NCT06881342

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 137 (actual)
• Sponsor: Global Institute of Human Development · Academic / Other
• Sex: All
• Age: 13 Years – 15 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression, Anxiety
• Distress, Emotional
• Psychosocial Problem
• Functioning, Psychosocial

Interventions

Type	Name	Description
BEHAVIORAL	Enhanced School Mental Health Program (eSMHP)	The first-stage intervention is eSMHP Plus in the intervention arm and eSMHP in the control arm. In the intervention arm, adolescents receive eSMHP Plus from teachers and non-specialists, while in the control arm, they receive eSMHP from teachers. eSMHP, based on developmental, behavioral, social, and cognitive theories, enhances teachers' mental health literacy, training them in early identification, basic counseling, life skills, positive discipline, parental engagement, referrals, and teacher well-being. The second-stage intervention is a CBT-based self-help app. At six weeks, adolescents scoring ≥28 on PSC in both arms (indicating psychosocial distress) are re-randomized to continue their initial treatment (eSMHP Plus or eSMHP) or receive a step-up, CBT-based guided self-help app for two months.

Timeline

• Start date: 2025-03-28
• Primary completion: 2025-06-30
• Completion: 2025-08-31
• First posted: 2025-03-18
• Last updated: 2025-04-22

Locations

1 site across 1 country: Pakistan