Clinical trial NCT06881342: Evaluating the Feasibility of a School-based Stepped Care Program for Internalizing Symptoms in Adolescents in Pakistan
Official title: Evaluating the Feasibility of a School-based Stepped Care Program for Internalizing Symptoms in Adolescents in Pakistan
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression, Anxiety
Distress, Emotional
Psychosocial Problem
Functioning, Psychosocial
Lead sponsor: Global Institute of Human Development
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-18
Enrollment: 137
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: In this pilot sequential multiple assignment cluster randomized controlled trial, randomization will occur in two stages. First, school clusters (N=8), stratified by sex, will be randomized to intervention or control arms in a 1:1 allocation ratio. Schools in the intervention arm will receive the Enhanced School Mental Health Program (eSMHP) Plus by teachers and non-specialists in classroom settings. It aims at improving providers' mental health literacy, enabling early identification and management of socioemotional issues in adolescents, and enhancing teachers' well-being. Adolescents in the control arm will receive Enhanced Treatment as Usual (ETAU), which is eSMHP delivered by teachers only. At 6 weeks from baseline, a second randomization will occur at the individual level based on gender and PSC scores. In both arms, adolescents scoring ≥28 on PSC will be re-randomised to continue initial treatment (eSMHP Plus or eSMHP) or a step-up CBT-based guided self-help app.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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).

Exclusion Criteria:

1. Adolescents who require immediate in-patient (medical and/or psychiatric) care
2. Adolescents with acute protection risks as assessed by a researcher applying the definitions in the WHO mhGAP intervention guide.

Primary outcomes:
measure: Patient Health Questionnaire (PHQ-9) for adolescents
timeFrame: Enrollment, and 6 weeks and 3-months from baseline
Secondary outcomes:
measure: Pediatric Symptoms Checklist (PSC)
timeFrame: Enrollment, and 6 weeks and 3-months from baseline
measure: Revised Children's Anxiety and Depression Scale (RCADS)
timeFrame: From enrollment to the end of treatment at 3-months
measure: Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom Measure
timeFrame: From enrollment to the end of treatment at 3-months
measure: Checklist of Somatic Symptoms of Distress
timeFrame: From enrollment to the end of treatment at 3-months
measure: Experience of bullying
timeFrame: From enrollment to the end of treatment at 3-months
measure: School climate
timeFrame: From enrollment to the end of treatment at 3-months
measure: Annual academic performance and classroom attendance questionnaire
timeFrame: From enrollment to the end of treatment at 3-months
measure: Wellbeing
timeFrame: From enrollment to the end of treatment at 3-months
measure: Teachers' wellness
timeFrame: From enrollment to the end of treatment at 3-months
measure: Teachers' sense of self-efficacy
timeFrame: From enrollment to the end of treatment at 3-months
measure: Psychosocial Profile of the School
timeFrame: From enrollment to the end of treatment at 3-months
measure: Caregivers' Wellbeing
timeFrame: From enrollment to the end of treatment at 3-months
measure: Alabama Parenting Questionnaire (APQ)
timeFrame: From enrollment to the end of treatment at 3-months
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Global Institute of Human Development
state: Punjab
Study officials:
affiliation: Global Institute of Human Development
name: Syed Usman Hamdani, PhD MBBS
role: PRINCIPAL_INVESTIGATOR
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