Early adolescent skills for emotions (EASE) program trial for young adolescents studying in public schools of rural Pakista

Not Applicable

Completed

• Conditions: Adolescents experiencing symptoms of psychosocial distress.; Mental and Behavioural Disorders

• Registration Number: ISRCTN17755448
• Lead Sponsor: Benazir Bhutto Hospital

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36153028/ (added 29/09/2022) 2024 Results article in https://pubmed.ncbi.nlm.nih.gov/39025557/ (added 19/07/2024)

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-22
• Study Completion: 2022-08-30
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 566

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 parent/primary caregiver in presence of a witness) 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

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. The suicide risk will be assessed by administering the screening item for suicide from the PHQ-9-Adolescents version. This will be supplemented by assessing suicidal thoughts based on WHO mhGAP guidelines for assessing current or historical suicidal (within one month) thoughts, plans, and attempts.
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.
4. 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of psychosocial distress in adolescents are measured using the self-reported Paediatric Symptoms Checklist (PSC) at baseline, immediate post-intervention, and 3-months post-intervention.