Depression in AdolescenceMyHeRoNCT07138664
Promoting Mental Health Among At-risk Adolescents in Malaysia
A study testing Super Skills for Life program and Study-Skills program in people with Depression in Adolescence and Anxiety, run by University of Roehampton at 5 sites in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Depression in Adolescence, Anxiety
- What is being tested?
- Super Skills for Life program and Study-Skills program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 428 participants
- Where
- 5 sitesMalaysia
- Study dates
- Aug 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Being diagnosed with neurodevelopmental disorders. (2) Being diagnosed with intellectual disability.
- -
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Malaysia5 sites, 5 recruiting
- Recruiting
Universiti Kebangsaan Malaysia
Bangi, Selangor, 43600
Suzaily Wahab, MD, +60193117251, suzaily@hctm.ukm.edu.my
Suzaily Wahab, MD
- Recruiting
Fakulti Psikologi Dan Pendidikan
Kota Kinabalu, Sabah, 88400
Suwaibah Zakaria, PhD, +60138837732, suwaibah@ums.edu.my
Suwaibah Zakaria, PhD
- Recruiting
Universiti Malaya
Kuala Lumpur, Selangor, 50603
Nik Daliana Nik Farid, PhD, +60122779250, daliana@um.edu.my
Nik Daliana Nik Farid, PhD
- Recruiting
Universiti Malaysia Sarawak
Kuching, Sarawak, 94300
Chuong Hock Ting, MD, +60163315598, chting@unimas.my
Chuong Hock Ting, MD
- Recruiting
Sunway University
Subang Jaya, Selangor, 47500
Alvin Lai Oon Ng, PhD, +60192808540, alvinn@sunway.edu.my
Alvin Ng Oon Ng, PhD
About this study
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.
Read the 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
- Being tested
- Super Skills for Life program, Study-Skills program
- Keywords
- Anxiety, Depression, Adolescents, School-based intervention
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Super Skills for Life programBehavioural
Also called 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.
Study-Skills programBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Study-Skills program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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").
Measured: 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).
Measured: 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.
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.
Measured: 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.
Measured: 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).
Measured: 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").
Measured: 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.
Measured: 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]).
Measured: 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".
Measured: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depression in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 428 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Roehampton
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Malaysia Sabah, University Malaysia Sarawak, Universidad Complutense de Madrid, Sunway University, Saglik Bilimleri Universitesi, University of Exeter, University of Malaya, National University of Malaysia
- Responsible party
- Principal investigator, Cecilia Essau, University of Roehampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138664
- Sponsor's protocol ID
- PSYC 23-483
- Acronym
- MyHeRo
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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;27(1):160. doi: 10.1186/s13063-025-09368-7.
PubMed 41593785
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Mental Health Among At-risk Adolescents in Malaysia
- ClinicalTrials.gov ID
- NCT07138664
- Acronym / sponsor ID
- MyHeRo / PSYC 23-483
- Conditions
- Depression in Adolescence, Anxiety
- Keywords
- Anxiety, Depression, Adolescents, School-based intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 428 participants (estimated)
- Lead sponsor
- University of RoehamptonUniversity, hospital or other
- Collaborators
- Universiti Malaysia Sabah, University Malaysia Sarawak, Universidad Complutense de Madrid, Sunway University, Saglik Bilimleri Universitesi, University of Exeter, University of Malaya, National University of Malaysia
- Study start
- Aug 2025 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Super Skills for Life program | Experimental | Behavioral: Super Skills for Life programA 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). |
| Study-Skills program | Experimental | Behavioral: Study-Skills programStudy-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. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Being diagnosed with neurodevelopmental disorders. (2) Being diagnosed with intellectual disability.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Super Skills for Life programAlso: Study-Skills programStudy-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. | Behavioural | Super Skills for Life program |
| Study-Skills programStudy-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. | Behavioural | Study-Skills program |
Primary outcome
Change in adolescent's anxiety and depression
Time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.
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").
Change in adolescent's wellbeing
Time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.
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).
7 secondary outcomes
Change in adolescent's emotion regulation strategies.
Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in adolescent's suicidal behaviour.
Time frame: 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.
Time frame: 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.
Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in adolescent's executive function.
Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in the severity of anxiety and depressive symptoms.
Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
Change in adolescent's lifestyle habits.
Time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Derived from this study: PubMed 41593785Essau 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;27(1):160. doi: 10.1186/s13063-025-09368-7.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Super Skills for Life program and Study-Skills program in people with Depression in Adolescence and Anxiety, run by University of Roehampton at 5 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cecilia A Essau, PhD (+442083923647, c.essau@roehampton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adolescent's anxiety and depression (time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07138664, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.