Promoting Mental Health Among At-risk Adolescents in Malaysia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-14
SponsorUniversity of Roehampton
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Super Skills for Life program
BehavioralStudy-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
BehavioralStudy-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.
Treatment groups
428 Participants
are divided into 2 treatment groupsGroup A: Super Skills for Life programExperimental treatment 1 intervention
Group B: Study-Skills programExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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").
Time frame
Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.2
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).
Time frame
Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.Secondary outcomes
1
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.
Time frame
Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.2
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.
Time frame
Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.3
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).
Time frame
Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.4
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").
Time frame
Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.Other outcomes
1
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).
Time frame
Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.2
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".
Time frame
Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.3
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).
Time frame
Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.4
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).
Time frame
Pre-intervention.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Roehampton
Lead sponsor
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
Source ClinicalTrials.gov