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Purpose: Depressive symptoms are prevalent among Chinese adolescents. However, there is a lack of effective prevention programs to reduce depressive symptoms. Methods: A pilot cluster randomized controlled trial was implemented in a sample of senior secondary school adolescents. Participants in the intervention group (N = 148) received a 6-week universal prevention course, whereas the control group (N = 131) received a routine course focusing on career development. Results: The linear mixed models showed that the group × time interaction was significant for depressive symptoms measured by DASS-21 (F (2, 550) = 5.72, p =.003) and marginally significant for that measured by SMFQ (F (2, 549) = 2.41, p =.09). Likewise, the level of anxiety and stress were significantly reduced after the program, but not maintained in the follow-up. Conclusions: This pilot study showed that a universal prevention program is promising in reducing adolescent depressive symptoms. [ABSTRACT FROM AUTHOR]

The incidence of premarital sexual behavior worldwide is increasing despite the fact that it is known that it may cause health and psychological problems. Hence, interventions are needed to reduce the incidence of premarital sexual behavior. The aim of this study was to provide an overview of the reported interventions used to reduce the incidence of premarital sexual behavior in adolescents and identify the implications for nursing practice. A systematic review was conducted using The Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines. The Scopus, Science Direct, Web of Science, and ProQuest databases were searched using the keywords "premarital sexual behavior” and “sexual,” and three researchers independently examined the resultant selected full-text articles. Articles published between 2020 and 2022 that described studies with a randomized controlled trial (RCT) design and that were published in English and had the full text available were included. The quality of each article was assessed using the Joanna Briggs Institute Critical Appraisal Checklist. Seven articles met the inclusion criteria and were subsequently analyzed. Our study showed that different types of interventions have been tested to variously enhance education, motivation, skills, and empowerment. The findings of our study have implications for nursing practice in terms of the creation of intervention-based programs and standard operating procedures for implementing programs designed to reduce the prevalence of premarital sexual behavior. Keywords: adolescent, incidence, randomized controlled trial, sexual behavior Abstrak Program Efikasi yang Dirancang untuk Menurunkan Kejadian Perilaku Seksual Pranikah pada Remaja: Tinjauan Sistematis. Angka kejadian perilaku seksual pranikah di seluruh dunia semakin meningkat meskipun diketahui dapat menimbulkan permasalahan kesehatan dan psikologis. Oleh karena itu, diperlukan intervensi untuk mengurangi kejadian perilaku seksual pranikah. Tujuan dari penelitian ini adalah untuk memberikan gambaran tentang intervensi yang digunakan untuk mengurangi kejadian perilaku seksual pranikah pada remaja dan mengidentifikasi implikasinya terhadap praktik keperawatan. Tinjauan sistematis dilakukan dengan menggunakan pedoman PRISMA. Basis data Scopus, Science Direct, Web of Science, dan ProQuest dicari menggunakan kata kunci "perilaku seksual pranikah" dan "seksual", dan tiga peneliti secara independen memeriksa artikel teks lengkap pilihan yang dihasilkan. Artikel yang diterbitkan antara tahun 2020 dan 2022 yang menjelaskan penelitian dengan desain randomized controlled trial (RCT) dan diterbitkan dalam bahasa Inggris serta teks lengkapnya disertakan. Kualitas setiap artikel dinilai menggunakan Joanna Briggs Institute Critical Appraisal Checklist. Tujuh artikel memenuhi kriteria inklusi dan kemudian dianalisis. Penelitian kami menunjukkan bahwa berbagai jenis intervensi telah diuji untuk meningkatkan pendidikan, motivasi, keterampilan, dan pemberdayaan. Temuan penelitian kami memiliki implikasi terhadap praktik keperawatan dalam hal penciptaan program berbasis intervensi dan prosedur operasi standar untuk implementasi program yang dirancang untuk mengurangi prevalensi perilaku seksual pranikah. Kata Kunci: kejadian, perilaku seksual, remaja, uji coba terkontrol secara acak

Summary: Purpose: Evidence on non-pharmacological interventions for adolescents with type 1 diabetes is unclear. This review aimed to evaluate the effectiveness of non-pharmacological intervention in adolescents with type 1 diabetes. Methods: We conducted a search on databases from November 11 to 19, 2022, for randomized controlled trials for the effects of non-pharmacological intervention in adolescents with type 1 diabetes. To identify recent research trends, we included studies published from 2017 to November 2022. The risk of bias was assessed using the Cochrane risk-of-bias tool 2.0. To estimate the effect size, a meta-analysis was performed using RevMan 5.4 program and R Studio. Results: A total of 45 studies were included in the systematic review. Among those, 30 studies were included in the meta-analysis. Non-pharmacological interventions were significantly effective in improving Glycated hemoglobin (HbA1c) (standardized mean difference [SMD] = −0.26, 95% confidence interval [CI]: −0.42, −0.09), quality of life (SMD = 0.44, 95% CI: 0.13 to 0.76), and anxiety (SMD = −0.91, 95% CI: −1.26, −0.56). Subgroup analysis showed that duration of intervention was not a covariate related to HbA1c levels. Conclusions: Non-pharmacological interventions have shown effectiveness in improving the HbA1c, quality of life, and anxiety in adolescents with type 1 diabetes. Future studies with more rigorous methodology are needed to confirm and strengthen the validity of these findings. Additionally, attention to changes in the lipid profile and self-care motivation among adolescents with type 1 diabetes is warranted. Trial registration number: Prospective Register of Systematic Reviews (CRD42022382190).

BACKGROUND: Suicide is the second‑leading cause of death among adolescents and young adults in the United States, with rates rising over much of the last decade. The design, testing, and implementation of interventions to prevent suicide in this population is a public health priority. This manuscript outlines the design and methods for a research study that compares two interventions aimed at reducing suicide and suicide attempts in youth. METHODS: We will enroll 300 youth aged 12-24 at high risk for suicide in this randomized controlled parallel group superiority trial. Participants will be randomly assigned to one of two study arms: (1) Zero Suicide Quality Improvement (ZSQI) implemented within the Kaiser Permanente Northwest (KPNW) health system, or (2) ZSQI plus a stepped care intervention for suicide prevention (SC-SP), where the services offered (including care management and dialectical behavior therapy [DBT]) increase based on risk level. Outcomes will be assessed at baseline, as well as 3-, 6-, and 12-months post randomization. The study was conceptualized and designed collaboratively by investigators at UCLA and KPNW. RESULTS: To be reported in future manuscripts. CONCLUSION: The main objective of the study is to determine whether the SC-SP intervention is superior to ZSQI with regard to lowering rates of fatal and nonfatal suicide attempts. Interventions that incorporate the latest research need to be designed and tested under controlled conditions to make progress toward the goal of achieving zero suicide. The results from this trial will directly inform those efforts. CLINICALTRIALS: gov, NCT03092271, https://clinicaltrials.gov/ct2/show/NCT03092271https://clinicaltrials.gov/ct2/show/NCT01379027.

BackgroundMethamphetamine use could jeopardize the current efforts to address opioid use disorder and HIV infection. Evidence-based behavioral interventions (EBI) are effective in reducing methamphetamine use. However, evidence on optimal combinations of EBI is limited. This protocol presents a type-1 effectiveness-implementation hybrid design to evaluate the effectiveness, cost-effectiveness of adaptive methamphetamine use interventions, and their implementation barriers in Vietnam.MethodDesign: Participants will be first randomized into two frontline interventions for 12 weeks. They will then be placed or randomized to three adaptive strategies for another 12 weeks. An economic evaluation and an ethnographic evaluation will be conducted alongside the interventions.ParticipantsWe will recruit 600 participants in 20 methadone clinics.Eligibility criteria(1) age 16+; (2) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST) scores ≥ 10 for methamphetamine use or confirmed methamphetamine use with urine drug screening; (3) willing to provide three pieces of contact information; and (4) having a cell phone.OutcomesOutcomes are measured at 13, 26, and 49 weeks and throughout the interventions. Primary outcomes include the (1) increase in HIV viral suppression, (2) reduction in HIV risk behaviors, and (3) reduction in methamphetamine use. COVID-19 response: We developed a response plan for interruptions caused by COVID-19 lockdowns to ensure data quality and intervention fidelity.DiscussionThis study will provide important evidence for scale-up of EBIs for methamphetamine use among methadone patients in limited-resource settings. As the EBIs will be delivered by methadone providers, they can be readily implemented if the trial demonstrates effectiveness and cost-effectiveness.Trial registrationClinicalTrials.gov NCT04706624. Registered on 13 January 2021. https://clinicaltrials.gov/ct2/show/NCT04706624.

Background: Adolescence is a critical period for the onset and maintenance of anxiety disorders, which raises the importance of intervening early; one possibility of doing so is via digital interventions. Within that research field, at least two important research paths have been explored in the past years. On the one hand, the anxiolytic effect of casual video games has been tested as such gaming activity may distract away from anxious thoughts through the induction of flow and redirection of attention toward the game and thus away of anxious thoughts. On the other hand, the bidirectional link between weak attentional control and higher anxiety has led to the design of interventions aiming at improving attentional control such as working memory training studies. Taking stock that another genre of gaming, action video games, improves attentional control, game-based interventions that combines cognitive training and action-like game features would seem relevant. This three-arm randomized controlled trial aims to evaluate the feasibility and the efficacy of two video game interventions to document how each may potentially alleviate adolescent anxiety-related symptoms when deployed fully on-line. Methods: The study aims to recruit 150 individuals, 12 to 14 years of age, with high levels of anxiety as reported by the parents' online form of the Screen for Child Anxiety Related Disorders questionnaire. This trial contrasts a child-friendly, "action-like" video game designed to improve attentional control abilities in a progressive and stepwise manner (Eco-Rescue), a casual puzzle video game selected to act as a positive distraction tool (Bejeweled) and finally a control group with no assigned training intervention to control for possible test-retest effects (No-training). Participants will be assigned randomly to one of the three study arms. They will be assessed for main (anxiety) and secondary outcomes (attentional control, affective working memory) at three time points, before training (T1), one week after the 6-week training (T2) and four months after completing the training (T3). Discussion: The results will provide evidence for the feasibility and the efficacy of two online video game interventions at improving mental health and emotional well-being in adolescents with high levels of anxiety. This project will contribute unique knowledge to the field, as few studies have examined the effects of video game play in the context of digital mental health interventions for adolescents. Trial registration: The trial is registered on ClinicalTrials.gov (NCT05923944, June 20, 2023). [ABSTRACT FROM AUTHOR]

This paper summarizes the results of the Improving Mood with Psychoanalytic and Cognitive Therapies (IMPACT) study and its implications for psychological treatment of adolescents with moderate to severe unipolar major depression. IMPACT was a pragmatic, superiority, randomized controlled trial conducted in the United Kingdom, which compared the clinical and cost-effectiveness of short-term psychoanalytic therapy (STPP), cognitive−behavioral therapy (CBT), and a brief psychosocial intervention (BPI) in reducing depression symptoms in 465 adolescents with unipolar major depression, aged 11 to 17 years. Although this was a clinically heterogeneous group of adolescents, some symptoms (eg, sleep and concentration difficulties, irritability/anger) were common and disabling. The trial reported no significant difference among the 3 treatments in reducing depression symptoms. One year after treatment, 84% of participants showed improvement in depressive symptoms (<50% of baseline symptoms) and improved psychosocial functioning, achieving this through different symptom reduction trajectories. Although participants attended fewer treatment sessions than planned, the 3 treatments were delivered with fidelity to their respective models. Ending treatment without therapist agreement occurred in 37% of cases. This was not associated with outcomes by treatment group. Adolescents emphasized the importance of the therapeutic relationship in all 3 treatments. Results suggest that although most adolescents respond to time-limited, structured psychological therapy, subgroups of depressed adolescents are likely to need additional treatment or support. These include adolescents who live in complex circumstances and/or who believe that their needs are not met in therapy, some who stop treatment early, and the 16% to 18% of adolescents who do not respond to treatment. Improving Mood and Preventing Relapse With Psychoanalytic Psychotherapy and Cognitive Behaviour Therapy; https://www.isrctn.com ; ISRCTN83033550. [ABSTRACT FROM AUTHOR]

PurposeYoung adult (YA) cancer survivors have high rates of adverse health and psychosocial outcomes. This risk-stratified, multicenter, randomized controlled trial (RCT) compared a self-management survivorship intervention to usual care in YA survivors with symptoms of cancer-related distress, insomnia, fatigue, pain, and/or depression.MethodsEligibility included age 18-39 at diagnosis with an invasive malignancy in the previous 1-5 years. Baseline assessment determined "high need" participants, with 2-5 elevated targeted symptoms. We randomized high need participants to intervention or usual care and offered intervention participants a survivorship clinic visit, which included mutually decided action plans for symptoms. Follow-up calls at 1 and 3 months after the clinic visit reviewed action plan progress. Outcomes compared rates of improved symptoms for intervention vs usual care at 6 months and 12 months.ResultsN = 344 completed baseline assessment, with n = 147 (43%) categorized as high need and randomized. Of n = 73 randomized to the intervention, n = 42 (58%) did not attend their survivorship clinic visit. In intent-to-treat analyses, aggregate symptom scores did not differ between arms, though distress improved for 46% in the intervention arm at 6 months compared to 18% in usual care (p = 0.03) among those with elevated distress at baseline.ConclusionsDistress improved for YAs who received self-management survivorship care. However, the study demonstrates a need for alternative strategies for providing YA survivorship care.Trial registrationNCT02192333 IMPLICATIONS FOR CANCER SURVIVORS: While YA survivors demonstrate some improved distress when provided survivorship care, to make care accessible and effective, they require options such as remote delivery of care.

Abstract Background Adolescence is a critical period for the onset and maintenance of anxiety disorders, which raises the importance of intervening early; one possibility of doing so is via digital interventions. Within that research field, at least two important research paths have been explored in the past years. On the one hand, the anxiolytic effect of casual video games has been tested as such gaming activity may distract away from anxious thoughts through the induction of flow and redirection of attention toward the game and thus away of anxious thoughts. On the other hand, the bidirectional link between weak attentional control and higher anxiety has led to the design of interventions aiming at improving attentional control such as working memory training studies. Taking stock that another genre of gaming, action video games, improves attentional control, game-based interventions that combines cognitive training and action-like game features would seem relevant. This three-arm randomized controlled trial aims to evaluate the feasibility and the efficacy of two video game interventions to document how each may potentially alleviate adolescent anxiety-related symptoms when deployed fully on-line. Methods The study aims to recruit 150 individuals, 12 to 14 years of age, with high levels of anxiety as reported by the parents’ online form of the Screen for Child Anxiety Related Disorders questionnaire. This trial contrasts a child-friendly, “action-like” video game designed to improve attentional control abilities in a progressive and stepwise manner (Eco-Rescue), a casual puzzle video game selected to act as a positive distraction tool (Bejeweled) and finally a control group with no assigned training intervention to control for possible test-retest effects (No-training). Participants will be assigned randomly to one of the three study arms. They will be assessed for main (anxiety) and secondary outcomes (attentional control, affective working memory) at three time points, before training (T1), one week after the 6-week training (T2) and four months after completing the training (T3). Discussion The results will provide evidence for the feasibility and the efficacy of two online video game interventions at improving mental health and emotional well-being in adolescents with high levels of anxiety. This project will contribute unique knowledge to the field, as few studies have examined the effects of video game play in the context of digital mental health interventions for adolescents. Trial registration The trial is registered on ClinicalTrials.gov (NCT05923944, June 20, 2023).

Objective: Anxiety disorders are among the most common co-occurring conditions in autism spectrum disorder (ASD). Despite their prevalence and impact, there are no randomized controlled trials (RCTs) aimed at evaluating the efficacy of selective serotonin reuptake inhibitors (SSRIs) for anxiolysis in this population, who may have a different biological basis for anxiety. Methods: Secondary analyses of the STAART double-blind, placebo-controlled RCT of citalopram in children with ASD examined whether citalopram reduced anxiety measured on the parent-reported Child and Adolescent Symptom Inventory-4 (CASI-4) as the primary outcome. An intention-to-treat analysis involving all 149 participants used multiple imputations for missing data and included baseline stratification factors of age group and site, among others. We prespecified as clinically significant a 33% reduction in anxiety in citalopram versus placebo, coinciding with 80% power. We tested whether communicative ability on the Vineland Communication score moderated treatment effect and explored whether initial anxiety was associated with greater adverse events, which could impact on dose titration and achieving optimal dose. Results: Both groups showed substantial reduction in anxiety. Citalopram was associated with a nonsignificant 16.5% greater reduction (observed coefficient = -0.181, bootstrap standard error = 0.126, p = 0.151, confidence interval = -0.428 to 0.066). Anxiety reports were significantly lower in children with reduced communicative ability, but communicative ability did not moderate the treatment effect (interaction p = 0.294). Initial anxiety levels were not associated with increased adverse effects (interaction ps 0.162-0.954). Conclusion: Citalopram did not statistically significantly improve anxiety in children with ASD. Clinicians should be cautious in their use of SSRIs for this indication. There remains a need for well-powered clinical trials testing the efficacy of SSRIs among autistic children with anxiety disorders.

The efficiency of partial body weight-supported treadmill training (PBWSTT) for treating various conditions in children and adolescents with cerebral palsy (CP) in diverse contexts of rehabilitation, households, or schools is unknown. The major objective of this systematic review and meta-analysis was to analyze the effectiveness of PBWSTT on various outcomes in different contexts among children and adolescents with CP. We incorporated full-text, randomized controlled trial studies that specifically assessed the effects of PBWSTT walking, motor function, stride, balance, and endurance in children and adolescents aged 3 to 18 years with CP. The literature search was carried out using Google Scholar, PubMed, Web of Science, CINAHL Plus, Scopus, PEDro, and ResearchGate databases. The methodological quality was evaluated using a Cochrane risk of bias instrument. A meta-analysis of pooled data from 10 studies with 255 participants demonstrated that PBWSTT for 4–12 weeks in rehabilitation (mean difference [MD] = 1.94, 95% confidence interval [CI] = 1.40—2.48, p < 0.0001), at home or in a school context (MD = 13.5, 95% CI = 13.9—16.0, p < 0.0001), was significantly effective for treating various conditions in children and adolescents suffering with CP. The period of 4–12 weeks of PBWSTT in rehabilitation and at-home/school settings is effective on various outcomes in children or adolescents with CP. [ABSTRACT FROM AUTHOR]

Nisang Chen,1,&ast; Xiaoting Wu,1,&ast; Mingqi Tu,1 Sangsang Xiong,1 Junyan Jin,1 Siying Qu,1 Shuangyi Pei,1,2 Jianqiao Fang,1,2 Xiaomei Shao1,2 1Key Laboratory of Acupuncture and Neurology of Zhejiang Province, Department of Neurobiology and Acupuncture Research, The Third Clinical Medical College, Zhejiang Chinese Medical University, Hangzhou, People’s Republic of China; 2Key Laboratory for Research of Acupuncture Treatment and Transformation of Emotional Diseases, The Third Affiliated Hospital of Zhejiang Chinese Medical University, Hangzhou, People’s Republic of China&ast;These authors contributed equally to this workCorrespondence: Xiaomei Shao; Jianqiao Fang, Zhejiang Chinese Medical University, No. 548, Binwen Road, Binjiang District, Hangzhou City, Zhejiang Province, People’s Republic of China, Email 13185097375@163.com; shaoxiaomei@zcmu.edu.cn; fangjianqiao7532@163.comBackground: Major depressive disorder (MDD) exhibits a pronounced occurrence among adolescents, aligning closely with the lifetime prevalence rate of 16.6% observed in adults. It is difficult to treat and prone to recurrence. Acupuncture has shown potential in enhancing treatment effectiveness. Nonetheless, there is a lack of research on the use of intradermal acupuncture (IA) in treating adolescent MDD.Methods: This study is a double-blind, randomized controlled trial. A cohort of 120 participants will be assigned randomly to three distinct groups, namely a Selective Serotonin Reuptake Inhibitors (SSRIs)-only group, a sham intradermal acupuncture combined with SSRIs (SIA) group, and an active intradermal acupuncture combined with SSRIs (AIA) group. Hamilton Depression Rating Scale will serve as the primary outcome, while Patient Health Questionnaire-9, Self-Rating Depression Scale, Pittsburgh Sleep Quality Index, and Short Form 36 Questionnaire will serve as secondary outcomes in assessing the amelioration of depressive symptoms in patients. These data will be analyzed using SPSS26.0 software.Results: We will assess the efficacy and safety of IA for MDD using commonly employed clinical psychiatric scales.Conclusion: The efficacy of IA in treating adolescent MDD may be demonstrated in this study, suggesting its potential for optimizing MDD treatment schemes.Trial Registration: ClinicalTrials.gov Identifier: NCT 05832619 (April 27, 2023).Keywords: major depressive disorder, intradermal acupuncture, selective serotonin reuptake inhibitors, adolescent, randomized controlled trial, protocol

BackgroundAdolescent and young adult use of electronic nicotine delivery systems ("vaping") has increased rapidly since 2018. There is a dearth of evidence-based vaping cessation interventions for this vulnerable population. Social media use is common among young people, and smoking cessation groups on social media have shown efficacy in the past. The objective of this study is to describe the protocol for a randomized controlled trial (RCT) testing the efficacy of an Instagram-based vaping cessation intervention for adolescents and young adults.MethodsAdolescents and young adults aged 13-21 residing in California who have vaped at least once per week in the past 30 days will be recruited through social media ads, community partners, and youth serving organizations. Participants will be randomly assigned to intervention or control conditions: the intervention group takes place on Instagram, where participants receive up to 3 posts per weekday for 25 days over 5 weeks; the control group will be directed to kickitca.org, a website offering links to chatline and texting cessation services operated by the California Smokers' Helpline. The primary outcome is biochemically verified 7-day point prevalence abstinence for nicotine vaping; secondary outcomes are vaping reduction by 50% or more, vaping quit attempts, readiness to quit vaping, confidence in ability to quit, desire to quit, commitment to abstinence, and use of evidence-based cessation strategies. Both the primary outcome and secondary outcomes will be assessed immediately, 3 months, and 6 months after the treatment.DiscussionThis is the first RCT to test a vaping cessation intervention delivered through Instagram. If effective, it will be one of the first evidence-based interventions to address vaping among adolescents and young adults and add to the evidence base for social media interventions for this population.Trial registrationClinicalTrials.gov: NCT04707911, registered on January 13, 2021.

Abstract Background The superiority of Enhanced Cognitive Behavior Therapy (CBT-E) with regard to weight gain and improvement of psychopathology of eating disorders for patients with anorexia nervosa (AN) over other psychotherapies and treatment as usual (TAU) has not been demonstrated in randomized controlled trials (RCTs). However, a previous RCT showed that patients with AN whose baseline body mass index (BMI) was less than 17.5 kg/m2 gained more weight when treated with CBT-E than with other psychotherapies. The aim of the study is to compare the efficacy of CBT-E and TAU for patients with AN. It was hypothesized that CBT-E would be superior to TAU, at least in terms of weight gain, as most patients with AN are likely to have a BMI lower than 17.5 kg/m2. Methods/design A randomized parallel-group multicenter trial will be conducted in three teaching hospitals in Japan between January 2023 and March 2026. Patients with DSM-5 AN, aged 16 years and older, with a BMI equal to or above 14.0 and below 18.5 will be eligible to participate. 56 patients will be randomly and evenly assigned to two intervention groups (CBT-E and TAU). Those assigned to CBT-E will be offered 25–40 sessions in accordance with their initial BMI. Patients assigned to TAU will have at least one session every 2 weeks, with the number of sessions and treatment period not fixed in advance. The primary outcome is BMI at 40 weeks after treatment initiation. The secondary outcomes are the results from the Japanese version of the Eating Disorder Examination Questionnaire and Clinical Impairment Assessment questionnaire to measure eating disorder psychopathology and psychological impairment. The follow-up assessment will be performed 6 months after the 40-week assessment. Discussion This multi-center randomized controlled study will probably evaluate the efficacy of CBT-E compared with TAU for patients with more severe AN than in previous studies since Japanese patients are likely to have a lower BMI than those in Western countries. While it may be difficult to generalize the results of a study conducted in Japan, it would be valuable to clarify the efficacy of CBT-E as a treatment package. Trial registration UMIN, UMIN000048847. Registered 12 Sep 2022.

BackgroundThe growing problem of adolescent mobile phone addiction has attracted significant attention, underscoring the importance of identifying approaches to address it. Exercise has been found to reduce adolescent mobile phone addiction; however, its mechanism remains unclear. This review aims to elucidate the potential moderating factors between exercise and mobile phone addiction based on previous studies to provide a reference for adolescents to effectively participate in exercise to reduce mobile phone addiction.MethodsArticles were searched in the CNKI, Web of Science, Scopus, Cochrane, PsycINFO, and PubMed databases according to the inclusion criteria and followed the Preferred Reporting Items for Systematic Assessment and Meta-analysis (PRISMA). The quality of the literature was assessed by two independent reviewers using the Cochrane Collaboration Risk of Bias tool for methodological quality assessment. Meta-analysis was performed using Stata 15.1 software for Meta-analysis, standardized mean difference (SMD) was combined using a random effects model, and subgroup analysis was used to explore heterogeneity.ResultsA total of 12 studies, 17 samples, and 861 subjects were included in the meta-analysis, and all studies were randomized controlled trials. The findings revealed that the exercise intervention significantly reduced mobile phone addiction in adolescents (SMD = −3.11; 95% CI: −3.91, −2.30; p

The efficacy and safety of bumetanide oral solution for the treatment of autism spectrum disorder (ASD) in children and adolescents was evaluated in two international, multi‐center, randomized, double‐blind, placebo‐controlled phase III trials; one enrolled patients aged 7–17 years (SIGN 1 trial) and the other enrolled younger patients aged 2–6 years (SIGN 2). In both studies, patients were randomized to receive bumetanide oral solution twice daily (BID) or placebo BID during a 6‐month double‐blind treatment period. The primary endpoint was change in Childhood Autism Rating Scale 2 (CARS2) total raw score from baseline to Week 26. Key secondary endpoints included changes in Social Responsiveness Scale‐2, Clinical Global Impression Scale, and Vineland Adaptive Behavior Scale. Each study enrolled 211 patients (bumetanide, n = 107; placebo, n = 104). Both studies were terminated early due to absence of any significant difference between bumetanide and placebo in the overall studied populations. In both studies, CARS2 total raw score decreased from baseline to Week 26 in the bumetanide and placebo groups, with no statistically significant difference between groups. No differences were observed between treatment groups for any of the secondary efficacy endpoints in either study. In both studies, treatment‐emergent adverse events that occurred more frequently with bumetanide than placebo included thirst, polyuria, hypokalemia, and dry mouth. These large phase III trials failed to demonstrate a benefit of bumetanide for the treatment of pediatric ASD compared with placebo. Consequently, the sponsor has discontinued the development of bumetanide for the treatment of this condition. Trial registration:https://clinicaltrials.gov: SIGN 1: NCT03715166; SIGN 2: NCT03715153. Lay Summary: Bumetanide is a diuretic medicine (sometimes called "water pills") that has been used for many years to treat swelling. Bumetanide can also act on nerve signals in the brain, suggesting that it might work as a treatment for autism. Two large studies (each including more than 200 patients) were therefore performed in children and adolescents with autism (age range 2–17 years) to test bumetanide. Both studies showed that bumetanide was no better than a placebo treatment for improving the main symptoms of autism. [ABSTRACT FROM AUTHOR]

Racial, ethnic, and socioeconomic disparities in childhood obesity in the United States (U.S.) originate in early life. Maternal sugar-sweetened beverage (SSB) consumption is an early life risk factor for later offspring obesity. The goal of this study was to test the effects of policy-relevant messages delivered by text messages mobile devices (mHealth) on maternal SSB consumption. In this three-arm 1-month randomized controlled trial (RCT), pregnant women or mothers of infants in predominantly Hispanic/Latino New York City neighborhoods were randomized to receive one of three text message sets: graphic beverage health warning labels, beverage sugar content information, or attention control. The main outcome was change in maternal self-reporting of average daily SSB consumption from baseline to one month. Among 262 participants, maternal SSB consumption declined over the 1-month period in all three arms. No intervention effect was detected in primary analyses. In sensitivity analyses accounting for outliers, graphic health warning labels reduced maternal SSB consumption by 28 kcal daily (95% CI: -56, -1). In this mHealth RCT among pregnant women and mothers of infants, graphic health warning labels and beverage sugar content information did not reduce maternal SSB consumption.

BackgroundThis first mixed-methods UK trial examined the feasibility and acceptability of a future definitive randomised controlled trial (RCT) to evaluate whether Family Focussed Treatment for Adolescents with Bipolar Disorder (FFT-A) UK version can improve family functioning and well-being as part of the management of Paediatric Bipolar Disorder (PBD).MethodThe trial used a randomised, parallel group, non-blinded design where participants received FFT-A UK (16 sessions over 6 months) immediately or after 12 months (delayed arm). Measures of family functioning, well-being and quality of life of the young person and the main carer (most commonly a parent) were completed at baseline, 6 and 12-months in both arms. Primary outcome measures included rates of eligibility, consent and retention along with estimates of variability in the measures and assessment of the intervention delivery. Qualitative interviews allowed assessment of participants' views about FFT-A and the trial processes.ResultsTwenty-seven of 36 young persons with PBD and their families consented; of these, 14 families were randomised to the immediate and 13 to the delayed arm. Two families from the immediate arm withdrew consent and discontinued participation. Quantitative measures were completed by 22 families (88%) at 6-months and 21 families (84%) at 12-months. Qualitative interviews were conducted with 30 participants (9 young people, 15 parents and 6 other family members). Nine families attended 3 post-trial focus groups.ConclusionIt was feasible to recruit and retain to this trial. The results highlighted that trial design and measures were acceptable to participants. A benefit in family relationships was reported by participants which they attributed to the intervention in qualitative interviews. Families recommended that future modifications include definitive trial(s) recruiting participants in the age range 15-25 years as it felt this was the age range with maximum need. Trial registration ISRCTN, ISRCTN59769322. Registered 20 January 2014, http://www.isrctn.com/ISRCTN59769322.

ObjectiveAnorexia nervosa (AN) is a disorder characterized by a profound fear of weight gain, resulting in significant weight loss, as well as behavioral symptoms that interfere with weight normalization. In concert, weight gain remains a proximal goal of treatment, and patient weighing is a critical component of treatment. However, divergent approaches exist in how patient weighing is undertaken in clinical practice. The aim of this study is to investigate the impact of a brief course of open weighing (sharing weight data with patients) versus blind weighing (not sharing weight data with patients) on distress around being weighed and AN symptom severity.Method216 patients with AN and atypical AN will be randomized to receive 4 weeks of open or blind weighing practices across residential, intensive outpatient, and outpatient treatment settings, within the context of manualized empirically supported treatment. Following 4 weeks of open or blind weighing, all patients will be enrolled into open weighing practices. Primary outcomes of interest will be patient-reported distress around being weighed at week 5 and eating disorder symptom severity at week 5. Secondary outcomes will assess weight prediction error, intolerance of uncertainty, and the fear of food.DiscussionNo best practice guidelines exist in determining optimal practices around weighing patients with AN. This multisite randomized controlled trial will provide the first known data on the impact of open versus blind weighing practices upon weight-related distress and AN symptom severity.

Between October 2015 and March 2018, we conducted the Modified Antiretroviral Treatment Access Study (MARTAS), a nurse-delivered case management intervention to improve linkage-to-care for persons recently tested HIV positive. Adult participants from nine urban clinics in three regions of Ukraine were randomized to either MARTAS or standard of care (SOC) using individual, parallel, two-arm design. The main study outcome was linkage-to-care (defined as registration at an HIV clinic) within a 3-month period from enrollment in the study. Intention-to-treat analysis of MARTAS (n = 135) versus SOC (n = 139) showed intervention efficacy in linkage to HIV care (84.4% vs. 33.8%; adjusted RR 2.45; 95% CI 1.72, 3.47; p

BackgroundTobacco use is one of the most important public health concerns, with approximately 8.7 million tobacco-related deaths each year, primarily in low- and middle-income countries. Even more concerning is the fact that 1.3 million of these deaths are seen in nonsmokers, including babies and children. This study was performed to determine whether a school-based “tobacco-free” educational intervention program among 12-year-old children would be effective in reducing their exposure to second-hand tobacco smoke (SHS) by improving their knowledge, attitude and behavior post intervention and estimating salivary cotinine levels as markers of SHS exposure.Materials and methodA randomized controlled trial was performed by a cluster random sampling technique, with 30 participants each in the experimental and control arms. A knowledge, attitude, avoidance behavior and self-efficacy of avoidance questionnaire was administered, followed by estimation of salivary cotinine levels. The experimental arm received the “tobacco-free” intervention, which comprised a 40-min health education session, with the first follow-up at 15 days and the second at 30 days after the intervention. After the intervention, the questionnaire was readministered, followed by re-estimation of salivary cotinine levels.ResultsOne month after the intervention, the number of participants who had a smoker who lived with them and the number of people who smoked inside the house were reduced in the experimental group compared to the control group. In the knowledge domain and the attitude domain, 80% and 60% of the items showed a statistically significant improvement in the experimental group compared to the control group. In the avoidance behavior domain and the Self-Efficacy of Avoidance Domain, all the items showed improvement in the experimental group compared to the control group. When the mean salivary cotinine levels were compared pre- and postintervention, it was found that although the mean postintervention salivary cotinine levels increased in both the experimental and control groups, the increase was less in the experimental group than in the control group.ConclusionThe present study has been shown to be effective in improving the knowledge, attitude and avoidance behavior of adolescents toward exposure to secondhand smoke.

Background: The superiority of Enhanced Cognitive Behavior Therapy (CBT-E) with regard to weight gain and improvement of psychopathology of eating disorders for patients with anorexia nervosa (AN) over other psychotherapies and treatment as usual (TAU) has not been demonstrated in randomized controlled trials (RCTs). However, a previous RCT showed that patients with AN whose baseline body mass index (BMI) was less than 17.5 kg/m2 gained more weight when treated with CBT-E than with other psychotherapies. The aim of the study is to compare the efficacy of CBT-E and TAU for patients with AN. It was hypothesized that CBT-E would be superior to TAU, at least in terms of weight gain, as most patients with AN are likely to have a BMI lower than 17.5 kg/m2. Methods/design: A randomized parallel-group multicenter trial will be conducted in three teaching hospitals in Japan between January 2023 and March 2026. Patients with DSM-5 AN, aged 16 years and older, with a BMI equal to or above 14.0 and below 18.5 will be eligible to participate. 56 patients will be randomly and evenly assigned to two intervention groups (CBT-E and TAU). Those assigned to CBT-E will be offered 25–40 sessions in accordance with their initial BMI. Patients assigned to TAU will have at least one session every 2 weeks, with the number of sessions and treatment period not fixed in advance. The primary outcome is BMI at 40 weeks after treatment initiation. The secondary outcomes are the results from the Japanese version of the Eating Disorder Examination Questionnaire and Clinical Impairment Assessment questionnaire to measure eating disorder psychopathology and psychological impairment. The follow-up assessment will be performed 6 months after the 40-week assessment. Discussion: This multi-center randomized controlled study will probably evaluate the efficacy of CBT-E compared with TAU for patients with more severe AN than in previous studies since Japanese patients are likely to have a lower BMI than those in Western countries. While it may be difficult to generalize the results of a study conducted in Japan, it would be valuable to clarify the efficacy of CBT-E as a treatment package. Trial registration: UMIN, UMIN000048847. Registered 12 Sep 2022. [ABSTRACT FROM AUTHOR]

BACKGROUND: This study evaluated in a rigorous 18-month randomized controlled trial the efficacy of an enhanced vocational intervention for helping individuals with a recent first schizophrenia episode to return to and remain in competitive work or regular schooling. METHODS: Individual Placement and Support (IPS) was adapted to meet the goals of individuals whose goals might involve either employment or schooling. IPS was combined with a Workplace Fundamentals Module (WFM) for an enhanced, outpatient, vocational intervention. Random assignment to the enhanced integrated rehabilitation program (N = 46) was contrasted with equally intensive clinical treatment at UCLA, including social skills training groups, and conventional vocational rehabilitation by state agencies (N = 23). All patients were provided case management and psychiatric services by the same clinical team and received oral atypical antipsychotic medication. RESULTS: The IPS-WFM combination led to 83% of patients participating in competitive employment or school in the first 6 months of intensive treatment, compared with 41% in the comparison group (p < 0.005). During the subsequent year, IPS-WFM continued to yield higher rates of schooling/employment (92% v. 60%, p < 0.03). Cumulative number of weeks of schooling and/or employment was also substantially greater with the IPS-WFM intervention (45 v. 26 weeks, p < 0.004). CONCLUSIONS: The results clearly support the efficacy of an enhanced intervention focused on recovery of participation in normative work and school settings in the initial phase of schizophrenia, suggesting potential for prevention of disability.

BackgroundConduct, anxiety, and depressive disorders account for over 75% of the adolescent mental health burden globally. The current protocol will test a low-intensity problem-solving intervention for school-going adolescents with common mental health problems in India. The protocol also tests the effects of a classroom-based sensitization intervention on the demand for counselling services in an embedded recruitment trial.Methods/designWe will conduct a two-arm, individually randomized controlled trial in six Government-run secondary schools in New Delhi. The targeted sample is 240 adolescents in grades 9-12 with persistent, elevated mental health symptoms and associated distress/impairment. Participants will receive either a brief problem-solving intervention delivered over 3 weeks by lay counsellors (intervention) or enhanced usual care comprised of problem-solving booklets (control). Self-reported adolescent mental health symptoms and idiographic problems will be assessed at 6 weeks (co-primary outcomes) and again at 12 weeks post-randomization. In addition, adolescent-reported distress/impairment, perceived stress, mental wellbeing, and clinical remission, as well as parent-reported adolescent mental health symptoms and impact scores, will be assessed at 6 and 12 weeks post-randomization. We will also complete a parallel process evaluation, including estimations of the costs of delivering the interventions. An embedded recruitment trial will apply a stepped-wedge, cluster (class)-randomized controlled design in 70 classes across the six schools. This will evaluate the added effect of a classroom-based sensitization intervention over and above school-level sensitization activities on the primary outcome of referral rate into the host trial. Other outcomes will be the proportion of referrals eligible to participate in the host trial, proportion of self-generated referrals, and severity and pattern of symptoms among referred adolescents in each condition. Power calculations were undertaken separately for each trial. A detailed statistical analysis plan will be developed separately for each trial prior to unblinding.DiscussionBoth trials were initiated on 20 August 2018. A single research protocol for both trials offers a resource-efficient methodology for testing the effectiveness of linked procedures to enhance uptake and outcomes of a school-based psychological intervention for common adolescent mental health problems.Trial registrationBoth trials are registered prospectively with the National Institute of Health registry ( www.clinicaltrials.gov ), registration numbers NCT03633916 and NCT03630471 , registered on 16th August, 2018 and 14th August, 2018 respectively).

Rationale & objectiveCompared with others, black and low-income patients receiving dialysis are less likely to receive kidney transplantation (KT) education within dialysis centers. We examined the efficacy of 2 supplementary KT education approaches delivered directly to patients.Study designProspective, 3-arm parallel-group, randomized, controlled trial.Settings & participantsAdult, black, and white low-income patients receiving dialysis in Missouri.InterventionPatients were randomly assigned to 1 of 3 educational conditions: (1) standard of care, usual KT education provided in dialysis centers (control); (2) Explore Transplant @ Home patient-guided, 4 modules of KT education sent directly to patients using print, video, and text messages; and (3) Explore Transplant @ Home educator-guided, the patient-guided intervention plus 4 telephonic discussions with an educator.OutcomesPrimary: patient knowledge of living (LDKT) and deceased donor KT (DDKT). Secondary: informed decision making, change in attitudes in favor of LDKT and DDKT, and change in the number of new steps taken toward KT.ResultsIn intent-to-treat analyses, patients randomly assigned to educator- and patient-guided interventions had greater knowledge gains (1.4 point increase) than control patients (0.8 point increase; P=0.02 and P=0.01, respectively). Compared with control patients, more patients randomly assigned to educator- and patient-guided interventions were able to make informed decisions about starting KT evaluation (82% vs 91% and 95%; P=0.003), pursuing DDKT (70% vs 84% and 84%; P=0.003), and pursuing LDKT (73% vs 91% and 92%; P

Abstract Background Previous research shows that adolescents with a chronic illness have more successful transfers to adult care if their parents are involved during the transition. However, there is a lack of structured and evaluated transfer programs for parents. Our aim will be to test a comprehensive transfer program for parents of adolescents with chronic illness during the transfer from pediatric to adult care and to evaluate the program’s effectiveness, acceptability, and costs. Methods The overall design for this protocol will be a randomized controlled trial. A total of 62 dyads consisting of an adolescent (age 16.5–17.5) and at least one parent will be recruited from one of four pediatric outpatient clinics (nephrology, hepatology, neurology, or rheumatology) at Copenhagen University Hospital - Rigshospitalet, Denmark. The dyads will be randomized to receive the transfer program in addition to usual care or to receive usual care only. The program includes an informative website, bi-annual online educational events, and transfer consultations across pediatric and adult care. Outcome measures will include transition readiness, allocation of responsibility, parental uncertainty level, and transfer satisfaction. Data will be collected from participants at baseline, every 6 months until transfer, at transfer, and 3 months after transfer. The parents’ acceptance of and satisfaction with the program will be explored through semi-structured interviews. Cost, barriers, and facilitators affecting future implementation will be identified in interviews with health care professionals, using the Normalization Process Theory as a framework for the process analysis. Discussion To our knowledge, this transfer program is one of the first interventions for parents of adolescents with a chronic illness during their child’s transfer to adult care. Our trial will include parental and adolescent measures allowing us to examine whether a transfer program for parents will improve transfer to adult care for both parents and adolescents. We believe that results from our trial will be helpful in forming recommendations to ensure better involvement of parents in transitional care. Trial registration ClinicalTrials.gov NCT04969328 . Retrospectively registered on 20 July 2021.

Objectives: Poor menstrual health may lead to school absenteeism and adverse health outcomes for adolescents. The purpose of this study was to determine the effect of pubertal and menstrual health education on health and preventive behaviors among Iranian secondary school girls. Methods: A quasi-experimental study was conducted to evaluate the effectiveness of a health intervention program. A total of 578 students (including intervention and control participants) in 12 schools in Tehran Province, Iran were included by multistage random sampling. The program comprised seven 2-hour educational sessions. After confirming the reliability and validity of a researcher-made questionnaire, that questionnaire was used to collect the required data, and the groups were followed up with after 6 months. Results: After the educational intervention, the mean scores of menstrual health-related knowledge and constructs of the theory of planned behavior were significantly higher in the intervention group than in the control group (p

Background and Study Aim. There is a void in the literature comparing the fitness effects of housework-based exercise (HBE) and conventional exercise (CE), including studies that adapt housework into an exercise program. This study examines the effectiveness of HBE and CE on adolescent learners' health-related fitness (HRF) and compares the effectiveness of the two exercises. Material and Methods. This study uses a parallel-group, randomized controlled trial with 120 adolescent learners; 60 are in the HBE group, and 60 are in the CE group. The participants in the HBE group exercised using housework activities, while the participants in the CE group exercised by doing push and pull, squats, lunges, leaps and jumps, planks, etc. The participants in both groups trained for at least an hour every weekday for 12 weeks under the supervision of qualified fitness instructors. Results. The findings show that HBE improves the fitness levels of adolescent learners, albeit it has no significant improvement in their BMI. Furthermore, HBE significantly improves the cardiorespiratory fitness of females more than males. Finally, CE outperforms the HBE in producing more significant and favorable fitness effects. Conclusions. When planned, implemented, and monitored carefully as an exercise program, doing housework is just as good as doing traditional exercise for keeping or improving adolescent learners’ fitness. Furthermore, the findings indicate that HBE may be more appropriate for females because it involves household-related tasks that they traditionally perform.However, CE produces more positive and significant fitness effects. Thus, teachers can use HBE in the remote exercise activities of their learners along with CE.

Objective: To evaluate the sustained impact of community‐based family planning (FP) interventions on current modern contraceptive and long‐acting reversible contraceptive (LARC) use among married adolescent girls in rural Niger. Methods: We used a cluster randomized controlled trial design following married adolescent girls and their husbands over 3 years. Villages were randomized to one of four arms: household visits, small group discussions, combined intervention, or control. For 1.5 years, couples were exposed to one intervention activity per month and 1.5 years after implementation ended, we used a multi‐level mixed effects logistic regression model to evaluate changes in key FP outcomes. Results: We analyzed survey data from 404 married adolescent girls with data at baseline and endline. Small group discussions (+35.6%; adjusted odds ratio [aOR] 7.94, P < 0.001) and the combined intervention (+17.9%: aOR 4.53, P = 0.005) led to statistically significant increases in the odds of using modern contraceptives at endline compared with the control. The combined intervention (+14.2%; aOR 7.98, P < 0.001) and home visits (+12.6%; aOR 8.09, P < 0.001) led to statistically significant increases in odds of using LARC methods at endline compared with the control. Increase in LARC use was driven by implant use across all intervention groups. Conclusion: This study contributes to the empirical evidence base on the sustained impact of community‐based interventions on increases in FP use among married adolescent girls in low‐ and middle‐income countries. Synopsis: Community‐based family planning interventions were associated with increased modern contraceptive and LARC use among married adolescent girls in rural Niger compared with a control group. [ABSTRACT FROM AUTHOR]

Antenatal multiple micronutrient supplementation has been shown to have beneficial effects on birth outcomes and may improve child development. However, whether there is an effect of antenatal micronutrient supplementation strategies on offspring socioemotional outcomes remains unknown. We aimed to examine the effect of antenatal folic acid (FA), iron-folic acid (IFA), and multiple micronutrient (MMN) supplementation on adolescent emotional and behavioral outcomes. We conducted a double-blind, cluster-randomized trial of antenatal micronutrient supplementation in rural western China between 2002 and 2006. Pregnant females were randomized by village to receive either daily (i) 400 μg FA, (ii) IFA containing 60 mg iron and 400 μg FA or (iii) MMN supplementation containing 30 mg iron, 400 μg FA plus 13 additional vitamins and minerals. A 14-year follow-up of their offspring was conducted in 2016. Adolescents were administered the locally adapted Youth Self-Report-2001 (YSR-2001) which produced internalizing, externalizing, and total behavior problem scores. We applied generalized estimating equations to assess the effect of the randomized regimens on YSR-2001 scores and explored the potential effect modification by household wealth and initial timing and duration of supplementation. A total of 1920 adolescents were included in the analysis, 1130 (58.9%) were male, and the mean (SD) age was 11.8 (0.78) years. Adolescents in IFA group had lower total (mean difference (MD): −2.89; 95% CI -5.73, −0.04) and externalizing (MD: −0.97; 95% CI -1.79, −0.15) problem scores as compared to those in FA group. There was no effect of MMN on behavior problem scores as compared to IFA and FA alone. Although, in effect modification analyses, MMN appeared to have greater beneficial effects in wealthier households than IFA and FA alone. Iron supplementation during pregnancy reduced adolescent emotional and behavioral problem scores which provides additional support for expanding coverage of iron-containing prenatal supplements in resource-limited settings. isrctn. org Identifier: ISRCTN08850194. [ABSTRACT FROM AUTHOR]

The efficiency of partial body weight-supported treadmill training (PBWSTT) for treating various conditions in children and adolescents with cerebral palsy (CP) in diverse contexts of rehabilitation, households, or schools is unknown. The major objective of this systematic review and meta-analysis was to analyze the effectiveness of PBWSTT on various outcomes in different contexts among children and adolescents with CP. We incorporated full-text, randomized controlled trial studies that specifically assessed the effects of PBWSTT walking, motor function, stride, balance, and endurance in children and adolescents aged 3 to 18 years with CP. The literature search was carried out using Google Scholar, PubMed, Web of Science, CINAHL Plus, Scopus, PEDro, and ResearchGate databases. The methodological quality was evaluated using a Cochrane risk of bias instrument. A meta-analysis of pooled data from 10 studies with 255 participants demonstrated that PBWSTT for 4–12 weeks in rehabilitation (mean difference [MD] = 1.94, 95% confidence interval [CI] = 1.40—2.48, p < 0.0001), at home or in a school context (MD = 13.5, 95% CI = 13.9—16.0, p < 0.0001), was significantly effective for treating various conditions in children and adolescents suffering with CP. The period of 4–12 weeks of PBWSTT in rehabilitation and at-home/school settings is effective on various outcomes in children or adolescents with CP.

There has been a significant increase in the development of interventions to improve the social competence and success of adolescents with autism spectrum disorder. The current investigation used direct observation and coding of social conversations as a rigorous method to further assess the efficacy of the Social Tools And Rules for Teens socialization intervention for adolescents with autism spectrum disorder in the context of a randomized controlled trial. A total of 35 adolescents with high-functioning autism spectrum disorder were randomized to either a treatment or waitlist control group. The 20-week group intervention took place once a week for 90 min per session. Brief video-recorded conversations between participants and unfamiliar, untrained peers were recorded at pre- and post-time points and coded for selected social behaviors (i.e. questions asked, positive facial expressions, and mutual engagement). Results revealed a significant Group × Time treatment effect for both questions asked and positive facial expressions. The findings support that the Social Tools And Rules for Teens intervention can positively impact specific, observable social behaviors through systematic coding of live social conversations within the context of a randomized controlled trial. This investigation is one of the first randomized controlled trials of a group socialization intervention to use systematic coding of live social conversations to assess social competence improvements.

Some evidence points to the positive effects of asset accumulation programs on mental health of children living in low-resource contexts. However, no evidence exists as to why and how such impact occurs. Our study aims to understand whether child poverty, child work, and household wealth serve as pathways through which the economic strengthening intervention affects the mental health of AIDS-orphaned children. The study employed a cluster-randomized experimental design with a family-based economic strengthening intervention conducted among 1410 school-going AIDS-orphaned children ages 10 and 16 years old in 48 primary schools in South Western Uganda. To test the hypothesized relationships between the intervention, mediators (household wealth, child poverty, and child's work) and mental health, we ran structural equation models that adjust for clustering of individuals within schools and account for potential correlation among the mediators. We found significant unmediated effect of the intervention on children's mental health at 24 months (B = -0.59; 95% CI: 0.93, -0.25; p

ObjectiveTo determine the efficacy in improving pain and health-related quality of life (HRQOL) of an online self-management program for adolescents with juvenile idiopathic arthritis (JIA).MethodsYouth ages 12-18 years with JIA were recruited from 10 rheumatology clinics across the United States and randomized to complete an online self-management program (n = 144) or an online disease education program (n = 145). Participants in the self-management group worked through multimedia-based modules comprising psychoeducation, training in cognitive-behavioral coping skills and stress management, and other self-management topics over a 12-week period. Participants in the control group viewed a series of preselected quality educational websites about JIA over the same interval. Online content for both groups was made available in English and Spanish to facilitate inclusion of Hispanic participants. Blinded assessment of main outcomes (pain intensity, pain interference, and HRQOL) and process outcomes (disease knowledge, self-efficacy, pain coping, and emotional adjustment) occurred at baseline, posttreatment, and at 6- and 12-month postrandomization follow-up visits.ResultsParticipants on average demonstrated significant improvements over the study period in the main outcomes, with no significant group differences in the degree of improvement. Effect sizes for these improvements were small. The amount of improvement in self-efficacy, emotional avoidance coping, disease knowledge, and emotional functioning in part predicted improvement in pain and HRQOL outcomes.ConclusionsPrimarily self-directed online self-management training and online disease education comparably and modestly improve pain and HRQOL in youth with JIA.

Abstract Background Persistent pain in adolescence adversely affects everyday life and is an important public health problem. The primary aim was to determine the feasibility of an 8-week app-based self-management intervention to reduce pain and improve health-related quality of life in a community-based population of adolescents with persistent pain. A secondary aim was to explore differences in health outcomes between the intervention and control groups. Methods A sample of 73 adolescents aged 16–19 years with persistent pain from a community-based population were randomized into 2 groups. The intervention group received the Norwegian culturally adapted version of the iCanCope with Pain TM app, which includes symptom tracking, goal setting, self-management strategies, and social support. The attention control group received a symptom tracking app. Feasibility was assessed as attrition rates and level of engagement (interactions with the app). The secondary outcomes included pain intensity, health-related quality of life, self-efficacy, pain self-efficacy, perceived social support from friends, anxiety and depression, and patient global impression. Statistical analyses were conducted using SPSS. Results Demographic and baseline outcome variables did not differ between the 2 groups. No differences were found between the participants completing the study and those who withdrew. Twenty-eight adolescents completed the intervention as planned (62% attrition). Both groups had a low level of app engagement. Intention-to-treat analysis (n = 19 + 14) showed no significant differences in outcomes between groups. However, the large effect size (Cohen’s d = .9) for depression suggested a lower depression score in the intervention group. Conclusions High treatment attrition and low engagement indicate the need for changes in trial design in a full-scale randomized controlled trial to improve participant retention. Trial registration The iCanCope with Pain Norway trial was retrospectively registered in Clinical Trials.gov (ID: NCT03551977 ). Registered 6 June 2018.

BackgroundMen who have sex with men (MSM) in India are a key group at risk for HIV acquisition and transmission. They are also an extremely marginalized and stigmatized population, facing immense psychosocial stressors including, but not limited to, stigma, homophobia, discrimination, criminalization, low self-esteem, low self-acceptance, distress, and, as a result, high rates of mental health problems. Although these multi-level psychosocial problems may put MSM at high risk for HIV acquisition and transmission, currently HIV prevention interventions in India do not address them. This paper describes the design of a psychosocial intervention to reduce HIV risk for MSM in India.MethodsFunded by the National Institute of Mental Health, this study is a two-arm randomized clinical efficacy trial of a self-acceptance based psychosocial HIV prevention intervention, informed by the minority stress model and syndemic theory, that was developed with extensive community-based formative work and input from the Indian MSM community and key informants who are knowledgeable about the experiences faced by MSM in India. Participants are MSM in Chennai and Mumbai who endorsed recent sexual behaviors placing them at high risk for HIV/sexually transmitted infection (STI) acquisition and transmission. Enrolled participants are equally randomized to either 1) the experimental condition, which consists of four group and six individual counseling sessions and includes standard of care HIV/STI testing and counseling, or 2) the standard of care condition, which includes HIV/STI testing and counseling alone. The primary outcomes are changes in the frequency of condomless anal sex acts and STI incidence (syphilis seropositivity and urethral, rectal, and pharyngeal gonorrhea and chlamydia infection. Major study assessment visits occur at baseline, 4-, 8-, and 12-months.DiscussionHIV prevention interventions that address the psychosocial stressors faced by MSM in India are needed; this study will examine the efficacy of such an intervention. If the intervention is successful, it may be able to reduce the national HIV/AIDS burden in India while empowering a marginalized and highly stigmatized group.Trial registrationClinicalTrials.gov Identifier: NCT02556294 , registered 22 September 2015.

Background: Black adolescent girls aged between 14 and 19 years are more likely than White girls to be diagnosed with a sexually transmitted infection (STI). As STI diagnosis is associated with an increase in the risk for HIV acquisition, an early intervention specifically tailored to Black adolescent girls is warranted. A web-based video game intervention has the potential to reach this demographic. Because studies of social and behavioral determinants of disease demonstrate the protective role of peer group structures on individual outcomes, a multiplayer game can facilitate opportunities to exchange and evaluate information, learn social norms, develop behavioral skills, and allow peers to influence attitudes and behavior. No prior research has examined the feasibility of a web-based multiplayer game intervention for this population. Objective: This study describes the protocol for a randomized controlled trial (RCT) pilot-testing the feasibility, acceptability, and limited efficacy of a multiplayer game-based intervention for increasing HIV and STI testing and condom use in Black adolescent girls. Methods: We enrolled 79 Black adolescent girls aged 14 to 19 years residing in the United States into a 2-arm parallel RCT. The intervention is a theory-based, community-informed, multiplayer game that can be played with peers on the web using videoconferencing software. The goal of the game is to empower Black adolescent girls to make healthy decisions regarding dating, relationships, and sex, thus reducing HIV and STI infection. Control condition participants received a list of resources after playing a time and attention control game. All study procedures were conducted via the internet. We conveniently sampled Black adolescent girls using web-based advertisements. Study assessments occurred at enrollment, 1 week, 1 month, and 4 months after enrollment. The primary outcome of this study is increased HIV and STI testing by Black adolescent girls. Secondary outcomes include increased condom use, self-efficacy to use condoms, positive attitudes toward condom use, intentions, harm perceptions, HIV and STI and pre-exposure prophylaxis knowledge, positive sexual norms, sexual communication with partners, and reduced incidence of sexual risk behaviors associated with HIV and STI transmission. Secondary outcomes also included assessment of intervention feasibility and acceptability. Results: From February to April 2022, a total of 79 Black adolescent girls were enrolled, with 40 (51%) having been randomized into the intervention condition and 39 (49%) into the control condition. At baseline, participant ages ranged from 14 to 19 (mean 16.4, SD 1.23) years. Conclusions: Web-accessible game interventions overcome common impediments of face-to-face interventions presenting a unique opportunity to reach Black adolescent girls and improve their sexual health and self-efficacy. Trial data will provide information about the limited efficacy of the intervention and inform future web-based studies and a larger RCT aimed at improving the sexual health of Black adolescent girls. [ABSTRACT FROM AUTHOR]

Background: Unmet pediatric mental health (MH) needs are growing as rates of pediatric depression and anxiety dramatically increase. Access to care is limited by multiple factors, including a shortage of clinicians trained in developmentally specific, evidence-based services. Novel approaches to MH care delivery, including technology-leveraged and readily accessible options, need to be evaluated in service of expanding evidence-based services to youths and their families. Preliminary evidence supports the use of Woebot, a relational agent that digitally delivers guided cognitive behavioral therapy (CBT) through a mobile app, for adults with MH concerns. However, no studies have evaluated the feasibility and acceptability of such app-delivered relational agents specifically for adolescents with depression and/or anxiety within an outpatient MH clinic, nor compared them to other MH support services. Objective: This paper describes the protocol for a randomized controlled trial evaluating the feasibility and acceptability of an investigational device, Woebot for Adolescents (W-GenZD), within an outpatient MH clinic for youths presenting with depression and/or anxiety. The study's secondary aim will compare the clinical outcomes of self-reported depressive symptoms with W-GenZD and a telehealth-delivered CBT-based skills group (CBT-group). Tertiary aims will evaluate additional clinical outcomes and therapeutic alliance between adolescents in W-GenZD and the CBT-group. Methods: Participants include youths aged 13-17 years with depression and/or anxiety seeking care from an outpatient MH clinic at a children's hospital. Eligible youths will have no recent safety concerns or complex comorbid clinical diagnoses; have no concurrent individual therapy; and, if on medications, are on stable doses, based on clinical screening and as well as study-specific criteria. Results: Recruitment began in May 2022. As of December 8, 2022, we have randomized 133 participants. Conclusions: Establishing the feasibility and acceptability of W-GenZD within an outpatient MH clinical setting will add to the field's current understanding of the utility and implementation considerations of this MH care service modality. The study will also evaluate the noninferiority of W-GenZD against the CBT-group. Findings may also have implications for patients, families, and providers looking for additional MH support options for adolescents seeking help for their depression and/or anxiety. Such options expand the menu of supports for youths with lower-intensity needs as well as possibly reduce waitlists and optimize clinician deployment toward more severe cases. [ABSTRACT FROM AUTHOR]

Background: Previous research shows that adolescents with a chronic illness have more successful transfers to adult care if their parents are involved during the transition. However, there is a lack of structured and evaluated transfer programs for parents. Our aim will be to test a comprehensive transfer program for parents of adolescents with chronic illness during the transfer from pediatric to adult care and to evaluate the program's effectiveness, acceptability, and costs. Methods: The overall design for this protocol will be a randomized controlled trial. A total of 62 dyads consisting of an adolescent (age 16.5–17.5) and at least one parent will be recruited from one of four pediatric outpatient clinics (nephrology, hepatology, neurology, or rheumatology) at Copenhagen University Hospital - Rigshospitalet, Denmark. The dyads will be randomized to receive the transfer program in addition to usual care or to receive usual care only. The program includes an informative website, bi-annual online educational events, and transfer consultations across pediatric and adult care. Outcome measures will include transition readiness, allocation of responsibility, parental uncertainty level, and transfer satisfaction. Data will be collected from participants at baseline, every 6 months until transfer, at transfer, and 3 months after transfer. The parents' acceptance of and satisfaction with the program will be explored through semi-structured interviews. Cost, barriers, and facilitators affecting future implementation will be identified in interviews with health care professionals, using the Normalization Process Theory as a framework for the process analysis. Discussion: To our knowledge, this transfer program is one of the first interventions for parents of adolescents with a chronic illness during their child's transfer to adult care. Our trial will include parental and adolescent measures allowing us to examine whether a transfer program for parents will improve transfer to adult care for both parents and adolescents. We believe that results from our trial will be helpful in forming recommendations to ensure better involvement of parents in transitional care. Trial registration: ClinicalTrials.gov NCT04969328. Retrospectively registered on 20 July 2021. [ABSTRACT FROM AUTHOR]

PurposeTo evaluate whether exposure to MyFamilyPlan-a web-based preconception health education module-changes the proportion of women discussing reproductive health with providers at well-woman visits.DesignCluster randomized controlled trial. One hundred thirty participants per arm distributed among 34 clusters (physicians) required to detect a 20% change in the primary outcome.SettingUrban academic medical center (California).ParticipantsEligible women were 18 to 45 years old, were English speaking, were nonpregnant, were able to access the Internet, and had an upcoming well-woman visit. E-mail and phone recruitment between September 2015 and May 2016; 292 enrollees randomized.InterventionIntervention participants completed the MyFamilyPlan module online 7 to 10 days before a scheduled well-woman visit; control participants reviewed standard online preconception health education materials.MeasuresThe primary outcome was self-reported discussion of reproductive health with the physician at the well-woman visit. Self-reported secondary outcomes were folic acid use, contraceptive method initiation/change, and self-efficacy score.AnalysisMultilevel multivariate logistic regression.ResultsAfter adjusting for covariates and cluster, exposure to MyFamilyPlan was the only variable significantly associated with an increase in the proportion of women discussing reproductive health with providers (odds ratio: 1.97, 95% confidence interval: 1.22-3.19). Prespecified secondary outcomes were unaffected.ConclusionMyFamilyPlan exposure was associated with a significant increase in the proportion of women who reported discussing reproductive health with providers and may promote preconception health awareness; more work is needed to affect associated behaviors.

The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning, including social and adaptive skills, self-determination skills, and coping self-efficacy. Forty-four adults with ASD (ages 18-38; 13 females) and their caregivers were randomly assigned to treatment or waitlist control. Compared to controls, adults in treatment significantly improved in adaptive and self-determination skills, per caregiver report, and self-reported greater belief in their ability to access social support to cope with stressors. Results provide evidence for the acceptability and efficacy of the ACCESS Program.

Abstract Background Minority stress may lead to poorer mental health for sexual and gender minority adolescents, yet no interventions have been tested through an RCT to address these concerns. Methods We report on an RCT of an intervention—Proud & Empowered—with four high schools. Measures assess the intervention’s impact on mental health symptoms. Results Compared to the control, participants in the treatment condition reported significant differences in minority stress, anxiety, and depressive symptoms. Moderation analyses showed that the intervention significantly moderated the relationship between minority stress and PTSD (b = -1.28, p = .032), depression (b = -0.79, p = .023), and suicidality (b = 0.14, p = .012) symptoms; those in the intervention condition had mitigated relationships between measures of stress and health outcomes compared to those in the control condition. Conclusions Results suggest that Proud & Empowered help reduce mental health symptoms and exposure to minority stressors and build coping strategies. Trial Registration The intervention was registered on clinicaltrials.gov on August 1, 2019 under Trial # NCT04041414 .

BackgroundWidespread increases in caesarean section (CS) rates have sparked concerns about risks to mothers and infants and rising healthcare costs. A multicentre, two-arm, cluster-randomized trial in Quebec, Canada assessed whether an audit and feedback intervention targeting health professionals would reduce CS rates for pregnant women compared to usual care, and concluded that it reduced CS rates without adverse effects on maternal or neonatal health. The effect was statistically significant but clinically small. We assessed cost-effectiveness to inform scale-up decisions.MethodsA prospective economic evaluation was undertaken using individual patient data from the Quality of Care, Obstetrics Risk Management, and Mode of Delivery (QUARISMA) trial (April 2008 to October 2011). Analyses took a healthcare payer perspective. The time horizon captured hospital-based costs and clinical events for mothers and neonates from labour onset to 3 months postpartum. Resource use was identified and measured from patient charts and valued using standardized government sources. We estimated the changes in CS rates and costs for the intervention group (versus controls) between the baseline and post-intervention periods. We examined heterogeneity between clinical subgroups of high-risk versus low-risk pregnancies and estimated the joint uncertainty in cost-effectiveness over 20,000 trial simulations. We decomposed costs to identify drivers of change.ResultsThe intervention group experienced per-patient reductions of 0.005 CS (95% confidence interval (CI): -0.015 to 0.004, P = 0.09) and $180 (95% CI: -$277 to - $83, P

Background: Self-management support is increasingly viewed as an integral part of chronic condition management in adolescence. It is well recognized that markers of chronic illness control deteriorate during adolescence. Due to the increasing prevalence of long-term chronic health conditions in childhood and improved survival rates of previously life-limiting conditions in children and adolescents, significant numbers of adolescents are having to manage their chronic condition effectively as they transition to adult health care. Therapy adherence has been identified as a major challenge for young people living with a chronic condition such as cystic fibrosis, diabetes, or asthma requiring long-term pharmacological therapy and/or lifestyle modifications. Most systematic reviews on self-management interventions address adult populations. Very few intervention studies are directed at adolescents with a chronic condition who are transitioning to adult health services. This protocol describes a prospective randomized controlled trial of a standardized self-management intervention program delivered to adolescents aged 15-18 years prior to their transfer to adult care. This study has been designed to provide evidence regarding self-management programs for adolescents and is the first study to use the Flinders Program with this important, under-researched age group.Methods: A randomized controlled trial is used to investigate the effectiveness of a modified adolescent-friendly version of an adult self-management program. This program is directed at improving self-management in an adolescent cohort 15-18 years of age with a chronic condition being treated in a specialist pediatric hospital. Participants will be randomized to either usual care or the modified Flinders Program plus usual care. Data collection will include measures of specific illness control, unscheduled hospital admissions, and questionnaires to record self-management competencies, quality of life, self-efficacy, and outcome measures specific to the chronic condition at baseline, 3 months, 6 months, and 12 months after delivery.Discussion: This study will provide a better understanding of the elements required for effective self-management programs in adolescents with a chronic condition and address some important knowledge gaps in current literature. The study will be carried out in collaboration with the Discipline of Behavioural Health at Flinders University, Adelaide, Australia, in order to inform the development of an adolescent version of the successful and validated Flinders Program™.Trial Registration: Australian and New Zealand Clinical Trials Registry (ACTRN12621000390886). Registered on April 8, 2021. [ABSTRACT FROM AUTHOR]

Background: Adolescence presents a window of opportunity to establish good nutrition and physical activity behaviours to carry throughout the life course. Adolescents are at risk of developing cardiovascular and other chronic diseases due to poor the complex interplay of physical and mental health lifestyle risk factors. Text messaging is adolescents main form of everyday communication and text message programs offer a potential solution for support and improvement of lifestyle health behaviours. The primary aim of this study is to determine effectiveness of the Health4Me text message program to improve adolescent's physical activity or nutrition behaviours among adolescents over 6-months, compared to usual care.Methods: Health4Me is a virtual, two-arm, single-blind randomised controlled trial, delivering a 6-month healthy lifestyle text message program with optional health counselling. Recruitment will be through digital advertising and primary care services. In total, 330 adolescents will be randomised 1:1 to intervention or control (usual care) groups. The intervention group will receive 4-5 text messages per week for 6-months. All text messages have been co-designed with adolescents. Messages promote a healthy lifestyle by providing practical information, health tips, motivation and support for behaviour change for physical activity, nutrition, mental health, body image, popular digital media and climate and planetary health. Virtual assessments will occur at baseline and 6-months assessing physical health (physical activity, nutrition, body mass index, sleep), mental health (quality of life, self-efficacy, psychological distress, anxiety, depression, eating disorder risk) and lifestyle outcomes (food insecurity and eHealth literacy).Discussion: This study will determine the effectiveness of a 6-month healthy lifestyle text message intervention to improve physical activity and nutrition outcomes in adolescents.Trial Registration: Australia New Zealand Clinical Trials Registry (ANZCTR) ACTRN12622000949785 , Date registered: 05/07/2022. [ABSTRACT FROM AUTHOR]

Background: Persistent pain in adolescence adversely affects everyday life and is an important public health problem. The primary aim was to determine the feasibility of an 8-week app-based self-management intervention to reduce pain and improve health-related quality of life in a community-based population of adolescents with persistent pain. A secondary aim was to explore differences in health outcomes between the intervention and control groups. Methods: A sample of 73 adolescents aged 16–19 years with persistent pain from a community-based population were randomized into 2 groups. The intervention group received the Norwegian culturally adapted version of the iCanCope with PainTM app, which includes symptom tracking, goal setting, self-management strategies, and social support. The attention control group received a symptom tracking app. Feasibility was assessed as attrition rates and level of engagement (interactions with the app). The secondary outcomes included pain intensity, health-related quality of life, self-efficacy, pain self-efficacy, perceived social support from friends, anxiety and depression, and patient global impression. Statistical analyses were conducted using SPSS. Results: Demographic and baseline outcome variables did not differ between the 2 groups. No differences were found between the participants completing the study and those who withdrew. Twenty-eight adolescents completed the intervention as planned (62% attrition). Both groups had a low level of app engagement. Intention-to-treat analysis (n = 19 + 14) showed no significant differences in outcomes between groups. However, the large effect size (Cohen's d =.9) for depression suggested a lower depression score in the intervention group. Conclusions: High treatment attrition and low engagement indicate the need for changes in trial design in a full-scale randomized controlled trial to improve participant retention. Trial registration: The iCanCope with Pain Norway trial was retrospectively registered in Clinical Trials.gov (ID: NCT03551977). Registered 6 June 2018. [ABSTRACT FROM AUTHOR]

Summary: To compare the effectiveness of family‐based behavioural social facilitation treatment (FBSFT) versus treatment as usual (TAU) in children with severe obesity. Parallel‐design, nonblinded, randomized controlled trial conducted at a Norwegian obesity outpatient clinic. Children aged 6–18 years referred to the clinic between 2014 and 2018 were invited to participate. Participants were randomly allocated using sequentially numbered, opaqued, sealed envelopes. FBSFT (n = 59) entailed 17 sessions of structured cognitive behavioural treatment, TAU (n = 55) entailed standard lifestyle counselling sessions every third month for 1 year. Primary outcomes included changes in body mass index standard deviation score (BMI SDS) and percentage above the International Obesity Task Force cut‐off for overweight (%IOTF‐25). Secondary outcomes included changes in sleep, physical activity, and eating behaviour. From pre‐ to posttreatment there was a statistically significant difference in change in both BMI SDS (0.19 units, 95% confidence interval [CI]: 0.10–0.28, p <.001) and %IOTF‐25 (5.48%, 95%CI: 2.74–8.22, p <.001) between FBSFT and TAU groups. FBSFT participants achieved significant reductions in mean BMI SDS (0.16 units, (95%CI: −0.22 to −0.10, p <.001) and %IOTF‐25 (6.53%, 95% CI: −8.45 to −4.60, p <.001), whereas in TAU nonsignificant changes were observed in BMI SDS (0.03 units, 95% CI: −0.03 to 0.09, p =.30) and %IOTF‐25 (−1.04%, 95% CI: −2.99 to −0.90, p =.29). More FBSFT participants (31.5%) had clinically meaningful BMI SDS reductions of ≥0.25 from pre‐ to posttreatment than in TAU (13.0%, p =.021). Regarding secondary outcomes, only changes in sleep timing differed significantly between groups. FBSFT improved weight‐related outcomes compared to TAU. [ABSTRACT FROM AUTHOR]

Abstract Background During the past decade there has been some evaluation of transition programmes for adolescents with chronic conditions. However, this has rarely involved process evaluations focusing on mechanisms leading to outcomes, thus hampering implementation of these complex interventions. Our aim was to (I) describe adolescents’ and parents’ experiences of participating in a person-centred transition programme aiming to empower them in transition to adulthood and (II) explore the mechanisms of impact. Methods A qualitative process evaluation was performed, embedded in a randomized controlled trial evaluating the effectiveness of a transition programme for adolescents with congenital heart disease in Sweden. A purposive sample of 14 adolescents and 12 parents randomized to the intervention group were interviewed after participation in the programme. Data were analysed deductively and inductively in NVivo v12. Results Experiences of participation in the transition programme were generally positive. Meeting a transition coordinator trained in person-centred care and adolescent health and embarking on an educational process based on the adolescents’ prerequisites in combination with peer support were considered key change mechanisms. However, support to parents were not sufficient for some participants, resulting in ambivalence about changing roles and the unmet needs of parents who required additional support. Conclusions Participants experienced increased empowerment in several dimensions of this construct, thus demonstrating that the transition programme was largely implemented as intended and the evidence-based behaviour-change techniques used proved effective in reaching the outcome. These findings can inform future implementation of transition programmes and illuminate challenges associated with delivering a complex intervention for adolescents with chronic conditions.

PurposeTest whether neighborhood mobility effects on adolescent risky behaviors varies at different developmental ages and gender.MethodsThe Moving to Opportunity (MTO) study randomly assigned volunteer families (1994-1997) to receive a Section 8 voucher to move to lower poverty neighborhoods versus a public housing control group. We tested three-way treatment, gender, and age-at-randomization interactions using intent-to-treat linear regression predicting a risky behavior index (RBI; measured in 2002, N = 2,829), defined as the fraction of 10 behaviors the youth reported (six measuring risky substance use [RSU], four measuring risky sexual behavior), and the RSU and risky sexual behavior subscales.ResultsThe treatment main effect on RBI was nonsignificant for girls (B = -.01, 95% confidence interval -.024 to .014) and harmful for boys (B = .03, 95% confidence interval .009 to .059; treatment-gender interaction p = .01). The treatment, gender, and age interaction was significant for RBI (p = .02) and RSU (p ≤ .001). Treatment boys 10 years or older at randomization were more likely (p < .05) than controls to exhibit RBI and RSU, whereas there was no effect of treatment for boys