Promoting Mental Health Among At-risk Adolescents in Malaysia

NCT07138664 | Recruiting DMC

• 1 other identifier: PSYC 23-483
• Study Type: interventional
• Target: 428
• Locations: 1 country
• Sites: 5

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.

Conditions

Depression in Adolescence; Anxiety

Keywords

Anxiety; Depression; Adolescents; School-based intervention

Outcome Measures

Primary Outcomes (2)

• Change in adolescent's anxiety and depression

  The Revised Children's Anxiety and Depression Scale will be used to identify symptoms of anxiety and depressive disorder in adolescents. It contains 6 items for measuring anxiety and 5 items for depression symptoms, which are to be rated on a 4-point Likert Scale from 0 ("never") to 3 ("always").

  Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.

• Change in adolescent's wellbeing

  Short Warwick-Edinburgh Mental Well-being Scale will be used to measure mental wellbeing. All its 7 items are worded positively and cover feeling and functioning aspects of mental wellbeing. The items can be rated on a 5-point scale from 1 (none of the time) to 5 (all of the time).

  Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.

Secondary Outcomes (7)

• Change in adolescent's emotion regulation strategies.

  Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.

• Change in adolescent's suicidal behaviour.

  Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.

• Change in adolescent's ability to carry out essential social behaviors.

  Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.

• Change in adolescent's working memory and inhibition.

  Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.

• Change in adolescent's executive function.

  Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.

Other Outcomes (7)

• Changes in adolescent's self-esteem.

  Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.

• Changes in adolescent's academic stress.

  Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.

• Changes in adolescents' feelings about their school and teachers.

  Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.

Study Arms (2)

Super Skills for Life program

EXPERIMENTAL

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).

Behavioral: Super Skills for Life program

Study-Skills program

EXPERIMENTAL

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.

Behavioral: Study-Skills program

Interventions

Super Skills for Life program 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.

Also known as: Study-Skills program

Super Skills for Life program

Study-Skills program 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.

Study-Skills program

Eligibility Criteria

• Age: 12 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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).
• Adolescent's parent/carer provides written consent.

You may not qualify if:

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

Sponsors & Collaborators

• University of Roehampton: lead
• Universiti Malaysia Sabah: collaborator
• University Malaysia Sarawak: collaborator
• Universidad Complutense de Madrid: collaborator
• Sunway University: collaborator
• Saglik Bilimleri Universitesi: collaborator
• University of Exeter: collaborator
• University of Malaya: collaborator
• National University of Malaysia: collaborator

Study Sites (5)

Fakulti Psikologi Dan Pendidikan

Kota Kinabalu, Sabah, 88400, Malaysia

RECRUITING

Universiti Malaysia Sarawak

Kuching, Sarawak, 94300, Malaysia

RECRUITING

Universiti Kebangsaan Malaysia

Bangi, Selangor, 43600, Malaysia

RECRUITING

Universiti Malaya

Kuala Lumpur, Selangor, 50603, Malaysia

RECRUITING

Sunway University

Subang Jaya, Selangor, 47500, Malaysia

RECRUITING

Related Publications (1)

• Essau CA, Zakaria S, Ting CH, Lee JAC, de la Torre-Luque A, Ng ALO, Majid HA, Dodd H, Nik Farid ND, Muhammad NA, Wahab S. Promoting mental health among at-risk adolescents in Malaysia (MyHeRo): study protocol for a cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of a school-based intervention compared with study skills condition for adolescents identified as at risk for anxiety and depression. Trials. 2026 Jan 28. doi: 10.1186/s13063-025-09368-7. Online ahead of print.

  PMID: 41593785 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Cecilia A Essau, PhD

CONTACT

+442083923647; c.essau@roehampton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Developmental Psychopathology

Study Record Dates

• First Submitted: August 16, 2025
• First Posted: August 24, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

MY (5)