Promoting Mental Health Among At-risk Adolescents in Malaysia (MyHeRo)

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Depression in Adolescence
• Intervention / Treatment: Behavioral: Super Skills for Life program; Behavioral: Study-Skills program

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.

• Study Type: Interventional
• Enrollment (Estimated): 428
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cecilia A Essau, PhD; Phone Number: +442083923647; Email: c.essau@roehampton.ac.uk

Study Locations

• Malaysia
  • Sabah
    • Kota Kinabalu, Sabah, Malaysia, 88400
      • Recruiting
      • Fakulti Psikologi Dan Pendidikan
      • Contact: Suwaibah Zakaria, PhD; Phone Number: +60138837732; Email: suwaibah@ums.edu.my
      • Principal Investigator: Suwaibah Zakaria, PhD
  • Sarawak
    • Kuching, Sarawak, Malaysia, 94300
      • Recruiting
      • Universiti Malaysia Sarawak
      • Contact: Chuong Hock Ting, MD; Phone Number: +60163315598; Email: chting@unimas.my
      • Principal Investigator: Chuong Hock Ting, MD
  • Selangor
    • Bangi, Selangor, Malaysia, 43600
      • Recruiting
      • Universiti Kebangsaan Malaysia
      • Contact: Suzaily Wahab, MD; Phone Number: +60193117251; Email: suzaily@hctm.ukm.edu.my
      • Principal Investigator: Suzaily Wahab, MD
    • Kuala Lumpur, Selangor, Malaysia, 50603
      • Recruiting
      • Universiti Malaya
      • Contact: Nik Daliana Nik Farid, PhD; Phone Number: +60122779250; Email: daliana@um.edu.my
      • Principal Investigator: Nik Daliana Nik Farid, PhD
    • Subang Jaya, Selangor, Malaysia, 47500
      • Recruiting
      • Sunway University
      • Contact: Alvin Lai Oon Ng, PhD; Phone Number: +60192808540; Email: alvinn@sunway.edu.my
      • Principal Investigator: Alvin Ng Oon Ng, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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).	Behavioral: 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.; Other Names: Study-Skills program
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in adolescent's emotion regulation strategies.	Cognitive Emotion Regulation Questionnaire will be used to measure emotion regulation strategies. It consists of 18 items, which can be rated on a 5-point Likert scale ranging from 1 (almost never) to 5 (almost always) in response to how often each of the 9 emotion regulation strategies are used: refocus on planning, putting into perspective, acceptance, positive refocusing, positive reappraisal, self-blame, other blame, rumination, and catastrophizing.	Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in adolescent's suicidal behaviour.	The Paykel Suicide Scale (PSS) will be used to measure suicidal behaviour. The scale consists of 5 items, with a dichotomous response system, i.e., Yes or No.	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.	The Social Skills Questionnaire will be used to measure essential social behaviors that contribute to success in social interactions. Its 13 items can be are rated from 0 (Not true), 1 (Sometimes true) to 2 (Mostly true).	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.	Teenage Executive Functioning Inventory will be used to measure working memory and inhibition. It contains 20 items which can be rated on a 5-point Likert scale ranging from 1 ("definitely not true") to 5 ("definitely true").	Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in adolescent's executive function.	Executive function will also be measured using milliseconds experimental task to measure attention control and working memory.	Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in the severity of anxiety and depressive symptoms.	Depression Anxiety and Stress Scale-21 (DASS-21) will be used to measure adolescent's severity of anxiety and depressive symptoms. The DASS-21 consists of 21 items which are divided equally across the anxiety, depressive and stress subscales, which can be rated on a 4-point Likert Scale (range from 0 [did not apply to me at all] to 3 [applied to me very much or most of the time]).	Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in adolescent's lifestyle habits.	Lifestyle and Habits Questionnaire (LHQ-B) will be used to measure adolescent's lifestyle habits (physical activity and exercise, sleep and sleep hygiene, and type of food consumption). LHQ-B contains 16 items which ask adolescents about how frequently they perform each behaviour in the past 30 days on a 5-point scale from "never" to "always".	Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in adolescent's self-esteem.	Rosenberg Self-Esteem Scale (RSES) will be used to measure global self-worth. Three out of 10 items will be used in the present study, which can be rated on a 4-point Likert scale format ranging from 4 (strongly agree) to 1 (strongly disagree).	Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Changes in adolescent's academic stress.	The Educational Stress Scale for Adolescents will be used to measure adolescent's perceived academic stress. Its 16 statements can be rated on a five-point Likert scale ranging from "strongly disagree" to "strongly agree".	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.	School Connectedness Scale will be used to adolescents' feelings about their school and teachers. Its 5 items can be rated on a five-point response format ranging from 0 (Strongly disagree) to 4 (Strongly agree).	Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Measure facilitators' attitudes toward the adoption of evidence-based practices.	Evidence-based Practice Attitude Scale for Teachers will be used to measure facilitators' attitudes toward the adoption of evidence-based practices (EBPs). It contains 13 items can be rated on a 5-Likert scale, ranging from "Not at All" (0) to "To a Very Great Extent" (4).	Pre-intervention.
Changes in adolescent's health-related quality of life.	The Child Health Utility will be used to measure health-related quality of life. It consists of 9 domains (worry, sadness, pain, tiredness, annoyance, school, sleep, daily routine and activities), and within each dimension, there are five different levels with increasing levels of severity.	Pre-intervention and at 12 months after the intervention.
Changes in parent's quality of life, cost-utility of healthcare interventions, and computation of quality-adjusted life years.	Self-reported European Quality of Life Five Dimension will be used to measure parent's quality of life, cost-utility of healthcare interventions, and computation of quality-adjusted life years.	Pre-intervention and at 12 months after the intervention.
Changes in cost incurred by adolescents across healthcare, social care and community settings.	Client Service Receipt Inventory to collect information from the parents related to cost-related data, by estimating associated costs across healthcare, social care and community settings. Parent will further be asked about adolescent's frequency and cost of using mental and physical health and social services.	Pre-intervention and at 12 months after the intervention.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: August 16, 2025
• First Submitted That Met QC Criteria: August 16, 2025
• First Posted (Actual): August 24, 2025

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 16, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Adolescents; Depression; Anxiety; School-based intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: PSYC 23-483

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will not be shared on an individual basis. Anonymised study data will be archived at the end of the study through the University of Roehampton data repository.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No