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

NCT07399314 | Active Not Recruiting DMC

• 2 other identifiers: GIHD/Trials/2025/03ISRCTN11220474
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to test the effectiveness of a stepped-care model to reduce depressive symptoms in adolescents in school settings in Pakistan. The study will examine whether the universal intervention, delivered by non-specialists, can reduce depressive symptoms in adolescents after 3 months. For adolescents who do not improve with universal intervention, the study will assess whether a Cognitive Behavioural Therapy (CBT)-based guided self-help app can provide additional support as a second-step intervention. Six hundred adolescents aged 13-15 from 40 schools in Rawalpindi, Pakistan, will take part. The study will determine which interventions work best and for which students to reduce depressive symptoms in school settings in Pakistan.

Conditions

Depression Anxiety Disorder; Psychological Distress; Well-Being, Psychological

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9) for adolescents

  Depressive symptoms will be measured using the Patient Health Questionnaire (PHQ-9) for adolescents, a 9-item instrument rated on a 4-point Likert scale. The total score ranges from 0 to 27, with higher scores indicating greater severity of depressive symptoms (worse outcome) over the past 2 weeks. The PHQ-9 has been previously adapted and validated in Pakistan and has demonstrated high internal consistency (Cronbach's α = 0.83).

  Enrollment, 3-months, 6-months and 9-months from baseline

Secondary Outcomes (15)

• Paediatric Symptoms Checklist (PSC)

  Enrollment, 3-months, 6-months and 9-months from baseline

• Revised Children's Anxiety and Depression Scale (RCADS)

  Enrollment, 6-months and 9-months from baseline

• DSM-5 Level 1 Cross-Cutting Symptom Measure

  Enrollment, 6-months and 9-months from baseline

• Checklist of Somatic Symptoms of Distress

  Enrollment, 6-months and 9-months from baseline

• Experience of Bullying

  Enrollment, 6-months and 9-months from baseline

Study Arms (2)

First Stage Intervention - Universal Intervention for Intervention & TAU for Control Arms

EXPERIMENTAL

The first-stage intervention involves a universal intervention delivered in the intervention arm, while the control arm receives treatment-as-usual (TAU). In the intervention arm, all adolescents aged 13-15 years receive a structured, school-based program delivered by non-specialists. It is grounded in developmental, behavioural, social, and cognitive theories and aims to provide basic psychological support to adolescents, build their socioemotional life skills, and strengthen collaboration between parents and schools, including referral pathways for those requiring specialist care. Using a structured manual, storybooks, and lesson plans, non-specialists deliver interactive sessions in class. Mental health services are not available in public schools in Pakistan, so no structured programs will be delivered to adolescents in schools in the control group (TAU).

Behavioral: Universal Intervention & CBT-based Guided Self-Help Application

Second Stage Intervention - CBT-based self-help app

EXPERIMENTAL

The second-stage intervention in both arms is a CBT-based self-help app. At 3 months from baseline, adolescents scoring ≥5 on PHQ-9 in both arms are individually re-randomised to continue initial treatments (universal intervention/TAU) or receive a step-up, CBT-based guided self-help app. The app, accessible via tablet/mobile, is based on empirically supported strategies.

Behavioral: Universal Intervention & CBT-based Guided Self-Help Application

Interventions

Universal Intervention & CBT-based Guided Self-Help Application BEHAVIORAL

The first-stage intervention is universal intervention in the intervention arm and TAU in the control arm. In the intervention arm, adolescents receive universal intervention from non-specialists, while in the control arm, they receive TAU. Universal intervention, based on developmental, behavioral, social, and cognitive theories, aims to provide basic psychological support to adolescents, build their socioemotional life skills, and strengthen collaboration between parents and schools, including referral pathways for those requiring specialist care. The second-stage intervention is a CBT-based self-help app. At 3-months, adolescents scoring ≥5 on the PHQ-9 in both arms (indicating the presence of depressive symptoms) are individually re-randomized to continue their initial treatment (universal or TAU) or receive a step-up, CBT-based guided self-help app.

First Stage Intervention - Universal Intervention for Intervention & TAU for Control Arms; Second Stage Intervention - CBT-based self-help app

Eligibility Criteria

• Age: 13 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Adolescents aged 13-15 years, currently enrolled in participating schools
• Provide assent for participation
• Parental/guardian consent provided
• Screen positive for psychosocial distress on the youth-reported Pediatric Symptom Checklist (PSC), defined as a total score ≥ 28

You may not qualify if:

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

Sponsors & Collaborators

• Global Institute of Human Development: lead
• National Ministry of Health Services, Regulations and Coordination: collaborator
• Institute of Psychiatry, Benazir Bhutto Hospital, Rawalpindi: collaborator
• Shifa Tameer-e-Millat University: collaborator

Study Sites (1)

Global Institute of Human Development

Islamabad, Punjab Province, 46000, Pakistan

Location

Related Publications (11)

• Hamdani SU, Huma ZE, Tamizuddin-Nizami A, Baneen UU, Suleman N, Javed H, Malik A, Wang D, Mazhar S, Khan SA, Minhas FA, Rahman A. Feasibility and acceptability of a multicomponent, group psychological intervention for adolescents with psychosocial distress in public schools of Pakistan: a feasibility cluster randomized controlled trial (cRCT). Child Adolesc Psychiatry Ment Health. 2022 Jun 21;16(1):47. doi: 10.1186/s13034-022-00480-z.

  PMID: 35729589 BACKGROUND

• Hamdani SU, Huma ZE, Malik A, Tamizuddin-Nizami A, Javed H, Minhas FA, Jordans MJD, Sijbrandij M, Suleman N, Baneen UU, Bryant RA, van Ommeren M, Rahman A, Wang D. Effectiveness of a group psychological intervention to reduce psychosocial distress in adolescents in Pakistan: a single-blind, cluster randomised controlled trial. Lancet Child Adolesc Health. 2024 Aug;8(8):559-570. doi: 10.1016/S2352-4642(24)00101-9.

  PMID: 39025557 BACKGROUND

• Hamdani, S., Huma, Z.E., Javed, H., Warraitch, A., Rahman, A., Nizami, A., & Minhas, F. (2021). Prevalence of psychosocial distress in school going adolescents in rural Pakistan: Findings from a cross-sectional epidemiological survey. BJPsych Open, 7(S1), S56-S57. doi:10.1192/bjo.2021.196

  BACKGROUND

• Naveed S, Waqas A, Memon AR, Jabeen M, Sheikh MH. Cross-cultural validation of the Urdu translation of the Patient Health Questionnaire for Adolescents among children and adolescents at a Pakistani school. Public Health. 2019 Mar;168:59-66. doi: 10.1016/j.puhe.2018.11.022. Epub 2019 Jan 25.

  PMID: 30685600 BACKGROUND

• Spence SH. Structure of anxiety symptoms among children: a confirmatory factor-analytic study. J Abnorm Psychol. 1997 May;106(2):280-97. doi: 10.1037//0021-843x.106.2.280.

  PMID: 9131848 BACKGROUND

• Shaffer D, Gould MS, Brasic J, Ambrosini P, Fisher P, Bird H, Aluwahlia S. A children's global assessment scale (CGAS). Arch Gen Psychiatry. 1983 Nov;40(11):1228-31. doi: 10.1001/archpsyc.1983.01790100074010.

  PMID: 6639293 BACKGROUND

• D'Zurilla, T. J., Nezu, A. M., & Maydeu-Olivares, A. (1999). Manualfor the Social Problem-Solving Inventory-Revised. North Towanda, NY: Multi-Health Systems

  BACKGROUND

• Clarke DE, Kuhl EA. DSM-5 cross-cutting symptom measures: a step towards the future of psychiatric care? World Psychiatry. 2014 Oct;13(3):314-6. doi: 10.1002/wps.20154. No abstract available.

  PMID: 25273306 BACKGROUND

• Jellinek MS, Murphy JM, Robinson J, Feins A, Lamb S, Fenton T. Pediatric Symptom Checklist: screening school-age children for psychosocial dysfunction. J Pediatr. 1988 Feb;112(2):201-9. doi: 10.1016/s0022-3476(88)80056-8.

  PMID: 3339501 BACKGROUND

• Richardson LP, McCauley E, Grossman DC, McCarty CA, Richards J, Russo JE, Rockhill C, Katon W. Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics. 2010 Dec;126(6):1117-23. doi: 10.1542/peds.2010-0852. Epub 2010 Nov 1.

  PMID: 21041282 BACKGROUND

• Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.

  PMID: 10024117 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• Syed Usman Hamdani, PhD MBBS

  Global Institute of Human Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions, it is not possible to blind adolescents, caregivers, facilitators, supervisors, data managers, or the trial manager. However, assessors, the trial statistician, and investigators will remain blinded. To maintain masking, intervention and assessment teams will operate from separate offices with no interaction. Participants will be instructed not to share their treatment allocation during follow-ups. Masking of fidelity will be assessed by asking assessors to guess participant allocation at the end of each follow-up assessment timepoint.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this sequential multiple assignment cluster randomized controlled trial, randomization will occur in two stages. First, school clusters (N=40), 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 universal socioemotional life skills intervention from non-specialists in classroom settings. It aims at improving socioemotional life skills and providing basic psychological support to adolescents in classroom settings. Adolescents in the control arm will receive Treatment as Usual (TAU). At 3-months from the baseline, a second randomisation will occur at the individual level based on gender and PHQ-9 scores. In both arms, adolescents scoring ≥5 on PHQ-9 will be re-randomised to continue initial treatment (universal or TAU) or a step-up CBT-based guided self-help app.

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 10, 2026
• Study Start: November 13, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 5, 2026

Record last verified: 2026-05

Locations

PA (1)