Evaluating the Effectiveness of a School-based Stepped Care Treatment Model for Adolescent Depression in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Patient Health Questionnaire (PHQ-9) for adolescents
研究概览
简要总结
This study aims to test the effectiveness of a stepped-care model to reduce depressive symptoms in adolescents in school settings in Pakistan. The study will examine whether the universal intervention, delivered by non-specialists, can reduce depressive symptoms in adolescents after 3 months. For adolescents who do not improve with universal intervention, the study will assess whether a Cognitive Behavioural Therapy (CBT)-based guided self-help app can provide additional support as a second-step intervention. Six hundred adolescents aged 13-15 from 40 schools in Rawalpindi, Pakistan, will take part. The study will determine which interventions work best and for which students to reduce depressive symptoms in school settings in Pakistan.
详细描述
Introduction:
Depression and anxiety symptoms among adolescents can have long-term negative effects on academic, social, and emotional development if not identified and treated early. School-based interventions, both universal and indicated, are recommended to address these symptoms. However, the optimal timing, dosage, and sequencing of such interventions remain unclear, particularly in low-resource settings. The SMART-STEP study in Pakistan aims to address this gap by evaluating two evidence-informed interventions within a stepped-care model: the universal intervention, delivered by trained non-specialists to provide early support to adolescents in schools, and a Cognitive Behavioural Therapy (CBT)-based guided self-help application, designed for adolescents with persistent symptoms. Both interventions are endorsed by the WHO and UNICEF as part of the Helping Adolescent Thrive Toolkit. This study seeks to answer the question, "What works, for whom, under what conditions, and why, for reducing depressive symptoms in adolescents?"
Methods and Analysis:
The investigators will conduct a clustered Sequential Multiple Assignment Randomized Controlled Trial (SMART) to evaluate the effectiveness of these interventions, determine optimal timing and dosage, and identify which students benefit most from which intervention.
Study Setting and Participants: Forty eligible public schools in Rawalpindi, Pakistan, stratified by gender, will be included. Following ethical approvals, adolescents aged 13-15 years will be screened for psychological distress using the Paediatric Symptoms Checklist (PSC). Adolescents scoring above the threshold (≥28 on PSC) will be eligible for the trial. 600 adolescents will be recruited.
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
Due to the nature of the interventions, it is not possible to blind adolescents, caregivers, facilitators, supervisors, data managers, or the trial manager. However, assessors, the trial statistician, and investigators will remain blinded. To maintain masking, intervention and assessment teams will operate from separate offices with no interaction. Participants will be instructed not to share their treatment allocation during follow-ups. Masking of fidelity will be assessed by asking assessors to guess participant allocation at the end of each follow-up assessment timepoint.
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
- •Adolescents aged 13-15 years, currently enrolled in participating schools
- •Provide assent for participation
- •Parental/guardian consent provided
- •Screen positive for psychosocial distress on the youth-reported Pediatric Symptom Checklist (PSC), defined as a 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
First Stage Intervention - Universal Intervention for Intervention & TAU for Control Arms
The first-stage intervention involves a universal intervention delivered in the intervention arm, while the control arm receives treatment-as-usual (TAU). In the intervention arm, all adolescents aged 13-15 years receive a structured, school-based program delivered by non-specialists. It is grounded in developmental, behavioural, social, and cognitive theories and aims to provide basic psychological support to adolescents, build their socioemotional life skills, and strengthen collaboration between parents and schools, including referral pathways for those requiring specialist care. Using a structured manual, storybooks, and lesson plans, non-specialists deliver interactive sessions in class.
Mental health services are not available in public schools in Pakistan, so no structured programs will be delivered to adolescents in schools in the control group (TAU).
干预措施: Universal Intervention & CBT-based Guided Self-Help Application (Behavioral)
Second Stage Intervention - CBT-based self-help app
The second-stage intervention in both arms is a CBT-based self-help app. At 3 months from baseline, adolescents scoring ≥5 on PHQ-9 in both arms are individually re-randomised to continue initial treatments (universal intervention/TAU) or receive a step-up, CBT-based guided self-help app. The app, accessible via tablet/mobile, is based on empirically supported strategies.
干预措施: Universal Intervention & CBT-based Guided Self-Help Application (Behavioral)
结局指标
主要结局
Patient Health Questionnaire (PHQ-9) for adolescents
时间窗: Enrollment, 3-months, 6-months and 9-months from baseline
Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9) for adolescents, a 9-item instrument rated on a 4-point Likert scale. The total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms (worse outcome) over the past 2 weeks. The PHQ-9 has been previously adapted and validated in Pakistan and has demonstrated high internal consistency (Cronbach's α = 0.83).
次要结局
- Paediatric Symptoms Checklist (PSC)(Enrollment, 3-months, 6-months and 9-months from baseline)
- Revised Children's Anxiety and Depression Scale (RCADS)(Enrollment, 6-months and 9-months from baseline)
- DSM-5 Level 1 Cross-Cutting Symptom Measure(Enrollment, 6-months and 9-months from baseline)
- Checklist of Somatic Symptoms of Distress(Enrollment, 6-months and 9-months from baseline)
- Experience of Bullying(Enrollment, 6-months and 9-months from baseline)
- School Climate(Enrollment, 6-months and 9-months from baseline)
- Annual Academic Performance and Classroom Attendance(From enrollment to the end of treatment at 9-months])
- Short Warwick Edinburgh Mental Wellbeing Scale (SWEMWS)(Enrollment, 6-months and 9-months from baseline)
- Caregivers' Wellbeing(Enrollment, 6-months and 9-months from baseline)
- Alabama Parenting Questionnaire (APQ)(Enrollment, 6-months and 9-months from baseline)
- PSYCHLOPS (Child's psychosocial well-being and functioning)(Enrollment, 6-months and 9-months from baseline)
- Children's Global Assessment Scale (CGAS)(Enrollment, 6-months and 9-months from baseline)
- The Social Problem-Solving Inventory - Revised Short Form(Enrollment, 6-months and 9-months from baseline)
- Perceived Emotional/Personal Support Scale(Enrollment, 6-months and 9-months from baseline)
- Client Service Receipt Inventory (CSRI)(Enrollment, and 9-months from baseline)