Evaluating the Effectiveness of a School-based Stepped Care Treatment Model for Adolescent Depression in Pakistan

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. Stage 1 Randomisation: Schools and participants will be randomized in a 1:1 allocation ratio into intervention and control arms. The universal socioemotional life skills intervention will be delivered by non-specialists to adolescents in classroom settings. Stage 2 Randomization: Adolescents who are non-responders at 3 months, defined as PHQ-9 scores ≥ 5, will be individually re-randomised to one of two options: Continue with the initial intervention or augment with the CBT-based guided self-help app Outcomes: The primary outcome is reduction in depressive symptoms at 9-month from baseline. Secondary outcomes include changes in symptoms of anxiety, psychosocial distress, functioning, and perceived psychological well-being. Ethics and Dissemination: Ethics approval has been obtained from the Institutional Review Board of the Global Institute of Human Development, Islamabad, Pakistan. Written informed consent will be obtained from parents or primary caregivers, and assent will be obtained from adolescents. Study findings will be disseminated through peer-reviewed publications, conferences, and community forums.