Clinical Trial

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

Study acronym: SMART-STEP

Active, Not Recruiting

Record status

This record was last updated April 22, 2025 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

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.

Protocol Amendment History 3 amendments

This ClinicalTrials.gov record has been amended 3 times since 2025-03-11; most recent amendment 2025-04-20.

Status change: Recruiting → Active, Not Recruiting 2025-04-20

Status change: Not Yet Recruiting → Recruiting 2025-03-28

Trial Details

NCT Number	NCT06881342
Lead Sponsor	Global Institute of Human Development Collaborators: National Institute of Mental Health (NIMH)
Conditions	Depression, Anxiety, Distress, Emotional, Psychosocial Problem, Functioning, Psychosocial
Enrollment	137 participants
Start Date	2025-03-28
Primary Completion	2025-06-30 (estimated)
Study Completion	2025-08-31 (estimated)
Updated on ClinicalTrials.gov	2025-04-22