plan (SNAP) program is a multicomponent intervention for boys between 6 and 11. This study tested putative treatment mechanisms using data from 252 boys in a randomized controlled trial of SNAP versus treatment as usual. SNAP includes a 3 month group treatment period followed by individualized intervention, which persisted through the 15 month study period. Measures were administered in four waves: at baseline and at 3, 9 and 15 months after baseline. A hierarchical linear modeling strategy was used. SNAP was associated with improved problem-solving skills, prosocial behavior, emotion regulation skills, and reduced parental stress. Prosocial behavior, emotion regulation skills and reduced parental stress partially mediated improvements in child aggression. Improved emotion regulation skills partially mediated treatment-related child anxious-depressed outcomes. Improvements in parenting behaviors did not differ between treatment conditions. The results suggest that independent processes may drive affective and behavioral outcomes, with some specificity regarding the mechanisms related to differing treatment outcomes. PMID:25619927
Full Text Available Abstract Background Implementation research is concerned with bridging the gap between evidence and practice through the study of methods to promote the uptake of research into routine practice. Good quality evidence has been summarised into guideline recommendations to show that peri-operative fasting times could be considerably shorter than patients currently experience. The objective of this trial was to evaluate the effectiveness of three strategies for the implementation of recommendations about peri-operative fasting. Methods A pragmatic cluster randomised trial underpinned by the PARIHS framework was conducted during 2006 to 2009 with a national sample of UK hospitals using time series with mixed methods process evaluation and cost analysis. Hospitals were randomised to one of three interventions: standard dissemination (SD of a guideline package, SD plus a web-based resource championed by an opinion leader, and SD plus plan-do-study-act (PDSA. The primary outcome was duration of fluid fast prior to induction of anaesthesia. Secondary outcomes included duration of food fast, patients’ experiences, and stakeholders’ experiences of implementation, including influences. ANOVA was used to test differences over time and interventions. Results Nineteen acute NHS hospitals participated. Across timepoints, 3,505 duration of fasting observations were recorded. No significant effect of the interventions was observed for either fluid or food fasting times. The effect size was 0.33 for the web-based intervention compared to SD alone for the change in fluid fasting and was 0.12 for PDSA compared to SD alone. The process evaluation showed different types of impact, including changes to practices, policies, and attitudes. A rich picture of the implementation challenges emerged, including inter-professional tensions and a lack of clarity for decision-making authority and responsibility. Conclusions This was a large, complex study and one of the first
Harada, Masanori; Adachi, Takako; Iwasa, Takashi; Kurita, Kouji; Nakamura, Tomoki; Hama, Yukinobu; Yamamoto, Ayako; Maegawa, Sanae
Mie Prefectural Mental Care Center is a public psychiatric hospital that has 400 beds and 250 outpatients a day. The main catchment area is Tsu City (population: 290,000). Our hospital started early intervention in Aug 2008, and opened the Youth Mental Support Center MIE (YMSC MIE) in Oct 2008. This article reports an early intervention trial in a regional area of Japan. The mission of YMSC MIE is the education, consultation, staff training, and intervention for mental health problems and early psychosis of youths. In Jul 2009, we set up the Youth Assist Clinic (YAC) to support youths with mental health problems and early psychoses. Our activities consist of school-based, community-based, and hospital-based approaches. Specific programs are as follows: 1) School-based approaches: Outreach consultation to school. Mental health lessens. Creating mental health textbooks. Education for parents and teachers. 2) Community-based approaches: To enlighten primary physicians and mental clinic psychiatrists about the importance of early psychosis. To survey their concerns regarding early psychosis. Promoting awareness of community staff and the general public. 3) Hospital-based approaches: YAC. Case manager system. Family meetings for the family including the young with mental disorders. Peer group. Looking back over our 3-year trials, especially in school and the community, we find several problems, as follows: 1) Lack of consultation skills of medical staff outside the hospital. 2) Limiting number of schools which have mental support system. 3) Support for school attendance and learning. 4) Lack of concern about early psychosis of primary physicians and mental clinic psychiatrists. 5) Staff training for early intervention. We are now getting close to improving these issues.
Full Text Available Abstract Background To respond to the rapid surge in the incidence of suicide in Japan, which appears to be an ongoing trend, the Japanese Multimodal Intervention Trials for Suicide Prevention (J-MISP have launched a multimodal community-based suicide prevention program, NOCOMIT-J. The primary aim of this study is to examine whether NOCOMIT-J is effective in reducing suicidal behavior in the community. Methods/DesignThis study is a community intervention trial involving seven intervention regions with accompanying control regions, all with populations of statistically sufficient size. The program focuses on building social support networks in the public health system for suicide prevention and mental health promotion, intending to reinforce human relationships in the community. The intervention program components includes a primary prevention measures of awareness campaign for the public and key personnel, secondary prevention measures for screening of, and assisting, high-risk individuals, after-care for individuals bereaved by suicide, and other measures. The intervention started in July 2006, and will continue for 3.5 years. Participants are Japanese and foreign residents living in the intervention and control regions (a total of population of 2,120,000 individuals. Discussion The present study is designed to evaluate the effectiveness of the community-based suicide prevention program in the seven participating areas. Trial registration UMIN Clinical Trials Registry (UMIN-CTR UMIN000000460.
Li, Nicole; Dunford, Elizabeth; Eyles, Helen; Crino, Michelle; Michie, Jo; Ni Mhurchu, Cliona
Background There is substantial interest in the effects of nutrition labels on consumer food-purchasing behavior. However, conducting randomized controlled trials on the impact of nutrition labels in the real world presents a significant challenge. Objective The Food Label Trial (FLT) smartphone app was developed to enable conducting fully automated trials, delivering intervention remotely, and collecting individual-level data on food purchases for two nutrition-labeling randomized controlled trials (RCTs) in New Zealand and Australia. Methods Two versions of the smartphone app were developed: one for a 5-arm trial (Australian) and the other for a 3-arm trial (New Zealand). The RCT protocols guided requirements for app functionality, that is, obtaining informed consent, two-stage eligibility check, questionnaire administration, randomization, intervention delivery, and outcome assessment. Intervention delivery (nutrition labels) and outcome data collection (individual shopping data) used the smartphone camera technology, where a barcode scanner was used to identify a packaged food and link it with its corresponding match in a food composition database. Scanned products were either recorded in an electronic list (data collection mode) or allocated a nutrition label on screen if matched successfully with an existing product in the database (intervention delivery mode). All recorded data were transmitted to the RCT database hosted on a server. Results In total approximately 4000 users have downloaded the FLT app to date; 606 (Australia) and 1470 (New Zealand) users met the eligibility criteria and were randomized. Individual shopping data collected by participants currently comprise more than 96,000 (Australia) and 229,000 (New Zealand) packaged food and beverage products. Conclusions The FLT app is one of the first smartphone apps to enable conducting fully automated RCTs. Preliminary app usage statistics demonstrate large potential of such technology, both for
Redding, Colleen A.; Prochaska, James O.; Armstrong, Kay; Rossi, Joseph S.; Hoeppner, Bettina B.; Sun, Xiaowu; Kobayashi, Hisanori; Yin, Hui-Qing; Coviello, Donna; Evers, Kerry; Velicer, Wayne F.
Smoking and sexual risk behaviors in urban adolescent females are prevalent and problematic. Family planning clinics reach those who are at most risk. This randomized effectiveness trial evaluated a transtheoretical model (TTM)-tailored intervention to increase condom use and decrease smoking. At baseline, a total of 828 14- to 17-year-old females…
Full Text Available Background: Educational interventions in hygienic practices have shown to be cost effective methods of controlling diarrhea and other diseases spread through poor hygiene. Hand washing is one method of breaking the chain of transmission between household contacts, and especially between mother and child. Effective interventions to promote this behavior should be expanded and encouraged in the developing world. Objectives: To determine the extent and credibility of intervention studies done to promote uptake of improved hand washing behaviors in communities. To assess these interventions on their results in terms of behavior change, and identify factors contributing to their success or failure. Methods: The investigators searched the databases SCOPUS, EMBASE (1980-2010, and Pubmed for English papers written about hygiene promotion interventions in developing countries. Interventions included were community based control trials examining the effectiveness of increased hygiene education through measured behavior change. Only studies measuring behavior change using structured observation or demonstration of hand washing skills were used. Results: The search terms: hand washing, health education, hygiene promotion, behavior change, and diarrhea were used, resulting in a total of 330 titles. The investigators scanned the titles and abstracts to narrow down to 13 hygiene interventions measuring behavior change. Only five control trial interventions met the observation measurement criteria. Behavior change measurements were compiled and compared based on the length of intervention and the degree of change noted with each study. Conclusion: Encouraging uptake of hand washing behavior is possible using educational interventions to promote improved hygiene. The most significant impacts were seen from interventions running for longer periods of time. More robust and long term control trials are necessary to gather conclusive data on the sustainability of
Purpose: Although vaginal dilation is often recommended to minimize or prevent vaginal scarring after pelvic radiotherapy, compliance with this recommendation has historically been very low. Therefore, effective intervention strategies are needed to enhance compliance with vaginal dilation after radiotherapy for gynecologic cancer. Methods and Materials: This study was a randomized controlled clinical trial of a psychoeducational intervention specifically designed to increase compliance with vaginal dilation. The information-motivation-behavioral skills model of enhancing compliance with behavioral change was the basis for the intervention design. Forty-two sexually active women, 21 to 65 years of age, diagnosed with Stages Ic-III cervical or endometrial cancer, who received pelvic radiotherapy, were randomized to either the experimental psychoeducational group or the information-only control group. Assessment via questionnaire occurred before treatment and at 6-week, 6-month, 12-month, 18-month, and 24-month follow-up. Assessment via interview also occurred at 6-month, 12-month, 18-month, and 24-month follow-up. Results: The psychoeducational intervention was successful in increasing compliance with vaginal dilation. Conclusions: This study is the first randomized controlled study to demonstrate the effectiveness of an intervention in increasing compliance with the use of vaginal dilators
Ferreira Isabel; Oenema Anke; Brug Johannes
Abstract Background The present paper intends to contribute to the debate on the usefulness and barriers in applying theories in diet and physical activity behavior-change interventions. Discussion Since behavior theory is a reflection of the compiled evidence of behavior research, theory is the only foothold we have for the development of behavioral nutrition and physical activity interventions. Application of theory should improve the effectiveness of interventions. However, some of the the...
Marc A Adams
intervention outperformed the static intervention for increasing PA. The adaptive goal and feedback algorithm is a "behavior change technology" that could be incorporated into mHealth technologies and scaled to reach large populations. TRIAL REGISTRATION: ClinicalTrials.gov NCT01793064.
Brothers, Brittany M.; Yang, Hae-Chung; Strunk, Daniel R.; Andersen, Barbara L.
Objective: In this Phase II trial, we evaluated a novel psychological treatment for depressed patients coping with the stresses of cancer. Effectiveness of a combined biobehavioral intervention (BBI) and cognitive behavior therapy (CBT) was studied. Method: Participants were 36 cancer survivors (mean age = 49 years; 88% Caucasian; 92% female)…
Howell, Elizabeth A; Bodnar-Deren, Susan; Balbierz, Amy; Loudon, Holly; Mora, Pablo A.; Zlotnick, Caron; Wang, Jason; Leventhal, Howard
Depressive symptoms and depression are a common complication of childbirth and a growing body of literature suggests that there are modifiable factors associated with their occurrence. We developed a behavioral educational intervention targeting these factors and successfully reduced postpartum depressive symptoms in a randomized trial among low-income black and Latina women. We now report results of 540 predominantly white, high income mothers in a second randomized trial. Mothers in the intervention arm received a 2-step intervention that prepared and educated mothers about modifiable factors associated with postpartum depressive symptoms (e.g., physical symptoms, low self-efficacy), bolstered social support, and enhanced management skills. The control arm received enhanced usual care. Participants were surveyed prior to randomization, 3-weeks, 3-months, and 6-months postpartum. Depressive symptoms were assessed using the Edinburgh Postnatal Depression Scale (EPDS of 10 or greater). Prevalence of depressive symptoms postpartum were unexpectedly low precluding detection of difference in rates of depressive symptoms among intervention vs. enhanced usual care post hospitalization: 3-weeks (6.0 % vs. 5.6%, p=.83), 3-months (5.1% vs. 6.5%, p=.53) and 6-months (3.6% vs. 4.6%, p=.53). PMID:24019052
Full Text Available Abstract Background Obesity and asthma have reached epidemic proportions in the US. Their concurrent rise over the last 30 years suggests that they may be connected. Numerous observational studies support a temporally-correct, dose-response relationship between body mass index (BMI and incident asthma. Weight loss, either induced by surgery or caloric restriction, has been reported to improve asthma symptoms and lung function. Due to methodological shortcomings of previous studies, however, well-controlled trials are needed to investigate the efficacy of weight loss strategies to improve asthma control in obese individuals. Methods/Design BE WELL is a 2-arm parallel randomized clinical trial (RCT of the efficacy of an evidence-based, comprehensive, behavioral weight loss intervention, focusing on diet, physical activity, and behavioral therapy, as adjunct therapy to usual care in the management of asthma in obese adults. Trial participants (n = 324 are patients aged 18 to 70 years who have suboptimally controlled, persistent asthma, BMI between 30.0 and 44.9 kg/m2, and who do not have serious comorbidities (e.g., diabetes, heart disease, stroke. The 12-month weight loss intervention to be studied is based on the principles of the highly successful Diabetes Prevention Program lifestyle intervention. Intervention participants will attend 13 weekly group sessions over a four-month period, followed by two monthly individual sessions, and will then receive individualized counseling primarily by phone, at least bi-monthly, for the remainder of the intervention. Follow-up assessment will occur at six and 12 months. The primary outcome variable is the overall score on the Juniper Asthma Control Questionnaire measured at 12 months. Secondary outcomes include lung function, asthma-specific and general quality of life, asthma medication use, asthma-related and total health care utilization. Potential mediators (e.g., weight loss and change in physical
Drummond, Jane; Fleming, Darcy; McDonald, Linda; Kysela, Gerard M
Adaptive problem solving contributes to individual and family health and development. In this article, the effect of the cooperative family learning approach (CFLA) on group family problem solving and on cooperative parenting communication is described. A pretest or posttest experimental design was used. Participant families were recruited from Head Start programs and exhibited two or more risk factors. Participant preschool children were screened to have two or more developmental delays. Direct behavioral observation measures were used to determine group family problem solving and cooperative parenting communication outcomes. Few group family problem-solving behaviors were coded, and they displayed little variability. However, intervention parents increased the length of time they played and extended the cooperative parent-child interactions. The evidence shows that CFLA has the potential to enhance parental-modeling of cooperative behavior while engaged in play activities with preschoolers. Direct measurement of group family problem solving was difficult. Solutions are suggested. PMID:15604228
Callahan Christopher M
Full Text Available Abstract Background Given the current lack of disease-modifying therapies, it is important to explore new models of longitudinal care for older adults with dementia that focus on improving quality of life and delaying functional decline. In a previous clinical trial, we demonstrated that collaborative care for Alzheimer’s disease reduces patients’ neuropsychiatric symptoms as well as caregiver stress. However, these improvements in quality of life were not associated with delays in subjects’ functional decline. Trial design Parallel randomized controlled clinical trial with 1:1 allocation. Participants A total of 180 community-dwelling patients aged ≥45 years who are diagnosed with possible or probable Alzheimer’s disease; subjects must also have a caregiver willing to participate in the study and be willing to accept home visits. Subjects and their caregivers are enrolled from the primary care and geriatric medicine practices of an urban public health system serving Indianapolis, Indiana, USA. Interventions All patients receive best practices primary care including collaborative care by a dementia care manager over two years; this best practices primary care program represents the local adaptation and implementation of our prior collaborative care intervention in the urban public health system. Intervention patients also receive in-home occupational therapy delivered in twenty-four sessions over two years in addition to best practices primary care. The focus of the occupational therapy intervention is delaying functional decline and helping both subjects and caregivers adapt to functional impairments. The in-home sessions are tailored to the specific needs and goals of each patient-caregiver dyad; these needs are expected to change over the course of the study. Objective To determine whether best practices primary care plus home-based occupational therapy delays functional decline among patients with Alzheimer’s disease compared
Schelvis, R.M; Oude Hengel, K.M.; Burdorf, A.; Blatter, B.M.; Strijk, J.E.; Beek, A.J. van
Occupational health researchers regularly conduct evaluative intervention research for which a randomized controlled trial (RCT) may not be the most appropriate design (eg, effects of policy measures, organizational interventions on work schedules). This article demonstrates the appropriateness of a
Full Text Available Abstract Background Too few young people engage in behaviors that reduce the risk of morbidity and premature mortality, such as eating healthily, being physically active, drinking sensibly and not smoking. The present research developed an online intervention to target these health behaviors during the significant life transition from school to university when health beliefs and behaviors may be more open to change. This paper describes the intervention and the proposed approach to its evaluation. Methods/design Potential participants (all undergraduates about to enter the University of Sheffield will be emailed an online questionnaire two weeks before starting university. On completion of the questionnaire, respondents will be randomly assigned to receive either an online health behavior intervention (U@Uni or a control condition. The intervention employs three behavior change techniques (self-affirmation, theory-based messages, and implementation intentions to target four heath behaviors (alcohol consumption, physical activity, fruit and vegetable intake, and smoking. Subsequently, all participants will be emailed follow-up questionnaires approximately one and six months after starting university. The questionnaires will assess the four targeted behaviors and associated cognitions (e.g., intentions, self-efficacy as well as socio-demographic variables, health status, Body Mass Index (BMI, health service use and recreational drug use. A sub-sample of participants will provide a sample of hair to assess changes in biochemical markers of health behavior. A health economic evaluation of the cost effectiveness of the intervention will also be conducted. Discussion The findings will provide evidence on the effectiveness of online interventions as well as the potential for intervening during significant life transitions, such as the move from school to university. If successful, the intervention could be employed at other universities to promote
Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie
Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a large Phas...
Luker, Julie A; Craig, Louise E; Bennett, Leanne; Ellery, Fiona; Langhorne, Peter; Wu, Olivia; Bernhardt, Julie
Background The implementation of multidisciplinary stroke rehabilitation interventions is challenging, even when the intervention is evidence-based. Very little is known about the implementation of complex interventions in rehabilitation clinical trials. The aim of study was to better understand how the implementation of a rehabilitation intervention in a clinical trial within acute stroke units is experienced by the staff involved. This qualitative process evaluation was part of a lar...
Thomson, Cynthia A; Ravia, Jennifer
Fruit and vegetable (F/V) intake in the United States remains below recommended levels despite evidence of the health benefits of regular consumption. Efforts to increase F/V intake include behavior-based interventions. A systematic review of MEDLINE PubMed and PsycINFO databases (2005-2010) was conducted to identify behavior-based intervention trials designed to promote F/V intake. Using predetermined limits and selection criteria, 34 studies were identified for inclusion. Behavior-based interventions resulted in an average increase in F/V intake of +1.13 and +0.39 servings per day in adults and children, respectively. Interventions involving minority adults or low-income participants demonstrated average increases in daily F/V consumption of +0.97 servings/day, whereas worksite interventions averaged +0.8 servings/day. Achieving and sustaining F/V intake at recommended levels of intake across the population cannot be achieved through behavior-based interventions alone. Thus, efforts to combine these interventions with other approaches including social marketing, behavioral economics approaches, and technology-based behavior change models should be tested to ensure goals are met and sustained.
Sean P Grant
Full Text Available BACKGROUND: Previous reviews show that reporting guidelines have improved the quality of trial reports in medicine, yet existing guidelines may not be fully suited for social and psychological intervention trials. OBJECTIVE/DESIGN: We conducted a two-part study that reviewed (1 reporting guidelines for and (2 the reporting quality of social and psychological intervention trials. DATA SOURCES: (1 To identify reporting guidelines, we systematically searched multiple electronic databases and reporting guideline registries. (2 To identify trials, we hand-searched 40 journals with the 10 highest impact factors in clinical psychology, criminology, education, and social work. ELIGIBILITY: (1 Reporting guidelines consisted of articles introducing a checklist of reporting standards relevant to social and psychological intervention trials. (2 Trials reported randomised experiments of complex interventions with psychological, social, or health outcomes. RESULTS: (1 We identified 19 reporting guidelines that yielded 147 reporting standards relevant to social and psychological interventions. Social and behavioural science guidelines included 89 standards not found in CONSORT guidelines. However, CONSORT guidelines used more recommended techniques for development and dissemination compared to other guidelines. (2 Our review of trials (n = 239 revealed that many standards were poorly reported, such as identification as a randomised trial in titles (20% reported the information and abstracts (55%; information about blinding (15%, sequence generation (23%, and allocation concealment (17%; and details about actual delivery of experimental (43% and control interventions (34%, participant uptake (25%, and service environment (28%. Only 11 of 40 journals referenced reporting guidelines in "Instructions to Authors." CONCLUSION: Existing reporting guidelines have important limitations in content, development, and/or dissemination. Important details are routinely
Lautenschlager Nicola T
Full Text Available Abstract Background There is scope to improve the quality of life (QOL of people with dementia living in residential care facilities (RCF. The DIRECT study will determine if delivery of education to General Practitioners (GPs and care staff improves the quality of life of residential care recipients with cognitive impairment. Methods/Design A prospective randomised controlled trial conduced in residential aged care facilities in the metropolitan area of Perth, Western Australia. Participants are care facility residents, aged 65 years and older and with mini-mental state examination scores less than 25. GPs and care facility staff have been independently randomised to intervention or control groups. An education programme, designed to meet the perceived needs of learners, will be delivered to GPs and care staff in the intervention groups. The primary outcome of the study will be quality of life of the people with dementia, measured using the QOL-Alzheimer's Disease Scale (QOL-AD and Alzheimer Disease Related QOL Scale (ADRQL, 4 weeks and 6 months after the conclusion of the education intervention. Results Recruitment of 351 people with dementia, cared for by staff in 39 residential facilities and 55 GPs, was undertaken between May 2007 and July 2008. Collection of baseline data is complete. Education has been delivered to GPs and Care staff between September 2008 and July 2009. Follow- up data collection is underway. Discussion The study results will have tangible implications for proprietors, managers and staff from the residential care sector and policy makers. The results have potential to directly benefit the quality of life of both patients and carers. Trial registration These trial methods have been prospectively registered (ACTRN12607000417482.
Burke, Mack D.; Rispoli, Mandy; Clemens, Nathan H.; Lee, Yuan-Hsuan; Sanchez, Lisa; Hatton, Heather
Universal behavioral screening is a major part of positive behavioral support and response to intervention systems. Program-wide positive behavioral interventions and supports (PBIS) focuses on establishing social, emotional, and behavioral competence through promotion of a small set of behavioral expectations that are agreed upon, taught, and…
Iranagh, Jamileh Amirzadeh; Rahman, Hejar Abdul; Motalebi, Seyedeh Ameneh
BACKGROUND/OBJECTIVES Nutrition is a determinant factor of health in elderly people. Independent living in elderly people can be maintained or enhanced by improvement of nutritional behavior. Hence, the present study was conducted to determine the impact of Health Belief Model (HBM)-based intervention on the nutritional behavior of elderly women. SUBJECTS/METHODS Cluster-random sampling was used to assess the sample of this clinical trial study. The participants of this study attended a 12-we...
Full Text Available Abstract Background Since siblings of pediatric cancer patients are at risk for emotional, behavioral, and social problems, there is considerable interest in development of early psychological interventions. This paper aimed at evaluating the effectiveness of a two-session psychological intervention for siblings of newly diagnosed pediatric cancer patients. Methods Thirty siblings age 6-17 years were randomly assigned to an intervention group or an active control group with standard psychosocial care. The manualized intervention provided to siblings in the first 2 months after the cancer diagnosis of the ill child included medical information, promotion of coping skills, and a psychoeducational booklet for parents. At 4 to 6 weeks, 4 months, and 7 months after the diagnosis, all siblings and their parents completed measures (from standardized instruments of social support, quality of life, medical knowledge, posttraumatic stress symptoms, and anxiety. Results At follow-up siblings in the intervention group showed better psychological well-being, had better medical knowledge, and reported receiving social support from more people. However, the intervention had no effects on posttraumatic stress symptoms and anxiety. Conclusions The results of this pilot trial suggest that a two-session sibling intervention can improve siblings' adjustment, particularly psychological well-being, in the early stage after a cancer diagnosis. Trial Registration ClinicalTrials.gov NCT00296907
Petrenko, Christie L M
Children with developmental disabilities are at higher risk for internalizing and externalizing behavioral problems than children in the general population. Effective prevention and treatment programs are necessary to reduce the burden of behavioral problems in this population. The current review identified 17 controlled trials of nine intervention programs for young children with developmental disabilities, with parent training the most common type of intervention in this population. Nearly all studies demonstrated medium to large intervention effects on child behavior post-intervention. Preliminary evidence suggests interventions developed for the general population can be effective for children with developmental disabilities and their families. A greater emphasis on the prevention of behavior problems in young children with developmental disabilities prior to the onset of significant symptoms or clinical disorders is needed. Multi-component interventions may be more efficacious for child behavior problems and yield greater benefits for parent and family adjustment. Recommendations for future research directions are provided.
Full Text Available Abstract Background Sexually transmitted infections (STIs are among the frequent risks encountered by travelers. Efficient interventions are needed to improve the understanding of the risks of STIs. We investigated the potential benefits of a motivational brief intervention (BI and the provision of condoms on the engagement in unprotected casual sex. Methods 3-arm randomized controlled trial performed among single travelers aged 18-44 years visiting a travel clinic in Switzerland. The main outcomes were the prevalence of casual unprotected sexual intercourse and their predictors. Results 5148 eligible travelers were seen from 2006 to 2008. 1681 agreed to participate and 1115 subjects (66% completed the study. 184/1115 (17% had a casual sexual relationship abroad and overall 46/1115 (4.1% had inconsistently protected sexual relations. Women (adjusted OR 2.7 [95%CI 1.4-5.6] and travelers with a history of past STI (adjusted OR 2.8 [95%CI 1.1-7.4] had more frequent casual sexual relationships without consistent protection. Regarding the effect of our intervention, the prevalence of subjects using condoms inconsistently was 28% (95%CI16-40 in the motivational BI group, 24% (95%CI10-37 in the condoms group and 24% (95%CI14-33 in the control group (p = 0.7. Conclusion This study showed that a motivational brief intervention and/or the provision of free condoms did not modify risky sexual behavior of young travelers. The rate of inconsistently protected sexual relationships during travel was however lower than expected Trial Registration Number ClinicalTrials.gov: NCT01056536
Full Text Available Background: Psychological debriefing has been widely advocated for routine use following major traumatic events. Cognitive Behavioral Interventions, art supportive therapies, and sport and recreational support activities are other interventions for reducing posttraumatic stress disorder. We assessed the effects of theses methods individually and in combination on reduction posttraumatic stress disorder symptoms in adolescents who had experienced Bam earthquake. Methods: In a field trial, we evaluated the efficacy of psychological debriefing, group cognitive-behavioral therapy, art and sport supportive interventions in 200 adolescents with PTSD symptoms who survived of Bam earthquake and compare it with a control group. Patients were randomly assigned to one of intervention programs including: group cognitive-behavioral therapy; group CBT plus art and sport interventions; art and sport interventions without group CBT; and control group. Results: Thirty one individuals were excluded because of migration. A statistically significant reduction in overall PTSD symptoms as well as in avoidance symptoms was observed after group cognitive-behavioral therapy. There was no significant difference in reduction of overall PTSD and avoidance symptoms between the other groups. Conclusion: Psychological interventions in form of group cognitive behavioral therapy can reduce the symptoms of PTSD symptoms but we couldn't find the art and sport supportive therapy alone or in combination with group CBT to be useful in this regard.
Mays, Darren; Peshkin, Beth N.; Sharff, McKane E.; Walker, Leslie R.; Abraham, Anisha A.; Hawkins, Kirsten B.; Tercyak, Kenneth P.
This study examined factors associated with teens' adherence to a multiple health behavior cancer preventive intervention. Analyses identified predictors of trial enrollment, run-in completion, and adherence (intervention initiation, number of sessions completed). Of 104 teens screened, 73% (n = 76) were trial eligible. White teens were more…
Welch Martha G
Full Text Available Abstract Background The stress that results from preterm birth, requisite acute care and prolonged physical separation in the Neonatal Intensive Care Unit (NICU can have adverse physiological/psychological effects on both the infant and the mother. In particular, the experience compromises the establishment and maintenance of optimal mother-infant relationship, the subsequent development of the infant, and the mother's emotional well-being. These findings highlight the importance of investigating early interventions that are designed to overcome or reduce the effects of these environmental insults and challenges. Methods This study is a randomized controlled trial (RCT with blinded assessment comparing Standard Care (SC with a novel Family Nurture Intervention (FNI. FNI targets preterm infants born 26-34 weeks postmenstrual age (PMA and their mothers in the NICU. The intervention incorporates elements of mother-infant interventions with known efficacy and organizes them under a new theoretical context referred to collectively as calming activities. This intervention is facilitated by specially trained Nurture Specialists in three ways: 1 In the isolette through calming interactions between mother and infant via odor exchange, firm sustained touch and vocal soothing, and eye contact; 2 Outside the isolette during holding and feeding via the Calming Cycle; and 3 through family sessions designed to engage help and support the mother. In concert with infant neurobehavioral and physiological assessments from birth through 24 months corrected age (CA, maternal assessments are made using standard tools including anxiety, depression, attachment, support systems, temperament as well as physiological stress parameters. Quality of mother-infant interaction is also assessed. Our projected enrolment is 260 families (130 per group. Discussion The FNI is designed to increase biologically important activities and behaviors that enhance maternally
Full Text Available Abstract Background The development, implementation and evaluation of any new health intervention is complex. This paper uses experiences from the design, implementation and evaluation of a rehabilitation programme to shed light on, and prompt discussion around, some of the complexities involved in such an undertaking. Methods Semi-structured interviews were conducted with 15 trial participants and five members of staff at the conclusion of a trial evaluating a rehabilitation programme aimed at promoting recovery after stem cell transplantation. Results This study identified a number of challenges relating to the development and evaluation of complex interventions. The difficulty of providing a standardised intervention that was acceptable to patients was highlighted in the participant interviews. Trial participants and some members of staff found the concept of equipoise and randomisation challenging and there was discord between the psychosocial nature of the intervention and the predominant bio-medical culture in which the research took place. Conclusions A lack of scientific evidence as to the efficacy of an intervention does not preclude staff and patients holding strong views about the benefits of an intervention. The evaluation of complex interventions should, where possible, facilitate not restrict that complexity. Within the local environment where the trial is conducted, acquiescence from those in positions of authority is insufficient; commitment to the trial is required.
Manne, Sharon L.; And Others
Investigated behavioral intervention to control child distress during invasive cancer treatment. Children (n=23) requiring physical restraint to complete venipuncture were alternately assigned to behavioral intervention or attention control condition. Observed child distress, parent-rated child distress, and parent ratings of own distress were…
Matos Margarida G
Full Text Available Abstract Background Research on the motivational model proposed by Self-Determination Theory (SDT provides theoretically sound insights into reasons why people adopt and maintain exercise and other health behaviors, and allows for a meaningful analysis of the motivational processes involved in behavioral self-regulation. Although obesity is notoriously difficult to reverse and its recidivism is high, adopting and maintaining a physically active lifestyle is arguably the most effective strategy to counteract it in the long-term. The purposes of this study are twofold: i to describe a 3-year randomized controlled trial (RCT aimed at testing a novel obesity treatment program based on SDT, and ii to present the rationale behind SDT's utility in facilitating and explaining health behavior change, especially physical activity/exercise, during obesity treatment. Methods Study design, recruitment, inclusion criteria, measurements, and a detailed description of the intervention (general format, goals for the participants, intervention curriculum, and main SDT strategies are presented. The intervention consists of a 1-year group behavioral program for overweight and moderately obese women, aged 25 to 50 (and pre-menopausal, recruited from the community at large through media advertisement. Participants in the intervention group meet weekly or bi-weekly with a multidisciplinary intervention team (30 2 h sessions in total, and go through a program covering most topics considered critical for successful weight control. These topics and especially their delivery were adapted to comply with SDT and Motivational Interviewing guidelines. Comparison group receive a general health education curriculum. After the program, all subjects are follow-up for a period of 2 years. Discussion Results from this RCT will contribute to a better understanding of how motivational characteristics, particularly those related to physical activity/exercise behavioral self
Kok, G.; Lo, S.H.; Peters, G-JY; Ruiter, R. A. C.
This paper's objective is to apply Intervention Mapping, a planning process for the systematic development of theory- and evidence-based health promotion interventions, to the development of interventions to promote energy conservation behavior. Intervention Mapping (IM) consists of six steps: needs assessment, program objectives, methods and applications, program development, planning for program implementation, and planning for program evaluation. Examples from the energy conservation field...
Heyman, Bob; Harrington, Barbara E.; Heyman, Anna
This paper discusses a pragmatic randomised controlled trial of a fuel poverty intervention undertaken in NE England over a four-year period, starting in 2000/2001. Home energy efficiency was measured through Standardised Assessment Procedure (SAP) ratings in each year of the trial. The trial group received an energy efficiency intervention package in year three, and the control group in year four. Year three room temperature data for a sub-sample of 100 households were obtained. A comparison...
Venditti, E M; Elliot, D L; Faith, M S; Firrell, L S; Giles, C M; Goldberg, L; Marcus, M D; Schneider, M; Solomon, S; Thompson, D; Yin, Z
HEALTHY was a multi-center primary prevention trial designed to reduce risk factors for type 2 diabetes in adolescents. Seven centers each recruited six middle schools that were randomized to either intervention or control. The HEALTHY intervention integrated multiple components in nutrition, physical education, behavior change and communications and promotion. The conceptual rationale as well as the design and development of the behavior intervention component are described. Pilot study data informed the development of the behavior intervention component. Principles of social learning and health-related behavior change were incorporated. One element of the behavior intervention component was a sequence of peer-led, teacher-facilitated learning activities known as FLASH (Fun Learning Activities for Student Health). Five FLASH modules were implemented over five semesters of the HEALTHY study, with the first module delivered in the second semester of the sixth grade and the last module in the second semester of the eighth grade. Each module contained sessions that were designed to be delivered on a weekly basis to foster self-awareness, knowledge, decision-making skills and peer involvement for health behavior change. FLASH behavioral practice incorporated individual and group self-monitoring challenges for eating and activity. Another element of the behavior intervention component was the family outreach strategy for extending changes in physical activity and healthy eating beyond the school day and for supporting the student's lifestyle change choices. Family outreach strategies included the delivery of newsletters and supplemental packages with materials to promote healthy behavior in the home environment during school summer and winter holiday breaks. In conclusion, the HEALTHY behavior intervention component, when integrated with total school food and physical education environmental changes enhanced by communications and promotional campaigns, is a feasible and
Benner, Gregory J.; Nelson, J. Ron; Sanders, Elizabeth A.; Ralston, Nicole C.
This article examined the efficacy of a primary-level, standard-protocol behavior intervention for students with externalizing behavioral disorders. Elementary schools were randomly assigned to treatment (behavior intervention) or control (business as usual) conditions, and K-3 students were screened for externalizing behavior risk status. The…
Racey, Megan; O'Brien, Charlene; Douglas, Sabrina; Marquez, Olivia; Hendrie, Gilly; Newton, Genevieve
Background: Owing to the associations between diet and health, it is important that effective health promotion strategies establish healthful eating behaviors from an early age. We reviewed the intensity of school-based interventions aimed to modify dietary behavior in preadolescent and adolescents and related intervention characteristics to…
姜斌; 左芳; 吴蕾; 何耀; 陈肇始; 郑家强; 林大庆
Objective To evaluate the effects of different smoking cessation interventions on cigarette consumption for young soldiers.Methods Sixty-eight soldiers were prospectively investigated in this randomly controlled clinical trial and assigned to the psychological intervention group,auricular acupuncture group,and smoking cessation medication group.Results All the participants showed significant reduction(33.3％ to 73.9％)in post-treatment cigarette consumption.The highest quit rate was found at 7 days,although this declining trend was faded over time.One-year follow-up indicated a 6-month quit rate of 16.7％,23.8％ and 30.4％ in three groups,respectively.Conclusion Psychological intervention,auricular acupuncture and smoking cessation medication may be effective methods of reducing cigarette consumption and improving quit rate in young soldiers.%目的 探讨和评价不同的干预措施对集体生活年轻人群吸烟行为的影响.方法 将68名吸烟战士随机分为3组,分别采取心理干预、心理干预+耳针和心理干预+药物对其吸烟行为进行干预.采用统一问卷进行基线调查,在1、3、6个月和1年进行随访,观察不同随访时点吸烟量的减少和戒烟率.结果 三组研究对象可比性较好.在1、3、6个月随访时点,各组吸烟者的吸烟量均有不同程度的下降(33.3％～73.9％).在上述各随访时点,7d时点戒烟率均较高,而持续1个月的戒烟率和持续3个月的戒炯率有随时间下降的趋势.但3组1年随访时,持续6个月的戒烟率仍可达到16.7％、23.8％、30.4％.结论 集体管理生活环境中的戒烟心理干预是年轻战士吸烟量的减少和提高戒烟成功率的有效措施之一,药物和耳针等辅助戒烟方法的使用亦有一定的促进作用.
Muratori, Pietro; Bertacchi, Iacopo; Giuli, Consuelo; Lombardi, Lavinia; Bonetti, Silvia; Nocentini, Annalaura; Manfredi, Azzurra; Polidori, Lisa; Ruglioni, Laura; Milone, Annarita; Lochman, John E
Children with high levels of aggressive behavior create a major management problem in school settings and interfere with the learning environment of their classmates. We report results from a group-randomized trial of a program aimed at preventing aggressive behaviors. The purpose of the current study, therefore, was to determine the extent to which an indicated prevention program, Coping Power Program, is capable of reducing behavioral problems and improving pro-social behavior when delivered as a universal classroom-based prevention intervention. Nine classes (five first grade and four second grade) were randomly assigned to intervention or control conditions. Findings showed a significant reduction in overall problematic behaviors and in inattention-hyperactivity problems for the intervention classes compared to the control classes. Students who received Coping Power Program intervention also showed more pro-social behaviors at postintervention. The implications of these findings for the implementation of strategies aimed at preventing aggressive behavior in school settings are discussed.
Full Text Available Abstract Background The number of overweight children in America has doubled to an estimated 10 million in the past 20 years. Establishing healthy dietary behaviors must begin early in childhood and include parents. The Healthy Toddlers intervention focuses on promoting healthy eating habits in 1- to 3-year-old children utilizing the Social Cognitive Theory and a learner-centered approach using Adult Learning principles. This Healthy Toddlers Trial aims to determine the efficacy of a community-based randomized controlled trial of an in-home intervention with economically and educationally disadvantaged mothers of toddlers. The intervention focuses on: (a promoting healthy eating behaviors in toddlers while dietary habits are forming; and (b providing initial evidence for the potential of Healthy Toddlers as a feasible intervention within existing community-based programs. Methods/Design This describes the study protocol for a randomized control trial, a multi-state project in Colorado, Michigan, and Wisconsin with economically and educationally disadvantaged mother-toddler dyads; toddlers are between 12 and 36 months. The Healthy Toddlers intervention consists of eight in-home lessons and four reinforcement telephone contacts, focusing on fruit, vegetable, and sweetened beverage consumption and parental behaviors, taught by paraprofessional instructors. Healthy Toddlers uses a randomized, experimental, short-term longitudinal design with intervention and control groups. In-home data collection (anthropometric measurements, feeding observations, questionnaires, 3-day dietary records occurs at baseline, immediately following the intervention, and 6 months after the intervention. Main toddler outcomes include: a increased fruit and vegetable consumption and decreased sweetened beverage consumption; and b improved toddler-eating skills (self-feeding and self-serving. Main parent outcomes include: a improved psychosocial attributes (knowledge
Kristjánsdóttir, O.B.; Fors, E.A.; Eide, E.; Finset, A.; Stensrud, T.L.; van Dulmen, S.; Wigers, S.H.; Eide, H.
Background Internet-based interventions using cognitive behavioral approaches can be effective in promoting self-management of chronic pain conditions. Web-based programs delivered via smartphones are increasingly used to support the self-management of various health disorders, but research on smartphone interventions for persons with chronic pain is limited. Objective The aim of this trial was to study the efficacy of a 4-week smartphone-delivered intervention with written diaries and therap...
Orban de Xivry J-J
Full Text Available Each task requires a specific motor behavior that is tuned to task demands. For instance, writing requires a lot of accuracy while clapping does not. It is known that the brain adjusts the motor behavior to different task demands as predicted by optimal control theory. In this study, the mechanism of this reoptimization process is investigated by varying the accuracy demands of a reaching task. In this task, the width of the reaching target (0.5 or 8 cm was varied either on a trial-to-trial basis (random schedule or in blocks (blocked schedule. On some trials, the hand of the subjects was clamped to a rectilinear trajectory that ended 2 cm on the left or right of the target center. The rejection of this perturbation largely varied with target width in the blocked schedule but not in the random schedule. That is, subjects exhibited different motor behavior in the different schedules despite identical accuracy demands. Therefore, while reoptimization has been considered immediate and automatic, the differences in motor behavior observed across schedules suggest that the reoptimization of the motor behavior is neither happening on a trial-by-trial basis nor obligatory. The absence of trial-to-trial mechanisms, the inability of the brain to adapt to two conflicting task demands and the existence of a switching cost are discussed as possible sources of the non-optimality of motor behavior during the random schedule.
Reed, Phil; Osborne, Lisa A; Corness, Mark
The effectiveness of home-based early behavioral interventions for children (2:6-4:0 years old) with autistic spectrum disorders was studied over 9-10 months. Measures of autistic severity, intellectual, educational, and adaptive behavioral functioning were taken. There was no evidence of recovery from autism. High-intensity behavioral approaches (mean 30 h/week) produced greater gains than low-intensity programs (mean 12 h/week). Lovaas- and complete application of behavior analysis to schools approach-type interventions produced largest gains [similar to gains produced by longer-term clinic-based applied behavior analysis (ABA) programs]. Within the high-intensity groups, increased temporal input on the program was not associated with increased gains in the children. The results from clinic-based ABA trials were partially replicated on a home-based sample, using children with greater autistic and intellectual impairments. PMID:17180714
Full Text Available ABSTRACTIntroduction:Scientific evidence supports the sinergy between biomedical and behavioral interventions aimed at preventing the transmission of HIV as a strategy to eradicate AIDS.Objective:To characterize comparatively the benefits from biomedical and behavioral interventions to prevent HIV transmission.Methods:Narrative review. We performed a comparative analysis of the benefits of studied interventions by means of estimating the number needed to treat (NNT. Evaluated interventions: counseling activities for behavior change to prevent exposure to HIV; antiretroviral pre-exposure prophylaxis (PrEP and antiretroviral post-exposure prophylasis (PEP for HIV and treatment of serodiscordant couples as a strategy for prevention of HIV transmission (TasP.Results:counseling interventions and TasP have smaller NNTs, equal to, respectively, 11 (95%CI 9 - 18 at 12 months and 34 (95%CI 23 - 54 in 42 months comparatively to PrEP interventions, that resulted in 41 (95%CI 28 - 67 individuals receiving antiretrovirals in order to prevent one case of HIV infection at 36 months for men and serodiscordant couples. PEP interventions are associated with protective effects estimated at 81%. Lack of trials evaluating PEP prevents estimate of NNT.Conclusion:The estimate of the NNT can be a helpful parameter in the comparison between the effectiveness of different behavioral and biomedical HIV prevention strategies. Studies evaluating the benefit and safety of combined behavioral and biomedical interventions are needed, especially considering the attributable fraction of each component. Integration of behavioral and biomedical interventions is required to achieve complete suppression of the virus, and thus reducing viral replication, infectivity and the number of cases.
Ferguson, Monika; Vandelanotte, Corneel; Plotnikoff, Ron; De Bourdeaudhuij, Ilse; Thomas, Samantha; Nelson-Field, Karen; Olds, Tim
Background Online social networks offer considerable potential for delivery of socially influential health behavior change interventions. Objective To determine the efficacy, engagement, and feasibility of an online social networking physical activity intervention with pedometers delivered via Facebook app. Methods A total of 110 adults with a mean age of 35.6 years (SD 12.4) were recruited online in teams of 3 to 8 friends. Teams were randomly allocated to receive access to a 50-day online social networking physical activity intervention which included self-monitoring, social elements, and pedometers (“Active Team” Facebook app; n=51 individuals, 12 teams) or a wait-listed control condition (n=59 individuals, 13 teams). Assessments were undertaken online at baseline, 8 weeks, and 20 weeks. The primary outcome measure was self-reported weekly moderate-to-vigorous physical activity (MVPA). Secondary outcomes were weekly walking, vigorous physical activity time, moderate physical activity time, overall quality of life, and mental health quality of life. Analyses were undertaken using random-effects mixed modeling, accounting for potential clustering at the team level. Usage statistics were reported descriptively to determine engagement and feasibility. Results At the 8-week follow-up, the intervention participants had significantly increased their total weekly MVPA by 135 minutes relative to the control group (P=.03), due primarily to increases in walking time (155 min/week increase relative to controls, Psocial networking physical activity intervention with pedometers can produce sizable short-term physical activity changes. Future work is needed to determine how to maintain behavior change in the longer term, how to reach at-need populations, and how to disseminate such interventions on a mass scale. Trial Registration Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12614000488606; https://www.anzctr.org.au/Trial/Registration/Trial
Full Text Available Abstract Background The present paper intends to contribute to the debate on the usefulness and barriers in applying theories in diet and physical activity behavior-change interventions. Discussion Since behavior theory is a reflection of the compiled evidence of behavior research, theory is the only foothold we have for the development of behavioral nutrition and physical activity interventions. Application of theory should improve the effectiveness of interventions. However, some of the theories we use lack a strong empirical foundation, and the available theories are not always used in the most effective way. Furthermore, many of the commonly-used theories provide at best information on what needs to be changed to promote healthy behavior, but not on how changes can be induced. Finally, many theories explain behavioral intentions or motivation rather well, but are less well-suited to explaining or predicting actual behavior or behavior change. For more effective interventions, behavior change theory needs to be further developed in stronger research designs and such change-theory should especially focus on how to promote action rather than mere motivation. Since voluntary behavior change requires motivation, ability as well as the opportunity to change, further development of behavior change theory should incorporate environmental change strategies. Conclusion Intervention Mapping may help to further improve the application of theories in nutrition and physical activity behavior change.
Zhai, Fuhua; Raver, C. Cybele; Li-Grining, Christine
Preschool teachers’ job stressors have received increasing attention but have been understudied in the literature. We investigated the impacts of a classroom-based intervention, the Chicago School Readiness Project (CSRP), on teachers’ perceived job stressors and confidence, as indexed by their perceptions of job control, job resources, job demands, and confidence in behavior management. Using a clustered randomized controlled trial (RCT) design, the CSRP provided multifaceted services to the...
Tesdahl, Eric; Gesell, Sabina B
Recent developments in the study of health and social networks have focused on linkages between health outcomes and naturally occurring social relations, such as friendship or kinship. Based on findings in this area, a new generation of health behavior intervention programs have been implemented that rely on the formation of new social relations among program participants. However, little is known about the qualities of these de novo social relations. We examined the social networks of 59 participants within a randomized controlled trial of an intervention designed to prevent excessive gestational weight gain. We employed exponential random graph modeling techniques to analyze supportive relationships formed between participants in the intervention arm, to detect unique effects of program participation on the likelihood of forming ties. Program participation had a positive effect on the likelihood of forming supportive social relations, however, in this particular timeframe we did not detect any additional effect of such relations on the health behaviors or outcomes of interest. Our findings raise two critical questions: do short-term group-level programs reliably lead to the formation of new social relations among participants; and do these relations have a unique effect on health outcomes relative to standard methods of health behavior intervention?
Samson, Séverine; Clément, Sylvain; Narme, Pauline; Schiaratura, Loris; Ehrlé, Nathalie
The management of patients with Alzheimer's disease is a significant public health problem given the limited effectiveness of pharmacological therapies combined with iatrogenic effects of drug treatments in dementia. Consequently, the development of nondrug care, such as musical interventions, has become a necessity. The experimental rigor of studies in this area, however, is often lacking. It is therefore difficult to determine the impact of musical interventions on patients with dementia. As part of a series of studies, we carried out randomized controlled trials to compare the effectiveness of musical activities to other pleasant activities on various functions in patients with severe Alzheimer's disease. The data obtained in these trials are discussed in light of the methodological constraints and requirements specific to these clinical studies. Although the results demonstrate the power of music on the emotional and behavioral status of patients, they also suggest that other pleasant activities (e.g., cooking) are also effective, leaving open the question about the specific benefits of music in patients with dementia. All these findings highlight the promising potential for nonpharmacological treatments to improve the well-being of patients living in residential care and to reduce caregiver burden. PMID:25773641
Laisaar, Kaja-Triin; Raag, Mait; Rosenthal, Marika; Uusküla, Anneli
Regular interactions with people living with HIV/AIDS (PLWHA) who are receiving care provide caregivers opportunities to deliver interventions to reduce HIV-related risks. We conducted a systematic review of behavioral interventions for PLWHA (provided at individual level by caregivers at HIV care settings) to determine their efficacy in reducing sexual risk behavior. Conference websites and biomedical literature databases were searched for studies from 1981 to 2013. Randomized and quasi-randomized controlled trials (with standard-of-care control groups), considering at least one of a list of HIV-related behavioral or biological outcomes in PLWHA aged ≥18 receiving HIV care with at least 3-month follow-up were included. No language or publication status restrictions were set. Standardized search, data abstraction, and evaluation methods were used. Five randomized controlled trials were included in the review. We found limited evidence that sexual risk reduction interventions increase condom use consistency in HIV transmission risk acts, and reduce the number of (casual) sexual partners. We still believe that regular interactions between HIV care providers and PLWHA provide valuable opportunities for theory-based sexual risk reduction interventions to restrain the spread of HIV. PMID:25844941
Sanetti, Lisa M. Hagermoser; Dobey, Lisa M.; Gritter, Katie L.
For more than 10 years, the "Journal of Positive Behavior Interventions" has published, among other types of articles, behavioral intervention outcome studies related to positive behavior support. Operationally defining interventions is important to facilitating replication studies and adoption of intervention in applied settings. Furthermore,…
Nimmer, Mark; Czachor, Jason; Turner, Laura; Thomas, Bobbe; Woodford, Ashley L; Carpenter, Karli; Gonzalez, Victor; Liem, Robert I; Ellison, Angela; Casper, T Charles; Brousseau, David C
Enrollment of patients in sickle cell intervention trials has been challenging due to difficulty in obtaining consent from a legal guardian and lack of collaboration between emergency medicine and hematology. We utilized education and preconsent in a pediatric multisite sickle cell intervention trial to overcome these challenges. Overall, 48 patients were enrolled after being preconsented. Variable Institutional Review Board policies related to preconsent validity and its allowable duration decreased the advantages of preconsent at some sites. The utility of preconsent for future intervention trials largely depends on local Institutional Review Board policies. Preeducation may also benefit the consent process, regardless of site differences. PMID:27081930
Reid, Allecia E; Carey, Kate B
Interventions to reduce college student drinking, although efficacious, generally yield only small effects on behavior change. Examining mechanisms of change may help to improve the magnitude of intervention effects by identifying effective and ineffective active ingredients. Informed by guidelines for establishing mechanisms of change, we conducted a systematic review of alcohol interventions for college students to identify (a) which constructs have been examined and received support as mediators, (b) circumstances that enhance the likelihood of detecting mediation, and (c) the extent of evidence for mechanisms of change. We identified 61 trials that examined 22 potential mediators of intervention efficacy. Descriptive norms consistently mediated normative feedback interventions. Motivation to change consistently failed to mediate motivational interviewing interventions. Multiple active ingredient interventions were not substantially more likely to find evidence of mediation than single ingredient interventions. Delivering intervention content remotely reduced likelihood of finding support for mediation. With the exception of descriptive norms, there is inadequate evidence for the psychosocial constructs purported as mechanisms of change in the college drinking literature. Evidence for mechanisms will be yielded by future studies that map all active ingredients to targeted psychosocial outcomes and that assess potential mediators early, inclusively, and at appropriate intervals following interventions. PMID:26164065
Peters Tim J
Full Text Available Abstract Background Standards for the reporting of factorial randomised trials remain to be established. We aimed to review the quality of reporting of methodological aspects of published factorial trials of complex interventions in community settings. Methods We searched MEDLINE, EMBASE, PsychInfo and the Cochrane Controlled Trials Register to identify factorial randomised trials of complex interventions in community settings from January 2000 to August 2009. We also conducted a citation search of two review papers published in 2003. Data were extracted by two reviewers on 22 items relating to study design, analysis and presentation. Results We identified 5941 unique titles, from which 116 full papers were obtained and 76 were included in the review. The included trials reflected a broad range of target conditions and types of intervention. The median sample size was 400 (interquartile range 191-1001. Most (88% trials employed a 2 × 2 factorial design. Few trials (21% explicitly stated the rationale for using a factorial design. Reporting of aspects of design, analysis or presentation specific to factorial trials was variable, but there was no evidence that reporting of these aspects was different for trials published before or after 2003. However, for CONSORT items that apply generally to the reporting of all trials, there was some evidence that later studies were more likely to report employing an intention-to-treat (ITT approach (78% vs 52%, present appropriate between-group estimates of effect (88% vs 63%, and present standard errors or 95% confidence intervals for such estimates (78% vs 56%. Interactions between interventions and some measure of the precision associated with such effects were reported in only 14 (18% trials. Conclusions Reports of factorial trials of complex interventions in community settings vary in the amount of information they provide regarding important methodological aspects of design and analysis. This variability
Zoellner, Jamie; Cook, Emily; Chen, Yvonnes; You, Wen; Davy, Brenda; Estabrooks, Paul
This Excessive sugar-sweetened beverage (SSB) consumption and low health literacy skills have emerged as two public health concerns in the United States (US); however, there is limited research on how to effectively address these issues among adults. As guided by health literacy concepts and the Theory of Planned Behavior (TPB), this randomized controlled pilot trial applied the RE-AIM framework and a mixed methods approach to examine a sugar-sweetened beverage (SSB) intervention (SipSmartER)...
McLaren, Elizabeth M.; Nelson, C. Michael
A withdrawal design repeated across three children enrolled in two Head Start classrooms was used to investigate the effectiveness of functional assessment-based interventions to decrease inappropriate behavior. The two questions addressed in the study were (a) Will a behavior intervention plan based on functional behavior assessment conducted in…
McIntosh, Kent; Campbell, Amy L.; Carter, Deborah Russell; Dickey, Celeste Rossetto
The purpose of this study was to investigate the effectiveness of a tier two daily behavior card intervention and differential effects based on function of problem behavior. The participants were 36 elementary school students nominated for additional intervention beyond universal School-Wide Positive Behavior Support. Measures included…
Harris, Karen R.; And Others
Two behavioral interventions (social reinforcement and token economy) and two cognitive-behavioral interventions (self-monitoring of work completed and academic self-instructional training) were rated by 203 special education teachers for acceptability at both mild and severe levels of academic and behavioral problems. Hypothetical case studies…
J. Brug (Hans); A. Oenema (Anke); A. Ferreira (Isabel)
textabstractBACKGROUND: The present paper intends to contribute to the debate on the usefulness and barriers in applying theories in diet and physical activity behavior-change interventions. DISCUSSION: Since behavior theory is a reflection of the compiled evidence of behavior research, theory is th
Althoff, Meghan D; Grayson, Cary T; Witt, Lucy; Holden, Julie; Reid, Daniel; Kissinger, Patricia
The objective of this meta-analysis was to determine the effect of behavioral interventions in reducing risky sexual behavior and incident sexually transmitted infections (STI) among Latina women living in the United States. Studies were found by systematically searching the MEDLINE, EMBASE, and PsychInfo databases without language restriction. Two independent reviewers screened abstracts and full texts of articles to find randomized control trials testing the effects of behavioral interventions aimed at changing risky sexual behavior among Latinas. Articles were selected using prespecified inclusion criteria. Two independent reviewers extracted data from the included trials in duplicate using a standardized data extraction form. Six randomized control trials met the inclusion criteria for a total of 2,909 participants. Using random effects models with inverse variance weighting, we found a protective effect of the behavioral intervention on reported risky sexual behavior (odds ratio = 0.52; 95% confidence interval = 0.42, 0.64) and on incident nonviral STI (odds ratio = 0.65; 95% confidence interval = 0.46, 0.93). Behavioral interventions targeted toward Latina populations are effective in reducing risky sexual behaviors and incident STI and should be considered by policymakers as a potential tool for HIV/STI prevention in this population.
Tait Robert J
Full Text Available Abstract Background The prevalence of amphetamine-type stimulant use is greater than that of opioids and cocaine combined. Currently, there are no approved pharmacotherapy treatments for amphetamine-type stimulant problems, but some face-to-face psychotherapies are of demonstrated effectiveness. However, most treatment services focus on alcohol or opioid disorders, have limited reach and may not appeal to users of amphetamine-type stimulants. Internet interventions have proven to be effective for some substance use problems but none has specifically targeted users of amphetamine-type stimulants. Design/method The study will use a randomized controlled trial design to evaluate the effect of an internet intervention for amphetamine-type stimulant problems compared with a waitlist control group. The primary outcome will be assessed as amphetamine-type stimulant use (baseline, 3 and 6 months. Other outcomes measures will include ‘readiness to change’, quality of life, psychological distress (K-10 score, days out of role, poly-drug use, help-seeking intention and help-seeking behavior. The intervention consists of three modules requiring an estimated total completion time of 90 minutes. The content of the modules was adapted from face-to-face clinical techniques based on cognitive behavior therapy and motivation enhancement. The target sample is 160 men and women aged 18 and over who have used amphetamine-type stimulants in the last 3 months. Discussion To our knowledge this will be the first randomized controlled trial of an internet intervention specifically developed for users of amphetamine-type stimulants. If successful, the intervention will offer greater reach than conventional therapies and may engage clients who do not generally seek treatment from existing service providers. Trial registration Australian and New Zealand Clinical Trials Registry (http://www.anzctr.org.au/ ACTRN12611000947909
Kern, Lee; Wehby, Joseph H.
In an earlier article (EJ1058920), Lee Kern and Joseph H. Wehby identified the reasons and process for using adaptive intensive behavioral intervention. Kern and Wehby use this article to present a fictional example of how the intervention is applied. Isaac, a 12 year old, 7th grade student at Highland Middle School, had a history of behavior…
Anne N Thorndike
Full Text Available BACKGROUND: Physicians are expected to serve as role models for healthy lifestyles, but long work hours reduce time for healthy behaviors. A hospital-based physical activity intervention could improve physician health and increase counseling about exercise. METHODS: We conducted a two-phase intervention among 104 medical residents at a large hospital in Boston, Massachusetts. Phase 1 was a 6-week randomized controlled trial comparing daily steps of residents assigned to an activity monitor displaying feedback about steps and energy consumed (intervention or to a blinded monitor (control. Phase 2 immediately followed and was a 6-week non-randomized team steps competition in which all participants wore monitors with feedback. Phase 1 outcomes were: 1 median steps/day and 2 proportion of days activity monitor worn. The Phase 2 outcome was mean steps/day on days monitor worn (≥500 steps/day. Physiologic measurements were collected at baseline and study end. Median steps/day were compared using Wilcoxon rank-sum tests. Mean steps were compared using repeated measures regression analyses. RESULTS: In Phase 1, intervention and control groups had similar activity (6369 vs. 6063 steps/day, p = 0.16 and compliance with wearing the monitor (77% vs. 77% of days, p = 0.73. In Phase 2 (team competition, residents recorded more steps/day than during Phase 1 (CONTROL: 7,971 vs. 7,567, p = 0.002; INTERVENTION: 7,832 vs. 7,739, p = 0.13. Mean compliance with wearing the activity monitor decreased for both groups during Phase 2 compared to Phase 1 (60% vs. 77%, p<0.001. Mean systolic blood pressure decreased (p = 0.004 and HDL cholesterol increased (p<0.001 among all participants at end of study compared to baseline. CONCLUSIONS: Although the activity monitor intervention did not have a major impact on activity or health, the high participation rates of busy residents and modest changes in steps, blood pressure, and HDL suggest that more
Montero-Marín, Jesús; Araya, Ricardo; Mayoral, Fermín; Gili, Margalida; Botella, Cristina; Baños, Rosa; Castro, Adoración; Romero-Sanchiz, Pablo; López-Del-Hoyo, Yolanda; Nogueira-Arjona, Raquel; Vives, Margarita; Riera, Antoni; García-Campayo, Javier
Background Depression is the most prevalent cause of illness-induced disability worldwide. Face-to-face psychotherapeutic interventions for depression can be challenging, so there is a need for other alternatives that allow these interventions to be offered. One feasible alternative is Internet-based psychological interventions. This is the first randomized controlled trial (RCT) on the effectiveness of an Internet-based intervention on depression in primary health care in Spain. Objective Our aim was to compare the effectiveness of a low-intensity therapist-guided (LITG) Internet-based program and a completely self-guided (CSG) Internet-based program with improved treatment as usual (iTAU) care for depression. Methods Multicenter, three-arm, parallel, RCT design, carried out between November 2012 and January 2014, with a follow-up of 15 months. In total, 296 adults from primary care settings in four Spanish regions, with mild or moderate major depression, were randomized to LITG (n=96), CSG (n=98), or iTAU (n=102). Research completers at follow-up were 63.5%. The intervention was Smiling is Fun, an Internet program based on cognitive behavioral therapy. All patients received iTAU by their general practitioners. Moreover, LITG received Smiling is Fun and the possibility of psychotherapeutic support on request by email, whereas CSG received only Smiling is Fun. The main outcome was the Beck Depression Inventory-II at 3 months from baseline. Mixed-effects multilevel analysis for repeated measures were undertaken. Results There was no benefit for either CSG [(B coefficient=-1.15; P=.444)] or LITG [(B=-0.71; P=.634)] compared to iTAU, at 3 months. There were differences at 6 months [iTAU vs CSG (B=-4.22; P=.007); iTAU vs LITG (B=-4.34; P=.005)] and 15 months [iTAU vs CSG (B=-5.10; P=.001); iTAU vs LITG (B=-4.62; P=.002)]. There were no differences between CSG and LITG at any time. Adjusted and intention-to-treat models confirmed these findings. Conclusions An Internet
Hops, Hyman; Ozechowski, Timothy J; Waldron, Holly B; Davis, Betsy; Turner, Charles W; Brody, Janet L; Barrera, Manuel
Adolescents who abuse substances are more likely to engage in health-risking sexual behavior (HRSB) and are at particularly high risk for HIV/AIDS. Thus, substance abuse treatment presents a prime opportunity to target HIV-risk behaviors. The present study evaluated a one-session HIV-risk intervention embedded in a controlled clinical trial for drug-abusing adolescents. The trial was conducted in New Mexico and Oregon with Hispanic and Anglo adolescents. Youths were randomly assigned to individual cognitive behavior therapy (CBT) or to an integrated behavioral and family therapy (IBFT) condition, involving individual and family sessions. The HIV-specific intervention was not associated with change. IBFT and CBT were both efficacious in reducing HIV-risk behaviors from intake to the 18-month follow-up for high-risk adolescents. For low-risk adolescents, CBT (versus IBFT) was more efficacious in suppressing HRSB. These data suggest that drug abuse treatments can have both preventative and intervention effects for adolescents, depending on their relative HIV-risk. PMID:21833690
van Scheppingen, Corinne; Schroevers, Maya J.; Pool, Grieteke; Smink, Ans; Mul, Veronique E.; Coyne, James C.; Sanderman, Robbert
ObjectivesPsychological interventions show greater efficacy when evaluated with distressed patients. We report on the feasibility of implementing screening for recruiting distressed cancer patients to a randomized controlled trial of problem-solving therapy (PST), characteristics associated with enr
Savović, J; Jones, He; Altman, Dg;
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...
Lindhiem, Oliver; Bennett, Charles B; Rosen, Dana; Silk, Jennifer
We conducted a meta-analysis on the effects of mobile technology on treatment outcome for psychotherapy and other behavioral interventions. Our search of the literature resulted in 26 empirical articles describing 25 clinical trials testing the benefits of smartphone applications, personal digital assistants (PDAs), or text messaging systems either to supplement treatment or substitute for direct contact with a clinician. Overall, mobile technology use was associated with superior treatment outcome across all study designs and control conditions, effect size (ES) = .34, p Treatment" versus "Treatment + Mobile" design, effect sizes were only slightly more modest (ES = .27) and still significant (p interventions.
Gao, Yongqing; CAI, Chunsheng; Li, Jian; Sun, Wenjie
Background: To examine the effect of nutritional education on children’s breakfast patternsMethods: A kindergarten based nutrition intervention was started in September 2001 among 8 kindergartens in Hefei with a total of 2,012 children aged 4-6 years and their parent pairs.Results: Monthly nutrition education sessions were held over two semesters in kindergartens part of the intervention arm. The approach in education and the content of other activities were uniform across all the kindergart...
Diet, physical exercise and cognitive behavioral training as a combined workplace based intervention to reduce body weight and increase physical capacity in health care workers - a randomized controlled trial
Holtermann Andreas; Overgaard Kristian; Ekner Dorte; Faber Anne; Christensen Jeanette R; Søgaard Karen
Abstract Background Health care workers comprise a high-risk workgroup with respect to deterioration and early retirement. There is high prevalence of obesity and many of the workers are overweight. Together, these factors play a significant role in the health-related problems within this sector. The present study evaluates the effects of the first 3-months of a cluster randomized controlled lifestyle intervention among health care workers. The intervention addresses body weight, general heal...
Full Text Available Abstract Background Caregivers of relatives with Alzheimer’s disease are highly stressed and at risk for physical and psychiatric conditions. Interventions are usually focused on providing caregivers with knowledge of dementia, skills, and/or support, to help them cope with the stress. This model, though true to a certain extent, ignores how caregiver stress is construed in the first place. Besides burden, caregivers also report rewards, uplifts, and gains, such as a sense of purpose and personal growth. Finding benefits through positive reappraisal may offset the effect of caregiving on caregiver outcomes. Design Two randomized controlled trials are planned. They are essentially the same except that Trial 1 is a cluster trial (that is, randomization based on groups of participants whereas in Trial 2, randomization is based on individuals. Participants are randomized into three groups - benefit finding, psychoeducation, and simplified psychoeducation. Participants in each group receive a total of approximately 12 hours of training either in group or individually at home. Booster sessions are provided at around 14 months after the initial treatment. The primary outcomes are caregiver stress (subjective burden, role overload, and cortisol, perceived benefits, subjective health, psychological well-being, and depression. The secondary outcomes are caregiver coping, and behavioral problems and functional impairment of the care-recipient. Outcome measures are obtained at baseline, post-treatment (2 months, and 6, 12, 18 and 30 months. Discussion The emphasis on benefits, rather than losses and difficulties, provides a new dimension to the way interventions for caregivers can be conceptualized and delivered. By focusing on the positive, caregivers may be empowered to sustain caregiving efforts in the long term despite the day-to-day challenges. The two parallel trials will provide an assessment of whether the effectiveness of the intervention
Emerson, John F; Welch, Madelyn; Rossman, Whitney E; Carek, Stephen; Ludden, Thomas; Templin, Megan; Moore, Charity G; Tapp, Hazel; Dulin, Michael; McWilliams, Andrew
Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH) services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32%) by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention, participants had a
John F. Emerson
Full Text Available Advances in technology are likely to provide new approaches to address healthcare disparities for high-risk populations. This study explores the feasibility of a new approach to health disparities research using a multidisciplinary intervention and advanced communication technology to improve patient access to care and chronic disease management. A high-risk cohort of uninsured, poorly-controlled diabetic patients was identified then randomized pre-consent with stratification by geographic region to receive either the intervention or usual care. Prior to enrollment, participants were screened for readiness to make a behavioral change. The primary outcome was the feasibility of protocol implementation, and secondary outcomes included the use of patient-centered medical home (PCMH services and markers of chronic disease control. The intervention included a standardized needs assessment, individualized care plan, intensive management by a multidisciplinary team, including health coach-facilitated virtual visits, and the use of a cloud-based glucose monitoring system. One-hundred twenty-seven high-risk, potentially eligible participants were randomized. Sixty-one met eligibility criteria after an in-depth review. Due to limited resources and time for the pilot, we only attempted to contact 36 participants. Of these, we successfully reached 20 (32% by phone and conducted a readiness to change screen. Ten participants screened in as ready to change and were enrolled, while the remaining 10 were not ready to change. Eight enrolled participants completed the final three-month follow-up. Intervention feasibility was demonstrated through successful implementation of 13 out of 14 health coach-facilitated virtual visits, and 100% of participants indicated that they would recommend the intervention to a friend. Protocol feasibility was demonstrated as eight of 10 participants completed the entire study protocol. At the end of the three-month intervention
de Haas M; Zajdel D; Kishiyama S; Flegal KE; BS, Oken
Abstract Background To determine factors that predict adherence to a mind-body intervention in a randomized trial. Design We analyzed adherence data from a 3-arm trial involving 135 generally healthy seniors 65–85 years of age randomized to a 6-month intervention consisting of: an Iyengar yoga class with home practice, an exercise class with home practice, or a wait-list control group. Outcome measures included cognitive function, mood, fatigue, anxiety, health-related quality of life, and ph...
Degarmo, David S; Chamberlain, Patricia; Leve, Leslie D; Price, Joe
OBJECTIVE: The authors conduct a within intervention group analysis to test whether caregiver engagement (e.g., participation, homework completion, openness to ideas, apparent satisfaction) in a group-based intervention moderates risk factors for foster child outcomes in a state-supported randomized trial of caregiver parent training. METHODS: The intervention is delivered in 16 weekly sessions by trained leaders. Outcomes are pre-post change in problem behaviors and negative placements. RESULTS: Analysis of 337 caregivers nested within 59 parent groups show caregiver engagement moderates number of prior placements on increases in child problem behaviors, and moderates risk of negative placement disruption for Hispanics. CONCLUSIONS: Variance in parent group process affects program effectiveness. Implications for practice and increasing effective engagement are discussed.
Korsten-Reck, U; Wolfarth, B; Bonk, M; Keul, J; Berg, A
Freiburg Intervention Trial for Obese Children (FITOC) is an interdisciplinary treatment program for obese children, which is established in Freiburg since 1987. Obese children at the age of 8-11 are treated in an eight months intensive period and a follow-up period of 4 months or more. Since 1990 data from 283 children coming out of 15 treatment groups (about 2 groups per year) were collected and analyzed. The program consists of regular physical training (3 times a week), comprehensive nutrition and behaviour training (overall 7 parents evenings each 4 to 6 weeks and 7 cookery courses for the kids in the same time scale). The parents evenings are filled with theoretical and practical information about nutrition as well as background information about the psychological and physiological problems in obese children. In the first examination and the regular control examinations anthropometric, biochemical and exercise physiology data are investigated. In addition, questionnaires for nutrition and behaviour are analysed on a regular basis. At each examination, depending on the progress in therapy, a new orientation with adapted goals will be discussed with the child and the parents. For the growing children a moderate reduction or long term stabilisation of weight will lead to success. Teaching goal for the children in the intensive period is to control themselves and, depending on their specific situation, to establish individual recommendations on a long term basis. The sports program should lead to an increase in self-esteem and a raise in daily energy expenditure. The team includes a physician, a nutritionist, a psychologist and a sports teacher. From 1997 the program was spread to institutions in the surroundings of Freiburg. Training for the external teams is provided for in continuous seminars. Teaching material includes a manual, forms and transparencies. The major goal is to secure quality by continuous training and close interaction between the institutions
This paper's objective is to apply Intervention Mapping, a planning process for the systematic development of theory- and evidence-based health promotion interventions, to the development of interventions to promote energy conservation behavior. Intervention Mapping (IM) consists of six steps: needs assessment, program objectives, methods and applications, program development, planning for program implementation, and planning for program evaluation. Examples from the energy conservation field are provided to illustrate the activities associated with these steps. It is concluded that applying IM in the energy conservation field may help the development of effective behavior change interventions, and thus develop a domain specific knowledge-base for effective intervention design. - Highlights: → Intervention Mapping (IM) is a planning process for developing evidence-based interventions.→ IM takes a problem-driven rather than theory-driven approach. → IM can be applied to the promotion of energy-conservation in a multilevel approach. → IM helps identifying determinants of behaviors and environmental conditions. → IM helps selecting appropriate theory-based methods and practical applications.
Gant, Judith R.
Objectives This study examined the differential impact of two telehealth programs for women caring for an older adult with a neurocognitive disorder. Outcomes examined were depressive symptoms, upset following disruptive behaviors, anxious and angry mood states, and caregiving self‐efficacy. Methods Women cohabitating with a family member diagnosed with a neurocognitive disorder were assigned via random allocation to either of the following: (1) a 14‐week behavioral intervention using video instructional materials, workbook and telephone coaching in behavioral management, pleasant events scheduling, and relaxation or (2) a basic education guide and telephone support comparison condition. Telephone assessments were conducted by interviewers blind to treatment condition at pre‐intervention, post‐intervention, and 6 months following intervention. Results For those providing in‐home care at post‐treatment, depressive symptoms, upset following disruptive behaviors, and negative mood states were statistically lower in the behavioral coaching condition than in the basic education and support condition. Reliable change index analyses for Beck Depression Inventory II scores favored the behavioral coaching condition. Caregiving self‐efficacy scores for obtaining respite and for managing patient behavioral disturbances were significantly higher in the coaching condition. Effect sizes were moderate but not maintained at the 6‐month follow‐up. Conclusions This study provides some initial evidence for the efficacy of a telehealth behavioral coaching intervention compared with basic education and telephone support. Carers' abilities to maintain strategy use during progressive disorders such as Alzheimer's disease likely require longer intervention contact than provided in the current study. Dementia carers, including those living in rural areas, can benefit from accessible and empirically supported interventions that can be easily disseminated across distances
Rasmussen, Ole Dahl; Malchow-Møller, Nikolaj; Andersen, Thomas Barnebeck
Recent advances in the use of randomised control trials to evaluate the effect of development interventions promise to enhance our knowledge of what works and why. A core argument supporting randomised studies is the claim that they have high internal validity. The authors argue that this claim i...... microfinance, they argue that a trial registry would also enhance external validity and foster innovative research....
Bello, Segun; Wei, Maoling; Hilden, Jørgen;
Background: Blinding is a pivotal method to avoid bias in randomised clinical trials. In blinded drug trials, experimental and control interventions are often designed to be matched, i.e. to appear indistinguishable. It is unknown how often matching procedures are inadequate, so we decided...
Leblanc, Marie-Pierre; Ricciardi, Joseph N.; Luiselli, James K.
We evaluated an abbreviated performance feedback intervention as a training strategy to improve discrete trial instruction of children with autism by three paraprofessional staff (assistant teachers) at a specialized day school. Feedback focused on 10 discrete trial instructional skills demonstrated by the staff during teaching sessions. Following…
Schölzel-Dorenbos, C.J.M.; Steen, M.J. van der; Engels, L.K.; Olde Rikkert, M.G.M.
We conducted a systematic review of the use of quality of life (QoL) measures as outcome in pharmacological and nonpharmacologic intervention trials in patients with Mild Cognitive Impairment or dementia, and their proxies. Randomized controlled trials (RCTs) were identified from a search of the Spe
Punthakee, Z; Bosch, J; Dagenais, G;
AIMS/OBJECTIVE: Conflicting data regarding cardiovascular effects of thiazolidinediones (TZDs) and extra-skeletal effects of vitamin D supported the need for a definitive trial. The Thiazolidinedione Intervention with vitamin D Evaluation (TIDE) trial aimed to assess the effects of TZDs (rosiglit...
Jakicic, John M.; Rickman, Amy D.; Lang, Wei; Davis, Kelliann K.; Gibbs, Bethany Barone; Neiberg, Rebecca; Marcus, Marsha D.
Purpose To examine whether enhancing standard behavior weight loss interventions (SBWP) with additional strategies at the initiation of the intervention (ADOPT) or providing the additional strategies at predetermined times over the intervention period (MAINTAIN) enhances 18 month weight loss. Methods This was a clinical trial with participants (n=195; age= 43.2±8.6 yrs; BMI= 33.0±3.4 kg/m2) randomized to SBWP, ADOPT, or MAINTAIN. All were prescribed an energy restricted diet and physical activity, with group intervention sessions delivered over 18 months. ADOPT received additional phone contact (months 1–3), supervised exercise (months 1–6), and behavior campaigns (months 4–9). MAINTAIN received additional phone contact (months 4–6), supervised exercise (months 7–12), and behavior campaigns (months 13–18). Results There was a significant Group X Time interaction for weight loss (p=0.0032). SBWP lost 9.3±0.9, 7.8±1.1, and 5.9±1.2 kg at 6, 12, and 18 months, respectively. ADOPT lost 8.9±0.9, 7.6±1.2, and 5.8±1.2 kg, and MAINTAIN lost 9.7±0.9, 11.0±1.2, and 9.0±1.2 kg at 6, 12, and 18 months, respectively. The Group X Time interaction for SBWP vs. MAINTAIN (p=0.0033) and ADOPT vs. MAINTAIN (p=0.0075) was significant. There was a significant Group X Time interaction for change in fitness (p=0.0060). The Group X Time interaction for MAINTAIN vs. ADOPT (p=0.0018) was significant with a trend for MAINTAIN vs. SBWP (p=0.0525). Conclusions MAINTAIN improved 18-month weight loss compared to SBWP and ADOPT, with statistical trends that MAINTAIN resulted in greater improvements in fitness. These results suggest that time-based strategies emphasizing physical activity conferred greater benefits when delivered later and over the full course of intervention. This provides valuable information for the implementation of time-based strategies to improve long-term weight loss and fitness in overweight and obese adults. PMID:25160843
Batista, Maja; Mestrović, Antonela; Vekić, Ana Marija; Malenical, Masa; Kukuruzović, Monika; Begovac, Ivan
A pilot study was conducted to examine the efficiency and satisfaction of cognitive behavioral therapy (CBT) intervention in youth with epilepsy regarding coping strategies. The CBT intervention was based on the main principles and empirically supported cognitive-behavioral techniques. The intervention consists of epilepsy education, stress education, and coping skill strategies. Seventeen children and adolescents aged 9-17 diagnosed with epilepsy for at least one year, with at least average intelligence and no history of serious mental illness completed the CBT intervention during summer camp, providing data on the efficiency of and satisfaction with CBT intervention. Upon completion of the CBT intervention, study subjects achieved significantly higher scores on the following Scale of Coping with Stress subscales: Problem solving; Seeking for social support from friends; Seeking for social support from family; and Cognitive restructuring, for both measures of usage frequency and effectiveness of each subscale. The participants reported a high level of satisfaction with the CBT intervention. This study provided explanation of research limitations and recommendations for future clinical trials.
Tussing-Humphreys, Lisa M; Fitzgibbon, Marian L; Kong, Angela; Odoms-Young, Angela
We performed a systematic review of the behavioral lifestyle intervention trials conducted in the United States published between 1990 and 2011 that included a maintenance phase of at least six months, to identify intervention features that promote weight loss maintenance in African American women. Seventeen studies met the inclusion criteria. Generally, African American women lost less weight during the intensive weight loss phase and maintained a lower % of their weight loss compared to Caucasian women. The majority of studies failed to describe the specific strategies used in the delivery of the maintenance intervention, adherence to those strategies, and did not incorporate a maintenance phase process evaluation making it difficult to identify intervention characteristics associated with better weight loss maintenance. However, the inclusion of cultural adaptations, particularly in studies with a mixed ethnicity/race sample, resulted in less % weight regain for African American women. Studies with a formal maintenance intervention and weight management as the primary intervention focus reported more positive weight maintenance outcomes for African American women. Nonetheless, our results present both the difficulty in weight loss and maintenance experienced by African American women in behavioral lifestyle interventions.
Batista, Maja; Mestrović, Antonela; Vekić, Ana Marija; Malenical, Masa; Kukuruzović, Monika; Begovac, Ivan
A pilot study was conducted to examine the efficiency and satisfaction of cognitive behavioral therapy (CBT) intervention in youth with epilepsy regarding coping strategies. The CBT intervention was based on the main principles and empirically supported cognitive-behavioral techniques. The intervention consists of epilepsy education, stress education, and coping skill strategies. Seventeen children and adolescents aged 9-17 diagnosed with epilepsy for at least one year, with at least average intelligence and no history of serious mental illness completed the CBT intervention during summer camp, providing data on the efficiency of and satisfaction with CBT intervention. Upon completion of the CBT intervention, study subjects achieved significantly higher scores on the following Scale of Coping with Stress subscales: Problem solving; Seeking for social support from friends; Seeking for social support from family; and Cognitive restructuring, for both measures of usage frequency and effectiveness of each subscale. The participants reported a high level of satisfaction with the CBT intervention. This study provided explanation of research limitations and recommendations for future clinical trials. PMID:27017721
Strom Joni L
Full Text Available Abstract Background African Americans with Type 2 diabetes (T2DM have higher prevalence of diabetes, poorer metabolic control, and greater risk for complications and death compared to American Whites. Poor outcomes in African Americans with T2DM can be attributed to patient, provider, and health systems level factors. Provider and health system factors account for Methods/Design We describe an ongoing four-year randomized clinical trial, using a 2 × 2 factorial design, which will test the efficacy of separate and combined telephone-delivered, diabetes knowledge/information and motivation/behavioral skills training interventions in high risk African Americans with poorly controlled T2DM (HbA1c ≥ 9%. Two-hundred thirty-two (232 male and female African-American participants, 18 years of age or older and with an HbA1c ≥ 9%, will be randomized into one of four groups for 12-weeks of phone interventions: (1 an education group, (2 a motivation/skills group, (3 a combined group or (4 a usual care/general health education group. Participants will be followed for 12-months to ascertain the effect of the interventions on glycemic control. Our primary hypothesis is that among African Americans with poorly controlled T2DM, patients randomized to the combined diabetes knowledge/information and motivation/behavioral skills training intervention will have significantly greater reduction in HbA1c at 12 months of follow-up compared to the usual care/general health education group. Discussion Results from this study will provide important insight into how best to deliver diabetes education and skills training in ethnic minorities and whether combined knowledge/information and motivation/behavioral skills training is superior to the usual method of delivering diabetes education for African Americans with poorly controlled T2DM. Trial registration National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier# NCT00929838.
Kern, Lee; Gallagher, Patricia; Starosta, Kristin; Hickman, Wesley; George, Michael
A critical measure of intervention effectiveness is durability over time. Still, few studies have examined the long-term outcomes of support derived from a functional behavioral assessment as well as enablers and barriers that contribute to or impede successful outcomes. In the current study, a functional behavioral assessment was conducted with a…
Verduyn, Chrissie; Calam, Rachel
Discussion of cognitive behavioral interventions with abused children and adolescents covers use of cognitive therapy with adults, therapeutic processes in cognitive therapy, involvement of parents and carers in cognitive behavioral therapy, and cognitive schema and maltreatment. Application is made to types of abuse (physical, emotional, sexual)…
McAllister, Joseph R., Jr.
A model for developing systemwide interventions for behavioral and social skill deficits in preschool children with handicaps is discussed. The model incorporates a comprehensive, curriculum-based approach to assessment and program planning and a competency-based, didactic approach to teaching behavioral and social skills. (Author/DB)
Ndebele Paul M
Full Text Available Abstract Background The intervention reported in this paper was a follow up to an empirical study conducted in Malawi with the aim of assessing trial participants’ understanding of randomisation, double-blinding and placebo use. In the empirical study, the majority of respondents (61.1%; n=124 obtained low scores (lower than 75% on understanding of all three concepts under study. Based on these findings, an intervention based on a narrative which included all three concepts and their personal implications was designed. The narrative used daily examples from the field of Agriculture because Malawi has an agro-based economy. Methods The intervention was tested using a sample of 36 women who had been identified as low scorers during the empirical study. The 36 low scorers were randomly assigned to control (n=18 and intervention arms (n=18. The control arm went through a session in which they were provided with standard informed consent information for the microbicide trial. The intervention arm went through a session in which they were provided with a narrative in ChiChewa, the local language, with the assistance of a power point presentation which included pictures as well as discussions on justification and personal implications of the concepts under study. Results The findings on the efficacy of the intervention suggest that the 3 scientific concepts and their personal implications can be understood by low literacy populations using simple language and everyday local examples. The findings also suggest that the intervention positively impacted on understanding of trial procedures under study, as 13 of the 18 women in the intervention arm, obtained high scores (above 75% during the post intervention assessment and none of the 18 in the control arm obtained a high score. Using Fischer’s exact test, it was confirmed that the effect of the intervention on understanding of the three procedures was statistically significant (p=0.0001. Conclusions
Duff, Fiona J.; Hulme, Charles; Grainger, Katy; Hardwick, Samantha J.; Miles, Jeremy N. V.; Snowling, Margaret J.
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…
Griffiths, Kathleen M.; Christensen, Helen
Self-help Internet interventions have the potential to enable consumers to play a central role in managing their own health. This paper contains a systematic review of 15 randomised controlled trials of the effectiveness of self-help Internet interventions for mental disorders and related conditions. Conditions addressed by the interventions…
VanderWeele, Tyler J.; Hawkley, Louise C.; Thisted, Ronald A.; Cacioppo, John T.
Objective: Clinical scientists, policymakers, and individuals must make decisions concerning effective interventions that address health-related issues. We use longitudinal data on loneliness and depressive symptoms and a new class of causal models to illustrate how empirical evidence can be used to inform intervention trial design and clinical…
Villarruel, Antonia M.; Cherry, Carol Loveland; Cabriales, Esther Gallegos; Ronis, David L.; Zhou, Yan
This article reports results of a randomized controlled trial designed to test an intervention to increase parent-adolescent sexual risk communication among Mexican parents. Data were analyzed from parents (n = 791) randomly assigned to an HIV risk reduction or health promotion intervention. Measures were administered at pretest, posttest, and 6-…
Fox, Patrick J.; Vazquez, Laurie; Tonner, Chris; Stevens, Judy A.; Fineman, Norman; Ross, Leslie K.
Using a randomized controlled trial, we tested the efficacy of a fall prevention intervention to reduce falls among adults in a community-based health promotion program. Adults aged 65 and older within two counties were recruited (control n = 257; intervention n = 286). After 12 months, there was a significant decrease in the number of falls in…
Mahantshetti Niranjana S
Full Text Available Abstract Background This randomized controlled trial aims to evaluate the effects of an early developmental intervention program on the development of young children in low- and low-middle-income countries who are at risk for neurodevelopmental disability because of birth asphyxia. A group of children without perinatal complications are evaluated in the same protocol to compare the effects of early developmental intervention in healthy infants in the same communities. Birth asphyxia is the leading specific cause of neonatal mortality in low- and low-middle-income countries and is also the main cause of neonatal and long-term morbidity including mental retardation, cerebral palsy, and other neurodevelopmental disorders. Mortality and morbidity from birth asphyxia disproportionately affect more infants in low- and low-middle-income countries, particularly those from the lowest socioeconomic groups. There is evidence that relatively inexpensive programs of early developmental intervention, delivered during home visit by parent trainers, are capable of improving neurodevelopment in infants following brain insult due to birth asphyxia. Methods/Design This trial is a block-randomized controlled trial that has enrolled 174 children with birth asphyxia and 257 without perinatal complications, comparing early developmental intervention plus health and safety counseling to the control intervention receiving health and safety counseling only, in sites in India, Pakistan, and Zambia. The interventions are delivered in home visits every two weeks by parent trainers from 2 weeks after birth until age 36 months. The primary outcome of the trial is cognitive development, and secondary outcomes include social-emotional and motor development. Child, parent, and family characteristics and number of home visits completed are evaluated as moderating factors. Discussion The trial is supervised by a trial steering committee, and an independent data monitoring
Verbakel, Natasha J.; Langelaan, Maaike; Verheij, Theo J M; Wagner, Cordula; Zwart, Dorien L M
Background: A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim: To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting: A three-arm cluster randomised trial
Noelle R Leonard
Full Text Available We investigated the impact of cognitive behavioral therapy and mindfulness training (CBT/MT on attentional task performance in incarcerated adolescents. Attention is a cognitive system necessary for managing cognitive demands and regulating emotions. Yet persistent and intensive demands, such as those experienced during high-stress intervals like incarceration and the events leading to incarceration, may deplete attention resulting in cognitive failures, emotional disturbances, and impulsive behavior. We hypothesized that CBT/MT may mitigate these deleterious effects of high stress and protect against degradation in attention over the high-stress interval of incarceration. Using a group randomized controlled trial design, we randomly assigned dormitories of incarcerated youth, ages 16 to 18, to a CBT/MT intervention (youth n = 147 or an active control intervention (youth n = 117. Both arms received approximately 750 minutes of intervention in a small-group setting over a 3-5 week period. Youth in the CBT/MT arm also logged the amount of out-of-session time spent practicing MT exercises. The Attention Network Test was used to index attentional task performance at baseline and 4 months post-baseline. Overall, task performance degraded over time in all participants. The magnitude of performance degradation was significantly less in the CBT/MT vs. control arm. Further, within the CBT/MT arm, performance degraded over time in those with no outside-of-class practice time, but remained stable over time in those who practiced mindfulness exercises outside of the session meetings. Thus, these findings suggest that sufficient CBT/MT practice may protect against functional attentional impairments associated with high-stress intervals. Keywords: adolescent development, incarcerated adolescents, detained adolescents, stress, attention, mindfulness meditation.
Stephenson, J M; Oakley, A; Charleston, S.; Brodala, A.; Fenton, K; Petruckevitch, A; Johnson, A. M.
OBJECTIVE: To assess the feasibility of conducting a large randomised controlled trial (RCT) of peer led intervention in schools to reduce the risk of HIV/STD and promote sexual health. METHODS: Four secondary schools in Greater London were randomly assigned to receive peer led intervention (two experimental schools) or to act as control schools. In the experimental schools, trained volunteers aged 16-17 years (year 12) delivered the peer led intervention to 13-14 year old pupils (year ...
Tadjerbashi, Kamelia; Rosales, Roberto S; Atroshi, Isam
Background: Although arthroscopy of upper extremity joints was initially a diagnostic tool, it is increasingly used for therapeutic interventions. Randomized controlled trials (RCTs) are considered the gold standard for assessing treatment efficacy. We aimed to review the literature for intervention RCTs involving wrist and shoulder arthroscopy. Methods: We performed a systematic review for RCTs in which at least one arm was an intervention performed through wrist arthroscopy or shoulder arth...
Alkahtani, Keetam D. F.
Children's challenging behaviors can be addressed with effective interventions that can meet children's emotional needs and support their families. Positive Behavioral Interventions and Supports (PBIS) value the family involvement in the process of their child treatment. The intention of this study was to use concept mapping as an adjunct to PBIS…
Fitzgerald, G K; Hinman, R S; Zeni, J; Risberg, M A; Snyder-Mackler, L; Bennell, K L
A Task Force of the Osteoarthritis Research Society International (OARSI) has previously published a set of guidelines for the conduct of clinical trials in osteoarthritis (OA) of the hip and knee. Limited material available on clinical trials of rehabilitation in people with OA has prompted OARSI to establish a separate Task Force to elaborate guidelines encompassing special issues relating to rehabilitation of OA. The Task Force identified three main categories of rehabilitation clinical trials. The categories included non-operative rehabilitation trials, post-operative rehabilitation trials, and trials examining the effectiveness of devices (e.g., assistive devices, bracing, physical agents, electrical stimulation, etc.) that are used in rehabilitation of people with OA. In addition, the Task Force identified two main categories of outcomes in rehabilitation clinical trials, which include outcomes related to symptoms and function, and outcomes related to disease modification. The guidelines for rehabilitation clinical trials provided in this report encompass these main categories. The report provides guidelines for conducting and reporting on randomized clinical trials. The topics include considerations for entering patients into trials, issues related to conducting trials, considerations for selecting outcome measures, and recommendations for statistical analyses and reporting of results. The focus of the report is on rehabilitation trials for hip, knee and hand OA, however, we believe the content is broad enough that it could be applied to rehabilitation trials for other regions as well.
Robbins, Michael S; Horigian, Viviana E; Szapocznik, José
Brief Strategic Family Therapy (BSFT) is an empirically-supported treatment for children and adolescents with behavior problems and substance use problems. For three decades, the efficacy and effectiveness of BSFT has been established through the results of rigorous clinical trials studies conducted at the University of Miami's Center for Family Studies. BSFT is based on family systems approaches, most notably the work of Salvador Minuchin and Jay Haley, but has been refined to meet the pressing needs of youth with behavior problems. BSFT theory and interventions cover four broad domains: joining with family members and the family system, assessing problematic family interactions, creating a motivational context for change, and restructuring family interactions.
Beich, A.; Gannik, D.; Saelan, H.;
and brief intervention (SBI) in general practice. METHODS: A randomized PCT (brief counselling intervention vs no intervention) involving 39 Danish general practitioners (GPs). Systematic screening of 6897 adults led to inclusion of 906 risky drinkers, and research follow-up on 537 of these after 12......AIMS: Recommendations for routine alcohol screening and brief counselling intervention in primary health care rest on results from intervention efficacy studies. By conducting a pragmatic controlled trial (PCT), we aimed at evaluating the effectiveness of the WHO recommendations for screening......-14 months. Outcome measures focused on patients' acceptance of screening and intervention and their self-reported alcohol consumption. RESULTS: Patient acceptance of screening and intervention -10.3% (N = 794) of the target population (N = 7, 691) explicitly refused screening. All intervention group...
O'Hare, Liam; Biggart, Andy; Kerr, Karen; Connolly, Paul
A randomized controlled trial was used to evaluate the effects of a prosocial behavior after-school program called Mate-Tricks for 9- and 10-year-old children and their parents living in an area of significant socioeconomic disadvantage. The children were randomly assigned to an intervention (n = 220) or a control group (n = 198). Children were…
Compas, Bruce E.; Forehand, Rex; Thigpen, Jennifer; HARDCASTLE, EMILY; Garai, Emily; McKee, Laura; Keller, Gary; DUNBAR, JENNIFER P.; Watson, Kelly H.; Rakow, Aaron; Bettis, Alexandra; Reising, Michelle; Cole, David; Sterba, Sonya
Building on an earlier study (Compas et al., 2011), tests of main effects and potential moderators of a family group cognitive-behavioral (FGCB) preventive intervention for children of parents with a history of depression are reported in a sample of 180 families (242 children ages 9-15 years) in a randomized controlled trial assessed at 2-, 6-, 12-, 18- and 24-months after baseline. Significant effects favoring the FGCB intervention over a written information (WI) comparison condition were fo...
Compas, Bruce E.; Forehand, Rex; Thigpen, Jennifer C.; Keller, Gary; Hardcastle, Emily J.; Cole, David A.; Potts, Jennifer; H. Watson, Kelly; Rakow, Aaron; Colletti, Christina; Reeslund, Kristen; Fear, Jessica; Garai, Emily; McKee, Laura; Merchant, M. J.; Roberts, Lorinda
Objective: In a long-term follow-up of a randomized controlled trial (Compas et al., 2009) to examine the effects at 18- and 24-month follow-ups of a family group cognitive-behavioral (FGCB) preventive intervention for mental health outcomes for children and parents from families (N = 111) of parents with a history of major depressive disorder…
Turner-McGrievy, Gabrielle M.; Davidson, Charis R.; Wilcox, Sara
Studies have found that people following plant-based eating styles, such as vegan or vegetarian diets, often have different demographic characteristics, eating styles, and physical activity (PA) levels than individuals following an omnivorous dietary pattern. There has been no research examining if there are differences in these characteristics among people who are willing to participate in a weight loss intervention using plant-based dietary approaches as compared to a standard reduced calor...
Protocol for the saMS trial (supportive adjustment for multiple sclerosis: a randomized controlled trial comparing cognitive behavioral therapy to supportive listening for adjustment to multiple sclerosis
Full Text Available Abstract Background Multiple Sclerosis (MS is an incurable, chronic, potentially progressive and unpredictable disease of the central nervous system. The disease produces a range of unpleasant and debilitating symptoms, which can have a profound impact including disrupting activities of daily living, employment, income, relationships, social and leisure activities, and life goals. Adjusting to the illness is therefore particularly challenging. This trial tests the effectiveness of a Cognitive Behavioural intervention compared to Supportive Listening to assist adjustment in the early stages of MS. Methods/Design This is a two arm randomized multi-centre parallel group controlled trial. 122 consenting participants who meet eligibility criteria will be randomly allocated to receive either Cognitive Behavioral Therapy or Supportive Listening. Eight one hour sessions of therapy (delivered over a period of 10 weeks will be delivered by general nurses trained in both treatments. Self-report questionnaire data will be collected at baseline (0 weeks, mid-therapy (week 5 of therapy, post-therapy (15 weeks and at six months (26 weeks and twelve months (52 weeks follow-up. Primary outcomes are distress and MS-related social and role impairment at twelve month follow-up. Analysis will also consider predictors and mechanisms of change during therapy. In-depth interviews to examine participants' experiences of the interventions will be conducted with a purposively sampled sub-set of the trial participants. An economic analysis will also take place. Discussion This trial is distinctive in its aims in that it aids adjustment to MS in a broad sense. It is not a treatment specifically for depression. Use of nurses as therapists makes the interventions potentially viable in terms of being rolled out in the NHS. The trial benefits from incorporating patient input in the development and evaluation stages. The trial will provide important information about the
Kamps, Debra; Wills, Howard; Dawson-Bannister, Harriett; Heitzman-Powell, Linda; Kottwitz, Esther; Hansen, Blake; Fleming, Kandace
The purpose of the study was to determine the efficacy of the Class-Wide Function-Related Intervention Teams (CW-FIT) program for improving students' on-task behavior, and increasing teacher recognition of appropriate behavior. The intervention is a group contingency classroom management program consisting of teaching and reinforcing appropriate…
Capodanno, Davide; Tamburino, Corrado
The Evaluation of Xience Prime or Xience V versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial is a multicenter, ongoing trial conducted in patients with left main disease and SYNTAX score ≤ 32 to establish the presumptive advantage of percutaneous coronary intervention (PCI) versus bypass surgery in patients with less complex coronary artery disease than those enrolled in the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial. In this article, we aimed at critically discussing key features and issues relevant to design and clinical interpretation of this new contemporary trial of left main PCI.
Zenilman, Jonathan M
Effective STD and HIV prevention requires synergism of individual-based prevention behaviors and societal/structural supports that will promote and maintain these behaviors. We should also expect the unexpected. STD rates in gay men have risen after effective prevention of HIV/STD in gay men and effective antiretroviral therapy. New drugs of abuse, such as methamphetamine ("crystal meth"), have induced risky sexual behaviors in gay and heterosexual communities. Economic dislocation in Eastern Europe has resulted in trafficking of commercial sex workers to Europe, the Mideast, and Asia, all with the potential for STD and HIV spread. James Curran, formerly director of the HIV epidemiology and prevention effort at the CDC, has written: It is ironic that the two clearest examples of large-scale success in HIV prevention-reduction in HIV transmission in gay men in the United States and national declines in HIV incidence in Thailand-arise in societies/communities known in their own way for sexual openness....the openness in both communities provided the environment to make the powerful revolutionary changes needed. In Africa, the powerful voice of President Museveni of Uganda has also encouraged candor about sexual risk-taking and facilitated that nation's encouraging early success in reducing HIV prevalence...Unfortunately, most of the world remains unable or unwilling to deal frankly and consistently with sexuality despite the considerable risks of HIV infection in many communities. There is a worldwide sexual hangup hampering HIV prevention efforts. PMID:15963887
CAROLINA BOTERO GARCÍA
Full Text Available The results of cognitive-behavioral group interventions applied from 2002 to 2004 to 42 colombian combat veteranswith Post Traumatic Stress Disorder (PTSD are presented. The goal of the study was to stablish the effectiveness ofthe group interventions based in Prolonged Exposition and Stress Inoculation treatment processes. Differencesbetween pre-in-post symptomatology scores of PTSD were measured by Foa Posttraumatic Stress Diagnostic Scale(PDS and the Beck Depression Inventory. The statistical analysis was made by t test for paired samples, with alpha of0.05. Results show significant decrease in symptomatology and severity level after the intervention both in depressionand PTSD symptoms.
Gilinsky Alyssa S
Full Text Available Abstract Background Many postnatal women are insufficiently physically active in the year after childbirth and could benefit from interventions to increase activity levels. However, there is limited information about the efficacy, feasibility and acceptability of motivational and behavioral interventions promoting postnatal physical activity in the UK. Methods The MAMMiS study is a randomized, controlled trial, conducted within a large National Health Service (NHS region in Scotland. Up to 76 postnatal women will be recruited to test the impact of two physical activity consultations and a 10-week group pram-walking program on physical activity behavior change. The intervention uses evidence-based motivational and behavioral techniques and will be systematically evaluated using objective measures (accelerometers at three months, with a maintenance measure taken at a six-month follow-up. Secondary health and well-being measures and psychological mediators of physical activity change are included. Discussion The (MAMMiS study will provide a test of a theoretical and evidence-based physical activity behavior change intervention for postnatal women and provide information to inform future intervention development and testing within this population. Trial registration Current Controlled Trials ISRCTN79011784
Full Text Available Abstract Background Depression is common in residents of Residential and Nursing homes (RNHs. It is usually undetected and often undertreated. Depression is associated with poor outcomes including increased morbidity and mortality. Exercise has potential to improve depression, and has been shown in existing trials to improve outcomes among younger and older people. Existing evidence comes from trials that are short, underpowered and not from RNH settings. The aim of the OPERA trial is to establish whether exercise is effective in reducing the prevalence of depression among older RNH residents. Method OPERA is a cluster randomised controlled trial. RNHs are randomised to one of two groups with interventions lasting 12 months Intervention group: a depression awareness and physical activity training session for care home staff, plus a whole home physical activation programme including twice weekly physiotherapist-led exercise groups. The intervention lasts for one year from randomisation, or Control group: a depression awareness training session for care home staff. Participants are people aged 65 or over who are free of severe cognitive impairment and willing to participate in the study. Our primary outcome is the prevalence of depressive symptoms, a GDS-15 score of five or more, in all participants at the end of the one year intervention period. Our secondary depression outcomes include remission of depressive symptoms and change in GDS-15 scores in those with depressive symptoms prior to randomisation. Other secondary outcomes include, fear of falling, mobility, fractures, pain, cognition, costs and health related quality of life. We aimed to randomise 77 RNHs. Discussion Home recruitment was completed in May 2010; 78 homes have been randomised. Follow up will finish in May 2011 and results will be available late 2011. Trial Registration [ISRCTN: ISRCTN43769277
Full Text Available Abstract Background To determine factors that predict adherence to a mind-body intervention in a randomized trial. Design We analyzed adherence data from a 3-arm trial involving 135 generally healthy seniors 65–85 years of age randomized to a 6-month intervention consisting of: an Iyengar yoga class with home practice, an exercise class with home practice, or a wait-list control group. Outcome measures included cognitive function, mood, fatigue, anxiety, health-related quality of life, and physical measures. Adherence to the intervention was obtained by class attendance and biweekly home practice logs. Results The drop-out rate was 13%. Among the completers of the two active interventions, average yoga class attendance was 77% and home practice occurred 64% of all days. Average exercise class attendance was 69% and home exercise occurred 54% of all days. There were no clear effects of adherence on the significant study outcomes (quality of life and physical measures. Class attendance was significantly correlated with baseline measures of depression, fatigue, and physical components of health-related quality of life. Significant differences in baseline measures were also found between study completers and drop-outs in the active interventions. Adherence was not related to age, gender, or education level. Conclusion Healthy seniors have good attendance at classes with a physically active intervention. Home practice takes place over half of the time. Decreased adherence to a potentially beneficial intervention has the potential to decrease the effect of the intervention in a clinical trial because subjects who might sustain the greatest benefit will receive a lower dose of the intervention and subjects with higher adherence rates may be functioning closer to maximum ability before the intervention. Strategies to maximize adherence among subjects at greater risk for low adherence will be important for future trials, especially complementary
Savović, Jelena; Jones, Hayley E; Altman, Douglas G;
Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta-analyses conta......Published evidence suggests that aspects of trial design lead to biased intervention effect estimates, but findings from different studies are inconsistent. This study combined data from 7 meta-epidemiologic studies and removed overlaps to derive a final data set of 234 unique meta......-analyses containing 1973 trials. Outcome measures were classified as "mortality," "other objective," "or subjective," and Bayesian hierarchical models were used to estimate associations of trial characteristics with average bias and between-trial heterogeneity. Intervention effect estimates seemed to be exaggerated......-blinding (vs. double-blinding) was associated with an average of 13% exaggeration of intervention effects (ratio of odds ratios, 0.87 [CrI, 0.79 to 0.96]), and between-trial heterogeneity was increased for such studies (SD increase in heterogeneity, 0.14 [CrI, 0.02 to 0.30]). For each characteristic, average...
Thyregod Hans Gustav
Full Text Available Abstract Background Degenerative aortic valve (AV stenosis is the most prevalent heart valve disease in the western world. Surgical aortic valve replacement (SAVR has until recently been the standard of treatment for patients with severe AV stenosis. Whether transcatheter aortic valve implantation (TAVI can be offered with improved safety and similar effectiveness in a population including low-risk patients has yet to be examined in a randomised setting. Methods/Design This randomised clinical trial will evaluate the benefits and risks of TAVI using the transarterial CoreValve System (Medtronic Inc., Minneapolis, MN, USA (intervention group compared with SAVR (control group in patients with severe degenerative AV stenosis. Randomisation ratio is 1:1, enrolling a total of 280 patients aged 70 years or older without significant coronary artery disease and with a low, moderate, or high surgical risk profile. Trial outcomes include a primary composite outcome of myocardial infarction, stroke, or all-cause mortality within the first year after intervention (expected rates 5% for TAVI, 15% for SAVR. Exploratory safety outcomes include procedure complications, valve re-intervention, and cardiovascular death, as well as cardiac, cerebral, pulmonary, renal, and vascular complications. Exploratory efficacy outcomes include New York Heart Association functional status, quality of life, and valve prosthesis and cardiac performance. Enrolment began in December 2009, and 269 patients have been enrolled up to December 2012. Discussion The trial is designed to evaluate the performance of TAVI in comparison with SAVR. The trial results may influence the choice of treatment modality for patients with severe degenerative AV stenosis. Trial registration ClinicalTrials.gov: NCT01057173
Full Text Available Abstract Background Physical activity shows potential in combating the poor outcomes associated with depression in older people. Meta-analyses show gaps in the research with poor trial design compromising certainty in conclusions and few programmes showing sustained effects. Methods/design The Depression in Late Life: an Intervention Trial of Exercise (DeLLITE is a 12 month randomised controlled trial of a physical activity intervention to increase functional status in people aged 75 years and older with depressive symptoms. The intervention involves an individualised activity programme based on goal setting and progression of difficulty of activities delivered by a trained nurse during 8 home visits over 6 months. The control group received time matched home visits to discuss social contacts and networks. Baseline, 6 and 12 months measures were assessed in face to face visits with the primary outcome being functional status (SPPB, NEADL. Secondary outcomes include depressive symptoms (Geriatric Depression Scale, quality of life (SF-36, physical activity (AHS Physical Activity Questionnaire and falls (self report. Discussion Due to report in 2008 the DeLLITE study has recruited 70% of those eligible and tests the efficacy of a home based, goal setting physical activity programme in improving function, mood and quality of life in older people with depressive symptomatology. If successful in improving function and mood this trial could prove for the first time that there are long term health benefit of physical activity, independent of social activity, in this high risk group who consume excess health related costs. Trial registration Australian and New Zealand Clinical Trials Register ACTRN12605000475640
Full Text Available Procrastination is defined as a voluntarily delay of an intended course of action despite expecting to be worse-off for the delay, and is considered a persistent behavior pattern that can result in major psychological suffering. About one-fifth of the adult population and half of the student population are presumed having substantial difficulties due to recurrent procrastination in their everyday lives. However, chronic and severe procrastinators seldom receive adequate care due to preconceptions and the lack of understanding regarding procrastination and the treatment interventions that are assumed beneficial. Cognitive-behavioral therapy is often deemed a treatment of choice, although the evidence supporting its use is scarce, and only one randomized controlled trial has been performed. The primary aim of the proposed study is therefore to test the efficacy of cognitive-behavioral therapy delivered as either a group intervention or via the Internet. Participants will consist of students recruited through the Student Health Centre at Karolinska Institutet. A randomized controlled trial with a sample size of 100 participants divided into blocks of thirty will be used, comparing an eight-week Internet-based cognitive-behavioral therapy intervention, and an eight-week group cognitive-behavioral therapy based intervention. It is believed that the proposed study will result in two important findings. First, different treatment interventions in cognitive-behavioral therapy are assumed to be helpful for people suffering from problems caused by procrastination. Second, both an Internet-based cognitive-behavioral therapy intervention and a group intervention are presumed suitable for administering treatment for procrastination, which is considered important as the availability of adequate care is limited, particularly among students. The proposed study will increase the knowledge regarding the efficacy of different treatments of procrastination, as well
Velasquez, Mary M.; von Sternberg, Kirk; Johnson, David H.; Green, Charles; Carbonari, Joseph P.; Parsons, Jeffrey T.
This randomized clinical trial (N = 253) evaluated the efficacy of a theory-based intervention designed to reduce both alcohol use and incidence of unprotected sexual behaviors among HIV-positive men who have sex with men with alcohol use disorders. An integrated, manualized intervention, using both individual counseling and peer group…
CAI Yumao(蔡于茂); ZENG Xuchun(曾序春); DONG Shifu(董时富)
Acquired Immune Deficiency Syndrome (AIDS) isan infectious disease caused by HIV. It has been epidemic formore than 20 years, but there is no cure of it. Health educationand behavioral interventions are some of the most effectiveapproaches in the control and prevention of AIDS. China isone of the countries with the fastest growing HIVseroprevalence rate, and is facing a widespread epidemic ofAIDS. Currently, high-risk populations such as individualswith multiple sexual partners and intravenous drug users arethe main foci of health education and behavioral interventionsin China. Encouraging results have been observed in manyforms of health education and behavioral intervention. Theapplication of health education and behavioral interventionsmust emerge from scientific evidence, follow a series ofstrategies, be carried out from various perspectives, andrequire the participation of all societal communities.
Price, Joseph M.; Roesch, Scott; Walsh, Natalia Escobar
Externalizing behavior problems are highly prevalent among children in foster care, placing them at risk for placement disruptions and later personal and social maladjustment. The KEEP foster parent intervention was designed to equip foster parents and relative caregivers with the parenting skills necessary for managing challenging behavior problems. In prior research, the KEEP intervention was found to be effective in reducing child behavior problems. In the current study, the KEEP foster pa...
Moskowitz, Lauren J.; Carr, Edward G.; Durand, V. Mark
Parents and professionals typically report problem behavior as a significant concern for children with fragile X syndrome. In the present study, the authors explored whether behaviorally based interventions would result in a reduction in problem behavior and an improvement in quality of life for 3 children with fragile X syndrome and their…
Steel, Jennifer; Geller, David A; Tsung, Allan; Marsh, J Wallis; Dew, Mary Amanda; Spring, Michael; Grady, Jonathan; Likumahuwa, Sonja; Dunlavy, Andrea; Youssef, Michael; Antoni, Michael; Butterfield, Lisa H; Schulz, Richard; Day, Richard; Helgeson, Vicki; Kim, Kevin H; Gamblin, T Clark
Background Collaborative care interventions to treat depression have begun to be tested in settings outside of primary care. However, few studies have expanded the collaborative care model to other settings and targeted comorbid physical symptoms of depression. Purpose The aims of this report were to: (1) describe the design and methods of a trial testing the efficacy of a stepped collaborative care intervention designed to manage cancer-related symptoms and improve overall quality of life in patients diagnosed with hepatobiliary carcinoma; and (2) share the lessons learned during the design, implementation, and evaluation of the trial. Methods The trial was a phase III randomized controlled trial testing the efficacy of a stepped collaborative care intervention to reduce depression, pain, and fatigue in patients diagnosed with advanced cancer. The intervention was compared to an enhanced usual care arm. The primary outcomes included the Center for Epidemiological Studies-Depression scale, Brief Pain Inventory, and Functional Assessment of Cancer Therapy (FACT)-Fatigue, and the FACT-Hepatobiliary. Sociodemographic and disease-specific characteristics were recorded from the medical record; Natural Killer cells and cytokines that are associated with these symptoms and with disease progression were assayed from serum. Results and Discussion The issues addressed include: (1) development of collaborative care in the context of oncology (e.g., timing of the intervention, tailoring of the intervention, ethical issues regarding randomization of patients, and changes in medical treatment over the course of the study); (2) use of a website by chronically ill populations (e.g., design and access to the website, development of the website and intervention, ethical issues associated with website development, website usage, and unanticipated costs associated with website development); (3) evaluation of the efficacy of intervention (e.g., patient preferences, proxy raters
Mays, Darren; Peshkin, Beth N.; Sharff, McKane E.; Walker, Leslie R.; Abraham, Anisha A.; Hawkins, Kirsten; Tercyak, Kenneth P.
This study examined factors associated with teens’ adherence to a multiple health behavior cancer preventive intervention. Analyses identified predictors of trial enrollment, run-in completion, and adherence (intervention initiation, number of sessions completed). Of 104 teens screened, 73% (n = 76) were trial-eligible. White teens were more likely to enroll than non-whites (χ2  df = 4.49, p = 0.04). Among enrolled teens, 76% (n = 50) completed the run-in; there were no differences between...
Gelberg, Lillian; Andersen, Ronald M.; Afifi, Abdelmonem A.; Leake, Barbara D.; Arangua, Lisa; Vahidi, Mani; Singleton, Kyle; Yacenda-Murphy, Julia; Shoptaw, Steve; Fleming, Michael F.; Baumeister, Sebastian E.
Aims To assess the effect of a multi-component primary care (PC)-delivered BI for reducing risky drug use (RDU) among patients identified by screening. Design Multicenter single-blind two-arm randomized controlled trial of patients enrolled from February 2011 to November 2012 with 3-month follow-up. Randomization and allocation to trial group were computer-generated. Setting Primary care waiting rooms of 5 federally qualified health centers (FQHCs) in Los Angeles County (LAC), USA. Participants 334 adult primary care patients (171 intervention; 163 control) with RDU scores (4–26) on the WHO Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) self-administered on tablet PCs; 261 (78%) completed follow-up. Mean age was 41.7 years; 63% were male; 38% were Caucasian. Intervention(s) and Measurement Intervention patients received brief (typically 3–4 minutes) clinician advice to quit/reduce their drug use reinforced by a video doctor message, health education booklet, and up to two 20–30 minute follow-up telephone drug use coaching sessions. Controls received usual care and cancer screening information. Primary outcome was patient self-reported use of highest scoring drug (HSD) at follow-up. Findings Intervention and control patients reported equivalent baseline HSD use; at follow-up, after adjustment for covariates in a linear regression model, intervention patients reported using their HSD an average of 2.21 fewer days in the previous month than controls (p0.10). Conclusions A clinician-delivered brief intervention with follow-up counseling calls may decrease drug use among risky users compared with usual care in low-income community health centers of Los Angeles County, USA. PMID:26471159
Having first introduced the pragmatic health care trial, the discussion then focuses on a selected list of technical problems that are important for the design, analysis and inference from such trials. The first is lack of independence of participants' outcomes do to clustering either arising from a cluster randomized design or to the way treatment is delivered (therapist and group effects). The second and third concern the implications of non-adherence to treatment and subsequent loss to follow-up, particularly, when non-adherence is associated with missing outcome data. Finally, it is argued that pragmatism and a desire for a scientific explanation should not be regarded as mutually exclusive. PMID:23458721
Double blinding requirement for validity claims in cognitive-behavioral therapy intervention trials for major depressive disorder. Analysis of Hollon S, et al., Effect of cognitive therapy with antidepressant medications vs antidepressants alone on the rate of recovery in major depressive disorder: a randomized clinical trial [version 1; referees: 2 approved
Full Text Available This paper will focus on problems in the inability to double-blind cognitive-behavioral therapy (CBT studies for major depressive disorder (MDD, and provides an analysis of a recently published study to show how this problem can lead to faulty conclusions. A study by Hollon et al. published in JAMA Psychiatry that compared an antidepressant medication-only arm with a combined CBT/antidepressant arm concluded that the cognitive therapy/antidepressant combination enhanced the recovery rates compared with antidepressant alone, and that the magnitude of this increment nearly doubled for patients with more severe depression. We propose that for subjects with greater severity, there could have been both antidepressant efficacy as well as more hope and expectation in the group who knew they had received combined cognitive therapy/medication, leading to an erroneous conclusion of greater efficacy for the combined group. The large subject number in this study could easily lead to an erroneous finding on statistical testing as a small amount of bias in the subjects adds-up. We opine that the conclusions of unblind CBT outcome research in conditions with subjective endpoints such as MDD need to be given with great caution. The validity of CBT (and its derivatives such as dialectical behavioral therapy for indications other than MDD is also part of a larger problem in the inability to blind outcome studies for these interventions.
Double blinding requirement for validity claims in cognitive-behavioral therapy intervention trials for major depressive disorder. Analysis of Hollon S, et al., Effect of cognitive therapy with antidepressant medications vs antidepressants alone on the rate of recovery in major depressive disorder: a randomized clinical trial.
This paper will focus on problems in the inability to double-blind cognitive-behavioral therapy (CBT) studies for major depressive disorder (MDD), and provides an analysis of a recently published study to show how this problem can lead to faulty conclusions. A study by Hollon et al. published in JAMA Psychiatry that compared an antidepressant medication-only arm with a combined CBT/antidepressant arm concluded that the cognitive therapy/antidepressant combination enhanced the recovery rates compared with antidepressant alone, and that the magnitude of this increment nearly doubled for patients with more severe depression. We propose that for subjects with greater severity, there could have been both antidepressant efficacy as well as more hope and expectation in the group who knew they had received combined cognitive therapy/medication, leading to an erroneous conclusion of greater efficacy for the combined group. The large subject number in this study could easily lead to an erroneous finding on statistical testing as a small amount of bias in the subjects adds-up. We opine that the conclusions of unblind CBT outcome research in conditions with subjective endpoints such as MDD need to be given with great caution. The validity of CBT (and its derivatives such as dialectical behavioral therapy) for indications other than MDD is also part of a larger problem in the inability to blind outcome studies for these interventions.
While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, "partially-controlled clinical data" because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials.
Morthorst, Britt; Krogh, Jesper; Erlangsen, Annette;
OBJECTIVE: To assess whether an assertive outreach intervention after suicide attempt could reduce the frequency of subsequent suicidal acts, compared with standard treatment. DESIGN: Randomised, parallel group, superiority trial with blinded outcome assessment. SETTING: Outpatient intervention a...
Ondersma, Steven J.; Beatty, Jessica R.; Svikis, Dace S.; Strickler, Ronald C.; Tzilos, Golfo K.; Chang, Grace; Divine, W.; Taylor, Andrew R.; Sokol, Robert J.
Background Although screening and brief intervention (SBI) for unhealthy alcohol use has demonstrated efficacy in some trials, its implementation has been limited. Technology-delivered approaches are a promising alternative, particularly during pregnancy when the importance of alcohol use is amplified. The present trial evaluated the feasibility and acceptability of an interactive, empathic, video-enhanced, and computer-delivered SBI (e-SBI) plus three separate tailored mailings, and estimated intervention effects. Methods We recruited 48 pregnant women who screened positive for alcohol risk at an urban prenatal care clinic. Participants were randomly assigned to the e-SBI plus mailings or to a control session on infant nutrition, and were reevaluated during their postpartum hospitalization. The primary outcome was 90-day period-prevalence abstinence as measured by timeline follow-back interview. Results Participants rated the intervention as easy to use and helpful (4.7-5.0 on a 5-point scale). Blinded follow-up evaluation at childbirth revealed medium-size intervention effects on 90-day period prevalence abstinence (OR = 3.4); similarly, intervention effects on a combined healthy pregnancy outcome variable (live birth, normal birthweight, and no NICU stay) were also of moderate magnitude in favor of e-SBI participants (OR=3.3). As expected in this intentionally under-powered pilot trial, these effects were non-significant (p = .19 and .09, respectively). Conclusions This pilot trial demonstrated the acceptability and preliminary efficacy of a computer-delivered screening and brief intervention (e-SBI) plus tailored mailings for alcohol use in pregnancy. These findings mirror the promising results of other trials using a similar approach, and should be confirmed in a fully-powered trial. PMID:26010235
Hendricks Ann M
Full Text Available Abstract Background Patient recruitment is one of the most difficult aspects of clinical trials, especially for research involving elderly subjects. In this paper, we describe our experience with patient recruitment for the behavioral intervention randomized trial, "The relaxation response intervention for chronic heart failure (RRCHF." Particularly, we identify factors that, according to patient reports, motivated study participation. Methods The RRCHF was a three-armed, randomized controlled trial designed to evaluate the efficacy and cost of a 15-week relaxation response intervention on veterans with chronic heart failure. Patients from the Veterans Affairs (VA Boston Healthcare System in the United States were recruited in the clinic and by telephone. Patients' reasons for rejecting the study participation were recorded during the screening. A qualitative sub-study in the trial consisted of telephone interviews of participating patients about their experiences in the study. The qualitative study included the first 57 patients who completed the intervention and/or the first follow-up outcome measures. Factors that distinguished patients who consented from those who refused study participation were identified using a t-test or a chi-square test. The reason for study participation was abstracted from the qualitative interview. Results We successfully consented 134 patients, slightly more than our target number, in 27 months. Ninety-five of the consented patients enrolled in the study. The enrollment rate among the patients approached was 18% through clinic and 6% through telephone recruitment. The most commonly cited reason for declining study participation given by patients recruited in the clinic was 'Lives Too Far Away'; for patients recruited by telephone it was 'Not Interested in the Study'. One factor that significantly distinguished patients who consented from patients who declined was the distance between their residence and the study
Clarke, Shelley; Dunlap, Glen
The "Journal of Positive Behavior Interventions" (JPBI) has been publishing reports of empirical intervention research since 1999, with a commitment to serve as a vehicle for dissemination of data and perspectives pertinent to positive behavior support (PBS). PBS is distinguished by an emphasis on certain features of interventions, such as…
Excessive gestational weight gain (GWG) is a key modifiable risk factor for negative maternal and child health. We examined the efficacy of a behavioral intervention in preventing excessive GWG. 230 participants (87.8% Caucasian, mean age= 29.1 years; second parity) completed the 36 week gestational...
Hill, Doris Adams; Flores, Margaret M.
The authors modeled programwide positive behavior interventions and supports (PBIS) principles to 26 preservice teachers during consolidated yearly extended school year (ESY) services delivered to elementary students from four school districts. While PBIS were in place for preservice teachers to implement with students, a similar system was…
Silagy, C; Lancaster, T.; Gray, S.; Fowler, G
OBJECTIVE--To assess the effectiveness of interventions that train healthcare professionals in methods for improving the quality of care delivered to patients who smoke. DESIGN--Systematic literature review. SETTING--Primary care medical and dental practices in the United States and Canada. Patients were recruited opportunistically. SUBJECTS--878 healthcare professionals and 11,228 patients who smoked and were identified in eight randomised controlled trials. In each of these trials healthcar...
Stines, Lisa R.; Feeny, Norah C.
In recent years, there has been a particular emphasis placed on conducting randomized controlled trials (RCTs) that compare the relative efficacy of psychosocial and pharmacological interventions. This article addresses relevant ethical considerations in the conduct of these treatment trials, with a focus on RCTs with children. Ethical concerns, including therapeutic misconception, treatment preference, therapeutic equipoise, structure of treatments, and balancing risks versus benefits, are i...
Buller, C; Rankin, J.; Carere, R; P. Buszman; Pfisterer, M.; Dzavik, V; Thomas, B.; Forman, S.; Ruzyllo, W; Mancini, G.; Michalis, L; de Abreu, G.; Lamas, G.; Hochman, J
BACKGROUND: The Occluded Artery Trial (OAT) was a 2,201-patient randomized clinical trial comparing routine stent-based percutaneous coronary intervention (PCI) versus optimal medical therapy alone in stable myocardial infarction (MI) survivors with persistent infarct-related artery occlusion identified day 3 to 28 post MI. Intent-to-treat analysis showed no difference between strategies with respect to the incidence of new class IV congestive heart failure, MI, or death. The influence of PCI...
Background Mindfulness meditation interventions improve a variety of health conditions and quality of life, are inexpensive, easy to implement, have minimal if any side effects, and engage patients to take an active role in their treatment. However, the group format can be an obstacle for many to take structured meditation programs. Internet Mindfulness Meditation Intervention (IMMI) is a program that could make mindfulness meditation accessible to all people who want and need to receive it. However, the feasibility, acceptability, and ability of IMMI to increase meditation practice have yet to be evaluated. Objectives The primary objectives of this pilot randomized controlled study were to (1) evaluate the feasibility and acceptability of IMMIs in the general population and (2) to evaluate IMMI’s ability to change meditation practice behavior. The secondary objective was to collect preliminary data on health outcomes. Methods Potential participants were recruited from online and offline sources. In a randomized controlled trial, participants were allocated to IMMI or Access to Guided Meditation arm. IMMI included a 1-hour Web-based training session weekly for 6 weeks along with daily home practice guided meditations between sessions. The Access to Guided Meditation arm included a handout on mindfulness meditation and access to the same guided meditation practices that the IMMI participants received, but not the 1-hour Web-based training sessions. The study activities occurred through the participants’ own computer and Internet connection and with research-assistant telephone and email contact. Feasibility and acceptability were measured with enrollment and completion rates and participant satisfaction. The ability of IMMI to modify behavior and increase meditation practice was measured by objective adherence of daily meditation practice via Web-based forms. Self-report questionnaires of quality of life, self-efficacy, depression symptoms, sleep disturbance
Karen J. Sherman
Full Text Available Little guidance is available to assist researchers in developing treatment protocols for research on yoga for health concerns. Because yoga is a complex multifactorial mind-body discipline historically developed for nonmedical purposes, numerous decisions must be made in order to thoughtfully develop such protocols. In this paper, a systematic approach is proposed to assist researchers in selecting an intervention that is appropriate for the condition under consideration and explicitly developed. Researchers need to consider the type or “style” of yoga, the components to include (e.g., breathing exercises, postures as well as the specific protocol for each component, the dose to be delivered (frequency, duration of practice, and the total duration of practice, and issues related to selection of instructors and monitoring the fidelity to the intervention. Each of these domains and the key issues for the development of protocols is discussed. Finally, some areas for further research related to protocol development are recommended.
Garbutt Jane M; Highstein Gabrielle; Yan Yan; Strunk Robert C
Abstract Background Many children with asthma live with frequent symptoms and activity limitations, and visits for urgent care are common. Many pediatricians do not regularly meet with families to monitor asthma control, identify concerns or problems with management, or provide self-management education. Effective interventions to improve asthma care such as small group training and care redesign have been difficult to disseminate into office practice. Methods and design This paper describes ...
Full Text Available Rahim Baghaei,1 Elham Sharifian,1 Aziz Kamran2 1Inpatient Safety Research Center, Nursing and Midwifery School, Urmia University of Medical Sciences, Urmia, 2Public Health Department, Khalkhal Faculty of Medical Sciences, Ardabil University of Medical Sciences, Ardabil, IranBackground: Hand washing is the best strategy to prevent known nosocomial infections but the nurses' hand hygiene is estimated to be poor in Iran.Objective: This study aimed to determine the effectiveness of BASNEF (Behavior, Attitude, Subjective Norms, and Enabling Factors model on hand hygiene adherence education.Methods: This controlled quasi-experimental study was conducted on 70 hemodialysis unit nurses (35 case and 35 control in the health and educational centers of the University of Medical Sciences of Urmia, Iran. To collect the data, a six-part validated and reliable questionnaire was used. The data were analyzed using SPSS version18, using Wilcoxon, Mann–Whitney, chi-square, and Fisher's exact tests. The significance level was considered P<0.05.Results: The mean age was 38.4±8.1 years for the intervention group and 40.2±8.0 years for the control group. There was no significant difference between the two groups for any demographic variables. Also, before the intervention, there was no significant difference between the two groups for any components of the BASNEF model. Post-intervention, the attitude, subjective norms, enabling factors, and intention improved significantly in the intervention group (P<0.001, but hand hygiene behavior did not show any significant change in the intervention group (P=0.16.Conclusion: Despite the improving attitudes and intention, the intervention had no significant effect on hand hygiene behavior among the studied nurses.Keywords: hand hygiene, adherence, education nurse, behavior
Mudde Aart N; de Vries Hein; van Stralen Maartje M; Bolman Catherine; Lechner Lilian
Abstract Background The aim of this study was to explore the working mechanisms of a computer tailored physical activity intervention for older adults with environmental information compared to a basic tailored intervention without environmental information. Method A clustered randomized controlled trial with two computer tailored interventions and a no-intervention control group was conducted among 1971 adults aged ≥ 50. The two tailored interventions were developed using Intervention Mappin...
Full Text Available Abstract Background While a number of preventive interventions delivered within schools have shown both short-term and long-term impact in epidemiologically based randomized field trials, programs are not often sustained with high-quality implementation over time. This study was designed to support two purposes. The first purpose was to test the effectiveness of a universal classroom-based intervention, the Whole Day First Grade Program (WD, aimed at two early antecedents to drug abuse and other problem behaviors, namely, aggressive, disruptive behavior and poor academic achievement. The second purpose--the focus of this paper--was to examine the utility of a multilevel structure to support high levels of implementation during the effectiveness trial, to sustain WD practices across additional years, and to train additional teachers in WD practices. Methods The WD intervention integrated three components, each previously tested separately: classroom behavior management; instruction, specifically reading; and family-classroom partnerships around behavior and learning. Teachers and students in 12 schools were randomly assigned to receive either the WD intervention or the standard first-grade program of the school system (SC. Three consecutive cohorts of first graders were randomized within schools to WD or SC classrooms and followed through the end of third grade to test the effectiveness of the WD intervention. Teacher practices were assessed over three years to examine the utility of the multilevel structure to support sustainability and scaling-up. Discussion The design employed in this trial appears to have considerable utility to provide data on WD effectiveness and to inform the field with regard to structures required to move evidence-based programs into practice. Trial Registration Clinical Trials Registration Number: NCT00257088
Flynn, Brian S.; Worden, John K.; Bunn, Janice Yanushka
This paper compares two controlled trials of mass media interventions, factors influencing their designs, and design lessons learned from these experiences. Mass media evaluations based on a scientific research model are motivated by gaps in knowledge. The results of such research are intended to serve the needs of consensus development processes through which confident recommendations can be made for intervention strategies that should be more widely applied. For these purposes, the scientif...
Rodgers, S.; Avery, A J; Meechan, D; Briant, S; Geraghty, M.; Doran, K; Whynes, D K
BACKGROUND: It has been suggested that the employment of pharmacists in general practice might moderate the growth in prescribing costs. However, empirical evidence for this proposition has been lacking. We report the results of a controlled trial of pharmacist intervention in United Kingdom general practice. AIM: To determine whether intervention practices made savings relative to controls. METHOD: An evaluation of an initiative set up by Doncaster Health Authority. Eight practices agreed to...
Spieker, Susan J.; Oxford, Monica L.; Kelly, Jean F.; Nelson, Elizabeth M.; Fleming, Charles B.
We conducted a community based, randomized control trial of Promoting First Relationships (PFR; Kelly, Sandoval, Zuckerman, & Buehlman, 2008) to improve parenting and toddler outcomes for toddlers in state dependency. Toddlers (10 – 24 months; N = 210) with a recent placement disruption were randomized to 10-week PFR or a comparison condition. Community agency providers were trained to use PFR in the intervention for caregivers. From baseline to post-intervention follow-up, observational rati...
Blum, N J; Mauk, J E; McComas, J J; Mace, F C
We investigated the separate and combined effects of a behavioral intervention and methylphenidate (Ritalin) on disruptive behavior and task engagement in 3 children with severe to profound mental retardation. The behavioral intervention involved differential reinforcement of appropriate behavior and guided compliance. All 3 children demonstrated decreased disruptive behavior and improved task engagement in response to the response to the behavioral intervention. Two of the 3 children demonst...
Denburg, Avram; Rodriguez-Galindo, Carlos; Joffe, Steven
Mounting evidence suggests that participation in clinical trials confers neither advantage nor disadvantage on those enrolled. Narrow focus on the question of a "trial effect," however, distracts from a broader mechanism by which patients may benefit from ongoing clinical research. We hypothesize that the existence of clinical trials infrastructure-the organizational culture, systems, and expertise that develop as a product of sustained participation in cooperative clinical trials research-may function as a quality improvement lever, improving the quality of care and outcomes of all patients within an institution or region independent of their individual participation in trials. We further contend that this "infrastructure effect" can yield particular benefits for patients in low- and middle-income countries (LMICs). The hypothesis of an infrastructure effect as a quality improvement intervention, if correct, justifies enhanced research capacity in LMIC as a pillar of health system development. PMID:27216089
Implementation of a Manualized Communication Intervention for School-Aged Children with Pragmatic and Social Communication Needs in a Randomized Controlled Trial: The Social Communication Intervention Project
Adams, Catherine; Lockton, Elaine; Gaile, Jacqueline; Earl, Gillian; Freed, Jenny
Background: Speech-language interventions are often complex in nature, involving multiple observations, variable outcomes and individualization in treatment delivery. The accepted procedure associated with randomized controlled trials (RCT) of such complex interventions is to develop and implement a manual of intervention in order that reliable…
Full Text Available Abstract Background Mother's diet during pregnancy is important, since plant lignans and their metabolites, converted by the intestinal microflora to enterolignans, are proposed to possess multiple health benefits. Aim of our study was to investigate whether a dietary intervention affects lignan concentrations in the serum of pregnant women. Methods A controlled dietary intervention trial including 105 first-time pregnant women was conducted in three intervention and three control maternity health clinics. The intervention included individual counseling on diet and on physical activity, while the controls received conventional care. Blood samples were collected on gestation weeks 8-9 (baseline and 36-37 (end of intervention. The serum levels of the plant lignans 7-hydroxymatairesinol, secoisolariciresinol, matairesinol, lariciresinol, cyclolariciresinol, and pinoresinol, and of the enterolignans 7-hydroxyenterolactone, enterodiol, and enterolactone, were measured using a validated method. Results The baseline levels of enterolactone, enterodiol and the sum of lignans were higher in the control group, whereas at the end of the trial their levels were higher in the intervention group. The adjusted mean differences between the baseline and end of the intervention for enterolactone and the total lignan intake were 1.6 ng/ml (p = 0.018, 95% CI 1.1-2.3 and 1.4 ng/mg (p = 0.08, 95% CI 1.0-1.9 higher in the intervention group than in the controls. Further adjustment for dietary components did not change these associations. Conclusion The dietary intervention was successful in increasing the intake of lignan-rich food products, the fiber consumption and consequently the plasma levels of lignans in pregnant women. Trial registration ISRCTN21512277, http://www.isrctn.org
Morrow, G R; Hickok, J T; Burish, T G
A less-than-optimal proportion of patients with cancer are entered into National Cancer Institute-sponsored clinical trials. This article reviews the literature on accrual in oncology clinical trials to characterize the extent of the problem, identify reasons for low accrual, and suggest ways to promote accrual. Four well known theories of health behavior (the Health Belief Model, Subjective Expected Utility Theory, Protection Motivation Theory, and the Theory of Reasoned Action) point to central concepts involved in understanding patient health-related behavior: (1) the probability that an unwelcomed health event will happen to a patient, (2) the severity of that event if it does occur, (3) the effectiveness of a particular behavior (such as taking part in a clinical trial) to modify the severity, and (4) the cost of adopting that behavior. These concepts form a framework for integrating the available information about accrual to clinical oncology trials. Patient and physician factors previously related to clinical trials suggest specific recommendations for increasing accrual to clinical oncology trials. PMID:7954285
Sisay, F; Byass, P; Snow, R W; Greenwood, B M; Perrin, L H; Yerly, S
Serum haptoglobin levels were measured by an enzyme-linked immunosorbent assay in Gambian children who participated in 3 malaria intervention trials with untreated or impregnated bed nets. In one study, in which a significant effect on clinical malaria was observed, the mean serum haptoglobin level was significantly higher in the intervention than in the control group. In the other 2 studies, in which no significant protection was observed, mean haptoglobin levels were similar in intervention and control groups. Measurement of serum haptoglobin may provide a useful indirect measure of the effectiveness of malaria control programmes. PMID:1566291
Verbakel, N.J.; Langelaan, M.; Verheij, T.J.M.; Wagner, C.; Zwart, D.L.M.
Background A constructive safety culture is essential for the successful implementation of patient safety improvements. Aim To assess the effect of two patient safety culture interventions on incident reporting as a proxy of safety culture. Design and setting A three-arm cluster randomised trial was
McCain, Nancy L.; Gray, D. Patricia; Elswick, R. K., Jr.; Robins, Jolynne W.; Tuck, Inez; Walter, Jeanne M.; Rausch, Sarah M.; Ketchum, Jessica McKinney
Research in psychoneuroimmunology suggests that immunosuppression associated with perceived stress may contribute to disease progression in persons with HIV infection. While stress management interventions may enhance immune function, few alternative approaches have yet been tested. This randomized clinical trial was conducted to test effects of…
Vivolo-Kantor, Alana; Hardin, James; Berkowitz, Alan
Background Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact. Objective This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration. Methods A random probability sample of 743 male undergraduate students (aged 18 to 24 years) attending a large, urban university located in the southeastern United States was recruited online and randomized to either RealConsent (n=376) or a Web-based general health promotion program (n=367). Participants were surveyed online at baseline, postintervention, and 6-months postintervention. RealConsent was delivered via a password-protected Web portal that contained six 30-minute media-based and interactive modules covering knowledge of informed consent, communication skills regarding sex, the role of alcohol and male socialization in sexual violence, empathy for rape victims, and bystander education. Primary outcomes were self-reported prosocial intervening behaviors and sexual violence perpetration. Secondary outcomes were theoretical mediators (eg, knowledge, attitudes). Results At 6-month follow-up RealConsent participants intervened more often (P=.04) and engaged in less sexual violence perpetration (P=.04) compared to controls. In addition, RealConsent participants reported greater legal knowledge of sexual assault (Prape myths (Prape victims (Prape attitudes (P<.001), less hostility toward women (P=.01), greater intentions to intervene (P=.04), less hyper-gender ideology (P<.001), less positive outcome expectancies for nonconsensual sex (P=.03), more positive outcome expectancies for intervening (P<.001), and less comfort with other men’s inappropriate behaviors (P<.001). Conclusions Our results support the
Sanders, Matthew R.; And Others
Conducted controlled clinical trial involving 44 children with recurrent abdominal pain randomly assigned to cognitive-behavioral family intervention (CBFI) or standard pediatric care (SPC). Both treatments resulted in significant improvements on measures of pain intensity and pain behavior. CBFI group had higher rate of complete elimination of…
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
Background Sedentary behavior (SB) has been linked to many health problems such as type 2 diabetes and heart disease. Increasing the length and frequency of breaks from sitting and increasing the time spent standing and engaged in light and moderate physical activity are ways to decrease SB. Text message-based interventions have succeeded in aiding smoking cessation and increase both physical activity and healthy eating, but they have not been shown to reduce SB. Objective The primary purpose of this pilot study was to determine the effectiveness of a text message-based intervention in increasing nonsedentary behaviors in university students. A secondary purpose was to (1) determine whether the intervention could enhance self-efficacy beliefs for decreasing SB and (2) whether these efficacious beliefs could predict actual SB. Methods Eighty-two university students were recruited via mass emails and randomized into intervention (SB-related text messages) or control (text messages unrelated to SB) groups. Participants received daily text messages scheduled by the researcher encouraging breaks from sitting, standing, light- and moderate-intensity physical activity (PA). They then reported various SBs via Web-based questionnaires at four time points (baseline, 2, 4, and 6 weeks). Self-efficacious beliefs toward taking breaks from sitting and decreasing the amount of time spent sitting were assessed at the same time points. Results Last observation carried forward (LOCF) method was used for incomplete data as an intent-to-treat (ITT) analysis (intervention group n=15, control group n=11). Small-to-moderate effects favoring the text intervention group were found at 6 weeks for break frequency -14.64 minutes, break length +.59 minutes, standing +24.30 min/day, light-intensity +74.34 min/day, and moderate-intensity + 9.97 min/day PA. Only light-intensity PA approached significance (P=.07). Self-efficacy beliefs also favored the text intervention group and reached
Bock, Beth C; Rosen, Rochelle K; Barnett, Nancy P; Thind, Herpreet; Walaska, Kristen; Foster, Robert; Deutsch, Christopher; Traficante, Regina
The development of mHealth applications is often driven by the investigators and developers with relatively little input from the targeted population. User input is commonly limited to "like/dislike" post- intervention consumer satisfaction ratings or device or application specific user analytics such as usability. However, to produce successful mHealth applications with lasting effects on health behaviors it is crucial to obtain user input from the start of each project and throughout development. The aim of this tutorial is to illustrate how qualitative methods in an iterative process of development have been used in two separate behavior change interventions (targeting smoking and alcohol) delivered through mobile technologies (ie, text messaging). A series of focus groups were conducted to assist in translating a face-to-face smoking cessation intervention onto a text message (short message service, SMS) delivered format. Both focus groups and an advisory panel were used to shape the delivery and content of a text message delivered intervention for alcohol risk reduction. An in vivo method of constructing message content was used to develop text message content that was consistent with the notion of texting as "fingered speech". Formative research conducted with the target population using a participatory framework led to important changes in our approach to intervention structure, content development, and delivery. Using qualitative methods and an iterative approach that blends consumer-driven and investigator-driven aims can produce paradigm-shifting, novel intervention applications that maximize the likelihood of use by the target audience and their potential impact on health behaviors.
Wilson Graeme B
Full Text Available Abstract Background Risky drinking in pregnancy by UK women is likely to result in many alcohol-exposed pregnancies. Studies from the USA suggest that brief intervention has promise for alcohol risk reduction in antenatal care. However, further research is needed to establish whether this evidence from the USA is applicable to the UK. This pilot study aims to investigate whether pregnant women can be recruited and retained in a randomized controlled trial of brief intervention aimed at reducing risky drinking in women receiving antenatal care. Methods The trial will rehearse the parallel-group, non-blinded design and procedures of a subsequent definitive trial. Over 8 months, women aged 18 years and over (target number 2,742 attending their booking appointment with a community midwife (n = 31 in north-east England will be screened for alcohol consumption using the consumption questions of the Alcohol Use Disorders Identification Test (AUDIT-C. Those screening positive, without a history of substance use or alcohol dependence, with no pregnancy complication, and able to give informed consent, will be invited to participate in the trial (target number 120. Midwives will be randomized in a 1:1 ratio to deliver either treatment as usual (control or structured brief advice and referral for a 20-minute motivational interviewing session with an alcohol health worker (intervention. As well as demographic and health information, baseline measures will include two 7-day time line follow-back questionnaires and the EuroQoL EQ-5D-3 L questionnaire. Measures will be repeated in telephone follow-ups in the third trimester and at 6 months post-partum, when a questionnaire on use of National Health Service and social care resources will also be completed. Information on pregnancy outcomes and stillbirths will be accessed from central health service records before the follow-ups. Primary outcomes will be rates of eligibility, recruitment, intervention
Larzelere, Michele McCarthy
The practice of family medicine includes the care of many patients with mental health or behavior change needs. Patients in mild to moderate distress may benefit from brief interventions performed in the family physician's office. Patients in more extreme distress may be helped by referral to behavioral health clinicians for short-term or open-ended therapies. Electronic therapy programs and bibliotherapy are also useful resources. The transition to the patient-centered medical home model may allow for more widespread integration of behavioral health care clinicians into primary care, in person and through telemental health care. Integrated care holds the promise of improved access, greater effectiveness of behavioral health service provision, and enhanced efficiency of primary care for patients with behavioral health care needs.
Full Text Available BACKGROUND: Observational studies suggest that male circumcision may provide protection against HIV-1 infection. A randomized, controlled intervention trial was conducted in a general population of South Africa to test this hypothesis. METHODS AND FINDINGS: A total of 3,274 uncircumcised men, aged 18-24 y, were randomized to a control or an intervention group with follow-up visits at months 3, 12, and 21. Male circumcision was offered to the intervention group immediately after randomization and to the control group at the end of the follow-up. The grouped censored data were analyzed in intention-to-treat, univariate and multivariate, analyses, using piecewise exponential, proportional hazards models. Rate ratios (RR of HIV incidence were determined with 95% CI. Protection against HIV infection was calculated as 1 - RR. The trial was stopped at the interim analysis, and the mean (interquartile range follow-up was 18.1 mo (13.0-21.0 when the data were analyzed. There were 20 HIV infections (incidence rate = 0.85 per 100 person-years in the intervention group and 49 (2.1 per 100 person-years in the control group, corresponding to an RR of 0.40 (95% CI: 0.24%-0.68%; p < 0.001. This RR corresponds to a protection of 60% (95% CI: 32%-76%. When controlling for behavioural factors, including sexual behaviour that increased slightly in the intervention group, condom use, and health-seeking behaviour, the protection was of 61% (95% CI: 34%-77%. CONCLUSION: Male circumcision provides a degree of protection against acquiring HIV infection, equivalent to what a vaccine of high efficacy would have achieved. Male circumcision may provide an important way of reducing the spread of HIV infection in sub-Saharan Africa. (Preliminary and partial results were presented at the International AIDS Society 2005 Conference, on 26 July 2005, in Rio de Janeiro, Brazil..
McCurdy, Barry L.; Thomas, Lisa; Truckenmiller, Adrea; Rich, Sara House; Hillis-Clark, Patricia; Lopez, Juan Carlos
This investigation employed a participatory action research method involving school psychology consultants and educators to design and evaluate the impact of school-wide positive behavioral interventions and supports in a self-contained school serving students with emotional and behavioral disorders. The traditional practices of a universal…
Campo Osaba Maria-Antonia
Full Text Available Abstract Background The promotion of health and the interventions in community health continue to be one of the pending subjects of our health system. The most prevalent health problems (cardiovascular diseases, cancer, diabetes... are for the most part related to life habits. We propose a holistic and integral approach as the best option for tackling behavior and its determinants. The research team has elaborated the necessary educational material to realize group teaching, which we call "Health Workshops". The goal of the present study is to evaluate the effectiveness of these Health Workshops in the following terms: Health Related Quality of Life (HRQOL, incorporate and maintain a balanced diet, do physical activity regularly, maintain risk factors such as tension, weight, cholesterol within normal limits and diminish cardiovascular risk. Methods/Design Controlled and random clinical testing, comparing a group of persons who have participated in the Health Workshops with a control group of similar characteristics who have not participated in the Health Workshops. Field of study: the research is being done in Health Centers of the city of Barcelona, Spain. Population studied: The group is composed of 108 persons that are actually doing the Health Workshops, and 108 that are not and form the control group. They are assigned at random to one group or the other. Data Analysis: With Student's t-distribution test to compare the differences between numerical variables or their non parametric equivalent if the variable does not comply with the criteria of normality. (Kolmogorov-Smirnof test. Chi-square test to compare the differences between categorical variables and the Logistic Regression Model to analyze different meaningful variables by dichotomous analysis related to the intervention. Discussion The Health Workshop proposed in the present study constitutes an innovative approach in health promotion, placing the emphasis on the person's self
Krogsbøll, Lasse Theis; Hróbjartsson, Asbjørn; Gøtzsche, Peter C
were psychological in 17 trials, physical in 15 trials, and pharmacological in 5 trials. Overall, across all conditions and interventions, there was a statistically significant change from baseline in all three arms. The standardized mean difference (SMD) for change from baseline was -0.24 (95...... from baseline, and we aimed at quantifying these contributions. METHODS: Systematic review and meta-analysis, based on a Cochrane review of the effect of placebo interventions for all clinical conditions. We selected all trials that had randomised the patients to three arms: no treatment, placebo...
Full Text Available Abstract Background Guidelines recommend multifactorial intervention programmes to prevent falls in older adults but there are few randomised controlled trials in a real life health care setting. We describe the rationale, intervention, study design, recruitment strategies and baseline characteristics of participants in a randomised controlled trial of a multifactorial falls prevention programme in primary health care. Methods Participants are patients from 19 primary care practices in Hutt Valley, New Zealand aged 75 years and over who have fallen in the past year and live independently. Two recruitment strategies were used – waiting room screening and practice mail-out. Intervention participants receive a community based nurse assessment of falls and fracture risk factors, home hazards, referral to appropriate community interventions, and strength and balance exercise programme. Control participants receive usual care and social visits. Outcome measures include number of falls and injuries over 12 months, balance, strength, falls efficacy, activities of daily living, quality of life, and physical activity levels. Results 312 participants were recruited (69% women. Of those who had fallen, 58% of people screened in the practice waiting rooms and 40% when screened by practice letter were willing to participate. Characteristics of participants recruited using the two methods are similar (p > 0.05. Mean age of all participants was 81 years (SD 5. On average participants have 7 medical conditions, take 5.5 medications (29% on psychotropics with a median of 2 falls (interquartile range 1, 3 in the previous year. Conclusion The two recruitment strategies and the community based intervention delivery were feasible and successful, identifying a high risk group with multiple falls. Recruitment in the waiting room gave higher response rates but was less efficient than practice mail-out. Testing the effectiveness of an evidence based intervention in a
Asarnow, Joan Rosenbaum; Berk, Michele; Hughes, Jennifer L.; Anderson, Nicholas L.
Objective To describe feasibility, safety, and outcome results from a treatment development trial of the SAFETY Program, a brief intervention designed for integration with emergency services for suicide-attempting youths. Method Suicide-attempting youths, ages 11–18, were enrolled in a 12-week trial of the SAFETY Program, a cognitive-behavioral family intervention designed to increase safety and reduce suicide-attempt (SA) risk (N=35). Rooted in a social-ecological cognitive-behavioral model, treatment sessions included individual youth and parent session-components, with different therapists assigned to youths and parents, and family session-components to practice skills identified as critical in the pathway for preventing repeat SAs in individual youths. Outcomes were evaluated at baseline, 3- and 6-month follow-ups. Results At the 3-month post-treatment assessment, there were statistically significant improvements on measures of suicidal behavior, hopelessness, youth and parent depression, and youth social adjustment. There was one reported suicide attempt by 3-months and another by 6-months, yielding cumulative attempt rates of 3% and 6% at 3 and 6-months respectively. Treatment satisfaction was high. Conclusions Suicide-attempting youths are at high-risk for repeat attempts and continuing mental health problems. Results support the value of a randomized controlled trial to further evaluate the SAFETY intervention. Extension of treatment effects to parent depression and youth social adjustment are consistent with our strong family focus and social-ecological model of behavior-change. PMID:25255931
Shahul Ebrahim, MD, MSc, PhD
Full Text Available International trade, population migration, changes in living conditions (i.e., consumption transition, nutritional transition, and changes in production, marketing, and availability of consumer goods (i.e., production transition have brought about continuous and rapid changes in the human environment. Such changes have improved the health and economic status of many people in developing countries. At the same time, a parallel phenomenon is occurring: the rapid emergence and expansion of modifiable risk behaviors. These behaviors adversely affect the national health of developing countries and that of future generations because of their impact on maternal, child, and adolescent health. Furthermore, these behaviors are increasing at a faster rate than interventions to curb their growth are being implemented. We discuss the current status of five modifiable risk behaviors — alcohol consumption, tobacco use, overweight and obesity, low fruit and vegetable consumption, and physical inactivity — to emphasize the need for global advocacy and local action to enhance policy formulation and diffusion of interventions necessary to moderate the spread of these behaviors.
Arthur V Peterson
Full Text Available The Hutchinson Study of High School Smoking was the first randomized trial to show effectiveness of a smoking cessation intervention on 6-months prolonged smoking abstinence at one year post-intervention in a large population-based sample of adolescent smokers. An important question remains: Do the positive effects from teen smoking cessation interventions seen at up to 12 months post-intervention endure into young adulthood? This study examines for the first time whether such positive early effects from teen smoking cessation intervention can endure into young adulthood in the absence of additional intervention.High school smokers (n = 2,151 were proactively recruited into the trial from fifty randomly selected Washington State high schools randomized to the experimental (Motivational Interviewing + Cognitive Behavioral Skills Training telephone counseling intervention or control (no intervention condition. These smokers were followed to 7 years post high school to ascertain rates of six-year prolonged smoking abstinence in young adulthood. All statistical tests are two-sided.No evidence of intervention impact at seven years post high school was observed for the main endpoint of six-year prolonged abstinence, neither among all smokers (14.2% in the experimental condition vs. 13.1% in the control condition, difference = +1.1%, 95% confidence interval (CI = -3.4 to 5.8, p = .61, nor among the subgroups of daily smokers and less-than-daily smokers, nor among other a priori subgroups. But, observed among males was some evidence of an intervention impact on two endpoints related to progress towards quitting: reduction in number of days smoked in the past month, and increase in the length of the longest quit attempt in the past year.There was no evidence from this trial among adolescent smokers that positive effectiveness of the proactive telephone intervention for smoking abstinence, observed previously at one year post-intervention, was sustained
Full Text Available This systematic review analyzes current data on effects of exercise interventions and physical activity behavior on objective and subjective cancer related cognitive impairments (CRCI. Out of the 19 studies which met all inclusion criteria, five RCTs investigated rodents, whereas the other 14 trials explored humans and these included six RCTs, one controlled trial, two prospective noncontrolled trials, one case series, one observational study, and three cross-sectional studies. The results from animal models revealed positive effects of exercise during and after chemotherapy or radiation on structural alterations of the central nervous system, physiological as well as neuropsychological outcomes. The overall study quality in patient studies was poor. The current data on intervention studies showed preliminary positive effects of Asian-influenced movement programs (e.g., Yoga with benefits on self-perceived cognitive functions as well as a reduction of chronic inflammation for breast cancer patients in the aftercare. Exercise potentially contributes to the prevention and rehabilitation of CRCI. Additional RCTs with standardized neuropsychological assessments and controlling for potential confounders are needed to confirm and expand preliminary findings.
van Balkom Anton
Full Text Available Abstract Background Panic disorder (PD is a common, severe and persistent mental disorder, associated with a high degree of distress and occupational and social disability. A substantial proportion of the population experiences subthreshold and mild PD and is at risk of developing a chronic PD. A promising intervention, aimed at preventing panic disorder onset and reducing panic symptoms, is the 'Don't Panic' course. It consists of eight sessions of two hours each. The purpose of this study is to evaluate the effectiveness of this early intervention – based on cognitive behavioural principles – on the reduction of panic disorder symptomatology. We predict that the experimental condition show superior clinical and economic outcomes relative to a waitlisted control group. Methods/design A pragmatic, pre-post, two-group, multi-site, randomized controlled trial of the intervention will be conducted with a naturalistic follow-up at six months in the intervention group. The participants are recruited from the general population and are randomized to the intervention or a waitlist control group. The intervention is offered by community mental health centres. Included are people over 18 years of age with subthreshold or mild panic disorder, defined as having symptoms of PD falling below the cut-off of 13 on the Panic Disorder Severity Scale-Self Report (PDSS-SR. Primary outcomes are panic disorder and panic symptoms. Secondary outcomes are symptoms of agoraphobia, anxiety, cognitive aspects of panic disorder, depressive symptoms, mastery, health-related quality of life, and cost-effectiveness. We will examine the following variables as potential mediators: cognitive aspects of panic disorder, symptoms of agoraphobia, anxiety and mastery. Potential moderating variables are: socio-demographic characteristics, panic disorder, agoraphobia, treatment credibility and mastery. Discussion This study was designed to evaluate the (cost effectiveness of an
Full Text Available Sara Cederbom,1,2 Elisabeth Rydwik,2,3 Anne Söderlund,2 Eva Denison,2 Kerstin Frändin,1 Petra von Heideken Wågert2 1Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Huddinge, 2School of Health, Care and Social Welfare, Mälardalen University, Eskilstuna, Vasteras, 3Research and Development Unit, Jakobsbergs Hospital, Stockholm County Council, Järfälla, Sweden Background: To be an older woman, live alone, have chronic pain, and be dependent on support are all factors that may have an impact on daily life. One way to promote ability in everyday activities in people with pain-related conditions is to use individualized, integrated behavioral medicine in physical therapy interventions. How this kind of intervention works for older women living alone at home, with chronic pain, and dependent on formal care to manage their everyday lives has not been studied. The aim was to explore the feasibility of a study and to evaluate an individually tailored integrated behavioral medicine in physical therapy intervention for the target group of women.Materials and methods: The study was a 12-week randomized trial with two-group design. Primary effect outcomes were pain-related disability and morale. Secondary effect outcomes focused on pain-related beliefs, self-efficacy for exercise, concerns of falling, physical activity, and physical performance.Results: In total, 23 women agreed to participate in the study and 16 women completed the intervention. The results showed that the behavioral medicine in physical therapy intervention was feasible. No effects were seen on the primary effect outcomes. The experimental intervention seemed to improve the level of physical activity and self-efficacy for exercise. Some of the participants in both groups perceived that they could manage their everyday life in a better way after participation in the study.Conclusion: Results from this study are encouraging, but
Jørgensen, Marie B; Faber, Anne; Jespersen, Tobias;
This study evaluates the implementation of physical coordination training (PCT) and cognitive behavioural training (CBTr) interventions in a randomised controlled trial at nine cleaners' workplaces. Female cleaners (n = 294) were randomised into a PCT, a CBTr or a reference (REF) group. Both 12...... intervention effects, more research on implementation is needed. Trial registration: ISRCTN96241850. Practitioner summary: Both physical coordination training and cognitive behavioural training are potential effective workplace interventions among low educated job groups with high physical work demands...
Mutale, Wilbroad; Stringer, Jeffrey; Chintu, Namwinga; Chilengi, Roma; Mwanamwenge, Margaret Tembo; Kasese, Nkatya; Balabanova, Dina; Spicer, Neil; Lewis, James; Ayles, Helen
Introduction In many low income countries, the delivery of quality health services is hampered by health system-wide barriers which are often interlinked, however empirical evidence on how to assess the level and scope of these barriers is scarce. A balanced scorecard is a tool that allows for wider analysis of domains that are deemed important in achieving the overall vision of the health system. We present the quantitative results of the 12 months follow-up study applying the balanced scorecard approach in the BHOMA intervention with the aim of demonstrating the utility of the balanced scorecard in evaluating multiple building blocks in a trial setting. Methods The BHOMA is a cluster randomised trial that aims to strengthen the health system in three rural districts in Zambia. The intervention aims to improve clinical care quality by implementing practical tools that establish clear clinical care standards through intensive clinic implementations. This paper reports the findings of the follow-up health facility survey that was conducted after 12 months of intervention implementation. Comparisons were made between those facilities in the intervention and control sites. STATA version 12 was used for analysis. Results The study found significant mean differences between intervention(I) and control (C) sites in the following domains: Training domain (Mean I:C; 87.5.vs 61.1, mean difference 23.3, p = 0.031), adult clinical observation domain (mean I:C; 73.3 vs.58.0, mean difference 10.9, p = 0.02 ) and health information domain (mean I:C; 63.6 vs.56.1, mean difference 6.8, p = 0.01. There was no gender differences in adult service satisfaction. Governance and motivation scores did not differ between control and intervention sites. Conclusion This study demonstrates the utility of the balanced scorecard in assessing multiple elements of the health system. Using system wide approaches and triangulating data collection methods seems to be key to successful
Killu, Kim; Weber, Kimberly P.; Derby, K. Mark; Barretto, Anjali
To address the behavioral needs of students with disabilities in school settings, the Individuals with Disabilities Education Improvement Act of 2004 (IDEIA) requires the development and implementation of a behavior intervention plan/positive behavioral support plan (BIP/PBSP) based on positive behavioral interventions and supports (PBIS). Despite…
Riley, William T.; Rivera, Daniel E.; Atienza, Audie A.; Nilsen, Wendy; Allison, Susannah M; Mermelstein, Robin
Mobile technologies are being used to deliver health behavior interventions. The study aims to determine how health behavior theories are applied to mobile interventions. This is a review of the theoretical basis and interactivity of mobile health behavior interventions. Many of the mobile health behavior interventions reviewed were predominately one way (i.e., mostly data input or informational output), but some have leveraged mobile technologies to provide just-in-time, interactive, and ada...
Andersen, Barbara L.; Golden-Kreutz, Deanna M.; Emery, Charles F.; Thiel, Debora L.
Trials testing the efficacy of psychological interventions for cancer patients had their beginnings in the 1970s. Since then, hundreds of trials have found interventions to be generally efficacious. In this article, we describe an intervention grounded in a conceptual model that includes psychological, behavioral, and biological components. It is…
Jennifer K Coffeng
Full Text Available OBJECTIVE: To investigate the effectiveness of a worksite social and physical environment intervention on need for recovery (i.e., early symptoms of work-related mental and physical fatigue, physical activity and relaxation. Also, the effectiveness of the separate interventions was investigated. METHODS: In this 2 × 2 factorial design study, 412 office employees from a financial service provider participated. Participants were allocated to the combined social and physical intervention, to the social intervention only, to the physical intervention only or to the control group. The primary outcome measure was need for recovery. Secondary outcomes were work-related stress (i.e., exhaustion, detachment and relaxation, small breaks, physical activity (i.e., stair climbing, active commuting, sport activities, light/moderate/vigorous physical activity and sedentary behavior. Outcomes were measured by questionnaires at baseline, 6 and 12 months follow-up. Multilevel analyses were performed to investigate the effects of the three interventions. RESULTS: In all intervention groups, a non-significant reduction was found in need for recovery. In the combined intervention (n = 92, exhaustion and vigorous physical activities decreased significantly, and small breaks at work and active commuting increased significantly compared to the control group. The social intervention (n = 118 showed a significant reduction in exhaustion, sedentary behavior at work and a significant increase in small breaks at work and leisure activities. In the physical intervention (n = 96, stair climbing at work and active commuting significantly increased, and sedentary behavior at work decreased significantly compared to the control group. CONCLUSION: None of the interventions was effective in improving the need for recovery. It is recommended to implement the social and physical intervention among a population with higher baseline values of need for recovery. Furthermore, the
Keeter, Dana; Bucholz, Jessica L.
This study was conducted to examine the effects literacy-based behavioral interventions have on improving the behavior of students with intellectual disability. A second purpose of this study was to determine if literacy-based behavioral interventions could be an effective intervention strategy when used simultaneously with a group of students…
McLaughlin, Tara W.; Denney, Maria K.; Snyder, Patricia A.; Welsh, Jill L.
Families are increasingly involved in the implementation of behavior support interventions to promote positive behaviors of young children in everyday family settings. Contextual fit, described as congruence between the behavior support intervention and the values, skills, resources, and routines of those who will implement the intervention, has…
Fletcher-Watson, Sue; Petrou, Alexandra; Scott-Barrett, Juliet; Dicks, Pamela; Graham, Catherine; O'Hare, Anne; Pain, Helen; McConachie, Helen
This study evaluated a technology-based early intervention for social communication skills in pre-schoolers in a randomised controlled trial. Participants were 54 children aged under 6 years with a diagnosis of autism, assigned to either intervention or control conditions. The app engaged children, who played consistently, regardless of developmental level, and was rated highly by parents. There were no significant group differences in parent-report measures post-intervention, nor in a measure of parent-child play at follow-up. Therefore, this intervention did not have an observable impact on real-world social communication skills and caution is recommended about the potential usefulness of iPad(™) apps for amelioration of difficulties in interaction. However, positive attitudes among participants, lack of harms and the potential of apps to deliver therapeutic content at low economic cost suggest this approach is worth pursuing further, perhaps targeting other skill domains.
Blom, Kerstin; Tarkian Tillgren, Hanna; Wiklund, Tobias; Danlycke, Ewa; Forssen, Mattias; Söderström, Alexandra; Johansson, Robert; Hesser, Hugo; Jernelov, Susanna; Lindefors, Nils; Andersson, Gerhard; Kaldo, Viktor
The aim of this study was to compare guided Internet-delivered to group-delivered cognitive behavioral therapy (CBT) for insomnia. We conducted an 8-week randomized controlled non-inferiority trial with 6-months follow-up. Participants were forty-eight adults with insomnia, recruited via media. Interventions were guided Internet-delivered CBT (ICBT) and group-delivered CBT (GCBT) for insomnia. Primary outcome measure was the Insomnia Severity Index (ISI), secondary outcome measures were sleep...
Smith Thomas A
Full Text Available Abstract Background Standard methods for defining clinical malaria in intervention trials in endemic areas do not guarantee that efficacy estimates will be unbiased, and do not indicate whether the intervention has its effect by modifying the force of infection, the parasite density, or the risk of pathology at given parasite density. Methods Three different sets, each of 500 Phase IIb or III malaria vaccine trials were simulated corresponding to each of a pre-erythrocytic, blood stage, and anti-disease vaccine, each in a population with 80% prevalence of patent malaria infection. Simulations considered only the primary effects of vaccination in a homogeneous trial population. The relationships between morbidity and parasite density and the performance of different case definitions for clinical malaria were analysed using conventional likelihood ratio tests to compare incidence of episodes defined using parasite density cut-offs. Bayesian latent class models were used to compare the overall frequencies of clinical malaria episodes in analyses that did not use diagnostic cut-offs. Results The different simulated interventions led to different relationships between clinical symptoms and parasite densities. Consequently, the operating characteristics of parasitaemia cut-offs in general differ between vaccine and placebo arms of the simulated trials, leading to different patterns of bias in efficacy estimates depending on the type of intervention effect. Efficacy was underestimated when low parasitaemia cut-offs were used but the efficacy of an asexual blood stage vaccine was overestimated when a high parasitaemia cut-off was used. The power of a trial may be maximal using case definitions that are associated with substantial bias in efficacy. Conclusion Secondary analyses of the data of malaria intervention trials should consider the relationship between clinical symptoms and parasite density, and attempt to estimate overall numbers of clinical
Hargreaves, Elaine Anne; Mutrie, Nanette; Fleming, Jade Dallas
Background Despite Internet-based interventions that incorporate pedometers with appropriate goal-setting processes and other theoretically-based behavior change strategies being proposed as a means of increasing walking behavior, few have incorporated all of these key features or assessed maintenance of behavior change. Objective The objective of our study was to investigate the effect of a 12-week pedometer step goal walking program individually tailored to baseline step counts, combined wi...
Hart, Trevor A.; Stratton, Natalie; Coleman, Todd A.; Wilson, Holly A.; Simpson, Scott H.; Julien, Rick E.; Adam, Barry D.
Background Even in the presence of promising biomedical treatment as prevention, HIV incidence among men who have sex with men has not always decreased. Counseling interventions, therefore, continue to play an important role in reducing HIV sexual transmission behaviors among gay and bisexual men and other men who have sex with men. The present study evaluated effects of a small-group counseling intervention on psychosocial outcomes and HIV sexual risk behavior. Method HIV-positive (HIV+) peer counselors administered seven 2-hour counseling sessions to groups of 5 to 8 HIV+ gay and bisexual men. The intervention employed information provision, motivational interviewing, and behavioral skills building to reduce sexual transmission risk behaviors. Results There was a significant reduction in condomless anal sex (CAS) with HIV-negative and unknown HIV-status partners, from 50.0% at baseline to 28.9% of the sample at 3-month follow-up. Findings were robust even when controlling for whether the participant had an undetectable viral load at baseline. Significant reductions were also found in the two secondary psychosocial outcomes, loneliness and sexual compulsivity. Conclusions The findings provide preliminary evidence that this intervention may offer an efficient way of concurrently reducing CAS and mental health problems, such as sexual compulsivity and loneliness, for HIV+ gay and bisexual men. Trial Registration ClinicalTrials.gov NCT02546271 PMID:27054341
Full Text Available To investigate whether carrying out various interventions part way through the day influences comfort in symptomatic daily disposable (DD contact lens wearers.A subject-masked, randomized, controlled clinical trial was conducted in thirty symptomatic soft lens wearers who wore their habitual DD contact lenses bilaterally for 12 h on two separate days. Five hours after lens application, one of the following three interventions or a control was performed on each eye: replacing the existing lens with a new lens; removing and reapplying the same lens; performing a 'scleral swish'; and no action (control. Comfort scores were recorded using SMS text messages every hour following lens application using a 0 (causes pain to 100 (excellent comfort scale. Comfort scores before lens application, at 6 mins post-application, and at 6 mins post-intervention were also recorded.There was a significant reduction in comfort from pre-lens application to 6 mins post-application for all groups (all p0.05. After the intervention, comfort continued to decline (p<0.0001 with slightly lower mean scores for the control group compared to the new lens group (p = 0.003. Change in comfort relative to pre-intervention (5 h was similar for all groups (p = 0.81. There was no difference in comfort at 12 h between groups (p = 0.83.This work has confirmed that comfort shows a continual and significant decline over a 12-h wearing period in symptomatic DD contact lens wearers. None of the interventions investigated had any significant impact on end-of-day comfort. These data suggest discomfort in lens wearers is more heavily influenced by changes to the ocular environment rather than to the lens itself.Controlled-Trials.com ISRCTN10419752 http://www.controlled-trials.com/ISRCTN10419752.
Beiranvand; Asadizaker; Fayazi; Yaralizadeh
Background It is known that health education on foot care is a common strategy for preventing diabetic foot and reducing the rate of lower limb amputation. Objectives To evaluate the efficacy of an intervention based on the theory of planned behavior for improving foot care in patients with type II diabetes in 2013 in Ahvaz, Iran. Patients and Methods In this clinical trial, 69 pat...
Ryan J. Watson
Full Text Available The reduction of risk behaviors in secondary schools is a key concern for parents, teachers, and school administrators. School is one of the primary contexts of socialization for young people; thus, the investment in school-based programs to reduce risk behaviors is essential. In this study, we report on youth who participated in an intervention designed to improve decision-making skills based on positive youth development approaches. We examine changes in decision-making skills before and after involvement in the Teen Interactive Theater Education (TITE program and retrospective self-assessment of change in knowledge, abilities, and beliefs as a result of participating in TITE (n = 127. Youth that reported increases in knowledge, abilities, and beliefs due to the intervention (n = 89 were more likely to think about the consequences of their decisions and list options before making a decision compared to their counterparts that reported less overall learning (n = 38. Implications for intervention research and stakeholders are discussed.
Kahlert, Daniela; Unyi-Reicherz, Annelie; Stratton, Gareth; Meinert Larsen, Thomas; Fogelholm, Mikael; Raben, Anne; Schlicht, Wolfgang
Background: Losing excess body weight and preventing weight regain by changing lifestyle is a challenging but promising task to prevent the incidence of type-2 diabetes. To be successful, it is necessary to use evidence-based and theory-driven interventions, which also contribute to the science of behavior modification by providing a deeper understanding of successful intervention components. Objective: To develop a physical activity and dietary behavior modification intervention toolbox (PREMIT) that fulfills current requirements of being theory-driven and evidence-based, comprehensively described and feasible to evaluate. PREMIT is part of an intervention trial, which aims to prevent the onset of type-2 diabetes in pre-diabetics in eight clinical centers across the world by guiding them in changing their physical activity and dietary behavior through a group counseling approach. Methods: The program development took five progressive steps, in line with the Public Health Action Cycle: (1) Summing-up the intervention goal(s), target group and the setting, (2) uncovering the generative psychological mechanisms, (3) identifying behavior change techniques and tools, (4) preparing for evaluation and (5) implementing the intervention and assuring quality. Results: PREMIT is based on a trans-theoretical approach referring to valid behavior modification theories, models and approaches. A major “product” of PREMIT is a matrix, constructed for use by onsite-instructors. The matrix includes objectives, tasks and activities ordered by periods. PREMIT is constructed to help instructors guide participants' behavior change. To ensure high fidelity and adherence of program-implementation across the eight intervention centers standardized operational procedures were defined and “train-the-trainer” workshops were held. In summary PREMIT is a theory-driven, evidence-based program carefully developed to change physical activity and dietary behaviors in pre-diabetic people
Full Text Available Background: Losing excess body weight and preventing weight regain by changing lifestyle is a challenging but promising task to prevent the incidence of type-2 diabetes. To be successful, it is necessary to use evidence-based and theory-driven interventions, which also contribute to the science of behavior modification by providing a deeper understanding of successful intervention components. Objective: To develop a physical activity and dietary behavior modification intervention toolbox (PREMIT that fulfills current requirements of being theory-driven and evidence-based, comprehensively described and feasible to evaluate. PREMIT is part of an intervention trial, which aims to prevent the onset of type-2 diabetes in pre-diabetics in eight clinical centers across the world by guiding them in changing their physical activity and dietary behavior through a group counselling approach. Methods: The program development took five progressive steps, in line with the Public Health Action Cycle: (1 Summing-up the intervention goal(s, target group and the setting, (2 uncovering the generative psychological mechanisms, (3 identifying behavior change techniques and tools, (4 preparing for evaluation and (5 implementing the intervention and assuring quality. Results: PREMIT is based on a trans-theoretical approach referring to valid behavior modification theories, models and approaches. A major ‘product’ of PREMIT is a matrix, constructed for use by onsite-instructors. The matrix includes objectives, tasks and activities ordered by periods. PREMIT is constructed to help instructors guide participant’s behavior change. To ensure high fidelity and adherence of program-implementation across the eight intervention centers standardized operational procedures were defined and train-the-trainer workshops were held. In summary PREMIT is a theory-driven, evidence-based program carefully developed to change physical activity and dietary behaviors in pre
Blum, N J; Mauk, J E; McComas, J J; Mace, F C
We investigated the separate and combined effects of a behavioral intervention and methylphenidate (Ritalin) on disruptive behavior and task engagement in 3 children with severe to profound mental retardation. The behavioral intervention involved differential reinforcement of appropriate behavior and guided compliance. All 3 children demonstrated decreased disruptive behavior and improved task engagement in response to the response to the behavioral intervention. Two of the 3 children demonstrated similar improvement in response to methylphenidate. Although both interventions were highly effective for these 2 participants, the relative efficacy of the interventions varied between the 2 children. There was no evidence of an additive or synergistic effect of the two interventions, but the high efficacy of each intervention alone limited our ability to detect such effects.
Vik, Frøydis N.; Lien, Nanna; Berntsen, Sveinung; De Bourdeaudhuij, Ilse; Grillenberger, Monika; Manios, Yannis; Kovacs, Eva; Chinapaw, Mai J. M.; Brug, Johannes; Bere, Elling
Background The UP4FUN intervention is a family-involved school-based intervention aiming at reducing and breaking up sitting time at home (with special emphasis on screen time), and breaking up sitting time in school among 10–12 year olds in Europe. The purpose of the present paper was to evaluate its short term effects. Methodology/Principal Findings A total of 3147 pupils from Belgium, Germany, Greece, Hungary and Norway participated in a school-randomized controlled trial. The intervention included 1–2 school lessons per week for a period of six weeks, along with assignments for the children and their parents. Screen time and breaking up sitting time were registered by self-report and total sedentary time and breaking up sitting time by accelerometry. The effect of the intervention on these behaviors was evaluated by multilevel regression analyses. All analyses were adjusted for baseline values and gender. Significance level was p≤0.01. No significant intervention effects were observed, neither for self-reported TV/DVD or computer/game console time, nor for accelerometer-assessed total sedentary time and number of breaks in sitting time. The intervention group, however, reported more positive attitudes towards (β = 0.25 (95% CI 0.11, 0.38)) and preferences/liking for (β = 0.20 (95% CI 0.08, 0.32)) breaking up sitting time than the control group. Conclusions/Significance No significant intervention effect on self-reported screen time or accelerometer-assessed sedentary time or breaks in sitting time was observed, but positive effects on beliefs regarding breaking up sitting time were found in favor of the intervention group. Overall, these results do not warrant wider dissemination of the present UP4FUN intervention. Trial Registration International Standard Randomized Controlled Trial Number Registry ISRCTN34562078 PMID:25826704
Full Text Available Abstract Background The aim of this study was to assess the reporting of harm in randomized controlled trials evaluating stents for percutaneous coronary intervention. Methods The study design was a methodological systematic review of randomized controlled trials. The data sources were MEDLINE and the Cochrane Central Register of Controlled Trials. All reports of randomized controlled trials assessing stent treatment for coronary disease published between January 1, 2003, and September 30, 2008 were selected. A standardized abstraction form was used to extract data. Results 132 articles were analyzed. Major cardiac adverse events (death, cardiac death, myocardial infarction or stroke were reported as primary or secondary outcomes in 107 reports (81%. However, 19% of the articles contained no data on cardiac events. The mode of data collection of adverse events was given in 29 reports (22% and a definition of expected adverse events was provided in 47 (36%. The length of follow-up was reported in 95 reports (72%. Assessment of adverse events by an adjudication committee was described in 46 reports (35%, and adverse events were described as being followed up for 6 months in 24% of reports (n = 32, between 7 to 12 months in 42% (n = 55 and for more than 1 year in 4% (n = 5. In 115 reports (87%, numerical data on the nature of the adverse events were reported per treatment arm. Procedural complications were described in 30 articles (23%. The causality of adverse events was reported in only 4 articles. Conclusion Several harm-related data were not adequately accounted for in articles of randomized controlled trials assessing stents for percutaneous coronary intervention. Trials Registration Trials manuscript: 5534201182098351 (T80802P
Full Text Available BACKGROUND: The HPTN 052 trial confirmed that antiretroviral therapy (ART can nearly eliminate HIV transmission from successfully treated HIV-infected individuals within couples. Here, we present the mathematical modeling used to inform the design and monitoring of a new trial aiming to test whether widespread provision of ART is feasible and can substantially reduce population-level HIV incidence. METHODS AND FINDINGS: The HPTN 071 (PopART trial is a three-arm cluster-randomized trial of 21 large population clusters in Zambia and South Africa, starting in 2013. A combination prevention package including home-based voluntary testing and counseling, and ART for HIV positive individuals, will be delivered in arms A and B, with ART offered universally in arm A and according to national guidelines in arm B. Arm C will be the control arm. The primary endpoint is the cumulative three-year HIV incidence. We developed a mathematical model of heterosexual HIV transmission, informed by recent data on HIV-1 natural history. We focused on realistically modeling the intervention package. Parameters were calibrated to data previously collected in these communities and national surveillance data. We predict that, if targets are reached, HIV incidence over three years will drop by >60% in arm A and >25% in arm B, relative to arm C. The considerable uncertainty in the predicted reduction in incidence justifies the need for a trial. The main drivers of this uncertainty are possible community-level behavioral changes associated with the intervention, uptake of testing and treatment, as well as ART retention and adherence. CONCLUSIONS: The HPTN 071 (PopART trial intervention could reduce HIV population-level incidence by >60% over three years. This intervention could serve as a paradigm for national or supra-national implementation. Our analysis highlights the role mathematical modeling can play in trial development and monitoring, and more widely in evaluating the
Full Text Available Abstract Background In the rural areas of sub-Saharan Africa, the majority of young children affected by malaria have no access to formal health services. Home treatment through mothers of febrile children supported by mother groups and local health workers has the potential to reduce malaria morbidity and mortality. Methods A cluster-randomized controlled effectiveness trial was implemented from 2002–2004 in a malaria endemic area of rural Burkina Faso. Six and seven villages were randomly assigned to the intervention and control arms respectively. Febrile children from intervention villages were treated with chloroquine (CQ by their mothers, supported by local women group leaders. CQ was regularly supplied through a revolving fund from local health centres. The trial was evaluated through two cross-sectional surveys at baseline and after two years of intervention. The primary endpoint of the study was the proportion of moderate to severe anaemia in children aged 6–59 months. For assessment of the development of drug efficacy over time, an in vivo CQ efficacy study was nested into the trial. The study is registered under http://www.controlled-trials.com (ISRCTN 34104704. Results The intervention was shown to be feasible under program conditions and a total of 1.076 children and 999 children were evaluated at baseline and follow-up time points respectively. Self-reported CQ treatment of fever episodes at home as well as referrals to health centres increased over the study period. At follow-up, CQ was detected in the blood of high proportions of intervention and control children. Compared to baseline findings, the prevalence of anaemia (29% vs 16%, p P. falciparum parasitaemia, fever and palpable spleens was lower at follow-up but there were no differences between the intervention and control group. CQ efficacy decreased over the study period but this was not associated with the intervention. Discussion The decreasing prevalence of malaria
Dionigi, Alberto; Sangiorgi, Diego; Flangini, Roberto
This study investigated whether a clown doctor intervention could reduce preoperative anxiety in children hospitalized for minor surgery and in their parents. A randomized controlled trial was conducted with 77 children and 119 parents: the clown group consisted of 52 children accompanied in the preoperating room by their parents (n = 89) and two clowns while the comparison group consisted of children accompanied by the parents only. The clown intervention significantly reduced the children's preoperative anxiety: children benefited from the clown's presence and showed better adjustment than children in the comparison group. Mothers in Comparison Group showed higher anxiety. PMID:23362335
Full Text Available Abstract Background Over the last 30 years the number of people who drink alcohol at harmful levels has increased in many countries. There have also been large increases in rates of sexually transmitted infections. Available evidence suggests that excessive alcohol consumption and poor sexual health may be linked. The prevalence of harmful alcohol use is higher among people attending sexual health clinics than in the general population, and a third of those attending clinics state that alcohol use affects whether they have unprotected sex. Previous research has demonstrated that brief intervention for alcohol misuse in other medical settings can lead to behavioral change, but the clinical- and cost-effectiveness of this intervention on sexual behavior have not been examined. Methods We will conduct a two parallel-arm, randomized trial. A consecutive sample of people attending three sexual health clinics in London and willing to participate in the study will be screened for excessive alcohol consumption. Participants identified as drinking excessively will then be allocated to either active treatment (Brief Advice and referral for Brief Intervention or control treatment (a leaflet on healthy living. Randomization will be via an independent and remote telephone randomization service and will be stratified by study clinic. Brief Advice will comprise feedback on the possible health consequences of excessive alcohol consumption, written information about alcohol and the offer of an appointment for further assessment and Brief Intervention. Follow-up data on alcohol use, sexual behavior, health related quality of life and service use will be collected by a researcher masked to allocation status six months later. The primary outcome for the study is mean weekly alcohol consumption during the previous three months, and the main secondary outcome is the proportion of participants who report unprotected sex during this period. Discussion Opportunistic
Family Intervention for Co-occurring Substance Use and Severe Psychiatric Disorders: Participant Characteristics and Correlates of Initial Engagement and More Extended Exposure in a Randomized Controlled Trial
MUESER, KIM T; Glynn, Shirley M.; Cather, Corrine; Zarate, Roberto; Fox, Lindy; Feldman, James; Wolfe, Rosemarie; Clark, Robin E.
Clients with severe mental illness and substance use disorder (i.e., dual disorders) frequently have contact with family members, who may provide valuable emotional and material support, but have limited skills and knowledge to promote recovery. Furthermore, high levels of family conflict and stress are related to higher rates of relapse. The present study was a two-site randomized controlled trial comparing a comprehensive, behaviorally-based family intervention for dual disorders program (F...
Oliai Araghi, Sadaf; Jeekel, Johannes; Reiss, Irwin K. M; Hunink, M. G. Myriam; van Dijk, Monique
Objective Neonatal intensive care units (NICU) around the world increasingly use music interventions. The most recent systematic review of randomized controlled trials (RCT) dates from 2009. Since then, 15 new RCTs have been published. We provide an updated systematic review on the possible benefits of music interventions on premature infants’ well-being. Methods We searched 13 electronic databases and 12 journals from their first available date until August 2016. Included were all RCTs published in English with at least 10 participants per group, including infants born prematurely and admitted to the NICU. Interventions were either recorded music interventions or live music therapy interventions. All control conditions were accepted as long as the effects of the music intervention could be analysed separately. A meta-analysis was not possible due to incompleteness and heterogeneity of the data. Results After removal of duplicates the searches retrieved 4893 citations, 20 of which fulfilled the inclusion/exclusion criteria. The 20 included studies encompassed 1128 participants receiving recorded or live music interventions in the NICU between 24 and 40 weeks gestational age. Twenty-six different outcomes were reported which we classified into three categories: physiological parameters; growth and feeding; behavioural state, relaxation outcomes and pain. Live music interventions were shown to improve sleep in three out of the four studies and heart rate in two out of the four studies. Recorded music improved heart rate in two out of six studies. Better feeding and sucking outcomes were reported in one study using live music and in two studies using recorded music. Conclusions Although music interventions show promising results in some studies, the variation in quality of the studies, age groups, outcome measures and timing of the interventions across the studies makes it difficult to draw strong conclusions on the effects of music in premature infants. PMID
Johnson, C R; Handen, B L; Lubetsky, M J; Sacco, K A
Using a combination of an alternating treatment and double-blind placebo-controlled drug design, the independent and combined effects of two behavioral interventions and two doses of methylphenidate (MPH) in 3 children with Attention Deficit Hyperactivity Disorder (ADHD) and mental retardation (MR) were assessed. In this single subject design, 2 of the 3 subjects responded positively to medication as measured by increased on-task behavior. The first behavioral intervention, a token economy for on-task behavior, was ineffective for increasing either on-task behavior or work accuracy when combined with placebo. However, improvement in work accuracy was realized with implementation of a second behavioral intervention that specifically targeted accuracy independent of drug conditions. The current findings highlight both the positive effects and limitations of the two commonly used treatment modalities for ADHD. Future studies should continue to extend this area of investigative efforts to produce more data-based knowledge as to the appropriate doses of treatment, both pharmacological and behavioral, with children with both ADHD and mental retardation. PMID:7980374
Johnson, C R; Handen, B L; Lubetsky, M J; Sacco, K A
Using a combination of an alternating treatment and double-blind placebo-controlled drug design, the independent and combined effects of two behavioral interventions and two doses of methylphenidate (MPH) in 3 children with Attention Deficit Hyperactivity Disorder (ADHD) and mental retardation (MR) were assessed. In this single subject design, 2 of the 3 subjects responded positively to medication as measured by increased on-task behavior. The first behavioral intervention, a token economy for on-task behavior, was ineffective for increasing either on-task behavior or work accuracy when combined with placebo. However, improvement in work accuracy was realized with implementation of a second behavioral intervention that specifically targeted accuracy independent of drug conditions. The current findings highlight both the positive effects and limitations of the two commonly used treatment modalities for ADHD. Future studies should continue to extend this area of investigative efforts to produce more data-based knowledge as to the appropriate doses of treatment, both pharmacological and behavioral, with children with both ADHD and mental retardation.
Salazar, Laura F.; Vivolo-Kantor, Alana; Hardin, James; Berkowitz, Alan
Background Bystander intervention approaches offer promise for reducing rates of sexual violence on college campuses. Most interventions are in-person small-group formats, which limit their reach and reduce their overall public health impact. Objective This study evaluated the efficacy of RealConsent, a Web-based bystander approach to sexual violence prevention, in enhancing prosocial intervening behaviors and preventing sexual violence perpetration. Methods A random probability sample of 743...
Cunningham, John Alastair
Background Alcohol problems are a serious public health concern, and few problem drinkers ever seek treatment. The Internet is one means of promoting access to care, but more research is needed to test the best types of interventions to employ. Evaluation of Internet-based interventions that contain a variety of research-validated cognitive-behavioral tools, which have been shown to be helpful to those with more severe alcohol concerns, should be a priority. Objective To evaluate whether prov...
Gage Brian F
Full Text Available Abstract Background There is currently much interest in pharmacogenetics: determining variation in genes that regulate drug effects, with a particular emphasis on improving drug safety and efficacy. The ability to determine such variation motivates the application of personalized drug therapies that utilize a patient's genetic makeup to determine a safe and effective drug at the correct dose. To ascertain whether a genotype-guided drug therapy improves patient care, a personalized medicine intervention may be evaluated within the framework of a randomized controlled trial. The statistical design of this type of personalized medicine intervention requires special considerations: the distribution of relevant allelic variants in the study population; and whether the pharmacogenetic intervention is equally effective across subpopulations defined by allelic variants. Methods The statistical design of the Clarification of Optimal Anticoagulation through Genetics (COAG trial serves as an illustrative example of a personalized medicine intervention that uses each subject's genotype information. The COAG trial is a multicenter, double blind, randomized clinical trial that will compare two approaches to initiation of warfarin therapy: genotype-guided dosing, the initiation of warfarin therapy based on algorithms using clinical information and genotypes for polymorphisms in CYP2C9 and VKORC1; and clinical-guided dosing, the initiation of warfarin therapy based on algorithms using only clinical information. Results We determine an absolute minimum detectable difference of 5.49% based on an assumed 60% population prevalence of zero or multiple genetic variants in either CYP2C9 or VKORC1 and an assumed 15% relative effectiveness of genotype-guided warfarin initiation for those with zero or multiple genetic variants. Thus we calculate a sample size of 1238 to achieve a power level of 80% for the primary outcome. We show that reasonable departures from these
Testa, Maria; Hoffman, Joseph H.; Livingston, Jennifer A.; Turrisi, Rob
A randomized controlled trial, using parent-based intervention (PBI) was designed to reduce the incidence of alcohol-involved sexual victimization among first-year college students. The PBI, adapted from Turrisi et al. (2001), was designed to increase alcohol-specific and general communication between mother and daughter. Female graduating high school seniors and their mothers were recruited from the community and randomly assigned to one of four conditions: Alcohol PBI (n=305), Enhanced Alco...
The advantages and limitations of RCT designs are discussed, and a range of alternative designs for medical and educational intervention studies considered. Designs selected are those that address the much neglected psychological issues involved in the recruitment of patients and allocation of patients to treatments within trials. Designs include Zelen's (18) randomized consent design, Brewin and Bradley's (20) partially randomized patient-centered design, and Korn and Baumrind's (21) partial...
Mahdi Tehranidoost; Anahita Basirnia; Shervin Assari; Mohammad Reza Mohammadi; Mostafa Najafi; Javad Alaghband-rad
Objective: The aim of the current study was to assess the impact of computer games and computer-assisted type instruction on dictation scores of elementary school children with attention deficit – hyperactivity disorder (ADHD). Method: In this single-blind clinical trial, 37 elementary school children with ADHD, selected by convenience sampling and divided into group I (n=17) and group II (n=20), underwent eight one-hour sessions (3 sessions per week) of intervention by computer games versus ...
White, Susan W.; Ollendick, Thomas; Albano, Anne Marie; Oswald, Donald; Johnson, Cynthia; Southam-Gerow, Michael A.; Kim, Inyoung; Scahill, Lawrence
Anxiety is common among adolescents with autism spectrum disorders (ASD) and may amplify the core social disability, thus necessitating combined treatment approaches. This pilot, randomized controlled trial (RCT) evaluated the feasibility and preliminary outcomes of the Multimodal Anxiety and Social Skills Intervention (MASSI) program in a sample of 30 adolescents with ASD and anxiety symptoms of moderate or greater severity. The treatment was acceptable to families, subject adherence was hig...
Thomson, NC; Rubin, AS; Niven, RM; Corris, PA; Siersted, HC; Olivenstein, R.; Pavord, ID; McCormack, D.; Laviolette, M.; Shargill, NS; Cox, G.
BACKGROUND: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. METHODS: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. Following initial...
Thomson, N C; Rubin, A.S.; Niven, R. M.; Corris, P A; Siersted, H. C.; Olivenstein, R.; Pavord, I.D.; McCormick, D.; Laviolette, M.; Shargill, N.S.; Cox, G.
Background: Bronchial thermoplasty (BT) is a bronchoscopic procedure that improves asthma control by reducing excess airway smooth muscle. Treated patients have been followed out to 5 years to evaluate long-term safety of this procedure. Methods: Patients enrolled in the Asthma Intervention Research Trial were on inhaled corticosteroids ≥200 μg beclomethasone or equivalent + long-acting-beta2-agonists and demonstrated worsening of asthma on long-acting-β2-agonist withdrawal. ...
Taljaard, Monica; Donner, Allan; Klar, Neil
Trials in which intact communities are the units of randomization are increasingly being used to evaluate interventions which are more naturally administered at the community level, or when there is a substantial risk of treatment contamination. In this article we focus on the planning of community intervention trials in which k communities (for example, medical practices, worksites, or villages) are to be randomly allocated to each of an intervention and a control group, and fixed cohorts of m individuals enrolled in each community prior to randomization. Formulas to determine k or m may be obtained by adjusting standard sample size formulas to account for the intracluster correlation coefficient rho. In the presence of individual-level attrition however, observed cohort sizes are likely to vary. We show that conventional approaches of accounting for potential attrition, such as dividing standard sample size formulas by the anticipated follow-up rate pi or using the average anticipated cohort size m pi, may, respectively, overestimate or underestimate the required sample size when cluster follow-up rates are highly variable, and m or rho are large. We present new sample size estimation formulas for the comparison of two means or two proportions, which appropriately account for variation among cluster follow-up rates. These formulas are derived by specifying a model for the binary missingness indicators under the population-averaged approach, assuming an exchangeable intracluster correlation coefficient, denoted by tau. To aid in the planning of future trials, we recommend that estimates for tau be reported in published community intervention trials. PMID:17068842
Wang, Jia-Sheng; Luo, Haitao; Wang, Piwen; Tang, Lili; YU, JIAHUA; Huang, Tianren; Cox, Stephen; Gao, Weimin
Health benefits of green tea polyphenols (GTPs) have been reported in many animal models, but human studies are inconclusive. This is partly due to a lack of biomarkers representing green tea consumption. In this study, GTP components and metabolites were analyzed in plasma and urine samples collected from a phase II intervention trial carried out in 124 healthy adults who received 500- or 1,000-mg GTPs or placebo for 3 months. A significant dose-dependent elevation was found for (-)-epicatec...
Zarei, Soheila; Valizadeh, Leila; BILAN, Nemat
Introduction: Controlling over allergens and environmental irritants is one of the essential elements of controlling asthma. Asthma control in adolescents is a challenge. The current study was performed with the goal of investigating the effect of an educational and modifying intervention about asthma triggers on asthma control among adolescents. Methods: The current study was a randomized clinical trial. 60 adolescents of 12-18 years of age participated in this study. The p...
Michelle W Voss
Full Text Available Research has shown the human brain is organized into separable functional networks during rest and varied states of cognition, and that aging is associated with specific network dysfunctions. The present study used functional magnetic resonance imaging (fMRI to examine low-frequency (.008<.08 Hz coherence of cognitively relevant and sensory brain networks in older adults who participated in a one-year intervention trial, comparing the effects of aerobic and non-aerobic fitness training on brain function and cognition. Results showed that aerobic training improved the aging brain’s resting functional efficiency in higher-level cognitive networks. One year of walking increased functional connectivity between aspects of the frontal, posterior, and temporal cortices within the Default Mode Network and a Frontal Executive Network, two brain networks central to brain dysfunction in aging. Length of training was also an important factor. Effects in favor of the walking group were observed only after 12 months of training, compared to non-significant trends after six months. A non-aerobic stretching and toning group also showed increased functional connectivity in the DMN after six months and in a Frontal Parietal Network after 12 months, possibly reflecting experience-dependent plasticity. Finally, we found that changes in functional connectivity were behaviorally relevant. Increased functional connectivity was associated with greater improvement in executive function. Therefore the study provides the first evidence for exercise-induced functional plasticity in large-scale brain systems in the aging brain, using functional connectivity techniques, and offers new insight into the role of aerobic fitness in attenuating age-related brain dysfunction.
Full Text Available Nilesh J Goswami,1 Mitch DeKoven,2 Andreas Kuznik,3 Jack Mardekian,3 Michelle R Krukas,2 Larry Z Liu,3,4 Patrick Bailey,1 Cynthia Deitrick,5 John Vincent3 1Prairie Heart Cardiovascular Consultants, Springfield, IL, USA; 2Health Economics and Outcomes Research, IMS Health, Alexandria, VA, USA; 3Pfizer Inc, New York, NY, USA; 4Weill Cornell Medical College, Cornell University, New York, NY, USA; 5Prairie Heart Education and Research Cooperative, Springfield, IL, USA Background: This trial evaluated the effectiveness of an integrated intervention program that included a 3-to-5-minute nurse counseling session, copay relief cards, and a monthly newsletter on adherence to atorvastatin treatment. Methods and results: A prospective, integrated (composed of nurse counseling, adherence tip sheet, copay relief card, opportunity to enroll in 12-week cholesterol management program randomized interventional study was designed involving patients >21 years of age who were prescribed atorvastatin at a large single-specialty cardiovascular physician practice in Illinois from March 2010 to May 2011. Data from the practice's electronic medical record were matched/merged to IMS Health's longitudinal data. A total of 500 patients were enrolled (125 in the control arm; 375 in the intervention arm. After data linkage, 53 control patients and 155 intervention patients were included in the analysis. Results: Mean age was 67.8 years (control and 69.5 years (intervention; 67.9% and 58.7%, respectively, were male. The mean 6-month adherence rate was 0.82 in both arms. The mean proportion of days covered for both the new-user control and intervention groups was the same, averaging 0.70 day (standard deviation [SD], 0.27 day; for continuing users, the proportion of days covered for the control group was 0.83 (SD, 0.24 and for the intervention group was 0.84 (SD, 0.22. For continuing users, the control group had mean persistent days of 151.6 (SD, 50.2 compared with 150.9 days
Osrin, David; Azad, Kishwar; Fernandez, Armida; Manandhar, Dharma S; Mwansambo, Charles W; Tripathy, Prasanta; Costello, Anthony M
Public health interventions usually operate at the level of groups rather than individuals, and cluster randomized controlled trials (RCTs) are one means of evaluating their effectiveness. Using examples from six such trials in Bangladesh, India, Malawi and Nepal, we discuss our experience of the ethical issues that arise in their conduct. We set cluster RCTs in the broader context of public health research, highlighting debates about the need to reconcile individual autonomy with the common good and about the ethics of public health research in low-income settings in general. After a brief introduction to cluster RCTs, we discuss particular challenges we have faced. These include the nature of - and responsibility for - group consent, and the need for consent by individuals within groups to intervention and data collection. We discuss the timing of consent in relation to the implementation of public health strategies, and the problem of securing ethical review and approval in a complex domain. Finally, we consider the debate about benefits to control groups and the standard of care that they should receive, and the issue of post-trial adoption of the intervention under test.
Tossmann, Hans-Peter; Jonas, Benjamin; Tensil, Marc-Dennan; Lang, Peter; Strüber, Evelin
In the last decade, several programs for the treatment of cannabis-related disorders were developed. Until now, no information is available on the efficacy of Internet-based counseling approaches for this target group. This article describes the evaluation of "quit the shit," a web-based intervention developed to help young people to quit or reduce their cannabis use significantly. Cannabis users seeking web-based treatment were included in a two-arm controlled trial conducted on a website for drug-related information and prevention. After the baseline assessment, members of the treatment condition were randomized to a 50-day intervention program. Other trial participants were put on a waiting list. A post-test was conducted 3 months after randomization. Of all 1,292 subjects included in the trial, a total of 206 participants took part at the post-test. Per-protocol- and intention-to-treat analyses were conducted. Members of the treatment condition showed a significantly stronger reduction in cannabis use (primary outcome) than the control group. In the per-protocol analyses, moderate-to-strong effects were found for the reduction of the frequency and the reduction of the quantity of consumed cannabis. Small-to-moderate effects were observed on the secondary outcomes (use-related self-efficacy, anxiety, depression, and life satisfaction). Despite limitations concerning the interpretation of the results, the intervention seems to offer an effective treatment option for persons with cannabis-related problems. PMID:21651419
Full Text Available Guidelines recommend implementation of multimodal interventions to help prevent recurrent TIA/stroke. We undertook a systematic review to assess the effectiveness of behavioral secondary prevention interventions.Searches were conducted in 14 databases, including MEDLINE (1980-January 2014. We included randomized controlled trials (RCTs testing multimodal interventions against usual care/modified usual care. All review processes were conducted in accordance with Cochrane guidelines.Twenty-three papers reporting 20 RCTs (6,373 participants of a range of multimodal behavioral interventions were included. Methodological quality was generally low. Meta-analyses were possible for physiological, lifestyle, psychosocial and mortality/recurrence outcomes. Note: all reported confidence intervals are 95%. Systolic blood pressure was reduced by 4.21 mmHg (mean (-6.24 to -2.18, P = 0.01 I2 = 58%, 1,407 participants; diastolic blood pressure by 2.03 mmHg (mean (-3.19 to -0.87, P = 0.004, I2 = 52%, 1,407 participants. No significant changes were found for HDL, LDL, total cholesterol, fasting blood glucose, high sensitivity-CR, BMI, weight or waist:hip ratio, although there was a significant reduction in waist circumference (-6.69 cm, -11.44 to -1.93, P = 0.006, I2 = 0%, 96 participants. There was no significant difference in smoking continuance, or improved fruit and vegetable consumption. There was a significant difference in compliance with antithrombotic medication (OR 1.45, 1.21 to 1.75, P<0.0001, I2 = 0%, 2,792 participants and with statins (OR 2.53, 2.15 to 2.97, P< 0.00001, I2 = 0%, 2,636 participants; however, there was no significant difference in compliance with antihypertensives. There was a significant reduction in anxiety (-1.20, -1.77 to -0.63, P<0.0001, I2 = 85%, 143 participants. Although there was no significant difference in odds of death or recurrent TIA/stroke, there was a significant reduction in the odds of cardiac events (OR 0.38, 0
Mitchell, Joanna; Hardeman, Wendy; Pears, Sally; Vasconcelos, Joana C.; Prevost, A. Toby; Wilson, Ed; Sutton, Stephen
Background: Physical activity interventions that are targeted at individuals can be effective in encouraging people to be more physically active. However, most such interventions are too long or complex and not scalable to the general population. This trial will test the effectiveness and cost-effectiveness of a very brief physical activity intervention when delivered as part of preventative health checks in primary care (National Health Service (NHS) Health Check). Methods/design: The Very B...
Kelly, Stephanie A.; Oswalt, Krista; Melnyk, Bernadette Mazurek; Jacobson, Diana
Fidelity in implementing an intervention is critical to accurately determine and interpret the effects of an intervention. It is important to monitor the manner in which the behavioral intervention is implemented (e.g. adaptations, delivery as intended and dose). Few interventions are implemented with 100% fidelity. In this study, high school…
Fjeldsoe Brianna S
Full Text Available Abstract Background Meaningful improvement in physical activity among control group participants in lifestyle intervention trials is not an uncommon finding, and may be partly explained by participant characteristics. This study investigated which baseline demographic, health and behavioural characteristics were predictive of successful improvement in physical activity in usual care group participants recruited into a telephone-delivered physical activity and diet intervention trial, and descriptively compared these characteristics with those that were predictive of improvement among intervention group participants. Methods Data come from the Logan Healthy Living Program, a primary care-based, cluster-randomized controlled trial of a physical activity and diet intervention. Multivariable logistic regression models examined variables predictive of an improvement of at least 60 minutes per week of moderate-to-vigorous intensity physical activity among usual care (n = 166 and intervention group (n = 175 participants. Results Baseline variables predictive of a meaningful change in physical activity were different for the usual care and intervention groups. Being retired and completing secondary school (but no further education were predictive of physical activity improvement for usual care group participants, whereas only baseline level of physical activity was predictive of improvement for intervention group participants. Higher body mass index and being unmarried may also be predictors of physical activity improvement for usual care participants. Conclusion This is the first study to examine differences in predictors of physical activity improvement between intervention group and control group participants enrolled in a physical activity intervention trial. While further empirical research is necessary to confirm findings, results suggest that participants with certain socio-demographic characteristics may respond favourably to minimal intensity
Fava, Leonardo; Vicari, Stefano; Valeri, Giovanni; D'Elia, Lidia; Arima, Serena; Strauss, Kristin
Although, reviews and outcome research supports empirical evidence for Early Intensive Behavior Intervention in pre-scholars, intensive behavioral service provision for school-aged children with autism spectrum disorders (ASD) are less subject to research studies. In order to provide effective behavioral interventions for school-aged children it…
Meriwether Rebecca A
Full Text Available Abstract Background The SenseWear™ Armband (SWA (BodyMedia, Inc. Pittsburgh, PA is a physical activity and lifestyle monitor that objectively and accurately measures free-living energy balance and sleep and includes software for self-monitoring of daily energy expenditure and energy intake. The real-time feedback of the SWA can improve individual self-monitoring and, therefore, enhance weight loss outcomes. Methods We recruited 197 sedentary overweight or obese adults (age, 46.8 ± 10.8 y; body mass index (BMI, 33.3 ± 5.2 kg/m2; 81% women, 32% African-American from the greater Columbia, South Carolina area. Participants were randomized into 1 of 4 groups, a self-directed weight loss program via an evidence-based weight loss manual (Standard Care, n = 50, a group-based behavioral weight loss program (GWL, n = 49, the armband alone (SWA-alone, n = 49, or the GWL plus the armband (GWL+SWA, n = 49, during the 9-month intervention. The primary outcome was change in body weight and waist circumference. A mixed-model repeated-measures analysis compared change in the intervention groups to the standard care group on weight and waist circumference status after adjusting for age, sex, race, education, energy expenditure, and recruitment wave. Results Body weight was available for 62% of participants at 9 months (52% standard care, 70% intervention. There was significant weight loss in all 3 intervention groups (GWL, 1.86 kg, P = 0.05; SWA-alone, 3.55 kg, P = 0.0002; GWL+SWA, 6.59 kg, P Conclusions Continuous self-monitoring from wearable technology with real-time feedback may be particularly useful to enhance lifestyle changes that promote weight loss in sedentary overweight or obese adults. This strategy, combined with a group-based behavioral intervention, may yield optimal weight loss. Trial Registration ClinicalTrials.gov: NCT00957008
Wong, Jessie J; Gonzales, Nancy A; Montaño, Zorash; Dumka, Larry; Millsap, Roger E
Parental depression is a major risk factor in child development. Growing research suggests parenting programs can positively impact parental depressive symptoms, although the specific mechanisms that explain these effects are unknown. The current study examined parenting mediated effects of a parenting program on mothers' and fathers' depressive symptoms, as well as the role of child behavior in linking parenting to reductions in depressive symptoms. The study samples included 494 mothers and 288 fathers of Mexican origin adolescents who participated in a randomized trial of the Bridges to High School Program/Proyecto Puentes a la Secundaria, a universal prevention and promotion intervention that included parent training but did not directly target parental depressive symptoms. Parenting mediator models tested program effects on parental depressive symptoms through changes in harsh and supportive parenting. Results showed a significant indirect intervention effect on maternal depressive symptoms through changes in mothers' harsh parenting. Next, child behavior models revealed a partial mediation effect of harsh parenting and a full mediation effect of supportive parenting on maternal depressive symptoms through mothers' reports of child externalizing symptoms. Indirect effects of fathers' harsh and supportive parenting on paternal depressive symptoms were also found through fathers' reports of child behavior. PMID:24798817
Wong, Jessie J; Gonzales, Nancy A; Montaño, Zorash; Dumka, Larry; Millsap, Roger E
Parental depression is a major risk factor in child development. Growing research suggests parenting programs can positively impact parental depressive symptoms, although the specific mechanisms that explain these effects are unknown. The current study examined parenting mediated effects of a parenting program on mothers' and fathers' depressive symptoms, as well as the role of child behavior in linking parenting to reductions in depressive symptoms. The study samples included 494 mothers and 288 fathers of Mexican origin adolescents who participated in a randomized trial of the Bridges to High School Program/Proyecto Puentes a la Secundaria, a universal prevention and promotion intervention that included parent training but did not directly target parental depressive symptoms. Parenting mediator models tested program effects on parental depressive symptoms through changes in harsh and supportive parenting. Results showed a significant indirect intervention effect on maternal depressive symptoms through changes in mothers' harsh parenting. Next, child behavior models revealed a partial mediation effect of harsh parenting and a full mediation effect of supportive parenting on maternal depressive symptoms through mothers' reports of child externalizing symptoms. Indirect effects of fathers' harsh and supportive parenting on paternal depressive symptoms were also found through fathers' reports of child behavior.
Patton, Susana R.; Odar, Cathleen; Midyett, L. Kurt; Clements, Mark A.
Objective This pilot study presents results for a parent-based educational intervention targeting mealtime behaviors plus nutrition among families of young children (M age: 5.0±1.2 years) with type 1 diabetes mellitus (T1DM). Methods We recruited nine caregivers who participated in the six-session intervention and completed baseline and post-treatment assessments. Results Children’s mean daily glycemic levels decreased from 185±46 mg/dl to 159±40 mg/dl (p<0.001). There were also decreases in problematic parent and child mealtime behaviors. There was no change in children’s dietary intake indicators. Conclusions and Implications It appears promising that our targeted behavior plus nutrition intervention can improve glycemic control and behavior for young children with T1DM. Our next step will be to modify the intervention to improve our nutrition education modules. Ultimately, we plan to test the intervention in a large randomized clinical trial to examine if it can yield improvements to children’s diet and glycated hemoglobin levels. PMID:24438850
Bonetti, Debbie; Eccles, Martin; Johnston, Marie; Steen, Nick; Grimshaw, Jeremy; Baker, Rachel; Walker, Anne; Pitts, Nigel
A consistent finding in health services research is the report of uneven uptake of research findings. Implementation trials have a variable record of success in effectively influencing clinicians' behaviour. A more systematic approach may be to conduct Intervention Modelling Experiments before service-level trials, examining intervention effects on 'interim endpoints' representing clinical behaviour, derived from empirically supported psychological theories. The objectives were to: (1) Design Intervention Modelling Experiments by backward engineering a 'real-world' randomised controlled trial (NEXUS); (2) examine the applicability of psychological theories to clinical decision-making; (3) explore whether psychological theories can illuminate how interventions achieve their effects. A 2 x 2 factorial randomised controlled trial was designed with pre- and post-intervention data collection by postal questionnaire surveys. The first survey was used to generate feedback data and the interventions were delivered in the second survey. General medical practitioners (GPs) in England and Scotland participated. First survey respondents were randomised twice to receive or not audit and feedback and educational reminder messages. The main outcome measures included behavioural intention (general plan to refer for lumbar X-rays) and simulated behaviour (specific, scenario-based, decisions to refer for lumbar X-ray). Predictors were attitude, subjective norm, perceived behavioural control (theory of planned behaviour), self-efficacy (social cognitive theory) and decision difficulty. Both interventions significantly influenced simulated behaviour, but neither influenced behavioural intention. There were no interaction effects. All theoretically derived cognitions significantly predicted simulated behaviour. Only subjective norm was not predictive of behavioural intention. The effect of audit and feedback on simulated behaviour was mediated through perceived behavioural control. The
Kim, Sun S; Sitthisongkram, Somporn; Bernstein, Kunsook; Fang, Hua; Choi, Won S; Ziedonis, Douglas
Introduction Korean women are reluctant to pursue in-person smoking cessation treatment due to stigma attached to women smokers and prefer treatment such as telephone and online smoking cessation programs that they can access secretively at home. However, there is some evidence that face-to-face interaction is the most helpful intervention component for them to quit smoking. Methods This study is a pilot clinical trial that examined the acceptability and feasibility of a videoconferencing smoking cessation intervention for Korean American women and compared its preliminary efficacy with a telephone-based intervention. Women of Korean ethnicity were recruited nationwide in the United States and randomly assigned at a ratio of 1:1 to either a video arm or a telephone arm. Both arms received eight 30-minute weekly individualized counseling sessions of a deep cultural smoking cessation intervention and nicotine patches for 8 weeks. Participants were followed over 3 months from the quit day. Results The videoconferencing intervention was acceptable and feasible for Korean women aged effective, and personal preference is likely an important factor in treatment matching. The deep cultural smoking cessation intervention may account for the outcomes of telephone counseling being better than prior studies in the literature for Korean women.
Full Text Available BACKGROUND: In developing countries, including Sri Lanka, a high proportion of acute poisoning and other medical emergencies are initially treated in rural peripheral hospitals. Patients are then usually transferred to referral hospitals for further treatment. Guidelines are often used to promote better patient care in these emergencies. We conducted a cluster randomized controlled trial (ISRCTN73983810 which aimed to assess the effect of a brief educational outreach ('academic detailing' intervention to promote the utilization of treatment guidelines for acute poisoning. METHODS AND FINDINGS: This cluster RCT was conducted in the North Central Province of Sri Lanka. All peripheral hospitals in the province were randomized to either intervention or control. All hospitals received a copy of the guidelines. The intervention hospitals received a brief out-reach academic detailing workshop which explained poisoning treatment guidelines and guideline promotional items designed to be used in daily care. Data were collected on all patients admitted due to poisoning for 12 months post-intervention in all study hospitals. Information collected included type of poison exposure, initial investigations, treatments and hospital outcome. Patients transferred from peripheral hospitals to referral hospitals had their clinical outcomes recorded. There were 23 intervention and 23 control hospitals. There were no significant differences in the patient characteristics, such as age, gender and the poisons ingested. The intervention hospitals showed a significant improvement in administration of activated charcoal [OR 2.95 (95% CI 1.28-6.80]. There was no difference between hospitals in use of other decontamination methods. CONCLUSION: This study shows that an educational intervention consisting of brief out-reach academic detailing was effective in changing treatment behavior in rural Sri Lankan hospitals. The intervention was only effective for treatments with
Full Text Available Abstract Background Knowledge about early physiotherapy to preterm infants is sparse, given the risk of delayed motor development and cerebral palsy. Methods/Design A pragmatic randomized controlled study has been designed to assess the effect of a preventative physiotherapy program carried out in the neonatal intensive care unit. Moreover, a qualitative study is carried out to assess the physiotherapy performance and parents' experiences with the intervention. The aim of the physiotherapy program is to improve motor development i.e. postural control and selective movements in these infants. 150 infants will be included and randomized to either intervention or standard follow-up. The infants in the intervention group will be given specific stimulation to facilitate movements based on the individual infant's development, behavior and needs. The physiotherapist teaches the parents how to do the intervention and the parents receive a booklet with photos and descriptions of the intervention. Intervention is carried out twice a day for three weeks (week 34, 35, 36 postmenstrual age. Standardized tests are carried out at baseline, term age and at three, six, 12 and 24 months corrected age. In addition eight triads (infant, parent and physiotherapist are observed and videotaped in four clinical encounters each to assess the process of physiotherapy performance. The parents are also interviewed on their experiences with the intervention and how it influences on the parent-child relationship. Eight parents from the follow up group are interviewed about their experience. The interviews are performed according to the same schedule as the standardized measurements. Primary outcome is at two years corrected age. Discussion The paper presents the protocol for a randomized controlled trial designed to study the effect of physiotherapy to preterm infants at neonatal intensive care units. It also studies physiotherapy performance and the parent's experiences
Carla FJ Nooijen
Full Text Available Questions: For people with subacute spinal cord injury, does rehabilitation that is reinforced with the addition of a behavioural intervention to promote physical activity lead to a more active lifestyle than rehabilitation alone? Design: Randomised, controlled trial with concealed allocation, intention-to-treat analysis, and blinded assessors. Participants: Forty-five adults with subacute spinal cord injury who were undergoing inpatient rehabilitation and were dependent on a manual wheelchair. The spinal cord injuries were characterised as: tetraplegia 33%; motor complete 62%; mean time since injury 150 days (SD 74. Intervention: All participants received regular rehabilitation, including handcycle training. Only the experimental group received a behavioural intervention promoting an active lifestyle after discharge. This intervention involved 13 individual sessions delivered by a coach who was trained in motivational interviewing; it began 2 months before and ended 6 months after discharge from inpatient rehabilitation. Outcome measures: The primary outcome was physical activity, which was objectively measured with an accelerometer-based activity monitor 2 months before discharge, at discharge, and 6 and 12 months after discharge from inpatient rehabilitation. The accelerometry data were analysed as total wheeled physical activity, sedentary time and motility. Self-reported physical activity was a secondary outcome. Results: The behavioural intervention significantly increased wheeled physical activity (overall between-group difference from generalised estimating equation 21 minutes per day, 95% CI 8 to 35. This difference was evident 6 months after discharge (28 minutes per day, 95% CI 8 to 48 and maintained at 12 months after discharge (25 minutes per day, 95% CI 1 to 50. No significant intervention effect was found for sedentary time or motility. Self-reported physical activity also significantly improved. Conclusion: The behavioural
Full Text Available Abstract Background Tobacco use continues to be a global public health problem. Helping patients to quit is part of the preventive role of all health professionals. There is now increasing interest in the role that the dental team can play in helping their patients to quit smoking. The aim of this study was to determine the feasibility of undertaking a randomised controlled smoking cessation intervention, utilising dental hygienists to deliver tobacco cessation advice to a cohort of periodontal patients. Methods One hundred and eighteen patients who attended consultant clinics in an outpatient dental hospital department (Periodontology were recruited into a trial. Data were available for 116 participants, 59 intervention and 57 control, and were analysed on an intention-to-treat basis. The intervention group received smoking cessation advice based on the 5As (ask, advise, assess, assist, arrange follow-up and were offered nicotine replacement therapy (NRT, whereas the control group received 'usual care'. Outcome measures included self-reported smoking cessation, verified by salivary cotinine measurement and CO measurements. Self-reported measures in those trial participants who did not quit included number and length of quit attempts and reduction in smoking. Results At 3 months, 9/59 (15% of the intervention group had quit compared to 5/57 (9% of the controls. At 6 months, 6/59 (10% of the intervention group quit compared to 3/57 (5% of the controls. At one year, there were 4/59 (7% intervention quitters, compared to 2/59 (4% control quitters. In participants who described themselves as smokers, at 3 and 6 months, a statistically higher percentage of intervention participants reported that they had had a quit attempt of at least one week in the preceding 3 months (37% and 47%, for the intervention group respectively, compared with 18% and 16% for the control group. Conclusion This study has shown the potential that trained dental hygienists
Fuller, Daniel; Potvin, Louise
Cluster randomized controlled trials are increasingly used in population health intervention research. Through randomization, researchers attempt to isolate the treatment effect and remove all other effects, including any effects of social context. In many cases, the constant effect assumption cannot be satisfied in cluster randomized controlled trials. We argue that when studying population health interventions, the effective mechanism of intervention lies in the interaction between the treatment and social context. Researchers should be cognizant that attempts to remove the effect of social context using CRTC may fail. The interaction between the treatment and social context should be the primary object of study in population health intervention research.
Marchant, Michelle R.; Solano, Brock R.; Fisher, Adam K.; Caldarella, Paul; Young, K. Richard; Renshaw, Tyler L.
There is little research regarding interventions for children with internalizing behaviors in schools, both within classrooms and in nonclassroom environments. In response to this need, a nonclassroom treatment package, consisting of (a) social skills instruction, (b) mediated self-management, and (c) a reinforcement system, was implemented to…
Hier, Bridget O; Eckert, Tanya L
Substantial numbers of students in the United States are performing below grade-level expectations in core academic areas, and these deficits are most pronounced in the area of writing. Although performance feedback procedures have been shown to produce promising short-term improvements in elementary-aged students' writing skills, evidence of maintenance and generalization of these intervention effects is limited. The purpose of this study was to examine the immediate, generalized, and sustained effects of incorporating multiple exemplar training into the performance feedback procedures of a writing intervention using a randomized controlled trial (RCT). Results indicated that although the addition of multiple exemplar training did not improve students' writing performance on measures of stimulus and response generalization, it did result in greater maintenance of intervention effects in comparison to students who received performance feedback without generality programming and students who engaged in weekly writing practice alone.
Andersen, Lars; Jørgensen, Marie Birk; Blangsted, Anne;
PURPOSE:: The objective of this study is to investigate the effect of three different workplace interventions on long-term compliance, muscle strength gains, and neck/shoulder pain in office workers. METHODS:: A 1-yr randomized controlled intervention trial was done with three groups: specific...... in maximal muscle strength, and changes in intensity of neck/shoulder pain (scale 0-9) in those with and without pain at baseline. RESULTS:: Regular participation was achieved by 54%, 31%, and 16% of those of the participants who answered the questionnaire in SRT (78%), APE (81%), and REF (80%), respectively......, during the first half of the intervention period, and decreased to 35%, 28% and 9%, respectively, during the second half. Shoulder elevation strength increased 9-11% in SRT and APE (P
Meenan, Richard T.; Vogt, Thomas M.; Williams, Andrew E.; Stevens, Victor J.; Albright, Cheryl L.; Nigg, Claudio
Objective Economic evaluation of Work, Weight, and Wellness (3W), a two-year randomized trial of a weight loss program delivered through Hawaii hotel worksites. Methods Business case analysis from hotel perspective. Program resources were micro-costed (2008 dollars). Program benefits were reduced medical costs, fewer absences, and higher productivity. Primary outcome was discounted 24-month net present value (NPV). Results Control program cost $222K to implement over 24 months ($61 per participant), intervention program cost $1.12M ($334). Including overweight participants (body mass index > 25), discounted control NPV was −$217K; −$1.1M for intervention program. Presenteeism improvement of 50% combined with baseline 10% productivity shortfall required to generate positive 24-month intervention NPV. Conclusions 3W’s positive clinical outcomes did not translate into immediate economic benefit for participating hotels, although modest cost savings were observed in the trial’s second year. PMID:20061889
Hier, Bridget O; Eckert, Tanya L
Substantial numbers of students in the United States are performing below grade-level expectations in core academic areas, and these deficits are most pronounced in the area of writing. Although performance feedback procedures have been shown to produce promising short-term improvements in elementary-aged students' writing skills, evidence of maintenance and generalization of these intervention effects is limited. The purpose of this study was to examine the immediate, generalized, and sustained effects of incorporating multiple exemplar training into the performance feedback procedures of a writing intervention using a randomized controlled trial (RCT). Results indicated that although the addition of multiple exemplar training did not improve students' writing performance on measures of stimulus and response generalization, it did result in greater maintenance of intervention effects in comparison to students who received performance feedback without generality programming and students who engaged in weekly writing practice alone. PMID:27268572
Full Text Available Abstract Background The OPERA trial is large cluster randomised trial testing a physical activity intervention to address depression amongst people living in nursing and residential homes for older people. A process evaluation was commissioned alongside the trial and we report the protocol for this process evaluation. Challenges included the cognitive and physical ability of the participants, the need to respect the privacy of all home residents, including study non-participants, and the physical structure of the homes. Evaluation activity had to be organised around the structured timetable of homes, leaving limited opportunities for data collection. The aims of this process evaluation are to provide findings that will assist in the interpretation of the clinical trial results, and to inform potential implementation of the physical activity intervention on a wider scale. Methods/design Quantitative data on recruitment of homes and individuals is being collected. For homes in the intervention arm, data on dose and fidelity of the intervention delivered; including individual rates of participation in exercise classes are collected. In the control homes, uptake and delivery of depression awareness training is monitored. These data will be combined with qualitative data from an in-depth study of a purposive sample of eight homes (six intervention and two control. Discussion Although process evaluations are increasingly funded alongside trials, it is still rare to see the findings published, and even rarer to see the protocol for such an evaluation published. Process evaluations have the potential to assist in interpreting and understanding trial results as well as informing future roll-outs of interventions. If such evaluations are funded they should also be reported and reviewed in a similar way to the trial outcome evaluation. Trial Registration ISRCTN No: ISRCTN43769277
Walther, Birte; Hanewinkel, Reiner; Morgenstern, Matthis
The aim of this study was to evaluate the effects of a four-session school-based media literacy curriculum on adolescent computer gaming and Internet use behavior. The study comprised a cluster randomized controlled trial with three assessments (baseline, posttest, and 12-month follow-up). At baseline, a total of 2,303 sixth and seventh grade adolescents from 27 secondary schools were assessed. Of these, 1,843 (80%) could be reached at all three assessments (Mage=12.0 years; SD=0.83). Students of the intervention group received the media literacy program Vernetzte www.Welten ("Connected www.Worlds ") implemented by trained teachers during class time. The control group attended regular class. Main outcome measures were adolescents' computer gaming and Internet use: days per month, hours per day, and addictive use patterns. Parental media monitoring and rules at home were assessed as secondary outcomes. Results of multilevel growth-curve models revealed a significant intervention effect in terms of a lower increase in self-reported gaming frequency (β = -1.10 [95% CI -2.06, -0.13]), gaming time (β = -0.27 [95% CI -0.40, -0.14]), and proportion of excessive gamers (AOR=0.21 [95% CI 0.08, 0.57]) in the intervention group. There were also significant group-time interactions for the addictive gaming scale (β=-0.08 [95% CI -0.12, -0.04]), and the Internet Addiction Scale (β = -0.06 [95% CI -0.10, -0.01]). No effect was found for days and hours of Internet use or parental media behavior. The study shows that the program Vernetzte www.Welten can influence adolescents' media use behavior. Future research should address mediating and moderating variables of program effects.
Ong Ken K
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.
Slater, Michael D; Edwards, Ruth W; Plested, Barbara A; Thurman, Pamela J; Kelly, Kathleen J; Comello, Maria Leonora G; Keefe, Thomas J
This study examines the role of key informant community readiness assessments in a randomized group trial testing the impact of a participatory community-media intervention (which was also complemented by in-school efforts). These assessments were used to help match communities in random assignment, as a source of formative data about the community, as the basis for a coalition-building workshop, and as an evaluation tool, with a follow-up set of surveys approximately 2 years after the baseline survey. Results of the nested, random effects analysis indicated that the intervention influenced community knowledge of efforts and (at marginally significant levels) improved prevention leadership quality and community climate supportive of prevention efforts. There was evidence that the professional affiliation of informants in some cases had an effect on their assessments, which could be controlled in the analysis. The authors conclude that key informant community readiness assessments can usefully serve to supplement aggregated measures of individual attitudes and behavior (reported elsewhere for this study) in evaluating community-based interventions. PMID:15751598
Pinheiro, Marina B; Ho, Kevin K; Ferreira, Manuela L; Refshauge, Kathryn M; Grunstein, Ron; Hopper, John L; Maher, Christopher G; Koes, Bart W; Ordoñana, Juan R; Ferreira, Paulo H
Poor sleep quality is highly prevalent in patients with low back pain (LBP) and is associated with high levels of pain, psychological distress, and physical disability. Studies have reported a bidirectional relationship between sleep problems and intensity of LBP. Accordingly, effective management of LBP should address sleep quality. In addition, genetics has been found to significantly affect the prevalence of both LBP and insomnia. Our study aims to establish the feasibility of a trial exploring the efficacy of a web-based sleep quality intervention in people with LBP, with the genetic influences being controlled for. 30 twins (15 complete pairs) with subacute or chronic LBP (>6 weeks) will be recruited from the Australian Twin Registry. Participants will be randomly assigned to one of the two groups with each twin within a pair receiving either an interactive web-based sleep intervention based on cognitive behavioral therapy principles (intervention) or a web-based education program (control) for 6 weeks. The feasibility of the trial will be investigated with regard to recruitment rate, feasibility of data collection and outcome measure completion, contamination of intervention, acceptability and experience of intervention, and sample size requirement for the full trial. Patient outcomes will be collected electronically at baseline, immediately post-treatment, and at 3-months' follow-up post-randomization. This trial employs a robust design that will effectively control for the influence of genetics on treatment effect. Additionally, this study addresses sleep quality, a significant but under-explored issue in LBP. Results will inform the design and implementation of the definitive trial. PMID:27571889
Didier N. Kramer
Full Text Available Background: Road traffic accidents (RTA and burns are frequent events in children. Although many children recover spontaneously, a considerable number develop long-term psychological sequelae. Evidence on early psychological interventions to prevent such long-term problems is still scarce for school-age children and completely lacking for pre-school children. Objectives: To evaluate the efficacy of an early two-session cognitive-behavioral intervention in 108 children ages 2–16 after RTAs and burns. Methods: Children assessed at risk for the development of posttraumatic stress disorder (PTSD were randomly assigned to either a control group offered treatment as usual or an intervention group. Primary outcomes were PTSD, behavioral problems, and depression symptoms. Baseline and blinded 3- and 6-month follow-up assessments were conducted. Results: In pre-school children, no intervention effects were found. School-age children in the intervention group exhibited significantly fewer internalizing problems at 3-month follow-up relative to controls and a borderline significant time-by-group effect for PTSD intrusion symptoms was found (p=0.06. Conclusions: This is the first study examining the efficacy of an indicated, early psychological intervention among both school-age and pre-school-age children. Because the intervention was ineffective for young children, no evidence-based practice can currently be suggested. Given that parents of pre-school children perceived the intervention as helpful, brief counseling of parents in terms of psychoeducation and training in coping skills still should be provided by clinicians, despite the current lack of evidence. To prevent trauma-related disorders in school-age children, the intervention might be used in a step-wise manner, where only children at risk for long-term psychological maladjustment are provided with psychological support.
Cooper, C.; Barber, J; Griffin, M.; Rapaport, P.; Livingston, G.
BACKGROUND: Family carers of people with dementia frequently report acting abusively toward them and carer psychological morbidity predicts this. We investigated whether START (STrAtegies for RelaTives), a psychological intervention which reduces depression and anxiety in family carers also reduces abusive behavior in carers of people living in their own homes. We also explored the longitudinal course of carer abusive behavior over two year. METHODS: We included self-identified family carers ...
Background. There is no consensus about the level of risk of gastrointestinal illness posed by consumption of drinking water that meets all regulatory requirements. Earlier drinking water intervention trials from Canada suggested that 14% - 40% of such gastrointestinal il...
Bierman, Arlene S
Arlene Bierman discusses new research findings from a randomized trial evaluating community-based nursing interventions in older adults, and and comments on how we need to to re-engineer health systems to provide greater quality of care.
Duncombe, Melissa E; Havighurst, Sophie S; Kehoe, Christiane E; Holland, Kerry A; Frankling, Emma J; Stargatt, Robyn
This study evaluated the effectiveness of a multisystemic early intervention that included a comparison of an emotion- and behavior-focused parenting program for children with emerging conduct problems. The processes that moderated positive child outcomes were also explored. A repeated measures cluster randomized group design methodology was employed with three conditions (Tuning in to Kids, Positive Parenting Program, and waitlist control) and two periods (preintervention and 6-month follow-up). The sample consisted of 320 predominantly Caucasian 4- to 9-year-old children who were screened for disruptive behavior problems. Three outcome measures of child conduct problems were evaluated using a parent (Eyberg Child Behavior Inventory) and teacher (Strengths and Difficulties Questionnaire) rating scale and a structured child interview (Home Interview With Child). Six moderators were assessed using family demographic information and a parent-rated measure of psychological well-being (Depression Anxiety and Stress Scales short form). The results indicated that the multisystemic intervention was effective compared to a control group and that, despite different theoretical orientations, the emotion- and behavior-focused parenting programs were equally effective in reducing child conduct problems. Child age and parent psychological well-being moderated intervention response. This effectiveness trial supports the use of either emotion- or behavior-focused parenting programs in a multisystemic early intervention and provides greater choice for practitioners in the selection of specific programs.
Fallon, Lindsay M.; Collier-Meek, Melissa A.; Sanetti, Lisa M. H.; Feinberg, Adam B.; Kratochwill, Thomas R.
Behavioral interventions delivered across home and school settings can promote positive outcomes for youth with autism spectrum disorders (ASD). Yet, stakeholders who deliver these interventions may struggle to implement interventions as intended. Low levels of treatment integrity can undermine potentially positive intervention outcomes. One way…
Geshi, Masayo; Hirokawa, Kumi; TANIGUCHI, Toshiyo; Fujii, Yasuhito; Kawakami, Norito
We conducted a randomized controlled trial involving Japanese junior college students aimed at investigating the effects of a single session of alcohol health education concerning the effects of alcohol, alcohol-related health problems, and drinking behavior. Students were randomly assigned to an intervention (n=38) or a control group (n=33). The intervention group attended a 90-minute alcohol health education session that included demonstration of an ethanol patch test, watching videos, and ...
Full Text Available Abstract Background While the HIV epidemic is levelling off in sub-Saharan Africa, it remains at an unacceptably high level. Young people aged 15-24 years remain particularly vulnerable, resulting in a regional HIV prevalence of 1.4% in young men and 3.3% in young women. This study assesses the effectiveness of a peer-led HIV prevention intervention in secondary schools in Rwanda on young people’s sexual behavior, HIV knowledge and attitudes. Methods In a non-randomized longitudinal controlled trial, fourteen schools were selected in two neighboring districts in Rwanda Bugesera (intervention and Rwamagana (control. Students (n = 1950 in eight intervention and six control schools participated in three surveys (baseline, six and twelve months in the intervention. Analysis was done using linear and logistic regression using generalized estimation equations adjusted for propensity score. Results The overall retention rate was 72%. Time trends in sexual risk behavior (being sexually active, sex in last six months, condom use at last sex were not significantly different in students from intervention and control schools, nor was the intervention associated with increased knowledge, perceived severity or perceived susceptibility. It did significantly reduce reported stigma. Conclusions Analyzing this and other interventions, we identified several reasons for the observed limited effectiveness of peer education: 1 intervention activities (spreading information are not tuned to objectives (changing behavior; 2 young people prefer receiving HIV information from other sources than peers; 3 outcome indicators are not adequate and the context of the relationship in which sex occurs and the context in which sex occurs is ignored. Effectiveness of peer education may increase through integration in holistic interventions and redefining peer educators’ role as focal points for sensitization and referral to experts and services. Finally, we argue that a
O'Connor, Thomas G.; Matias, Carla; Futh, Annabel; Tantam, Grace; Scott, Stephen
Parenting programs for school-aged children are typically based on behavioral principles as applied in social learning theory. It is not yet clear if the benefits of these interventions extend beyond aspects of the parent-child relationship quality conceptualized by social learning theory. The current study examined the extent to which a social…
Full Text Available Internet interventions provide an option for those who either cannot or choose not to engage with traditional treatments. Most research on internet interventions involves guided or supported interventions. However, unsupported interventions offer considerably more scalability and cost-effectiveness, which makes them attractive for large-scale implementation. In this study, 309 participants recruited via Google AdWords entered an unsupported cognitive–behavioral internet intervention for depressive symptoms. To maximize the ecological validity of the study, participants received no incentives or live contact with study personnel. Furthermore, the study was open to individuals at any level of depressive symptoms, and all participants received the active intervention. The main outcome measures were depressive symptom level and self-efficacy in managing depressive symptoms. At follow-up, depression scores were significantly lower than baseline scores at each follow-up point (1, 2, 4, and 7 months, with pre–post effect sizes ranging from medium to large. Follow-up depression self-efficacy scores were significantly higher than baseline scores at each follow-up point, with pre–post effect sizes in the medium range. The results remained significant when analyzing only participants with depression scores indicative of a presence of a major depressive episode; results likewise remained significant when employing the conservative last observation carried forward convention, even in the presence of high attrition observed in this study. The results illustrate the potential of unsupported internet intervention to address the health needs of the global community.
Fishbein, Martin; Ajzen, Icek
Hobbis and Sutton (this issue) suggest that Cognitive Behavior Therapy (CBT) techniques can be used in interventions based on the Theory of Planned Behavior (TPB). Although this suggestion has merit, CBT is only one of many applicable methods for producing belief and behavior change. Moreover, CBT's primary purpose is to help people carry out intended behaviors, not to influence intentions, and that it is more useful in face-to-face than in community-level interventions. Contrary to Hobbis and Sutton's critique, TPB can accommodate core beliefs or fundamental assumptions, but the theory suggests that interventions targeted at such beliefs are less effective than interventions targeted at behavior specific beliefs. PMID:15576497
Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja
Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication.
Gulpers Math JM
Full Text Available Abstract Background Physical restraints are still frequently used in nursing home residents despite growing evidence for the ineffectiveness and negative consequences of these methods. Therefore, reduction in the use of physical restraints in psycho-geriatric nursing home residents is very important. The aim of this study was to investigate the short-term effects of an educational intervention on the use of physical restraints in psycho-geriatric nursing home residents. Methods A cluster randomized trial was applied to 5 psycho-geriatric nursing home wards (n = 167 residents with dementia. The wards were assigned at random to either educational intervention (3 wards or control status (2 wards. The restraint status was observed and residents' characteristics, such as cognitive status, were determined by using the Minimum Data Set (MDS at baseline and 1 month after intervention. Results Restraint use did not change significantly over time in the experimental group (55%–56%, compared to a significant increased use (P Conclusion An educational programme for nurses combined with consultation with a nurse specialist did not decrease the use of physical restraints in psycho-geriatric nursing home residents in the short term. However, the residents in the control group experienced more restraint use during the study period compared to the residents in the experimental group. Whether the intervention will reduce restraint use in the long term could not be inferred from these results. Further research is necessary to gain insight into the long-term effects of this educational intervention.
Bronstein, Laura R; Gould, Paul; Berkowitz, Shawn A; James, Gary D; Marks, Kris
This study assessed how a social work-led care coordination intervention would reduce the within-30-day hospital readmission rate among moderate- and high-risk patients age 50 years or older. Authors ran a randomized controlled trial to determine whether there was a significant difference in within-30-day readmission rates between patients receiving usual care post-discharge and those receiving intervention from an MSW intern (one home visit and one to two phone calls). Results were obtained using a sample of hospitalized patients with a LACE index score of 7 or higher (N = 89). Analysis suggests that the intervention improved the likelihood of not being readmitted by some 22 percent (RR = 1.222; 95% CI = 1.063-1.405). The risk improvement with the intervention was highly statistically significant (p = .003). This study shows that a time-efficient care coordination intervention by MSW interns may decrease hospital readmission rates. Replications of this study in other communities, with more diverse populations, and with larger numbers of patients will indicate whether results are generalizable.
Pelleboer-Gunnink, Hannah A; Van der Valk, Inge E; Branje, Susan J T; Van Doorn, Muriel D; Deković, Maja
Children of divorced parents have an increased risk of a variety of problems in comparison to children from intact families. Therefore, several intervention programs have been developed directed at children of divorced parents. Yet, empirical data on the effectiveness of these interventions are limited. This study evaluated the school-based, child-directed prevention program Kids In Divorce Situations (KIDS) using a randomized controlled trial. The sample consisted of 156 children randomly assigned at the school level into an experimental (80 children) and control condition (76 children). In addition, 131 mothers and 76 fathers participated in the study. Four assessments took place: a pretest, a posttest, and two follow-up assessments conducted 6 months and 1 year after finishing KIDS. Latent growth analyses demonstrated that the intervention significantly reduced child-reported emotional problems and enhanced child-reported communication with the father and mother-reported communication with the child. The effect sizes ranged from .30-.63. Few moderation effects of gender, time since divorce, or perceived parental conflict on the intervention effects were found. After parental divorce, a limited school-based intervention for children can be efficacious in promoting children's emotional well-being and parent-child communication. PMID:26121535
Nelson, Geoffrey; Macnaughton, Eric; Goering, Paula
Using the case of a large-scale, multi-site Canadian Housing First research demonstration project for homeless people with mental illness, At Home/Chez Soi, we illustrate the value of qualitative methods in a randomized controlled trial (RCT) of a complex community intervention. We argue that quantitative RCT research can neither capture the complexity nor tell the full story of a complex community intervention. We conceptualize complex community interventions as having multiple phases and dimensions that require both RCT and qualitative research components. Rather than assume that qualitative research and RCTs are incommensurate, a more pragmatic mixed methods approach was used, which included using both qualitative and quantitative methods to understand program implementation and outcomes. At the same time, qualitative research was used to examine aspects of the intervention that could not be understood through the RCT, such as its conception, planning, sustainability, and policy impacts. Through this example, we show how qualitative research can tell a more complete story about complex community interventions.
Full Text Available Background: Prostate cancer has been reported as the second leading cause of cancer death among men in 2013. Prevention and early detection of cancer are considered as critical factors in controlling the disease and increasing the survival of patients. Therefore, we aimed to investigate the effect of Health Belief Model (HBM-based education onknowledge and prostate cancer screening behaviors in a randomized controlled trial. Methods: This study was a non-blinded randomized controlled trial. We enrolled 210 men aged 50-70. Balanced block randomization method was used to randomize the final participants who had inclusion criteria into intervention (n=93 and control (n=87 groups. The participants of the intervention group attended training workshops based on HBM. Data were collected using three questionnaires, i.e. demographic questionnaire, Prostate Cancer Screening-Health Belief Model Scale (PCS-HBMS, and the Knowledge about Prostate Cancer Screening questionnaire, all given before and immediately one month after the intervention. Results: The mean scores of the perceived susceptibility, severity, barriers and benefits increased significantly after the intervention (P>0.05 in the intervention group. In the control group, such a difference was reported only for perceived susceptibility (P>0.05. The rate of participation in prostate cancer screening in the intervention group increased from 7.5% to 24% and 43.3% one month and three months after the intervention, respectively. Conclusion: Our findings showed that the health education programs designed based on HBM could positively affect prostate cancer preventive behaviors of individuals by improving their knowledge level and leaving positive effects on perceived susceptibility and severity as well as considering the perceived barriers, benefits and health motivations.
Full Text Available Abstract Background Prevention is considered effective in combating the obesity epidemic. Prenatal environment may increase offspring's risk for obesity. A child starts to adopt food preferences and other behavioral habits affecting weight gain during preschool years. We report the study protocol of a pragmatic lifestyle intervention aiming at primary prevention of childhood obesity. Methods/Design A non-randomized controlled pragmatic trial in maternity and child health care clinics. The control group was recruited among families who visited the same clinics one year earlier. Eligibility criteria was mother at risk for gestational diabetes: body mass index ≥ 25 kg/m2, macrosomic newborn in any previous pregnancy, immediate family history of diabetes and/or age ≥ 40 years. All maternity clinics in town involved in recruitment. The gestational intervention consisted of individual counseling on diet and physical activity by a public health nurse, and of two group counseling sessions. Intervention continues until offspring’s age of five years. An option to participate a group counseling at child’s age 1 to 2 years was offered. The intervention includes advice on healthy diet, physical activity, sedentary behavior and sleeping pattern. The main outcome measure is offspring BMI z-score and its changes by the age of six years. Discussion Early childhood is a critical time period for prevention of obesity. Pragmatic trials targeting this period are necessary in order to find effective obesity prevention programs feasible in normal health care practice. Trial registration Clinical Trials gov NCT00970710
Huis in ’t Veld Diana
Full Text Available Abstract Background Alcohol abuse comes with risks for increased morbidity and mortality among patients with HIV. This study aims to determine the prevalence of alcohol use and other risk factors in a sample of primary care patients with HIV in South Africa and to assess a brief intervention to reduce the use of alcohol in this group. Methods/Design A single-blinded randomized controlled trial is designed to determine the efficacy of a brief intervention to reduce hazardous alcohol use in patients with HIV. The study will be carried out on out-patients with HIV in two primary healthcare HIV clinics near Pretoria, South Africa. Alcohol use will be assessed with the Alcohol Use Disorder Identification Test questionnaire. Other data that will be collected relate to health-related quality of life, depression, sexual behavior, internalized AIDS stigma, HIV-related information and adherence to antiretroviral therapy (self-reported 7-day recall of missed doses, Visual Analog Scale and pill count. The intervention consists of a brief counseling session to reduce alcohol risk; the control group receives a health education leaflet. Discussion The findings will be important in the public health setting. If the intervention proves to be efficient, it could potentially be incorporated into the HIV care policy of the Ministry of Health. Trial registration Pan African Clinical trial Registry: PACTR201202000355384
Frøydis N Vik
Full Text Available The UP4FUN intervention is a family-involved school-based intervention aiming at reducing and breaking up sitting time at home (with special emphasis on screen time, and breaking up sitting time in school among 10-12 year olds in Europe. The purpose of the present paper was to evaluate its short term effects.A total of 3147 pupils from Belgium, Germany, Greece, Hungary and Norway participated in a school-randomized controlled trial. The intervention included 1-2 school lessons per week for a period of six weeks, along with assignments for the children and their parents. Screen time and breaking up sitting time were registered by self-report and total sedentary time and breaking up sitting time by accelerometry. The effect of the intervention on these behaviors was evaluated by multilevel regression analyses. All analyses were adjusted for baseline values and gender. Significance level was p≤0.01. No significant intervention effects were observed, neither for self-reported TV/DVD or computer/game console time, nor for accelerometer-assessed total sedentary time and number of breaks in sitting time. The intervention group, however, reported more positive attitudes towards (β = 0.25 (95% CI 0.11, 0.38 and preferences/liking for (β = 0.20 (95% CI 0.08, 0.32 breaking up sitting time than the control group.No significant intervention effect on self-reported screen time or accelerometer-assessed sedentary time or breaks in sitting time was observed, but positive effects on beliefs regarding breaking up sitting time were found in favor of the intervention group. Overall, these results do not warrant wider dissemination of the present UP4FUN intervention.International Standard Randomized Controlled Trial Number Registry ISRCTN34562078.
Risk assessments and intervention trials have been used to inform the EPA on drinking water risks. Seldom are both methods used concurrently. Between 2001 and 2003, illness data from a trial were collected simultaneously with exposure data, providing a unique opportunity to com...
P.A.C. van Lier
textabstractKnowledge about the development of children with disruptive behaviors, leading to disruptive disorders and related poor outcomes, guides prevention research in the development and evaluation of preventive interventions. The overview of effective interventions in this chapter showed that
Vergidis, Paschalis I; Falagas, Matthew E
Different behavioral interventions have found to be efficacious in reducing high-risk sexual activity. Interventions have been evaluated in both original research and meta-analytic reviews. Most of the studies have shown that interventions are efficacious among different study populations. In adolescents, both in- and out-of-the classroom interventions showed a decrease in the risk of unprotected sex. In African Americans, greater efficacy was found for interventions including peer education. For Latinos, effect was larger in interventions with segmentation in the same gender. Geographic and social isolation are barriers in approaching MSM. For IDUs, interventions provided within a treatment program have an impact on risk reduction above that produced by drug treatment alone. Finally, people diagnosed with HIV tend to reduce their sexual risk behavior. However, adherence to safe sex practices for life can be challenging. Relentless efforts for implementation of behavioral interventions to decrease high-risk behavior are necessary to decrease HIV transmission. PMID:19393911
Michaelson, Peter; Gard, Gunvor; Eriksson, Margareta K
Background Web-based interventions with a focus on behavior change have been used for pain management, but studies of Web-based interventions integrated in clinical practice are lacking. To emphasize the development of cognitive skills and behavior, and to increase activity and self-care in rehabilitation, the Web Behavior Change Program for Activity (Web-BCPA) was developed and added to multimodal pain rehabilitation (MMR). Objective The objective of our study was to evaluate the effects of MMR in combination with the Web-BCPA compared with MMR among persons with persistent musculoskeletal pain in primary health care on pain intensity, self-efficacy, and copying, as part of a larger collection of data. Web-BCPA adherence and feasibility, as well as treatment satisfaction, were also investigated. Methods A total of 109 participants, mean age 43 (SD 11) years, with persistent pain in the back, neck, shoulder, and/or generalized pain were recruited to a randomized controlled trial with two intervention arms: (1) MMR+WEB (n=60) and (2) MMR (n=49). Participants in the MMR+WEB group self-guided through the eight modules of the Web-BCPA: pain, activity, behavior, stress and thoughts, sleep and negative thoughts, communication and self-esteem, solutions, and maintenance and progress. Data were collected with a questionnaire at baseline and at 4 and 12 months. Outcome measures were pain intensity (Visual Analog Scale), self-efficacy to control pain and to control other symptoms (Arthritis Self-Efficacy Scale), general self-efficacy (General Self-Efficacy Scale), and coping (two-item Coping Strategies Questionnaire; CSQ). Web-BCPA adherence was measured as minutes spent in the program. Satisfaction and Web-BCPA feasibility were assessed by a set of items. Results Of 109 participants, 99 received the allocated intervention (MMR+WEB: n=55; MMR: n=44); 88 of 99 (82%) completed the baseline and follow-up questionnaires. Intention-to-treat analyses were performed with a sample
Connell, Arin M.; Dishion, Thomas J.; Yasui, Miwa; Kavanagh, Kathryn
This study used Complier Average Causal Effect analysis (CACE; see G. Imbens & D. Rubin, 1997) to examine the impact of an adaptive approach to family intervention in the public schools on rates of substance use and antisocial behavior among students ages 11-17. Students were randomly assigned to a family-centered intervention (N = 998) in 6th…
Cappella, Elise; Reinke, Wendy M.; Hoagwood, Kimberly E.
School psychology research focused on child outcomes is critical for understanding which social and behavioral interventions affect children in schools. Yet effective interventions fulfill their promise when they fit their implementation contexts, are implemented well with existing resources, and can be sustained or scaled up to new populations.…
Full Text Available Abstract Background With the burden of mental illness estimated to be costing the English economy alone around £22.5 billion a year 1, coupled with growing evidence that many mental disorders have their origins in adolescence, there is increasing pressure for schools to address the emotional well-being of their students, alongside the stigma and discrimination of mental illness. A number of prior educational interventions have been developed and evaluated for this purpose, but inconsistency of findings, reporting standards, and methodologies have led the majority of reviewers to conclude that the evidence for the efficacy of these programmes remains inconclusive. Methods/Design A cluster randomised controlled trial design has been employed to enable a feasibility study of 'SchoolSpace', an intervention in 7 UK secondary schools addressing stigma of mental illness, mental health literacy, and promotion of mental health. A central aspect of the intervention involves students in the experimental condition interacting with a young person with lived experience of mental illness, a stigma reducing technique designed to facilitate students' engagement in the project. The primary outcome is the level of stigma related to mental illness. Secondary outcomes include mental health literacy, resilience to mental illness, and emotional well-being. Outcomes will be measured pre and post intervention, as well as at 6 month follow-up. Discussion The proposed intervention presents the potential for increased engagement due to its combination of education and contact with a young person with lived experience of mental illness. Contact as a technique to reduce discrimination has been evaluated previously in research with adults, but has been employed in only a minority of research trials investigating the impact on youth. Prior to this study, the effect of contact on mental health literacy, resilience, and emotional well-being has not been evaluated to the authors
Bonner, Melanie Jean
The present study evaluated the effectiveness of a behavioral family intervention on adherence and metabolic control in insulin dependent diabetic children (IODM). Specifically, assumption of regimen responsibilities between the parent and child were manipulated to facilitate regimen adherence. The intervention delivered was a target-specific behavioral contract extended sequentially across four target behaviors (Le., blood glucose testing, insulin injections, diet, and exercise). Regimen...
Matson, Johnny L.; Tureck, Kimberly; Turygin, Nicole; Beighley, Jennifer; Rieske, Robert
The use of applied behavior analysis (ABA) to treat persons with autism goes back several decades. Many specific target behaviors and intervention strategies have been developed. In the last two decades the most heavily studied of these methods has been Early Intensive Behavioral Interventions (EIBI). This package of ABA methods is unique in two…
Volpe, Robert J.; Young, Gregory I.; Piana, Maureen G.; Zaslofsky, Anne F.
Kindergarten Peer Assisted Learning Strategies and directly teaching and reinforcing behavioral expectations are empirically supported interventions for building early literacy skills and increasing on-task behavior, respectively. Previous research has not investigated the application of both academic and behavior interventions simultaneously to…
Dowling, Nicki; Jackson, Alun C.; Thomas, Shane A.
Cognitive and behavioral interventions have been cautiously recommended as "best practice" in the treatment of pathological gambling. Behavioral interventions, using a range of techniques, have been the most commonly evaluated approach to the psychological treatment of pathological gambling. The recent literature evaluating behavioral treatments…
Jay, Susan M.; And Others
Evaluated efficacy of cognitive-behavioral intervention package and low-risk pharmacologic intervention (oral Valium) as compared with minimal treatment-attention control condition, in reducing children leukemia patients' distress during bone marrow aspirations. The cognitive-behavioral therapy reduced behavioral distress, pain ratings and pulse…
Clements, Douglas H.; Sarama, Julie; Spitler, Mary Elaine; Lange, Alissa A.; Wolfe, Christopher B.
This study employed a cluster randomized trial design to evaluate the effectiveness of a research-based intervention for improving the mathematics education of very young children. This intervention includes the "Building Blocks" mathematics curriculum, which is structured in research-based learning trajectories, and congruous professional…
Dwivedi, Umesh C; Kumari, Sony; Nagendra, H R
Counterproductive work behavior (CWB) has long been recognized as a broad spectrum of job behaviors and its link with negative affectivity and hostile behaviors. It is a major concern practically for all organizations. Repeated exposure to workplace stressor can result in a strain, an outcome of the job stress process that can be psychological, physical, or behavioral in nature, leading to CWBs. Yoga is a technique that brings an improvement on mental and physical level by means of posture, breathing control methods, and silencing the mind through meditation. Though yoga has received less scientific consideration, there has been a significant growth in the study of yoga in the healthy population. Mindfulness and self-control practices like yoga encourage individuals to be aware and accept their aggression linked thoughts and emotions simply as a short-lived state rather than to control them. The positive effects of yoga on the improvement of personality traits are already proven. This paper introduces a simple model of cost-effective, trials of yoga intervention at the workplace which could result in the twin benefits of substantial savings from losses for the employers by reducing the CWB and health improvements for the employees by reducing the negative affectivity and aggression. Internet databases such as PubMed, Google Scholar, and APA PsycNET were accessed. The available data were systematically reviewed in a structured manner and analyzed. PMID:27212813
Umesh C Dwivedi
Full Text Available Counterproductive work behavior (CWB has long been recognized as a broad spectrum of job behaviors and its link with negative affectivity and hostile behaviors. It is a major concern practically for all organizations. Repeated exposure to workplace stressor can result in a strain, an outcome of the job stress process that can be psychological, physical, or behavioral in nature, leading to CWBs. Yoga is a technique that brings an improvement on mental and physical level by means of posture, breathing control methods, and silencing the mind through meditation. Though yoga has received less scientific consideration, there has been a significant growth in the study of yoga in the healthy population. Mindfulness and self-control practices like yoga encourage individuals to be aware and accept their aggression linked thoughts and emotions simply as a short-lived state rather than to control them. The positive effects of yoga on the improvement of personality traits are already proven. This paper introduces a simple model of cost-effective, trials of yoga intervention at the workplace which could result in the twin benefits of substantial savings from losses for the employers by reducing the CWB and health improvements for the employees by reducing the negative affectivity and aggression. Internet databases such as PubMed, Google Scholar, and APA PsycNET were accessed. The available data were systematically reviewed in a structured manner and analyzed.
Westerhof, Gerben J.; Bohlmeijer, Ernst T.
Background There is a rapidly growing interest in psychological well-being (PWB) as outcome of interventions. Ryff developed theory-based indicators of PWB that are consistent with a eudaimonic perspective of happiness. Numerous interventions have been developed with the aim to increase PWB. However, the effects on PWB measured as coherent outcome have not been examined across studies yet. This meta-analysis of randomized controlled trials of behavioral interventions aims to answer the question whether it is possible to enhance PWB. Methods A systematic literature search was performed in PsycINFO, Cochrane and Web of Science. To be included, studies had to be randomized controlled trials of behavioral interventions with psychological well-being as primary or secondary outcome measure, measured with either Ryff’s Psychological Well-Being Scales or the Mental Health Continuum—Short Form. The meta-analysis was performed using a random effects model. From the 2,298 articles found, 27 met the inclusion criteria. The included studies involved 3,579 participants. Results We found a moderate effect (Cohen’s d = 0.44; z = 5.62; p research of psychological well-being. Heterogeneity is a limitation of the study and there is need for more high-quality studies. PMID:27328124
Full Text Available Abstract Background Recent years have seen publication of a considerable number of clinical trials of preventive interventions against clinical malaria in children. There has been variability in the specification of end-points, case definitions, analysis methods and reporting and the relative lack of standardization complicates the ability to make comparative evaluations between trials. Methods To prepare for a WHO consultation on design issues in malaria vaccine trials, controlled trials of preventive interventions against malaria in children in endemic countries were identified in which clinical malaria, or death, had been one of the main end-points. Trials were included that evaluated the impact of vaccines, insecticide-treated bed nets (ITN, intermittent presumptive or preventive therapy in infants (IPTi or, in one instance, vitamin A supplementation. Methods that had been used in these trials were summarized and compared in order to identify issues that were directly relevant to the design of malaria vaccine trials. Results 29 controlled trials of preventive malaria interventions were identified, of which eight were vaccine trials. Vaccine trials that were designed to detect an effect on clinical malaria all reported the incidence rate of first episodes of clinical malaria as their primary endpoint. Only one trial of a preventive intervention (of ITN was identified that was designed to detect an effect on severe malaria. A group of larger trials were designed to detect an effect of impregnated bed nets or curtains on all-cause mortality as the primary end-point. Key methodological and reporting differences between trials are noted in the text. Two issues have been identified that are of some concern. Firstly, the choice of primary endpoint is not stated in the reports of a number of the trials and, secondly, the relationship between pre-specified analysis plans and trial reports is rarely made clear. Conclusion This article reports an
Hiscock, H; Wake, M
Objective To compare the effect of a behavioural sleep intervention with written information about normal sleep on infant sleep problems and maternal depression. Design Randomised controlled trial. Setting Well child clinics, Melbourne, Australia Participants 156 mothers of infants aged 6-12 months with severe sleep problems according to the parents. Main outcome measures Maternal report of infant sleep problem; scores on Edinburgh postnatal depression scale at two and four months. Intervention Discussion on behavioural infant sleep intervention (controlled crying) delivered over three consultations. Results At two months more sleep problems had resolved in the intervention group than in the control group (53/76 v 36/76, P=0.005). Overall depression scores fell further in the intervention group than in the control group (mean change −3.7, 95% confidence interval −4.7 to −2.7, v −2.5, −1.7 to −3.4, P=0.06). For the subgroup of mothers with depression scores of 10 and over more sleep problems had resolved in the intervention group than in the control group (26/33 v 13/33, P=0.001). In this subgroup depression scores also fell further for intervention mothers than control mothers at two months (−6.0, −7.5 to −4.0, v −3.7, −4.9 to −2.6, P=0.01) and at four months (−6.5, −7.9 to 5.1 v –4.2, –5.9 to −2.5, P=0.04). By four months, changes in sleep problems and depression scores were similar. Conclusions Behavioural intervention significantly reduces infant sleep problems at two but not four months. Maternal report of symptoms of depression decreased significantly at two months, and this was sustained at four months for mothers with high depression scores. What is already known on this topicInfant sleep problems and postnatal depression are both common potentially serious problemsWomen whose infants have sleep problems are more likely to report symptoms of depressionUncontrolled studies in clinical populations suggest that reducing infant
Damgaard, Pia; Bartels, Else Marie; Ris, Inge; Christensen, Robin; Juul-Kristensen, Birgit
Chronic neck pain (CNP) is common and costly, and the effect of physiotherapeutic interventions on the condition is unclear. We reviewed the literature for evidence of effect of physiotherapy interventions on patients with CNP. Five bibliographic databases (MEDLINE, EMBASE, CINAHL, Cochrane Library, and PEDro) were systematically searched. Randomised, placebo and active-treatment-controlled trials including physiotherapy interventions for adults with CNP were selected. Data were extracted pri...
Fitzgerald, Sarah; Geaney, Fiona; Kelly, Clare; McHugh, Sheena; Perry, Ivan J
Background Ambiguity exists regarding the effectiveness of workplace dietary interventions. Rigorous process evaluation is vital to understand this uncertainty. This study was conducted as part of the Food Choice at Work trial which assessed the comparative effectiveness of a workplace environmental dietary modification intervention and an educational intervention both alone and in combination versus a control workplace. Effectiveness was assessed in terms of employees’ dietary intakes, nutri...
Burke Linda; Lee Andy H; Jancey Jonine; Xiang Liming; Kerr Deborah A; Howat Peter A; Hills Andrew P; Anderson Annie S
Abstract Background This intervention aimed to ascertain whether a low-cost, accessible, physical activity and nutrition program could improve physical activity and nutrition behaviours of insufficiently active 60–70 year olds residing in Perth, Australia. Methods A 6-month home-based randomised controlled trial was conducted on 478 older adults (intervention, n = 248; control, n = 230) of low to medium socioeconomic status. Both intervention and control groups completed postal questionnaires...
Downer, Mary Kathryn; Gea, Alfredo; Stampfer, Meir; Sánchez-Tainta, Ana; Corella, Dolores; Salas-Salvadó, Jordi; Ros, Emilio; Estruch, Ramón; Fitó, Montserrat; Gómez-Gracia, Enrique; Arós, Fernando; Fiol, Miquel; De-la-Corte, Francisco Jose Garcia; Serra-Majem, Lluís; Pinto, Xavier
Background Dietary intervention success requires strong participant adherence, but very few studies have examined factors related to both short-term and long-term adherence. A better understanding of predictors of adherence is necessary to improve the design and execution of dietary intervention trials. This study was designed to identify participant characteristics at baseline and study features that predict short-term and long-term adherence with interventions promoting the Mediterranean-ty...
Downer, Mary Kathryn; Gea, Alfredo; Stampfer, Meir; Sánchez-Tainta, Ana; Corella, Dolores; Salas-Salvadó, Jordi; Ros, Emilio; Estruch, Ramón; Fitó, Montserrat; Gómez-Gracia, Enrique; Arós, Fernando; Fiol, Miquel; De-la-Corte, Francisco Jose Garcia; Serra-Majem, Lluís; Pinto, Xavier
Background: Dietary intervention success requires strong participant adherence, but very few studies have examined factors related to both short-term and long-term adherence. A better understanding of predictors of adherence is necessary to improve the design and execution of dietary intervention trials. This study was designed to identify participant characteristics at baseline and study features that predict short-term and long-term adherence with interventions promoting the Mediterranean-t...
Smolkowski, Keith; Biglan, Anthony; Barrera, Manuel; Taylor, Ted; Black, Carol; Blair, Jason
This paper reports a randomized controlled trial of the effects of behavioral parenting skills training, social skills training, and supplemental reading instruction on the social behavior of early elementary school children (K through 3). We selected children based on teacher-rated aggressive behavior or reading-skill deficits, delivered the intervention over a 2-year period, and obtained follow-up data for two additional years. The intervention affected only two of eight measures of child functioning--parent daily reports of antisocial behavior and parent ratings of coercive behavior. There was evidence that parents of boys in the intervention condition displayed significantly greater declines in their rated use of coercive discipline than did parents of boys in the control condition. PMID:15889626
Full Text Available Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09–0.25. KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions.
Jindani, Farah; Turner, Nigel; Khalsa, Sat Bir S
Yoga may be effective in the reduction of PTSD symptomology. The purpose of this study was to evaluate the impact of a Kundalini Yoga (KY) treatment on PTSD symptoms and overall wellbeing. To supplement the current field of inquiry, a pilot randomized control trial (RCT) was conducted comparing an 8-session KY intervention with a waitlist control group. 80 individuals with current PTSD symptoms participated. Both groups demonstrated changes in PTSD symptomology but yoga participants showed greater changes in measures of sleep, positive affect, perceived stress, anxiety, stress, and resilience. Between-groups effect sizes were small to moderate (0.09-0.25). KY may be an adjunctive or alternative intervention for PTSD. Findings indicate the need for further yoga research to better understand the mechanism of yoga in relation to mental and physical health, gender and ethnic comparisons, and short- and long-term yoga practice for psychiatric conditions. PMID:26366179
Boeckner Linda S
Full Text Available Abstract Background Weight loss is challenging and maintenance of weight loss is problematic among midlife and older rural women. Finding effective interventions using innovative delivery methods that can reach underserved and vulnerable populations of overweight and obese rural women is a public health challenge. Methods/Design This Women Weigh-In for Wellness (The WWW study randomized-controlled trial is designed to compare the effectiveness of theory-based behavior-change interventions using (1 website only, (2 website with peer-led support, or (3 website with professional email-counseling to facilitate initial weight loss (baseline to 6 months, guided continuing weight loss and maintenance (7-18 months and self-directed weight maintenance (19-30 months among rural women ages 45-69 with a BMI of 28-45. Recruitment efforts using local media will target 306 rural women who live within driving distance of a community college site where assessments will be conducted at baseline, 3, 6, 12, 18, 24 and 30 months by research nurses blinded to group assignments. Primary outcomes include changes in body weight, % weight loss, and eating and activity behavioral and biomarkers from baseline to each subsequent assessment. Secondary outcomes will be percentage of women achieving at least 5% and 10% weight loss without regain from baseline to 6, 18, and 30 months and achieving healthy eating and activity targets. Data analysis will use generalized estimating equations to analyze average change across groups and group differences in proportion of participants achieving target weight loss levels. Discussion The Women Weigh-In for Wellness study compares innovative web-based alternatives for providing lifestyle behavior-change interventions for promoting weight loss and weight maintenance among rural women. If effective, such interventions would offer potential for reducing overweight and obesity among a vulnerable, hard-to-reach, population of rural women
Norberg, Melissa M; Hides, Leanne; Olivier, Jake; Khawar, Laila; McKetin, Rebecca; Copeland, Jan
Studies examining the ability of motivational enhancement therapy (MET) to augment education provision among ecstasy users have produced mixed results and none have examined whether treatment fidelity was related to ecstasy use outcomes. The primary objectives of this multi-site, parallel, two-group randomized controlled trial were to determine if a single-session of MET could instill greater commitment to change and reduce ecstasy use and related problems more so than an education-only intervention and whether MET sessions delivered with higher treatment fidelity are associated with better outcomes. The secondary objective was to assess participants' satisfaction with their assigned interventions. Participants (N=174; Mage=23.62) at two Australian universities were allocated randomly to receive a 15-minute educational session on ecstasy use (n=85) or a 50-minute session of MET that included an educational component (n=89). Primary outcomes were assessed at baseline, and then at 4-, 16-, and 24-weeks postbaseline, while the secondary outcome measure was assessed 4-weeks postbaseline by researchers blind to treatment allocation. Overall, the treatment fidelity was acceptable to good in the MET condition. There were no statistical differences at follow-up between the groups on the primary outcomes of ecstasy use, ecstasy-related problems, and commitment to change. Both intervention groups reported a 50% reduction in their ecstasy use and a 20% reduction in the severity of their ecstasy-related problems at the 24-week follow up. Commitment to change slightly improved for both groups (9%-17%). Despite the lack of between-group statistical differences on primary outcomes, participants who received a single session of MET were slightly more satisfied with their intervention than those who received education only. MI fidelity was not associated with ecstasy use outcomes. Given these findings, future research should focus on examining mechanisms of change. Such work may
Pas, Elise T; Waasdorp, Tracy E; Bradshaw, Catherine P
Although it is widely recognized that variation in implementation fidelity influences the impact of preventive interventions, little is known about how specific contextual factors may affect the implementation of social and behavioral interventions in classrooms. Theoretical research highlights the importance of multiple contextual influences on implementation, including factors at the classroom and school level (Domitrovich et al., Advances in School Mental Health Promotion, 1, 6-28, 2008). The current study used multi-level modeling to empirically examine the influence of teacher, classroom, and school characteristics on the implementation of classroom-based positive behavior support strategies over the course of 4 years. Data were collected in the context of a 37-school randomized controlled trial examining the effectiveness of school-wide Positive Behavioral Interventions and Supports. Multi-level results identified several school-level contextual factors (e.g., school size, behavioral disruptions) and teacher-level factors (perceptions of school organizational health and grade level taught) associated with variability in the implementation of classroom-based positive behavior supports. Implications for prevention research and practice are discussed. PMID:24793222
Daunic, Ann P; Smith, Stephen W; Garvan, Cynthia W; Barber, Brian R; Becker, Mallory K; Peters, Christine D; Taylor, Gregory G; Van Loan, Christopher L; Li, Wei; Naranjo, Arlene H
Researchers have demonstrated that cognitive-behavioral intervention strategies - such as social problem solving - provided in school settings can help ameliorate the developmental risk for emotional and behavioral difficulties. In this study, we report the results of a randomized controlled trial of Tools for Getting Along (TFGA), a social problem-solving universally delivered curriculum designed to reduce the developmental risk for serious emotional or behavioral problems among upper elementary grade students. We analyzed pre-intervention and post-intervention teacher-report and student self-report data from 14 schools, 87 classrooms, and a total of 1296 students using multilevel modeling. Results (effect sizes calculated using Hedges' g) indicated that students who were taught TFGA had a more positive approach to problem solving (g=.11) and a more rational problem-solving style (g=.16). Treated students with relatively poor baseline scores benefited from TFGA on (a) problem-solving knowledge (g=1.54); (b) teacher-rated executive functioning (g=.35 for Behavior Regulation and .32 for Metacognition), and proactive aggression (g=.20); and (c) self-reported trait anger (g=.17) and anger expression (g=.21). Thus, TFGA may reduce risk for emotional and behavioral difficulties by improving students' cognitive and emotional self-regulation and increasing their pro-social choices. PMID:22386118
Full Text Available OBJECTIVE: Human papillomavirus (HPV self-sampling (Self-HPV may be used as a primary cervical cancer screening method in a low resource setting. Our aim was to evaluate whether an educational intervention would improve women's knowledge and confidence in the Self-HPV method. METHOD: Women aged between 25 and 65 years old, eligible for cervical cancer screening, were randomly chosen to receive standard information (control group or standard information followed by educational intervention (interventional group. Standard information included explanations about what the test detects (HPV, the link between HPV and cervical cancer and how to perform HPV self-sampling. The educational intervention consisted of a culturally tailored video about HPV, cervical cancer, Self-HPV and its relevancy as a screening test. All participants completed a questionnaire that assessed sociodemographic data, women's knowledge about cervical cancer and acceptability of Self-HPV. RESULTS: A total of 302 women were enrolled in 4 health care centers in Yaoundé and the surrounding countryside. 301 women (149 in the "control group" and 152 in the "intervention group" completed the full process and were included into the analysis. Participants who received the educational intervention had a significantly higher knowledge about HPV and cervical cancer than the control group (p<0.05, but no significant difference on Self-HPV acceptability and confidence in the method was noticed between the two groups. CONCLUSION: Educational intervention promotes an increase in knowledge about HPV and cervical cancer. Further investigation should be conducted to determine if this intervention can be sustained beyond the short term and influences screening behavior. TRIALS REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN Register ISRCTN78123709.
Donna M. Kazemi
Conclusions: Intervention programs to reduce drinking by college students need to address developmental dynamics of freshmen students, including gender, psychosocial factors, personality, and lifestyle health-promoting behaviors.
Efficacy of two educational interventions about inhalation techniques in patients with chronic obstructive pulmonary disease (COPD. TECEPOC: study protocol for a partially randomized controlled trial (preference trial
Full Text Available Abstract Background Drugs for inhalation are the cornerstone of therapy in obstructive lung disease. We have observed that up to 75 % of patients do not perform a correct inhalation technique. The inability of patients to correctly use their inhaler device may be a direct consequence of insufficient or poor inhaler technique instruction. The objective of this study is to test the efficacy of two educational interventions to improve the inhalation techniques in patients with Chronic Obstructive Pulmonary Disease (COPD. Methods This study uses both a multicenter patients´ preference trial and a comprehensive cohort design with 495 COPD-diagnosed patients selected by a non-probabilistic method of sampling from seven Primary Care Centers. The participants will be divided into two groups and five arms. The two groups are: 1 the patients´ preference group with two arms and 2 the randomized group with three arms. In the preference group, the two arms correspond to the two educational interventions (Intervention A and Intervention B designed for this study. In the randomized group the three arms comprise: intervention A, intervention B and a control arm. Intervention A is written information (a leaflet describing the correct inhalation techniques. Intervention B is written information about inhalation techniques plus training by an instructor. Every patient in each group will be visited six times during the year of the study at health care center. Discussion Our hypothesis is that the application of two educational interventions in patients with COPD who are treated with inhaled therapy will increase the number of patients who perform a correct inhalation technique by at least 25 %. We will evaluate the effectiveness of these interventions on patient inhalation technique improvement, considering that it will be adequate and feasible within the context of clinical practice. Trial registration Current Controlled Trials ISRTCTN15106246
Full Text Available Abstract Background Very low birthweight infants are at risk for deficits in cognitive and language development, as well as attention and behaviour problems. Maternal sensitive behaviour (i.e. awareness of infant cues and appropriate responsiveness to those cues in interaction with her very low birthweight infant is associated with better outcomes in these domains; however, maternal anxiety interferes with the mother's ability to interact sensitively with her very low birthweight infant. There is a need for brief, cost-effective and timely interventions that address both maternal psychological distress and interactive behaviour. The Cues and Care trial is a randomized controlled trial of an intervention designed to reduce maternal anxiety and promote sensitive interaction in mothers of very low birthweight infants. Methods and design Mothers of singleton infants born at weights below 1500 g are recruited in the neonatal intensive care units of 2 tertiary care hospitals, and are randomly assigned to the experimental (Cues intervention or to an attention control (Care condition. The Cues intervention teaches mothers to attend to their own physiological, cognitive, and emotional cues that signal anxiety and worry, and to use cognitive-behavioural strategies to reduce distress. Mothers are also taught to understand infant cues and to respond sensitively to those cues. Mothers in the Care group receive general information about infant care. Both groups have 6 contacts with a trained intervener; 5 of the 6 sessions take place during the infant's hospitalization, and the sixth contact occurs after discharge, in the participant mother's home. The primary outcome is maternal symptoms of anxiety, assessed via self-report questionnaire immediately post-intervention. Secondary outcomes include maternal sensitive behaviour, maternal symptoms of posttraumatic stress, and infant development at 6 months corrected age. Discussion The Cues and Care trial will
Livingstone, Katherine M; Fallaize, Rosalind; Kolossa, Silvia; Hallmann, Jacqueline; San-Cristobal, Rodrigo; Navas-Carretero, Santiago; O'Donovan, Clare B; Woolhead, Clara; Forster, Hannah; Moschonis, George; Lambrinou, Christina-Paulina; Surwillo, Agnieszka; Godlewska, Magdalena; Hoonhout, Jettie; Goris, Annelies; Macready, Anna L; Walsh, Marianne C; Gibney, Eileen R; Brennan, Lorraine; Manios, Yannis; Traczyk, Iwona; Drevon, Christian A; Lovegrove, Julie A; Martinez, J Alfredo; Daniel, Hannelore; Gibney, Michael J; Mathers, John C; Saris, Wim HM
Background There is evidence that physical activity (PA) can attenuate the influence of the fat mass- and obesity-associated (FTO) genotype on the risk to develop obesity. However, whether providing personalized information on FTO genotype leads to changes in PA is unknown. Objective The purpose of this study was to determine if disclosing FTO risk had an impact on change in PA following a 6-month intervention. Methods The single nucleotide polymorphism (SNP) rs9939609 in the FTO gene was genotyped in 1279 participants of the Food4Me study, a four-arm, Web-based randomized controlled trial (RCT) in 7 European countries on the effects of personalized advice on nutrition and PA. PA was measured objectively using a TracmorD accelerometer and was self-reported using the Baecke questionnaire at baseline and 6 months. Differences in baseline PA variables between risk (AA and AT genotypes) and nonrisk (TT genotype) carriers were tested using multiple linear regression. Impact of FTO risk disclosure on PA change at 6 months was assessed among participants with inadequate PA, by including an interaction term in the model: disclosure (yes/no) × FTO risk (yes/no). Results At baseline, data on PA were available for 874 and 405 participants with the risk and nonrisk FTO genotypes, respectively. There were no significant differences in objectively measured or self-reported baseline PA between risk and nonrisk carriers. A total of 807 (72.05%) of the participants out of 1120 in the personalized groups were encouraged to increase PA at baseline. Knowledge of FTO risk had no impact on PA in either risk or nonrisk carriers after the 6-month intervention. Attrition was higher in nonrisk participants for whom genotype was disclosed (P=.01) compared with their at-risk counterparts. Conclusions No association between baseline PA and FTO risk genotype was observed. There was no added benefit of disclosing FTO risk on changes in PA in this personalized intervention. Further RCT studies
Eyer, Joshua C; Thorn, Beverly E
Chronic pain is a critical public health problem that affects over 100 million Americans. Medical pain treatments carry undesirable side effects, whereas low-risk psychosocial treatments offer notable benefits, in combination or in isolation. This report presents the protocol for the Learning About My Pain study, one of the first comparative-effectiveness trials funded by the Patient-Centered Outcomes Research Institute. Adhering to published standards for clinical trials (e.g. Standard Protocol Items: Recommendations for Intervention Trials), it provides an overview of the trial (n = 294), comparing cognitive-behavioral and education pain interventions to usual care, and a detailed description of how its methodology reduces the risks from bias. PMID:25712491
Corbett, Teresa; Walsh, Jane C; Groarke, AnnMarie; Moss-Morris, Rona; McGuire, Brian E
Introduction Many post-treatment cancer survivors experience persistent fatigue that can disrupt attempts to resume normal everyday activities after treatment. Theoretical models that aim to explain contributory factors that initiate and sustain fatigue symptoms, or that influence the efficacy of interventions for cancer-related fatigue (CrF) require testing. Adjustment to fatigue is likely to be influenced by coping behaviours that are guided by the representations of the symptom. Objectives This paper describes the protocol for a pilot trial of a systematically and theoretically designed online intervention to enable self-management of CrF after cancer treatment. Methods and analysis This 2-armed randomised controlled pilot trial will study the feasibility and potential effectiveness of an online intervention. Participants will be allocated to either the online intervention (REFRESH (Recovery from Cancer-Related Fatigue)), or a leaflet comparator. Participants 80 post-treatment cancer survivors will be recruited for the study. Interventions An 8-week online intervention based on cognitive–behavioural therapy. Primary and secondary outcome measures The primary outcome is a change in fatigue as measured by the Piper Fatigue Scale (revised). Quality of life will be measured using the Quality of Life in Adult Survivors of Cancer Scale. Outcome measures will be collected at baseline, and at completion of intervention. Results The feasibility of trial procedures will be tested, as well as the effect of the intervention on the outcomes. Conclusions This study may lead to the development of a supportive resource to target representations and coping strategies of cancer survivors with CrF post-treatment. Setting Recruitment from general public in Ireland. Ethics and dissemination This trial was approved by the Research Ethics Committee at National University of Ireland Galway in January 2013. Trial results will be communicated in a peer-reviewed journal. Trial
Kooijmans, H.; Post, M.W.M.; van der Woude, L H V; Groot, S.; Stam, H. J.; Bussmann, J.B.J
Purpose: To evaluate the effectiveness of a 16-week self-management intervention on physical activity level and self-management skills (self-efficacy, proactive coping and problem solving skills) in persons with chronic SCI. Method and design: Multicenter randomized controlled trial (RCT). Eighty persons with a SCI for at least 10 years and aged 18 to 65 will randomly be assigned to the intervention (self-management) or the control group (information provision). During the 16-week self-manage...
Ostroff, Jamie S.; Burkhalter, Jack E.; Cinciripini, Paul M.; Li, Yuelin; Shiyko, Mariya P.; Lam, Cho Y.; Hay, Jennifer L.; Dhingra, Lara K.; Lord-Bessen, Jennifer; Holland, Susan M.; Manna, Ruth
Objective Cancer patients are advised to quit smoking to reduce treatment complications and future cancer risk. This study's main objective was to evaluate the efficacy of a novel, pre-surgical cessation intervention in newly diagnosed cancer patients scheduled for surgical hospitalization. Methods We conducted a parallel-arm, randomized controlled trial comparing the efficacy of our hospital-based, tobacco cessation “best practices” treatment model (BP; cessation counseling and nicotine replacement therapy) with BP enhanced by a behavioral tapering regimen (scheduled reduced smoking; BP+SRS) administered by a handheld computer before hospitalization for surgery. Cessation outcomes were short (hospital admission and three months) and longer-term (6 months) biochemically-verified smoking abstinence. We hypothesized that BP+SRS would be superior to BP alone. One hundred eighty-five smokers were enrolled. Results Overall, 7-day-point prevalence, confirmed abstinence rates at six months for BP alone (32%) and BP+SRS (32%) were high; however, no main effect of treatment was observed. Patients who were older and diagnosed with lung cancer were more likely to quit smoking. Conclusions Compared to best practices for treating tobacco dependence, a pre-surgical, scheduled reduced smoking intervention did not improve abstinence rates among newly diagnosed cancer patients. PMID:23895203
Murphy, Susan L; Kratz, Anna L; Kidwell, Kelley; Lyden, Angela K; Geisser, Michael E; Williams, David A
Osteoarthritis (OA) of the lower extremities is a prevalent cause of disability in which symptoms interfere with mobility and activity participation. Behavioral self-management for OA symptomatology is commonly recommended; but these interventions are underutilized, unstandardized in application, and at times, unavailable in the context of clinical care. For people with chronic pain, rehabilitation professionals may select to apply activity pacing instruction as one behavioral strategy to manage symptoms. Activity pacing is widely used in combination with other pharmacological and behavioral interventions but has not been studied as a singular behavioral intervention for people with OA. The purpose of this study was to evaluate the effectiveness of an occupational therapist-delivered, time-based activity pacing program for treatment of pain, fatigue, and physical function in people with symptomatic knee or hip OA. A 3-arm randomized controlled trial was conducted in which 193 people were randomized into tailored activity pacing, general activity pacing, or usual care arms. Assessments were done at 10 weeks and 6 months after baseline. Using linear mixed models, Western Ontario and McMaster Universities Osteoarthritis Index pain scores changed over time, decreasing the most in the general and usual care groups; only the usual care group had decreased pain over 6 months. The tailored and general activity pacing groups reported higher frequency of pacing behaviors than the usual care group at 10 weeks, but pacing was not sustained at 6 months. This trial does not support the use of time-based pacing as a singular behavioral strategy for people with knee or hip OA. PMID:26963847
view: diet, anthropometry and biochemistry in dependent patients at nutritional risk and to assess the effect of a nutritional education intervention. The design with random allocation, inclusion of all patients, validated methods, caregivers’ education and standardization between nurses allows us to obtain valuable information about nutritional status and prevention. Trial Registration number Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360775
Gitlin Laura N
Full Text Available Abstract Background Primary care is the principle setting for depression treatment; yet many older African Americans in the United States fail to report depressive symptoms or receive the recommended standard of care. Older African Americans are at high risk for depression due to elevated rates of chronic illness, disability and socioeconomic distress. There is an urgent need to develop and test new depression treatments that resonate with minority populations that are hard-to-reach and underserved and to evaluate their cost and cost-effectiveness. Methods/Design Beat the Blues (BTB is a single-blind parallel randomized trial to assess efficacy of a non-pharmacological intervention to reduce depressive symptoms and improve quality of life in 208 African Americans 55+ years old. It involves a collaboration with a senior center whose care management staff screen for depressive symptoms (telephone or in-person using the Patient Health Questionnaire (PHQ-9. Individuals screened positive (PHQ-9 ≥ 5 on two separate occasions over 2 weeks are referred to local mental health resources and BTB. Interested and eligible participants who consent receive a baseline home interview and then are randomly assigned to receive BTB immediately or 4 months later (wait-list control. All participants are interviewed at 4 (main study endpoint and 8 months at home by assessors masked to study assignment. Licensed senior center social workers trained in BTB meet with participants at home for up to 10 sessions over 4 months to assess care needs, make referrals/linkages, provide depression education, instruct in stress reduction techniques, and use behavioral activation to identify goals and steps to achieve them. Key outcomes include reduced depressive symptoms (primary, reduced anxiety and functional disability, improved quality of life, and enhanced depression knowledge and behavioral activation (secondary. Fidelity is enhanced through procedure manuals and staff
Harrington Kathleen F
Full Text Available Abstract Background E-health tools are a new mechanism to expand patient care, allowing supplemental resources to usual care, including enhanced patient-provider communication. These applications to smoking cessation have yet to be tested in a hospitalized patient sample. This project aims to evaluate the effectiveness and cost-effectiveness of a tailored web-based and e-message smoking cessation program for current smokers that, upon hospital discharge, transitions the patient to continue a quit attempt when home (Decide2Quit. Design A randomized two-arm follow-up design will test the effectiveness of an evidence- and theoretically-based smoking cessation program designed for post-hospitalization. Methods A total of 1,488 patients aged 19 or older, who smoked cigarettes in the previous 30 days, are being recruited from 27 patient care areas of a large urban university hospital. Study-eligible hospitalized patients receiving usual tobacco cessation usual care are offered study referral. Trained hospital staff assist the 744 patients who are being randomized to the intervention arm with registration and orientation to the intervention website. This e-mail and web-based program offers tailored messages as well as education, self-assessment and planning aids, and social support to promote tobacco use cessation. Condition-blind study staff assess participants for tobacco use history and behaviors, tobacco use cost-related information, co-morbidities and psychosocial factors at 0, 3, 6, and 12 months. The primary outcome is self-reported 30-day tobacco abstinence at 6 months follow-up. Secondary outcomes include 7-day point prevalence quit rates at 3-, 6-, and 12-month follow-up, 30-day point prevalence quit rates at 3 and 12 months, biologically confirmed tobacco abstinence at 6-month follow-up, and multiple point-prevalence quit rates based on self-reported tobacco abstinence rates at each follow-up time period. Healthcare utilization and quality
Full Text Available As HIV infection continues unabated, there is a need for effective interventions targeting at-risk men who have sex with men (MSM. Engaging MSM online where they meet sexual partners is critical for HIV prevention efforts.A randomized controlled trial (RCT conducted online among U.S. MSM recruited from several gay sexual networking websites assessed the impact of 2 HIV prevention videos and an HIV prevention webpage compared to a control condition for the study outcomes HIV testing, serostatus disclosure, and unprotected anal intercourse (UAI at 60-day follow-up. Video conditions were pooled due to reduced power from low retention (53%, n = 1,631. No participant incentives were provided.Follow-up was completed by 1,631 (53% of 3,092 eligible men. In the 60 days after the intervention, men in the pooled video condition were significantly more likely than men in the control to report full serostatus disclosure ('asked and told' with their last sexual partner (OR 1.32, 95% CI 1.01-1.74. Comparing baseline to follow-up, HIV-negative men in the pooled video (OR 0.70, 95% CI 0.54-0.91 and webpage condition (OR 0.43, 95% CI 0.25-0.72 significantly reduced UAI at follow-up. HIV-positive men in the pooled video condition significantly reduced UAI (OR 0.38, 95% CI 0.20-0.67 and serodiscordant UAI (OR 0.53, 95% CI 0.28-0.96 at follow-up.Findings from this online RCT of MSM recruited from sexual networking websites suggest that a low cost, brief digital media intervention designed to engage critical thinking can increase HIV disclosure to sexual partners and decrease sexual risk. Effective, brief HIV prevention interventions featuring digital media that are made widely available may serve as a complementary part of an overall behavioral and biomedical strategy for reducing sexual risk by addressing the specific needs and circumstances of the target population, and by changing individual knowledge, motivations, and community norms.ClinicalTrials.gov NCT
Full Text Available Research findings are inconsistent about improvement of specific cardio-metabolic variables after lifestyle intervention in obese children. The aim of this trial was to evaluate the effect of a 1-year intervention, based on normocaloric diet and physical activity, on body mass index (BMI, blood lipid profile, glucose metabolism and metabolic syndrome. Eighty-five obese children aged ≥6 years were analyzed. The BMI z-score was calculated. Fasting blood samples were analyzed for lipids, insulin and glucose. The homeostatic model assessment of insulin resistance (HOMA-IR was calculated and insulin resistance was defined as HOMA-IR >3.16. HOMA-β%, quantitative insulin sensitivity check index and triglyceride glucose index were calculated. The metabolic syndrome was defined in accordance with the International Diabetes Federation criteria. At the end of intervention children showed a reduction (mean (95% CI in BMI z-score (−0.58 (−0.66; −0.50, triglycerides (−0.35 (−0.45; −0.25 mmol/L and triglyceride glucose index (−0.29 (−0.37; −0.21, and an increase in HDL cholesterol (0.06 (0.01; 0.11 mmol/L. Prevalence of insulin resistance declined from 51.8% to 36.5% and prevalence of metabolic syndrome from 17.1% to 4.9%. Nutritional-behavioral interventions can improve the blood lipid profile and insulin sensitivity in obese children, and possibly provide benefits in terms of metabolic syndrome.
Full Text Available Abstract Background To investigate the effects of a school-based physical activity-related injury prevention program, called 'iPlay', on risk behavior and neuromotor fitness. Methods In this cluster randomized controlled trial 40 primary schools throughout the Netherlands were randomly assigned in an intervention (n = 20 or control group (n = 20. The study includes 2,210 children aged 10-12 years. The iPlay-intervention takes one school year and consists of a teacher manual, informative newsletters and posters, a website, and simple exercises to be carried out during physical education classes. Outcomes measures were self-reported injury preventing behavior, self-reported behavioral determinants (knowledge, attitude, social-influence, self-efficacy, and intention, and neuromotor fitness. Results The iPlay-program was not able to significantly improve injury-preventing behavior. The program did significantly improve knowledge and attitude, two determinants of behavior. The effect of the intervention-program on behavior appeared to be significantly mediated by knowledge and attitude. Improved scores on attitude, social norm, self-efficacy and intention were significantly related to changes in injury preventing behavior. Furthermore, iPlay resulted in small non-significant improvements in neuromotor fitness in favor of the intervention group. Conclusion This cluster randomized controlled trial showed that the iPlay-program did significantly improved behavioral determinants. However, this effect on knowledge and attitude was not strong enough to improve injury preventing behavior. Furthermore, the results confirm the hypothetical model that injury preventing behavior is determined by intention, attitude, social norm and self-efficacy. Trial number ISRCTN78846684
Full Text Available Abstract Background Skin cancer is the most prevalent yet most preventable cancer in the US. While protecting oneself from ultraviolet radiation (UVR can largely reduce risk, rates of unprotected sun exposure remain high. Because the desire to be tan often outweighs health concerns among sunbathers, very few interventions have been successful at reducing sunbathing behavior. Sunless tanning (self-tanners and spray tans, a method of achieving the suntanned look without UVR exposure, might be an effective supplement to prevention interventions. Methods and Design This cluster randomized trial will examine whether a beach-based intervention that promotes sunless tanning as a substitute for sunbathing and includes sun damage imaging and sun safety recommendations is superior to a questionnaire only control group in reducing sunbathing frequency. Female beach visitors (N = 250 will be recruited from 2 public beaches in eastern Massachusetts. Beach site will be the unit of randomization. Follow-up assessment will occur at the end of the summer (1-month following intervention and 1 year later. The primary outcome is average sunbathing time per week. The study was designed to provide 90% power for detecting a difference of .70 hours between conditions (standard deviation of 2.0 at 1-year with an intra-cluster correlation coefficient of 0.01 and assuming a 25% rate of loss to follow-up. Secondary outcomes include frequency of sunburns, use of sunless tanning products, and sun protection behavior. Discussion Interventions might be improved by promoting behavioral substitutes for sun exposure, such as sunless tanners, that create a tanned look without exposure to UVR. Trial registration NCT00403377
Full Text Available While double-blinding is a crucial aspect of study design in an interventional clinical trial of medication for a disorder with subjective endpoints such as major depressive disorder, psychotherapy clinical trials, particularly cognitive-behavioral therapy trials, cannot be double-blinded. This paper highlights the evidence-based medicine problem of double-blinding in the outcome research of a psychotherapy and opines that psychotherapy clinical trials should be called, “partially-controlled clinical data” because they are not double-blinded. The implications for practice are, 1. For practitioners to be clear with patients the level of rigor to which interventions have been studied, 2. For authors of psychotherapy outcome studies to be clear that the problem in the inability to blind a psychotherapy trial severely restricts the validity of any conclusions that can be drawn, and 3. To petition National Health Insurance plans to use caution in approving interventions studied without double-blinded confirmatory trials as they may lead patients to avoid other treatments shown to be effective in double-blinded trials.
Chan, Agnes S.; Wong, Queenie Y.; Sophia L. Sze; Kwong, Patrick P. K.; Yvonne M. Y. Han; Mei-chun Cheung
Sleep disturbance is a common problem associated with depression, and cognitive-behavioral therapy (CBT) is a more common behavioral intervention for sleep problems. The present study compares the effect of a newly developed Chinese Chan-based intervention, namely Dejian mind-body intervention (DMBI), with the CBT on improving sleep problems of patients with depression. Seventy-five participants diagnosed with major depressive disorder were randomly assigned to receive 10 weekly sessions of C...
Campo Osaba Maria-Antonia; Del Val José-Luis; Lapena Carolina; Laguna Vicencia; García Araceli; Lozano Olga; Martín Ziortza; Rodriguez Rómulo; Borrás Enriqueta; Orfila Francesc; Tierno María Teresa
Abstract Background The promotion of health and the interventions in community health continue to be one of the pending subjects of our health system. The most prevalent health problems (cardiovascular diseases, cancer, diabetes...) are for the most part related to life habits. We propose a holistic and integral approach as the best option for tackling behavior and its determinants. The research team has elaborated the necessary educational material to realize group teaching, which we call "H...
Oort, FJ; Dijkstra, A; de Haes, JCJM; Legemate, DA; Smets, EMA
Background. Action aimed at changing smoking behavior to prevent cardiovascular patients from further impairing their health is advisable. Cognitive behavioral interventions can be effective in this regard since they attempt to influence cognitive determinants that presumably lead to smoking cessati
O'Reilly, M.F.; Fragale, C.; Gainey, S.; Kang, S.Y.; Koch, H.; Shubert, J.; El Zein, F.; Longino, D.; Chung, M.; Xu, Z.W.; White, P.J.; Lang, R.; Davis, T.; Rispoli, M.; Lancioni, G.E.; Didden, H.C.M.; Healy, O.; Kagohara, D.; Meer, L. van der; Sigafoos, J.
We examined the influence of an antecedent communication intervention on challenging behavior for three students with developmental disorders. Students were taught to request tangible items that were identified as reinforcers for challenging behavior in a prior functional analysis. individual partic
Spring, Bonnie; Saligram, Nalini; Davé, Raj; Gowda, Arun; Blais, Linelle; Arora, Monika; Ranjani, Harish; Ganda, Om; Hedeker, Donald; Reddy, Sethu; Ramalingam, Sandhya
Background In low/middle income countries like India, diabetes is prevalent and health care access limited. Most adults have a mobile phone, creating potential for mHealth interventions to improve public health. To examine the feasibility and initial evidence of effectiveness of mDiabetes, a text messaging program to improve diabetes risk behaviors, a global nonprofit organization (Arogya World) implemented mDiabetes among one million Indian adults. Objective A prospective, parallel cohort design was applied to examine whether mDiabetes improved fruit, vegetable, and fat intakes and exercise. Methods Intervention participants were randomly selected from the one million Nokia subscribers who elected to opt in to mDiabetes. Control group participants were randomly selected from non-Nokia mobile phone subscribers. mDiabetes participants received 56 text messages in their choice of 12 languages over 6 months; control participants received no contact. Messages were designed to motivate improvement in diabetes risk behaviors and increase awareness about the causes and complications of diabetes. Participant health behaviors (exercise and fruit, vegetable, and fat intake) were assessed between 2012 and 2013 via telephone surveys by blinded assessors at baseline and 6 months later. Data were cleaned and analyzed in 2014 and 2015. Results 982 participants in the intervention group and 943 in the control group consented to take the phone survey at baselne. At the end of the 6-month period, 611 (62.22%) in the intervention and 632 (67.02%) in the control group completed the follow-up telephone survey. Participants receiving texts demonstrated greater improvement in a health behavior composite score over 6 months, compared with those who received no messages F(1, 1238) = 30.181, Phttps://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=367946&isReview=true (Archived by WebCite at http://www.webcitation.org/6j5ptaJgF) PMID:27496271
Friedrich C. Jassil
Full Text Available Background. Lifestyle intervention programs after bariatric surgery have been suggested to maximise health outcomes. This pilot study aimed to investigate the feasibility and impact of an 8-week combined supervised exercise with nutritional-behavioral intervention following Roux-en-Y gastric bypass and sleeve gastrectomy. Methods. Eight female patients (44 ± 8 years old, BMI = 38.5 ± 7.2 kgm−2 completed the program. Before and after intervention, anthropometric measures, six-minute walk test (6MWT, physical activity level, eating behavior, and quality of life (QoL were assessed. Percentage weight loss (%WL outcomes were compared with a historical matched control group. Results. The program significantly improved functional capacity (mean increment in 6MWT was 127 ± 107 meters, p=0.043, increased strenuous intensity exercise (44 ± 49 min/week, p=0.043, increased consumption of fruits and vegetables (p=0.034, reduced consumption of ready meals (p=0.034, and improved “Change in Health” in QoL domain (p=0.039. The intervention group exhibited greater %WL in the 3–12-month postsurgery period compared to historical controls, 12.2 ± 7.5% versus 5.1 ± 5.4%, respectively (p=0.027. Conclusions. Lifestyle intervention program following bariatric surgery is feasible and resulted in several beneficial outcomes. A large randomised control trial is now warranted.
Quinn, Gwendolyn P; Pratt, Christie L; Bryant-George, Kathy; Caraway, Vicki D; Paternoster, Bonnie; Roldan, Tere; Shaffer, Andrea; Shimizu, Cynthia O; Vaughn, Elizabeth J; Williams, Charles; Bepler, Gerold
The theory of planned behavior explores the relationship between behavior, beliefs, attitudes, and intentions presupposing that behavioral intention is influenced by a person's attitude about the behavior and beliefs about whether individuals, who are important to them, approve or disapprove of the behavior (subjective norm). An added dimension to the theory is the idea of perceived behavioral control, or the belief that one has control over performing the behavior. The theory of planned behavior suggests that people may make greater efforts to perform a behavior if they feel they have a high level of control over it. In this examination of data, we explored the application of the theory of planned behavior to patient's decisions about participating in a clinic trial. Twelve respondents in this study had previously participated in a clinical trial for lung cancer and nine respondents had declined a clinical trial for lung cancer. The data were analyzed with regard to the four constructs associated with the theory of planned behavior: behavioral intention, attitude, subjective norm, and perceived behavioral control. Results indicate that the theory of planned behavior may be a useful tool to examine psychosocial needs in relation to behavioral intention of clinical trial participation.
Morris David W
Full Text Available Abstract Background There is a need for novel approaches to the treatment of stimulant abuse and dependence. Clinical data examining the use of exercise as a treatment for the abuse of nicotine, alcohol, and other substances suggest that exercise may be a beneficial treatment for stimulant abuse, with direct effects on decreased use and craving. In addition, exercise has the potential to improve other health domains that may be adversely affected by stimulant use or its treatment, such as sleep disturbance, cognitive function, mood, weight gain, quality of life, and anhedonia, since it has been shown to improve many of these domains in a number of other clinical disorders. Furthermore, neurobiological evidence provides plausible mechanisms by which exercise could positively affect treatment outcomes. The current manuscript presents the rationale, design considerations, and study design of the National Institute on Drug Abuse (NIDA Clinical Trials Network (CTN CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE study. Methods/Design STRIDE is a multisite randomized clinical trial that compares exercise to health education as potential treatments for stimulant abuse or dependence. This study will evaluate individuals diagnosed with stimulant abuse or dependence who are receiving treatment in a residential setting. Three hundred and thirty eligible and interested participants who provide informed consent will be randomized to one of two treatment arms: Vigorous Intensity High Dose Exercise Augmentation (DEI or Health Education Intervention Augmentation (HEI. Both groups will receive TAU (i.e., usual care. The treatment arms are structured such that the quantity of visits is similar to allow for equivalent contact between groups. In both arms, participants will begin with supervised sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual sessions
Full Text Available Abstract Background The aim of the present research is to conduct a fully powered explanatory trial to evaluate the efficacy of a brief self-regulation intervention to increase walking. The intervention will be delivered in primary care by practice nurses (PNs and Healthcare Assistants (HCAs to patients for whom increasing physical activity is a particular priority. The intervention has previously demonstrated efficacy with a volunteer population, and subsequently went through an iterative process of refinement in primary care, to maximise acceptability to both providers and recipients. Methods/ Design This two arm cluster randomised controlled trial set in UK general practices will compare two strategies for increasing walking, assessed by pedometer, over six months. Patients attending practices randomised to the self-regulation intervention arm will receive an intervention consisting of behaviour change techniques designed to increase walking self-efficacy (confidence in ability to perform the behaviour, and to help people translate their "good" intentions into behaviour change by making plans. Patients attending practices randomised to the information provision arm will receive written materials promoting walking, and a short unstructured discussion about increasing their walking. The trial will recruit 20 PN/HCAs (10 per arm, who will be trained by the research team to deliver the self-regulation intervention or information provision control intervention, to 400 patients registered at their practices (20 patients per PN/HCA. This will provide 85% power to detect a mean difference of five minutes/day walking between the self-regulation intervention group and the information provision control group. Secondary outcomes include health services costs, and intervention effects in sub-groups defined by age, ethnicity, gender, socio-economic status, and clinical condition. A mediation analysis will investigate the extent to which changes in
Ames, Steven C; Pokorny, Steven B; Schroeder, Darrell R; Tan, Winston; Werch, Chudley E
Alcohol consumption is strongly associated with cigarette smoking in young adults. The primary aim of this investigation was to complete a pilot evaluation of the efficacy of an integrated intervention that targets both cigarette smoking and binge drinking on the cigarette smoking and binge behavior of young adults at 6-month follow-up. Participants were 95 young adult (M=24.3; SD=3.5 years) smokers (≥1 cigarettes per day) who binge drink (≥1 time per month) and who were randomly assigned to standard treatment (n=47) involving six individual treatment visits plus eight weeks of nicotine patch therapy or the identical smoking cessation treatment integrated with a binge drinking intervention (integrated intervention; n=48). Using an intent-to-treat analysis for tobacco abstinence, at both 3 month end of treatment and 6 month follow-up, more participants who received integrated intervention were biochemically confirmed abstinent from tobacco than those who received standard treatment at 3 months (19% vs. 9%, p=0.06) and 6 months (21% vs. 9%, p=0.05). At 6 months, participants who completed the study and who received integrated intervention consumed fewer drinks per month (psmoking cessation and reduces binge drinking compared to standard treatment.
Wipfli, Brad; Thompson, Sharon V.; Elliot, Diane L.; Anger, W. Kent; Bodner, Todd; Hammer, Leslie B.; Perrin, Nancy A.
Objectives. To evaluate the effectiveness of the Safety and Health Involvement For Truckers (SHIFT) intervention with a randomized controlled design. Methods. The multicomponent intervention was a weight-loss competition supported with body weight and behavioral self-monitoring, computer-based training, and motivational interviewing. We evaluated intervention effectiveness with a cluster-randomized design involving 22 terminals from 5 companies in the United States in 2012 to 2014. Companies were required to provide interstate transportation services and operate at least 2 larger terminals. We randomly assigned terminals to intervention or usual practice control conditions. We assessed participating drivers (n = 452) at baseline and 6 months. Results. In an intent-to-treat analysis, the postintervention difference between groups in mean body mass index change was 1.00 kilograms per meters squared (P fruit and vegetable consumption and physical activity. Conclusions. Results establish the effectiveness of a multicomponent and remotely administered intervention for producing significant weight loss among commercial truck drivers. PMID:27463067
Full Text Available "n "n "nObjective :Post traumatic stress disorder (PTSD may be the first reaction after disasters. Many studies have shown the efficacy of cognitive- behavioral therapy in treatment of post traumatic stress disorder. The main objective of this study is to evaluate the effect of group CBT in adolescent survivors of a large scale disaster (Bam earthquake. "n "nMethods: In a controlled trial, we evaluated the efficacy of a short term method of group cognitive-behavioral therapy in adolescent survivors of Bam earthquake who had PTSD symptoms and compared it with a control group. The adolescents who had severe PTSD or other psychiatric disorders that needed pharmacological interventions were excluded. We evaluated PTSD symptoms using Post traumatic Stress Scale (PSS pre and post intervention and compared them with a control group. "n "nResults: 100 adolescents were included in the study and 15 were excluded during the intervention. The mean age of the participants was 14.6±2.1 years. The mean score of total PTSD symptoms and the symptoms of avoidance was reduced after interventions, and was statistically significant. The mean change of re-experience and hyper arousal symptoms of PTSD were not significant. "n "nConclusion: Psychological debriefing and group cognitive behavioral therapy may be effective in reducing some of the PTSD symptoms.
Hodgson, Jan; Metcalfe, Sylvia; Gaff, Clara; Donath, Susan; Delatycki, Martin B; Winship, Ingrid; Skene, Loane; Aitken, MaryAnne; Halliday, Jane
When an inherited genetic condition is diagnosed in an individual it has implications for other family members. Privacy legislation and ethical considerations can restrict health professionals from communicating directly with other family members, and so it is frequently the responsibility of the first person in a family to receive the diagnosis (the proband) to share this news. Communication of genetic information is challenging and many at-risk family members remain unaware of important information that may be relevant to their or their children's health. We conducted a randomised controlled trial in six public hospitals to assess whether a specifically designed telephone counselling intervention improved family communication about a new genetic diagnosis. Ninety-five probands/parents of probands were recruited from genetics clinics and randomised to the intervention or control group. The primary outcome measure was the difference between the proportion of at-risk relatives who contacted genetics services for information and/or genetic testing. Audit of the family genetic file after 18 months revealed that 25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services (adjusted odds ratio (OR) 1.30, 95% confidence interval 0.70-2.42, P=0.40). Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring (adjusted OR 24.0, 95% confidence interval 3.4-168.5, P=0.001). The increasing sophistication and scope of genetic testing makes it imperative for health professionals to consider additional ways of supporting families in communicating genetic information.
Zhang, Yang; Pan, Kai-Feng; Zhang, Lian; Ma, Jun-Ling; Zhou, Tong; Li, Ji-You; Shen, Lin; You, Wei-Cheng
To investigate the role of cyclooxygenase (COX)-2/prostaglandin E2 (PGE2) in the process of Helicobacter pylori-induced gastric carcinogenesis, a prospective study based on an intervention trial was conducted in Linqu County, China. A total of 1401 subjects with histopathologic diagnosis were investigated at baseline, among those, 919 completed subsequent interventions (anti-H.pylori and/or celecoxib treatment). Expressions of COX-2 and Ki-67 were assessed by immunohistochemistry, and PGE2 levels were measured by enzyme immunoassay before and after interventions, respectively. We found a grade-response relationship between COX-2 expression level and risk of advanced gastric lesions at baseline. Stratified analysis indicated an additive interaction between COX-2 expression and H.pylori infection on the elevated risk of advanced gastric lesions. The odds ratios (ORs) for both factors combined were 9.31 [95% confidence interval (CI): 4.13-20.95] for chronic atrophic gastritis, 16.26 (95% CI: 7.29-36.24) for intestinal metaplasia and 21.13 (95% CI: 7.87-56.75) for dysplasia, respectively. After interventions, COX-2 expression and Ki-67 labeling index (LI) were decreased in anti-H.pylori group (OR: 1.65, 95% CI: 1.36-1.99 for COX-2; OR: 1.78, 95% CI: 1.49-2.12 for Ki-67) or anti-H.pylori followed by celecoxib group (OR: 1.41, 95% CI: 1.17-1.70 for COX-2; OR: 1.63, 95% CI: 1.37-1.94 for Ki-67). PGE2 levels were decreased in all treatment groups. Furthermore, the regression of gastric lesions was associated with the decrease of COX-2 expression or Ki-67 LI after interventions. Our findings indicate that H.pylori-induced COX-2/PGE2 pathways play an important role on the progression of precancerous gastric lesions in a Chinese population. PMID:26449252
Hodgson, Jan; Metcalfe, Sylvia; Gaff, Clara; Donath, Susan; Delatycki, Martin B; Winship, Ingrid; Skene, Loane; Aitken, MaryAnne; Halliday, Jane
When an inherited genetic condition is diagnosed in an individual it has implications for other family members. Privacy legislation and ethical considerations can restrict health professionals from communicating directly with other family members, and so it is frequently the responsibility of the first person in a family to receive the diagnosis (the proband) to share this news. Communication of genetic information is challenging and many at-risk family members remain unaware of important information that may be relevant to their or their children's health. We conducted a randomised controlled trial in six public hospitals to assess whether a specifically designed telephone counselling intervention improved family communication about a new genetic diagnosis. Ninety-five probands/parents of probands were recruited from genetics clinics and randomised to the intervention or control group. The primary outcome measure was the difference between the proportion of at-risk relatives who contacted genetics services for information and/or genetic testing. Audit of the family genetic file after 18 months revealed that 25.6% of intervention group relatives compared with 20.9% of control group relatives made contact with genetic services (adjusted odds ratio (OR) 1.30, 95% confidence interval 0.70-2.42, P=0.40). Although no major difference was detected overall between the intervention and control groups, there was more contact in the intervention group where the genetic condition conferred a high risk to offspring (adjusted OR 24.0, 95% confidence interval 3.4-168.5, P=0.001). The increasing sophistication and scope of genetic testing makes it imperative for health professionals to consider additional ways of supporting families in communicating genetic information. PMID:26130486
Full Text Available Abstract Background Childhood obesity and its related metabolic and psychological abnormalities are becoming serious health problems in China. Effective, feasible and practical interventions should be developed in order to prevent the childhood obesity and its related early onset of clinical cardiovascular diseases. The objective of this paper is to describe the design of a multi-centred random controlled school-based clinical intervention for childhood obesity in China. The secondary objective is to compare the cost-effectiveness of the comprehensive intervention strategy with two other interventions, one only focuses on nutrition education, the other only focuses on physical activity. Methods/Design The study is designed as a multi-centred randomised controlled trial, which included 6 centres located in Beijing, Shanghai, Chongqing, Shandong province, Heilongjiang province and Guangdong province. Both nutrition education (special developed carton style nutrition education handbook and physical activity intervention (Happy 10 program will be applied in all intervention schools of 5 cities except Beijing. In Beijing, nutrition education intervention will be applied in 3 schools and physical activity intervention among another 3 schools. A total of 9750 primary students (grade 1 to grade 5, aged 7-13 years will participate in baseline and intervention measurements, including weight, height, waist circumference, body composition (bioelectrical impendence device, physical fitness, 3 days dietary record, physical activity questionnaire, blood pressure, plasma glucose and plasma lipid profiles. Data concerning investments will be collected in our study, including costs in staff training, intervention materials, teachers and school input and supervising related expenditure. Discussion Present study is the first and biggest multi-center comprehensive childhood obesity intervention study in China. Should the study produce comprehensive results, the
Caldarella, Paul; Williams, Leslie; Hansen, Blake D.; Wills, Howard
Comprehensive evidence-based interventions are needed to help early childhood educators manage challenging student behaviors. One such intervention, class-wide function-related intervention teams (CW-FIT), is a multi-tiered behavioral intervention program based on positive behavior support principles, including four main elements: (a) teaching…
Besera, Ghenet T; Cox, Shanna; Malotte, C Kevin; Rietmeijer, Cornelis A; Klausner, Jeffrey D; O'Donnell, Lydia; Margolis, Andrew D; Warner, Lee
Safe in the City, a video intervention for clinic waiting rooms, was previously shown to reduce sexually transmitted disease (STD) incidence. However, little is known about patients' recall of exposure to the intervention. Using data from a nested study of patients attending clinics during the trial, we assessed whether participants recalled Safe in the City, and, if so, how the intervention affected subsequent attitudes and behaviors. Analyses were restricted to responses to a 3-month follow-up questionnaire among participants who were exposed to the video (n = 708). Impact was measured as participants' reports of the video's effect on behaviors and attitudes. Associations were evaluated using multivariable logistic regression. Of participants who were exposed, 685 (97%) recalled viewing the video, and 68% recalled all three vignettes. After watching the video, participants felt more positive about condoms (69%) and comfortable acquiring condoms (56%), were reminded of important information about STDs and condoms (90%), and tried to apply what they learned to their lives (59%). Compared with those who recalled viewing one or two vignettes, participants who recalled viewing all three vignettes reported more positive attitudes toward condoms and peer/provider communication. These findings demonstrate that a low-resource video intervention for waiting rooms can provide sufficient exposure to positively influence STD-related attitudes/behaviors. PMID:27091608
Naar-King, Sylvie; Ellis, Deborah A; Idalski Carcone, April; Templin, Thomas; Jacques-Tiura, Angela J; Brogan Hartlieb, Kathryn; Cunningham, Phillippe; Jen, Kai-Lin Catherine
The purpose of this study was to develop an adaptive behavioral treatment for African American adolescents with obesity. In a sequential multiple assignment randomized trial, 181 youth ages 12-16 years with primary obesity and their caregiver were first randomized to 3 months of home-based versus office-based delivery of motivational interviewing plus skills building. After 3 months, nonresponders to first phase treatment were rerandomized to continued home-based skills or contingency management. Primary outcome was percent overweight and hypothesized moderators were adolescent executive functioning and depression. There were no significant differences in primary outcome between home-based or office-based delivery or between continued home-based skills or contingency management for nonresponders to first-phase treatment. However, families receiving home-based treatment initially attended significantly more sessions in both phases of the trial, and families receiving contingency management attended more sessions in the second phase. Overall, participants demonstrated decreases in percent overweight over the course of the trial (3%), and adolescent executive functioning moderated this effect such that those with higher functioning lost more weight. More potent behavioral treatments to address the obesity epidemic are necessary, targeting new areas such as executive functioning. Delivering treatment in the home with contingency management may increase session attendance for this population.
Naar-King, Sylvie; Ellis, Deborah A; Idalski Carcone, April; Templin, Thomas; Jacques-Tiura, Angela J; Brogan Hartlieb, Kathryn; Cunningham, Phillippe; Jen, Kai-Lin Catherine
The purpose of this study was to develop an adaptive behavioral treatment for African American adolescents with obesity. In a sequential multiple assignment randomized trial, 181 youth ages 12-16 years with primary obesity and their caregiver were first randomized to 3 months of home-based versus office-based delivery of motivational interviewing plus skills building. After 3 months, nonresponders to first phase treatment were rerandomized to continued home-based skills or contingency management. Primary outcome was percent overweight and hypothesized moderators were adolescent executive functioning and depression. There were no significant differences in primary outcome between home-based or office-based delivery or between continued home-based skills or contingency management for nonresponders to first-phase treatment. However, families receiving home-based treatment initially attended significantly more sessions in both phases of the trial, and families receiving contingency management attended more sessions in the second phase. Overall, participants demonstrated decreases in percent overweight over the course of the trial (3%), and adolescent executive functioning moderated this effect such that those with higher functioning lost more weight. More potent behavioral treatments to address the obesity epidemic are necessary, targeting new areas such as executive functioning. Delivering treatment in the home with contingency management may increase session attendance for this population. PMID:25668386
Habteyes Hailu Tola
decreased treatment non-adherence level among intervention group. Provision of psychological counseling and health education to TB patients who are on regular treatment is recommended. This could be best achieved if these interventions are guided by behavioral theories and incorporated into the routine TB treatment strategy.Pan African Clinical Trials Registry PACTR201506001175423.
Groeneveld Iris F
Full Text Available Abstract Background The prevalence of overweight and elevated cardiovascular disease (CVD risk among workers in the construction industry is relatively high. Improving lifestyle lowers CVD risk and may have work-related benefits. The purpose of the study was to evaluate the effects on physical activity (PA, diet, and smoking of a lifestyle intervention consisting of individual counseling among male workers in the construction industry with an elevated risk of cardiovascular disease (CVD. Methods In a randomized controlled trial including 816 male blue- and white-collar workers in the construction industry with an elevated risk of CVD, usual care was compared to a 6-month lifestyle intervention. The intervention consisted of individual counseling using motivational interviewing techniques, and was delivered by an occupational physician or occupational nurse. In three face to face and four telephone contacts, the participant's risk profile, personal determinants, and barriers for behavior change were discussed, and personal goals were set. Participants chose to aim at either diet and PA, or smoking. Data were collected at baseline and after six and 12 months, by means of a questionnaire. To analyse the data, linear and logistic regression analyses were performed. Results The intervention had a statistically significant beneficial effect on snack intake (β-1.9, 95%CI -3.7; -0.02 and fruit intake (β 1.7, 95%CI 0.6; 2.9 at 6 months. The effect on snack intake was sustained until 12 months; 6 months after the intervention had ended (β -1.9, 95%CI -3.6; -0.2. The intervention effects on leisure time PA and metabolic equivalent-minutes were not statistically significant. The beneficial effect on smoking was statistically significant at 6 (OR smoking 0.3, 95%CI 0.1;0.7, but not at 12 months (OR 0.8, 95%CI 0.4; 1.6. Conclusions Beneficial effects on smoking, fruit, and snack intake can be achieved by an individual-based lifestyle intervention among
Full Text Available Abstract Background Many studies reported that brief interventions are effective in reducing excessive drinking. This study aimed to assess the efficacy of a protocol of brief intervention for college students (BASICS, delivered face-to-face, to reduce risky alcohol consumption and negative consequences. Methods A systematic review with meta-analysis was performed by searching for randomized controlled trials (RCTs in Medline, PsycInfo, Web of Science and Cochrane Library databases. A quality assessment of RCTs was made by using a validated scale. Combined mean effect sizes, using meta-analysis random-effects models, were calculated. Results 18 studies were included in the review. The sample sizes ranged from 54 to 1275 (median = 212. All studies presented a good evaluation of methodological quality and four were found to have excellent quality. After approximately 12 months of follow-up, students receiving BASICS showed a significant reduction in alcohol consumption (difference between means = −1.50 drinks per week, 95% CI: -3.24 to −0.29 and alcohol-related problems (difference between means = −0.87, 95% CI: -1.58 to −0.20 compared to controls. Conclusions Overall, BASICS lowered both alcohol consumption and negative consequences in college students. Gender and peer factors seem to play an important role as moderators of behavior change in college drinking. Characteristics of BASICS procedure have been evaluated as more favorable and acceptable by students in comparison with others interventions or control conditions. Considerations for future researches were discussed.
Full Text Available Abstract Background Lifestyle factors playing a role in the development of late-life disability may be modifiable. There is a need for robust evidence about the potential for prevention of disability through behavior change interventions. Methods/design This feasibility study involves the development, implementation and initial testing of a behavior change intervention in a naturalistic setting. A small-scale randomized controlled trial (RCT will investigate the implementation of a goal-setting intervention aimed at promoting behavior change in the domains of physical and cognitive activity in the context of a community resource center for over-50s. Healthy older participants attending the center (n = 75 will be randomized to one of three conditions: control (an interview involving a general discussion about the center; goal-setting (an interview involving identification of up to five personal goals in the domains of physical activity, cognitive activity, diet and health, and social engagement; or goal-setting with mentoring (the goal-setting interview followed by bi-monthly telephone mentoring. All participants will be reassessed after 12 months. Primary outcomes are levels of physical and cognitive activity. Secondary outcomes address psychosocial (self-efficacy, mood, quality of life, cognitive (memory and executive function, and physical fitness (functional and metabolic domains. Cost-effectiveness will also be examined. Discussion This study will provide information about the feasibility of a community-based lifestyle intervention model for over-50s and of the implementation of a goal-setting intervention for behavior change, together with initial evidence about the short-term effects of goal-setting on behavior. Trial Registration Current Controlled Trials ISRCTN30080637 (http://www.controlled-trials.com
P.A.C. van Lier (Pol); P. Vuijk (Patricia); A.A.M. Crijnen (Alfons)
textabstractThe association between the development of antisocial behavior, affiliation with deviant friends, and peer rejection was tested with a preventive intervention; 664 boys and girls were randomly assigned to a universal classroom-based intervention targeting disruptive behavior or a control
Parenting interventions are a promising strategy to prevent antisocial behavior in society. Evidence accumulates that parenting interventions can reduce disruptive child behavior, and insight rapidly increases into which families they benefit most. At the same time, however, several high risk popula
Alstot, Andrew E.; Kang, Minsoo; Alstot, Crystal D.
Techniques based in applied behavior analysis (ABA) have been shown to be useful across a variety of settings to improve numerous behaviors. Specifically within physical activity settings, several studies have examined the effect of interventions based in ABA on a variety of motor skills, but the overall effects of these interventions are unknown.…
Stormont, Melissa; Reinke, Wendy M.; Newcomer, Lori; Marchese, Dana; Lewis, Carla
Children with social behavior problems need teachers who are prepared to use evidence-based interventions to increase their likelihood of success. However, it is clear that teachers do not feel prepared to support children in this area. One approach for supporting teachers in using more effective interventions for children with behavior needs is…
Full Text Available Abstract Background The Diabetes Manual is a type 2 diabetes self-management programme based upon the clinically effective 'Heart Manual'. The 12 week programme is a complex intervention theoretically underpinned by self-efficacy theory. It is a one to one intervention meeting United Kingdom requirements for structured diabetes-education and is delivered within routine primary care. Methods/design In a two-group cluster randomized controlled trial, GP practices are allocated by computer minimisation to an intervention group or a six-month deferred intervention group. We aim to recruit 250 participants from 50 practices across central England. Eligibility criteria are adults able to undertake the programme with type 2 diabetes, not taking insulin, with HbA1c over 8% (first 12 months and following an agreed protocol change over 7% (months 13 to 18. Following randomisation, intervention nurses receive two-day training and delivered the Diabetes Manual programme to participants. Deferred intervention nurses receive the training following six-month follow-up. Primary outcome is HbA1c with total and HDL cholesterol; blood pressure, body mass index; self-efficacy and quality of life as additional outcomes. Primary analysis is between-group HbA1c differences at 6 months powered to give 80% power to detect a difference in HbA1c of 0.6%. A 12 month cohort analysis will assess maintenance of effect and assess relationship between self-efficacy and outcomes, and a qualitative study is running alongside. Discussion This trial incorporates educational and psychological diabetes interventions into a single programme and assesses both clinical and psychosocial outcomes. The trial will increase our understanding of intervention transferability between conditions, those diabetes related health behaviours that are more or less susceptible to change through efficacy enhancing mechanisms and how this impacts on clinical outcomes.
Full Text Available Abstract Background The al-Andalus physical activity intervention study is a randomised control trial to investigate the effectiveness of a land- and water-based exercise intervention for reducing the overall impact of fibromyalgia (primary outcome, and for improving tenderness and pain-related measures, body composition, functional capacity, physical activity and sedentary behaviour, fatigue, sleep quality, health-related quality of life, and cognitive function (secondary outcomes in women with fibromyalgia. Methods/Design One hundred eighty women with fibromyalgia (age range: 35-65 years will be recruited from local associations of fibromyalgia patients in Andalucía (Southern Spain. Patients will be randomly assigned to a usual care (control group (n = 60, a water-based exercise intervention group (n = 60 or a land-based exercise intervention group (n = 60. Participants in the usual care group will receive general physical activity guidelines and participants allocated in the intervention groups will attend three non-consecutive training sessions (60 min each per week during 24 weeks. Both exercise interventions will consist of aerobic, muscular strength and flexibility exercises. We will also study the effect of a detraining period (i.e., 12 weeks with no exercise intervention on the studied variables. Discussion Our study attempts to reduce the impact of fibromyalgia and improve patients' health status by implementing two types of exercise interventions. Results from this study will help to assess the efficacy of exercise interventions for the treatment of fibromyalgia. If the interventions would be effective, this study will provide low-cost and feasible alternatives for health professionals in the management of fibromyalgia. Results from the al-Andalus physical activity intervention will help to better understand the potential of regular physical activity for improving the well-being of women with fibromyalgia. Trial registration ClinicalTrials
Weiss, Mary Jane; DelPizzo-Cheng, Eliza; LaRue, Robert H.; Sloman, Kimberly
In recent years, there has been a great deal of controversy regarding the definition and independence of Positive Behavioral Supports (PBS) within the context of behavioral intervention. Specifically, behavior analysts have argued over whether PBS is subsumed within Applied Behavior Analysis (ABA) or whether it can be considered a separate…
Hansen, Blake D.; Wills, Howard P.; Kamps, Debra M.; Greenwood, Charles R.
Children with emotional and behavioral disorders (E/BD) struggle to achieve social and academic outcomes. Many studies have demonstrated self-management interventions to be effective at reducing problem behavior and increasing positive social and academic behaviors. Functional behavior assessment (FBA) information may be used in designing…
Full Text Available Abstract Background Effectiveness of combined physician and patient-level interventions for blood pressure (BP control in low-income, hypertensive African Americans with multiple co-morbid conditions remains largely untested in community-based primary care practices. Demographic, clinical, psychosocial, and behavioral characteristics of participants in the Counseling African American to Control Hypertension (CAATCH Trial are described. CAATCH evaluates the effectiveness of a multi-level, multi-component, evidence-based intervention compared with usual care (UC in improving BP control among poorly controlled hypertensive African Americans who receive primary care in Community Health Centers (CHCs. Methods Participants included 1,039 hypertensive African Americans receiving care in 30 CHCs in the New York Metropolitan area. Baseline data on participant demographic, clinical (e.g., BP, anti-hypertensive medications, psychosocial (e.g., depression, medication adherence, self-efficacy, and behavioral (e.g., exercise, diet characteristics were gathered through direct observation, chart review, and interview. Results The sample was primarily female (71.6%, middle-aged (mean age = 56.9 ± 12.1 years, high school educated (62.4%, low-income (72.4% reporting less than $20,000/year income, and received Medicaid (35.9% or Medicare (12.6%. Mean systolic and diastolic BP were 150.7 ± 16.7 mm Hg and 91.0 ± 10.6 mm Hg, respectively. Participants were prescribed an average of 2.5 ± 1.9 antihypertensive medications; 54.8% were on a diuretic; 33.8% were on a beta blocker; 41.9% were on calcium channel blockers; 64.8% were on angiotensin converting enzyme (ACE inhibitors/angiotensin receptor blockers (ARBs. One-quarter (25.6% of the sample had resistant hypertension; one-half (55.7% reported medication non-adherence. Most (79.7% reported one or more co-morbid medical conditions. The majority of the patients had a Charlson Co-morbidity score ≥ 2. Diabetes
Parker, Jack; Wales, Gill; Chalhoub, Nevyne; Harpin, Val
Purpose To systematically identify and review the currently available evidence on the long-term outcomes of recommended attention-deficit hyperactivity disorder (ADHD) interventions following randomized controlled trials with children and young people. Method A systematic search was conducted to identify trials >1 year in length using the following databases: CINAHL (January 1982– July 2012), MEDLINE (Ovid and Cambridge Scientific Abstracts [CSA]), Psych info, Science Direct (Elsevier), and Cochrane Library. Hand searches of key journals in the subject, book chapters, and conference proceedings were also carried out. Relevant papers were critically appraised using the Cochrane risk of bias tool. Results Eight controlled trials were identified as being relevant, of duration ranging from 1 year to 8 years (at follow up). The total number of participants in the studies was 1,057, of whom 579 (54.7%) were from one cohort and included 26 different outcome measures. Results suggest there is moderate-to-high-level evidence that combined pharmacological and behavioral interventions, and pharmacological interventions alone can be effective in managing the core ADHD symptoms and academic performance at 14 months. However, the effect size may decrease beyond this period. Conclusion This review has highlighted the paucity and limitations of the evidence investigating the long-term outcomes of recommended interventions for managing ADHD symptoms. There is little evidence to suggest that the effects observed over the relatively short term are maintained throughout longer periods of impairment. Furthermore, much of the existing evidence examining effectiveness beyond 12 months does not include newer medications currently available or consider significant contextual and cultural differences, such as UK/European and Asian populations. Longitudinal studies are required to examine the long-term outcomes for children and young people with ADHD managed with currently recommended
The effects of exposure to ultraviolet radiation are a significant concern in Australia which has one of the highest incidences of skin cancer in the world. Despite most skin cancers being preventable by encouraging consistent adoption of sun-protective behaviours, incidence rates are not decreasing. There is a dearth of research examining the factors involved in engaging in sun-protective behaviours. Further, online multi-behavioural theory-based interventions have yet to be explored fully as a medium for improving sun-protective behaviour in adults. This paper presents the study protocol of a randomised controlled trial of an online intervention based on the Theory of Planned Behaviour (TPB) that aims to improve sun safety among Australian adults. Approximately 420 adults aged 18 and over and predominantly from Queensland, Australia, will be recruited and randomised to the intervention (n = 200), information only (n = 200) or the control group (n = 20). The intervention focuses on encouraging supportive attitudes and beliefs toward sun-protective behaviour, fostering perceptions of normative support for sun protection, and increasing perceptions of control/self-efficacy over sun protection. The intervention will be delivered online over a single session. Data will be collected immediately prior to the intervention (Time 1), immediately following the intervention (Time 1b), and one week (Time 2) and one month (Time 3) post-intervention. Primary outcomes are intentions to sun protect and sun-protective behaviour. Secondary outcomes are the participants’ attitudes toward sun protection, perceptions of normative support for sun protection (i.e. subjective norms, group norms, personal norms and image norms) and perceptions of control/self-efficacy toward sun protection. The study will contribute to an understanding of the effectiveness of a TPB-based online intervention to improve Australian adults’ sun-protective behaviour. Australian and New Zealand Trials
Putnam, Robert F; Handler, Marcie W; Ramirez-Platt, Christina M; Luiselli, James K
We describe a multicomponent intervention to improve bus-riding behavior of students attending an urban public school. The intervention was developed with technical assistance consultation that emphasized collaboration among students, school personnel, and bus drivers. The primary intervention procedures were identifying appropriate behaviors during transportation ("bus rules"), training bus drivers to deliver positive reinforcement, and rewarding student performance through a weekly school-b...
Texeira, Pedro J; Carraça, Eliana V; Marques, Marta M; Rutter, Harry; Oppert, Jean-Michel; De Bourdeaudhuij, Ilse; Lakerveld, Jeroen; Brug, Johannes
Background Relapse is high in lifestyle obesity interventions involving behavior and weight change. Identifying mediators of successful outcomes in these interventions is critical to improve effectiveness and to guide approaches to obesity treatment, including resource allocation. This article reviews the most consistent self-regulation mediators of medium- and long-term weight control, physical activity, and dietary intake in clinical and community behavior change interventions targeting ove...
Carter Alice S
Full Text Available Abstract Background The prevalence of social-emotional and behavioral problems is estimated to be 8 to 9% among preschool children. Effective early detection tools are needed to promote the provision of adequate care at an early stage. The Brief Infant-Toddler Social and Emotional Assessment (BITSEA was developed for this purpose. This study evaluates the effectiveness of the BITSEA to enhance social-emotional and behavioral health of preschool children. Methods and Design A cluster randomized controlled trial is set up in youth health care centers in the larger Rotterdam area in the Netherlands, to evaluate the BITSEA. The 31 youth health care centers are randomly allocated to either the control group or the intervention group. The intervention group uses the scores on the BITSEA and cut-off points to evaluate a child's social-emotional and behavioral health and to decide whether or not the child should be referred. The control group provides care as usual, which involves administering a questionnaire that structures the conversation between child health professionals and parents. At a one year follow-up measurement the social-emotional and behavioral health of all children included in the study population will be evaluated. Discussion It is hypothesized that better results will be found, in terms of social-emotional and behavioral health in the intervention group, compared to the control group, due to more adequate early detection, referral and more appropriate and timely care. Trial registration Current Controlled Trials NTR2035
Devlin, Sarah; Leader, Geraldine; Healy, Olive
The current study investigates the comparative effects of sensory-integration therapy and behavioral interventions on rates of self-injurious behavior (SIB) in a 9-year-old boy with diagnosis of autism. A functional analysis was conducted to identify the variables maintaining the self-injurious behavior. This analysis demonstrated that SIB was…
Full Text Available Abstract Background Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality. Self management interventions have been shown to be effective in improving compliance in other chronic populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care. Methods/Design This is a multicentre parallel arm block randomized controlled trial (RCT of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard care. Primary outcomes are biochemical markers of clinical status and adherence. Secondary outcomes include general health related quality of life, disease-specific quality of life, mood, self efficacy and self-reported adherence. Outcomes will be measured at baseline, immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points. A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change. Discussion The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management. The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinically significant changes in biochemical markers, recruitment of a sufficiently large representative sample, a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points. Inclusion of multiple dependent
Cameron, David; Epton, Tracy; Norman, Paul; Sheeran, Paschal; Harris, Peter R; Webb, Thomas L.; Julious, Steven A.; Brennan, Alan; Thomas, Chloe; Petroczi, Andrea; Naughton, Declan; Shah, Iltaf
Background This paper reports the results of a repeat trial assessing the effectiveness of an online theory-based intervention to promote healthy lifestyle behaviours in new university students. The original trial found that the intervention reduced the number of smokers at 6-month follow-up compared with the control condition, but had non-significant effects on the other targeted health behaviours. However, the original trial suffered from low levels of engagement, which the repeat trial sou...
Full Text Available The double-blind randomized controlled trial (DBRCT is the gold standard of medical research. We show that DBRCTs fail to fully account for the efficacy of treatment if there are interactions between treatment and behavior, for example, if a treatment is more effective when patients change their exercise or diet. Since behavioral or placebo effects depend on patients' beliefs that they are receiving treatment, clinical trials with a single probability of treatment are poorly suited to estimate the additional treatment benefit that arises from such interactions. Here, we propose methods to identify interaction effects, and use those methods in a meta-analysis of data from blinded anti-depressant trials in which participant-level data was available. Out of six eligible studies, which included three for the selective serotonin re-uptake inhibitor paroxetine, and three for the tricyclic imipramine, three studies had a high (>65% probability of treatment. We found strong evidence that treatment probability affected the behavior of trial participants, specifically the decision to drop out of a trial. In the case of paroxetine, but not imipramine, there was an interaction between treatment and behavioral changes that enhanced the effectiveness of the drug. These data show that standard blind trials can fail to account for the full value added when there are interactions between a treatment and behavior. We therefore suggest that a new trial design, two-by-two blind trials, will better account for treatment efficacy when interaction effects may be important.
Watkins, E R; Taylor, R S; Baeyens, C;
Background The development of widely accessible, effective psychological interventions for depression is a priority. This randomized trial provides the first controlled data on an innovative cognitive bias modification (CBM) training guided self-help intervention for depression. Method One hundred...
Healy, Karyn L; Sanders, Matthew R
This study examined the effects of a family intervention on victimization and emotional distress of children bullied by peers. The intervention, Resilience Triple P, combined facilitative parenting and teaching children social and emotional skills relevant to developing strong peer relationships and addressing problems with peers. Facilitative parenting is parenting that supports the development of children's peer relationship skills. A randomized controlled trial was conducted with 111 families who reported chronic bullying of children aged 6 to 12 years. Families were randomly allocated to either an immediate start to Resilience Triple P (RTP) or an assessment control (AC) condition. Assessments involving children, parents, teachers, and observational measures were conducted at 0 (pre), 3 (post) and 9 months follow-up. RTP families had significantly greater improvements than AC families on measures of victimization, child distress, child peer and family relationships, including teacher reports of overt victimization (d=0.56), child internalizing feelings (d=0.59), depressive symptoms (d=0.56), child overt aggression towards peers (d=0.51), acceptance by same sex and opposite sex peers (d=0.46/ 0.60), and child liking school (d=0.65). Families in both conditions showed significant improvements on most variables over time including child reports of bullying in the last week reducing to a near zero and indistinguishable from the normative sample. The intervention combining facilitative parenting and social and emotional skills training for children produced better results than the comparison assessment control condition. This study demonstrated that family interventions can reduce victimization and distress and strengthen school efforts to address bullying. PMID:25311286
Full Text Available Objective: The aim of the current study was to assess the impact of computer games and computer-assisted type instruction on dictation scores of elementary school children with attention deficit – hyperactivity disorder (ADHD. Method: In this single-blind clinical trial, 37 elementary school children with ADHD, selected by convenience sampling and divided into group I (n=17 and group II (n=20, underwent eight one-hour sessions (3 sessions per week of intervention by computer games versus computer-assisted type instruction, respectively. 12 school dictation scores were considered: 4 scores preintervention, 4 scores during interventions, and 4 scores post-intervention. Dictation test was taken during each session. Data was analyzed using repeated measure ANOVA. Results: Two groups were matched for age, gender, school grade, medication, IQ, parent’s and teacher’s Conners’ scale scores, having computer at home, history of working with computer, and mean dictation scores. There was no significant difference in dictation scores before and after interventions and also between the study groups. The improvement in school dictation scores had no significant correlation with age, gender, Ritalin use, owning a computer at home and past history of computer work, baseline dictation scores, Ritalin dose, educational status, IQ, and the total score of parent’s and teacher’s Conners’ rating scale. Conclusion: Absence of significant improvement in dictation scores in study groups may be due to the confounding effect of other variables with known impact on dictation scores. Further studies in this field should also assess the change of attention and memory.
Full Text Available BACKGROUND: Interventions delivered via the Internet have the potential to address the problem of hazardous alcohol consumption at minimal incremental cost, with potentially major public health implications. It was hypothesised that providing access to a psychologically enhanced website would result in greater reductions in drinking and related problems than giving access to a typical alcohol website simply providing information on potential harms of alcohol. DYD-RCT Trial registration: ISRCTN 31070347. METHODOLOGY/PRINCIPAL FINDINGS: A two-arm randomised controlled trial was conducted entirely on-line through the Down Your Drink (DYD website. A total of 7935 individuals who screened positive for hazardous alcohol consumption were recruited and randomized. At entry to the trial, the geometric mean reported past week alcohol consumption was 46.0 (SD 31.2 units. Consumption levels reduced substantially in both groups at the principal 3 month assessment point to an average of 26.0 (SD 22.3 units. Similar changes were reported at 1 month and 12 months. There were no significant differences between the groups for either alcohol consumption at 3 months (intervention: control ratio of geometric means 1.03, 95% CI 0.97 to 1.10 or for this outcome and the main secondary outcomes at any of the assessments. The results were not materially changed following imputation of missing values, nor was there any evidence that the impact of the intervention varied with baseline measures or level of exposure to the intervention. CONCLUSIONS/SIGNIFICANCE: Findings did not provide support for the hypothesis that access to a psychologically enhanced website confers additional benefit over standard practice and indicate the need for further research to optimise the effectiveness of Internet-based behavioural interventions. The trial demonstrates a widespread and potentially sustainable demand for Internet based interventions for people with hazardous alcohol consumption
Melissa A. Napolitano
Full Text Available Examining behavioral and psychological factors relating to weight stability over a 1-year period is of public health importance. We conducted a physical activity (PA intervention trial for women (N=247; mean age=47.5±10.7; mean BMI=28.6±5.3 in which participants were assigned to one of three groups (two PA and one contact-control. By Month 12, participants achieved 140.4±14.82 min of PA/week, with no group differences. Weight status change from baseline to Month 12 was categorized: no change (N=154; 62.4%; increase (N=34; 13.8%; decrease (N=59; 23.9%. Discriminant function analyses indentified two statistically significant dimensions associated with weight change. Dimension 1 was positively weighted by mood (0.73 and self-efficacy (0.79; dimension 2 was positively weighted to change in physical activity (0.58 and fat consumption (0.55. Results provide further evidence for the importance of behavior in long-term weight maintenance, particularly physical activity and dietary fat. These findings also provide evidence for the importance of addressing psychosocial variables, in particular depressed mood and self-efficacy.
Mudde Aart N
Full Text Available Abstract Background The aim of this study was to explore the working mechanisms of a computer tailored physical activity intervention for older adults with environmental information compared to a basic tailored intervention without environmental information. Method A clustered randomized controlled trial with two computer tailored interventions and a no-intervention control group was conducted among 1971 adults aged ≥ 50. The two tailored interventions were developed using Intervention Mapping and consisted of three tailored letters delivered over a four-month period. The basic tailored intervention targeted psychosocial determinants alone, while the environmentally tailored intervention additionally targeted environmental determinants, by providing tailored environmental information. Study outcomes were collected with questionnaires at baseline, three and six months and comprised total physical activity (days/week, walking (min/week, cycling (min/week, sports (min/week, environmental perceptions and use and appreciation of the interventions. Results Mediation analyses showed that changes in cycling, sports and total physical activity behaviour induced by the environmentally tailored intervention were mediated by changes in environmental perceptions. Changes in environmental perceptions did not mediate the effect of the basic tailored intervention on behaviour. Compared with the basic tailored intervention, the environmentally tailored intervention significantly improved cycling behaviour (τ = 30.2. Additionally, the tailored letters of the environmentally tailored intervention were better appreciated and used, although these differences did not mediate the intervention effect. Discussion This study gave some first indications of the relevance of environmental perceptions as a determinant of changing physical activity behaviours and the potential effectiveness of providing environmental information as an intervention strategy aimed at
Full Text Available Abstract Background Physical activity and motor skills acquisition are of high importance for health-related prevention and a normal development in childhood. However, few intervention studies exist in preschool children focussing on an increase in physical activity and motor skills. Proof of positive effects is available but not consistent. Methods/Design The design, curriculum, and evaluation strategy of a cluster randomised intervention study in preschool children are described in this manuscript. In the Prevention through Activity in Kindergarten Trial (PAKT, 41 of 131 kindergartens of Wuerzburg and Kitzingen, Germany, were randomised into an intervention and a control group by a random number table stratified for the location of the kindergarten in an urban (more than 20.000 inhabitants or rural area. The aims of the intervention were to increase physical activity and motor skills in the participating children, and to reduce health risk factors as well as media use. The intervention was designed to involve children, parents and teachers, and lasted one academic year. It contained daily 30-min sessions of physical education in kindergarten based on a holistic pedagogic approach termed the "early psychomotor education". The sessions were instructed by kindergarten teachers under regular supervision by the research team. Parents were actively involved by physical activity homework cards. The kindergarten teachers were trained in workshops and during the supervision. Assessments were performed at baseline, 3-5 months into the intervention, at the end of the intervention and 2-4 months after the intervention. The primary outcomes of the study are increases in physical activity (accelerometry and in motor skills performance (composite score of obstacle course, standing long jump, balancing on one foot, jumping sidewise to and fro between baseline and the two assessments during the intervention. Secondary outcomes include decreases in body
Patterson Thomas L
Full Text Available Abstract Background Studies of implementation of efficacious human immunodeficiency virus (HIV prevention interventions are rare, especially in resource-poor settings, but important, because they have the potential to increase the impact of interventions by improving uptake and sustainability. Few studies have focused on provider and organizational factors that may influence uptake and fidelity to core intervention components. Using a hybrid design, we will study the implementation of an efficacious intervention to reduce sexually transmitted infections (STIs among female sex workers (FSWs in 12 cities across Mexico. Our protocol will test a ‘train-the-trainer’ implementation model for transporting the Mujer Segura (Healthy Woman intervention into community-based organizations (CBOs. Methods We have partnered with Mexican Foundation for Family Planning (Mexfam, a non-governmental organization that has CBOs throughout Mexico. At each CBO, trained ethnographers will survey CBO staff on characteristics of their organization and on their attitudes toward their CBO and toward the implementation of evidence-based interventions (EBIs. Then, after CBO staff recruit a sample of 80 eligible FSWs and deliver a standard-care, didactic intervention to 40 women randomly selected from that pool, a Mexfam staff person will be trained in the Mujer Segura intervention and will then train other counselors to deliver Mujer Segura to the 40 remaining participating FSWs. FSW participants will receive a baseline behavioral assessment and be tested for HIV and STIs (syphilis, gonorrhea, and chlamydia; they will be reassessed at six months post-intervention to measure for possible intervention effects. At the same time, both qualitative and quantitative data will be collected on the implementation process, including measures of counselors’ fidelity to the intervention model. After data collection at each CBO is complete, the relative efficacy of the Mujer Segura
Hilde K Brekke
Full Text Available OBJECTIVE: To examine the effects of Diet (D and Exercise (E interventions on cardiovascular fitness, waist circumference, blood lipids, glucose metabolism, inflammation markers, insulin-like growth factor 1 (IGF-1 and blood pressure in overweight and obese lactating women. METHODS: At 10-14 wk postpartum, 68 Swedish women with a self-reported pre-pregnancy BMI of 25-35 kg/m(2 were randomized to a 12-wk behavior modification treatment with D, E, both or control using a 2×2 factorial design. The goal of D treatment was to reduce body weight by 0.5 kg/wk, accomplished by decreasing energy intake by 500 kcal/d and monitoring weight loss through self-weighing. The goal of E treatment was to perform 4 45-min walks per wk at 60-70% of max heart-rate using a heart-rate monitor. Effects were measured 12 wk and 1 y after randomization. General Linear Modeling was used to study main and interaction effects adjusted for baseline values of dependent variable. RESULTS: There was a significant main effect of the D treatment, decreasing waist circumference (P = 0.001, total cholesterol (P = 0.007, LDL-cholesterol (P = 0.003 and fasting insulin (P = 0.042, at the end of the 12-wk treatment. The decreased waist circumference (P<0.001 and insulin (P = 0.024 was sustained and HDL-cholesterol increased (P = 0.005 at the 1-y follow-up. No effects from the E treatment or any interaction effects were observed. CONCLUSIONS: Dietary behavior modification that produced sustained weight loss among overweight and obese lactating women also improved risk factors for cardiovascular disease and type 2 diabetes. This intervention may not only reduce weight-related risks with future pregnancies but also long-term risk for metabolic disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT01343238.
Monasta, L; Batty, G D; Macaluso, A; Ronfani, L; Lutje, V; Bavcar, A; van Lenthe, F J; Brug, J; Cattaneo, A
The objective of this study was to analyse interventions for the prevention of overweight and obesity in children under 5 years of age. We carried out a systematic review focusing exclusively on randomized controlled trials (RCTs). Data sources include Medline, Cochrane Library, EMBASE, CINHAL, PsychInfo and Web of Science. Data were extracted from seventeen articles describing seven RCTs identified through electronic search, screening of references in systematic reviews, own files and contact with authors. RCTs were assessed with the Jadad scale. Four trials were carried out in preschool settings, one with an exclusive educational component, two with an exclusive physical activity component and one with both. Two trials were family-based, with education and counselling for parents and children. The remaining trial was carried out in maternity hospitals, with a training intervention on breastfeeding. None of the interventions had an effect in preventing overweight and obesity. The failure to show an effect may be due to the choice of outcomes, the quality of the RCTs, the suboptimal implementation of the interventions, the lack of focus on social and environmental determinants. More rigorous research is needed on interventions and on social and environmental factors that could impact on lifestyle.
Full Text Available Abstract Background Although lifestyle interventions targeting multiple lifestyle behaviors are more effective in preventing unhealthy weight gain and chronic diseases than intervening on a single behavior, few studies have compared individual and combined effects of diet and/or exercise interventions on health-related quality of life (HRQOL. In addition, the mechanisms of how these lifestyle interventions affect HRQOL are unknown. The primary aim of this study was to examine the individual and combined effects of dietary weight loss and/or exercise interventions on HRQOL and psychosocial factors (depression, anxiety, stress, social support. The secondary aim was to investigate predictors of changes in HRQOL. Methods This study was a randomized controlled trial. Overweight/obese postmenopausal women were randomly assigned to 12 months of dietary weight loss (n = 118, moderate-to-vigorous aerobic exercise (225 minutes/week, n = 117, combined diet and exercise (n = 117, or control (n = 87. Demographic, health and anthropometric information, aerobic fitness, HRQOL (SF-36, stress (Perceived Stress Scale, depression [Brief Symptom Inventory (BSI-18], anxiety (BSI-18 and social support (Medical Outcome Study Social Support Survey were assessed at baseline and 12 months. The 12-month changes in HRQOL and psychosocial factors were compared using analysis of covariance, adjusting for baseline scores. Multiple regression was used to assess predictors of changes in HRQOL. Results Twelve-month changes in HRQOL and psychosocial factors differed by intervention group. The combined diet + exercise group improved 4 aspects of HRQOL (physical functioning, role-physical, vitality, and mental health, and stress (p ≤ 0.01 vs. controls. The diet group increased vitality score (p Conclusions A combined diet and exercise intervention has positive effects on HRQOL and psychological health, which may be greater than that from exercise or diet alone. Improvements in
Chadwick, Paul; Strauss, Clara; Jones, Anna-Marie; Kingdon, David; Ellett, Lyn; Dannahy, Laura; Hayward, Mark
Group Person-Based Cognitive Therapy (PBCT) integrates cognitive therapy and mindfulness to target distinct sources of distress in psychosis. The present study presents data from the first randomised controlled trial investigating group PBCT in people distressed by hearing voices. One-hundred and eight participants were randomised to receive either group PBCT and Treatment As Usual (TAU) or TAU only. While there was no significant effect on the primary outcome, a measure of general psychological distress, results showed significant between-group post-intervention benefits in voice-related distress, perceived controllability of voices and recovery. Participants in the PBCT group reported significantly lower post-treatment levels of depression, with this effect maintained at six-month follow-up. Findings suggest PBCT delivered over 12weeks effectively impacts key dimensions of the voice hearing experience, supports meaningful behaviour change, and has lasting effects on mood. PMID:27146475
Adamsen, Lis; Quist, Morten; Andersen, Christina;
OBJECTIVE: To assess the effect of a multimodal group exercise intervention, as an adjunct to conventional care, on fatigue, physical capacity, general wellbeing, physical activity, and quality of life in patients with cancer who were undergoing adjuvant chemotherapy or treatment for advanced...... disease. DESIGN: Randomised controlled trial. SETTING: Two university hospitals in Copenhagen, Denmark. PARTICIPANTS: 269 patients with cancer; 73 men, 196 women, mean age 47 years (range 20-65) representing 21 diagnoses. Main exclusion criteria were brain or bone metastases. 235 patients completed follow...... and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Medical Outcomes Study Short Form (MOS SF-36), Leisure Time Physical Activity Questionnaire, muscular strength (one repetition maximum), maximum oxygen consumption (Vo(2)max). Statistical methods The general linear model was used...
Using the Medical Research Council Framework for the Development and Evaluation of Complex Interventions in a Theory-Based Infant Feeding Intervention to Prevent Childhood Obesity: The Baby Milk Intervention and Trial
Full Text Available Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients and healthcare professionals (intervention deliverers to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial.
Gaete, Jorge; Martinez, Vania; Fritsch, Rosemarie; Rojas, Graciela; Montgomery, Alan A.; Araya, Ricardo
Background Depression is a disabling condition affecting people of all ages, but generally starting during adolescence. Schools seem to be an excellent setting where preventive interventions may be delivered. This study aimed to test the effectiveness of an indicated school-based intervention to reduce depressive symptoms among at-risk adolescents from low-income families. Methods A two-arm, parallel, randomized controlled trial was conducted in 11 secondary schools in vulnerable socioeconomi...
Fachini Alexandre; Aliane Poliana P; Martinez Edson Z; Furtado Erikson F
Abstract Background Many studies reported that brief interventions are effective in reducing excessive drinking. This study aimed to assess the efficacy of a protocol of brief intervention for college students (BASICS), delivered face-to-face, to reduce risky alcohol consumption and negative consequences. Methods A systematic review with meta-analysis was performed by searching for randomized controlled trials (RCTs) in Medline, PsycInfo, Web of Science and Cochrane Library databases. A quali...
Fernandez, AC; Wood, MD; Laforge, R; Black, JT
Background Matriculation from high school to college is typified by an increase in alcohol use and related harm for many students. Therefore, this transition period is an ideal time for preventive interventions to target alcohol use and related problems. Purpose The purpose of this report is to describe the design and methods used in the Transitions Project, a randomized controlled trial of two interventions designed to prevent and reduce heavy episodic drinking and alcohol-related negative c...
Kim, Min-Ji; Han, Chang-Wan; Min, Kyoung-Youn; CHO, Chae-Yoon; Lee, Chae-Won; Ogawa, Yoshiko; Mori, Etsuro; Kohzuki, Masahiro
Aims This study aimed to investigate the effect of 6-month physical exercise with a multicomponent cognitive program (MCP) on the cognitive function of older adults with moderate to severe Alzheimer's disease (AD). Methods We included 33 participants with AD in a 6-month randomized controlled trial. The intervention group participated in physical exercise and received a MCP. The control group received only the MCP. Before and after the intervention, cognitive outcomes were assessed using the ...
Schulz, Richard; Rosen, Jules; KLINGER, JULIE; Musa, Donald; Castle, Nicholas G; KANE, APRIL; Lustig, Amy
Many caregivers continue to provide care and support to their care recipients after institutional placement. A two-group randomized controlled trial was carried out to test the efficacy of a psychosocial intervention for informal caregivers whose care recipients resided in a long-term care facility. The intervention was delivered during the 6 month period following baseline assessment. Follow-up assessments were carried out at 6, 12, and 18 months. Primary outcomes were caregiver depression, ...