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

NCT06881342 | Active Not Recruiting

• 2 other identifiers: GIHD/Trials/2024/01R01MH131025-03
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Patient Health Questionnaire (PHQ-9) for adolescents

  Patient Health Questionnaire (PHQ-9) for adolescents is a 9-item instrument (on a 4-point Likert scale; range 0-27) to measure depressive symptoms in the past 2 weeks (Richardson et al., 2010) and that is previously adapted, validated and shown high reliability in Pakistan (Cronbach α=0.83).

  Enrollment, and 6 weeks and 3-months from baseline

Secondary Outcomes (13)

• Pediatric Symptoms Checklist (PSC)

  Enrollment, and 6 weeks and 3-months from baseline

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

  From enrollment to the end of treatment at 3-months

• Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Level 1 Cross-Cutting Symptom Measure

  From enrollment to the end of treatment at 3-months

• Checklist of Somatic Symptoms of Distress

  From enrollment to the end of treatment at 3-months

• Experience of bullying

  From enrollment to the end of treatment at 3-months

Study Arms (2)

Intervention arm - Enhanced School Mental Health Program (eSMHP) Plus

EXPERIMENTAL

The first-stage intervention, eSMHP Plus, is delivered by teachers and non-specialists in classrooms. eSMHP enhances mental health literacy, training providers in early identification, counseling, life skills, positive discipline, parental engagement, referrals, and teacher well-being. Teachers follow a lesson plan, supported by non-specialists through biweekly school visits. Non-specialists co-deliver activities and supervise teachers to address challenges and promote well-being. At six weeks, adolescents scoring ≥28 on PSC are re-randomized to continue eSMHP Plus or receive a step-up, CBT-based guided self-help app for two months. The app, accessible via tablet/mobile, is based on empirically supported strategies.

Behavioral: Enhanced School Mental Health Program (eSMHP)

Enhanced Treatment-as-usual

ACTIVE COMPARATOR

The first-stage intervention in the control arm, eSMHP, is delivered by teachers only. Teachers in ETAU complete online training (www.learnwithshine.org) to enhance mental health literacy, learning to identify socioemotional issues and provide basic psychosocial support through counseling skills, life skills, positive discipline, parental engagement, and referrals. A dedicated module promotes teacher well-being. At six weeks, adolescents scoring ≥28 on PSC are re-randomized to continue eSMHP or receive a step-up, CBT-based guided self-help app for two months. The app, accessible via tablet/mobile, is based on empirically supported strategies and offers comprehensive features for adolescents.

Behavioral: Enhanced School Mental Health Program (eSMHP)

Interventions

Enhanced School Mental Health Program (eSMHP) BEHAVIORAL

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.

Also known as: CBT-based Guided Self-Help Application

Enhanced Treatment-as-usual; Intervention arm - Enhanced School Mental Health Program (eSMHP) Plus

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, studying in grades 7 and 8 of participating schools, provide assent and parental consent for participation in the study and screen positive for psychosocial distress on youth reported PSC (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 Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Global Institute of Human Development

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Related Publications (15)

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• Hamdani, S. U., Muzaffar, N., Huma, Z.E, Hamdani, A., Rauf, R., Farzeen, M., ... & Rahman, A. (2019). Using technology to advance school mental health: Experience from the Eastern Mediterranean Region Journal of the American Academy of Child & Adolescent Psychiatry, 58(10), S22.

  BACKGROUND

• 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.

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• 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.

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• 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

• Hamdani SU; Zill-e-Huma; Warraitch A, Suleman N, Muzzafar N, Minhas FA; F.R.C.Psych; Nizami AT; F.C.P.S.; Sikander S; F.C.P.S.; Pringle B, Hamoda HM, Wang D, Rahman A, Wissow LS. Technology-Assisted Teachers' Training to Promote Socioemotional Well-Being of Children in Public Schools in Rural Pakistan. Psychiatr Serv. 2021 Jan 1;72(1):69-76. doi: 10.1176/appi.ps.202000005. Epub 2020 Aug 25.

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• Hamdani SU, Huma ZE, Wissow L, Rahman A, Gladstone M. Measuring functional disability in children with developmental disorders in low-resource settings: validation of Developmental Disorders-Children Disability Assessment Schedule (DD-CDAS) in rural Pakistan. Glob Ment Health (Camb). 2020 Jul 13;7:e17. doi: 10.1017/gmh.2020.10. eCollection 2020.

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• 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.

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Related Links

• PedsQLTM. (2021). Measurement Model for the Pediatric Quality of Life Inventory.

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

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: Participants will not be blinded to treatment allocation. However, all outcome measures will be administered by researchers' blind to allocation status. It is not possible to blind adolescents, caregivers, intervention facilitators, intervention supervisors, data managers, or the trial manager to the treatment allocation because of the nature of the intervention. The assessors, trial statistician, and investigator(s) will be blind to treatment allocation status. To ensure masking during the trial, the intervention and assessment teams will be based at separate office locations and will not have any interaction. The assessment team members will also be non-residents of the study place. Furthermore, participants will be each individually instructed not to disclose their treatment allocation status to the assessors during any follow-up assessments. The fidelity of masking will be measured by having assessors guess the condition of each participant at the end of each assessment.
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this pilot sequential multiple assignment cluster randomized controlled trial, randomization will occur in two stages. First, school clusters (N=8), 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 Enhanced School Mental Health Program (eSMHP) Plus by teachers and non-specialists in classroom settings. It aims at improving providers' mental health literacy, enabling early identification and management of socioemotional issues in adolescents, and enhancing teachers' well-being. Adolescents in the control arm will receive Enhanced Treatment as Usual (ETAU), which is eSMHP delivered by teachers only. At 6 weeks from baseline, a second randomization will occur at the individual level based on gender and PSC scores. In both arms, adolescents scoring ≥28 on PSC will be re-randomised to continue initial treatment (eSMHP Plus or eSMHP) or a step-up CBT-based guided self-help app.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 18, 2025
• Study Start: March 28, 2025
• Primary Completion: June 30, 2025
• Study Completion: August 31, 2025
• Last Updated: April 22, 2025

Record last verified: 2025-04

Locations

PA (1)