Promoting Mental Health Among At-risk Adolescents in Malaysia

NCT ID: NCT07138664

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 428 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-09-30

Brief Summary

The primary objective of this trial is to evaluate a school-based intervention designed to promote mental health among at-risk adolescents from low-income communities in Malaysia. The study will employ a two-arm, cluster randomised controlled trial design, comparing a school-based intervention to a control condition. Adolescents will be recruited from at least 20 secondary schools located in economically disadvantaged rural and urban areas of Malaysia. Assessments will take place at multiple time points: during screening, at baseline (pre-intervention), immediately after the intervention (8 weeks), and at two follow-up points-6 and 12 months post-intervention. The primary outcomes are a reduction in anxiety and depressive symptoms, along with improved mental wellbeing at the 12-month follow-up.

Detailed Description

The overall aim of this trial is to use a school-based intervention to promote mental health among at-risk adolescents from low-income communities in Malaysia. Our primary aim is to evaluate the effectiveness and cost-effectiveness of a school-based intervention ("Super Skills for Life"; SSL) in reducing anxiety and depression, and in improving mental wellbeing in adolescents aged 12-14 years. We also aim to identify contextual factors related to the successful implementation of SSL in Malaysian schools.

This study will use a two-arm, cluster randomised controlled trial design with a 1:1 allocation ratio to compare a school-based intervention (Super Skills for Life; SSL) to a control condition (Study Skills Programme; SSP). Three stratification factors will be used for randomisation: school size, classes/forms and school location (urban vs rural). These adolescents will be invited to complete a screening questionnaire (i.e., Depression Anxiety and Stress Scale-21; DASS-21).

Based on power calculations, a total of 428 adolescents (214 per arm) with moderate to severe symptoms of anxiety and depression will be recruited to participate in the trial. Classrooms will be randomly assigned to either the intervention or control group, and eligible adolescents within each class will receive the intervention assigned to their group. Assessments will be conducted at screening, baseline (pre-intervention), immediately after the intervention (8 weeks), and at two follow-up points-6 and 12 months post-intervention. The primary outcomes will include reductions in anxiety and depressive symptoms, along with improvements in mental wellbeing at the 12-month follow-up.

Findings of this trial will determine if delivering a group school-based intervention by school staff for adolescents at risk of anxiety and depression is effective and cost-effective.

Conditions

Depression in Adolescence; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Super Skills for Life program

A manualized psychosocial program for preventing anxiety and depression and for promoting healthy lifestyles (called "Super Skills for Life; SSL"). SSL focuses on: (1) teaching about healthy lifestyles; (2) building emotional resilience through stress management; (3) encouraging peer learning and building peer networks; and (4) promoting self-confidence and social skills. These key elements are organized over 8 weekly sessions in a group format (45-60 minutes per session).

Group Type: EXPERIMENTAL

Super Skills for Life program

Intervention Type: BEHAVIORAL

Study-Skills program will be implemented in a group format (45-60 minutes per session) in 8 weekly sessions, covering: note-taking skills, effective study strategies, and time management.

Study-Skills program

Study-Skills program will be implemented in a group format (45-60 minutes per session) in 8 weekly sessions, covering: note-taking skills, effective study strategies, and time management.

Group Type: EXPERIMENTAL

Study-Skills program

Intervention Type: BEHAVIORAL

Study-Skills program will be used as a comparator intervention, which will be implemented in a group format (45-60 minutes per session) in 8 weekly sessions, covering: note-taking skills, effective study strategies, and time management.

Interventions

Super Skills for Life program

Study-Skills program will be implemented in a group format (45-60 minutes per session) in 8 weekly sessions, covering: note-taking skills, effective study strategies, and time management.

Intervention Type: BEHAVIORAL

Study-Skills program

Study-Skills program will be used as a comparator intervention, which will be implemented in a group format (45-60 minutes per session) in 8 weekly sessions, covering: note-taking skills, effective study strategies, and time management.

Intervention Type: BEHAVIORAL

Other Intervention Names

Study-Skills program

Eligibility Criteria

Inclusion Criteria

1. Adolescent (aged 12-14) who are in the first two years (Form 1 and Form 2, equivalent to year 7 and 8 in the United Kingdom school system, respectively) in lower secondary schools.

2. Adolescents score moderate to severe levels of anxiety and/or depression on the Depression Anxiety and Stress Scale-21 (DASS-21) based on the original cut-off norms (DASS-21 Anxiety scale ≥ 10 and/or DASS-21 Depression scale ≥ 14).

3. Adolescent's parent/carer provides written consent.

Exclusion Criteria

(1) Being diagnosed with neurodevelopmental disorders. (2) Being diagnosed with intellectual disability.

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• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiti Malaysia Sabah

OTHER

Sponsor Role: collaborator

University Malaysia Sarawak

OTHER

Sponsor Role: collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role: collaborator

Sunway University

OTHER

Sponsor Role: collaborator

Saglik Bilimleri Universitesi

OTHER

Sponsor Role: collaborator

University of Exeter

OTHER

Sponsor Role: collaborator

University of Malaya

OTHER

Sponsor Role: collaborator

National University of Malaysia

OTHER

Sponsor Role: collaborator

University of Roehampton

OTHER

Sponsor Role: lead

Responsible Party

Cecilia Essau

Professor of Developmental Psychopathology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fakulti Psikologi Dan Pendidikan

Kota Kinabalu, Sabah, Malaysia

Site Status: RECRUITING

Universiti Malaysia Sarawak

Kuching, Sarawak, Malaysia

Site Status: RECRUITING

Universiti Kebangsaan Malaysia

Bangi, Selangor, Malaysia

Site Status: RECRUITING

Universiti Malaya

Kuala Lumpur, Selangor, Malaysia

Site Status: RECRUITING

Sunway University

Subang Jaya, Selangor, Malaysia

Site Status: RECRUITING

Countries

Malaysia

Central Contacts

Cecilia A Essau, PhD

Role: CONTACT

c.essau@roehampton.ac.uk

+442083923647

Facility Contacts

Suwaibah Zakaria, PhD

Role: primary

suwaibah@ums.edu.my

+60138837732

Chuong Hock Ting, MD

Role: primary

chting@unimas.my

+60163315598

Suzaily Wahab, MD

Role: primary

suzaily@hctm.ukm.edu.my

+60193117251

Nik Daliana Nik Farid, PhD

Role: primary

daliana@um.edu.my

+60122779250

Alvin Lai Oon Ng, PhD

Role: primary

alvinn@sunway.edu.my

+60192808540

Other Identifiers

PSYC 23-483

Identifier Type: -

Identifier Source: org_study_id