Evaluating the Feasibility of a School-based Stepped Care Program for Internalizing Symptoms in Adolescents in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 2
- 主要终点
- Patient Health Questionnaire (PHQ-9) for adolescents
研究概览
简要总结
This study aims to explore effective ways to reduce depressive symptoms in adolescents through two school-based interventions. This study examines whether the Enhanced School Mental Health Program (eSMHP) Plus, delivered by teachers and non-specialists, can serve as a first-line intervention to reduce psychosocial distress-an intermediate outcome that must be addressed to lower the risk of depression (primary outcome) in adolescents. For those who do not respond to eSMHP Plus, the study investigates if a Cognitive Behavioural Therapy (CBT) based guided self-help app could be an effective step-up or second-level intervention. Researchers will assess the feasibility and acceptability of these approaches among 200 adolescents (aged 13-15) from 8 public schools in Rawalpindi, Pakistan. Findings will guide future large-scale studies and strategies for personalised mental health care for adolescents in low-resource settings.
详细描述
Background:
Internalizing symptoms among adolescents can have long-term devastating impacts on their lives unless they are identified and treated early and effectively. Both universal and indicated school-based interventions are recommended to address internalizing symptoms among adolescents. However, determining the optimal timing and dosage of these interventions remains a crucial question for effective adolescent mental healthcare. The investigators will conduct a pilot Sequential Multiple Assignment Randomized Controlled Trial (SMART) to explore the feasibility and acceptability of two evidence-informed intervention strategies (universal and indicated interventions) within the stepped care model, compare their timing and dosage, and determine in which sequence these interventions should be delivered to whom. This study aims to answer the question, "What works, for whom, under what conditions, and why, for internalizing symptoms in adolescents with a focus on depressive symptoms?"
Methods:
A 20-week single-blind pilot cluster SMART study will be conducted in 8 public schools in Rawalpindi, Pakistan, to assess the feasibility and acceptability of 2 intervention strategies (i.e., 1. teachers plus non-specialist delivered universal intervention called Enhanced School Mental Health Program [eSMHP] Plus and 2. Guided self-help application of Cognitive Behavioural Therapy-based indicated intervention to reduce depression (internalising symptoms) in adolescents. The study participants will be approximately 200 adolescents, aged 13-15 of both sexes, with psychosocial distress. Data on the feasibility and acceptability of the study design, views about augmented intervention options and procedures, and treatment response rates will be collected. Results from the pilot study will yield additional research questions and will improve our ability to successfully conduct the definitive SMART to inform personalised interventions for internalising symptoms in adolescents.
Discussion: The findings of the study will be used to inform the design of a subsequent fully powered, definitive SMART study in Pakistan.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will not be blinded to treatment allocation. However, all outcome measures will be administered by researchers' blind to allocation status. It is not possible to blind adolescents, caregivers, intervention facilitators, intervention supervisors, data managers, or the trial manager to the treatment allocation because of the nature of the intervention. The assessors, trial statistician, and investigator(s) will be blind to treatment allocation status. To ensure masking during the trial, the intervention and assessment teams will be based at separate office locations and will not have any interaction. The assessment team members will also be non-residents of the study place. Furthermore, participants will be each individually instructed not to disclose their treatment allocation status to the assessors during any follow-up assessments. The fidelity of masking will be measured by having assessors guess the condition of each participant at the end of each assessment.
入排标准
- 年龄范围
- 13 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Adolescents aged 13-15 years, studying in grades 7 and 8 of participating schools, provide assent and parental consent for participation in the study and screen positive for psychosocial distress on youth reported PSC (total score ≥ 28).
排除标准
- •Adolescents who require immediate in-patient (medical and/or psychiatric) care
- •Adolescents with acute protection risks as assessed by a researcher applying the definitions in the WHO mhGAP intervention guide.
研究组 & 干预措施
Intervention arm - Enhanced School Mental Health Program (eSMHP) Plus
The first-stage intervention, eSMHP Plus, is delivered by teachers and non-specialists in classrooms. eSMHP enhances mental health literacy, training providers in early identification, counseling, life skills, positive discipline, parental engagement, referrals, and teacher well-being. Teachers follow a lesson plan, supported by non-specialists through biweekly school visits. Non-specialists co-deliver activities and supervise teachers to address challenges and promote well-being. At six weeks, adolescents scoring ≥28 on PSC are re-randomized to continue eSMHP Plus or receive a step-up, CBT-based guided self-help app for two months. The app, accessible via tablet/mobile, is based on empirically supported strategies.
干预措施: Enhanced School Mental Health Program (eSMHP) (Behavioral)
Enhanced Treatment-as-usual
The first-stage intervention in the control arm, eSMHP, is delivered by teachers only. Teachers in ETAU complete online training (www.learnwithshine.org) to enhance mental health literacy, learning to identify socioemotional issues and provide basic psychosocial support through counseling skills, life skills, positive discipline, parental engagement, and referrals. A dedicated module promotes teacher well-being. At six weeks, adolescents scoring ≥28 on PSC are re-randomized to continue eSMHP or receive a step-up, CBT-based guided self-help app for two months. The app, accessible via tablet/mobile, is based on empirically supported strategies and offers comprehensive features for adolescents.
干预措施: Enhanced School Mental Health Program (eSMHP) (Behavioral)
结局指标
主要结局
Patient Health Questionnaire (PHQ-9) for adolescents
时间窗: Enrollment, and 6 weeks and 3-months from baseline
Patient Health Questionnaire (PHQ-9) for adolescents is a 9-item instrument (on a 4-point Likert scale; range 0-27) to measure depressive symptoms in the past 2 weeks (Richardson et al., 2010) and that is previously adapted, validated and shown high reliability in Pakistan (Cronbach α=0.83).
次要结局
- Revised Children's Anxiety and Depression Scale (RCADS)(From enrollment to the end of treatment at 3-months)
- Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom Measure(From enrollment to the end of treatment at 3-months)
- Pediatric Symptoms Checklist (PSC)(Enrollment, and 6 weeks and 3-months from baseline)
- Checklist of Somatic Symptoms of Distress(From enrollment to the end of treatment at 3-months)
- Experience of bullying(From enrollment to the end of treatment at 3-months)
- School climate(From enrollment to the end of treatment at 3-months)
- Annual academic performance and classroom attendance questionnaire(From enrollment to the end of treatment at 3-months)
- Wellbeing(From enrollment to the end of treatment at 3-months)
- Teachers' wellness(From enrollment to the end of treatment at 3-months)
- Teachers' sense of self-efficacy(From enrollment to the end of treatment at 3-months)
- Psychosocial Profile of the School(From enrollment to the end of treatment at 3-months)
- Caregivers' Wellbeing(From enrollment to the end of treatment at 3-months)
- Alabama Parenting Questionnaire (APQ)(From enrollment to the end of treatment at 3-months)