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Evaluating the effectiveness of a school-based stepped care treatment model for adolescent depression in Pakistan

Evaluating the effectiveness of a school-based stepped care intervention model for adolescent depression in Pakistan: a clustered sequential multiple assignment randomized trial (SMARTSTEP)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11220474
Enrollment
600
Registered
2025-11-06
Start date
2025-11-13
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescents experiencing symptoms of psychosocial distress Mental and Behavioural Disorders

Interventions

First stage intervention: universal intervention for intervention & TAU for control arms: The first-stage intervention involves a universal intervention delivered in the intervention arm, while the c

Sponsors

Global Institute of Human Development
Lead Sponsor

Eligibility

Sex/Gender
All
Age
13 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1. Adolescents aged 13-15 years 2. Living with parents/primary caregivers, attending high public schools in the study area. 3. Written parent/primary caregiver informed consent or witnessed consent (in case the parent/primary caregiver is unable to read and write, the informed consent will be obtained from parent and adolescent assent for participation in the study. 4. Screened positive on self-reported PSC (cut- off score =28). 5. Where there is more than one eligible child in a family unit, we will include the youngest eligible child.

Exclusion criteria

Exclusion criteria: 1. Adolescents at high risk of imminent suicide as reported by the students themselves or parents /primary caregivers, or identified by the trained assessment team during screening. 2. Adolescents with acute medical conditions who require immediate or on-going in-patient medical or psychiatric care, as reported by student themselves or parents/primary caregivers or identified by the trained assessment team during screening. 3. Adolescents with deafness, blindness and speech difficulties or with a severe mental, neurological or substance use disorders (e.g., psychosis, mutism, intellectual disability, autism or drug dependence) identified by the trained assessment team during screening.

Design outcomes

Primary

MeasureTime frame
Symptoms of depression in adolescents are measured using the Patient Health Questionnaire-9 (PHQ-9) at baseline and 3, 6 and 9 months post-intervention.

Secondary

MeasureTime frame
Measured at baseline and 6 and 9 months post-intervention: 1. Adolescent psychosocial distress measured using the Pediatric Symptoms Checklist (PSC) 2. Adolescent symptoms of anxiety and depression measured using the Revised Children's Anxiety and Depression Scale (RCADS) 3. Adolescent mental health domains measured using DSM-5 Level 1 Cross-Cutting Symptom Measure 4. Adolescent somatic symptoms measured using the Checklist of Somatic Symptoms of Distress 5. Adolescent well-being measures using the Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWS) 6. Adolescent perceived psychological functioning measured using PSYCHLOPS (Psychological Outcome Profile) 7. Adolescent functioning measures using Children's Global Assessment Scale (CGAS) 8. Adolescent problem solving measured using The Social Problem-Solving Inventory - Revised Short Form 9. Adolescent perceived social and emotional support measured using the Perceived Emotional /Personal Support Scale 10. Adolescent experience of bullying measured using the Bullying Victimization Questionnaire 11. Academic performance measured through the teacher-rated student academic achievement record form 12. Adolescent- and carer-reported school climate measured using Beyound Blue School Climate Questionnaire 13. Caregivers' Wellbeing measured using Self Reporting Questionnaire (SRQ) 14. Parents’ positive involvement using the Alabama Parenting Questionnaire (APQ) 15. Caregivers reported health services utilization measured using Client Service Receipt Inventory (CSRI)

Countries

Pakistan

Contacts

Public ContactSyed Usman Hamdani
director@gihd.onmicrosoft.com+92 (0)330 9979750

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 14, 2026