NCT Number: NCT07138664
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.
Interested in participating?
Request Info12 year–14 year
All sexes
Interventional
Not applicable
Fakulti Psikologi Dan Pendidikan, Kota Kinabalu, Sabah, Malaysia
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
(1) Being diagnosed with neurodevelopmental disorders. (2) Being diagnosed with intellectual disability.
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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
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.
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").
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).
Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
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.
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 6 and 12 months after the intervention.
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 12 months after the intervention.
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.
Executive function will also be measured using milliseconds experimental task to measure attention control and working memory.
Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
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]).
Time frame: Pre-intervention, as well as at 8 weeks, and at 6 and 12 months after the intervention.
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".
Time frame: Pre-intervention, as well as at 8 weeks, and at 12 months after the intervention.
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 6 and 12 months after the intervention.
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 12 months after the intervention.
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.
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 and at 12 months after the intervention.
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.
Time frame: Pre-intervention and at 12 months after the intervention.
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.
Time frame: Pre-intervention and at 12 months after the intervention.
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.
Contact information is provided by the study sponsor or research team.
University of Roehampton
Other
Acronym: MyHeRo
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