Evaluating the Feasibility of a School-based Stepped Care Program for Internalizing Symptoms in Adolescents in Pakistan

Phase

N/A

Condition

Depression

Treatment

Enhanced School Mental Health Program (eSMHP)

Clinical Study ID

NCT06881342

GIHD/Trials/2024/01

R01MH131025-03

Ages 13-15
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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 ≥ 28).

Exclusion

Exclusion Criteria:

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

Study Design

Enhanced School Mental Health Program (eSMHP)

March 28, 2025

August 31, 2025

Study 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.

Connect with a study center

Global Institute of Human Development
Rawalpindi, Punjab 46000
Pakistan
Site Not Available

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