- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06849154
The Effectiveness of the REAL™, a School-based, Virtual Reality-integrated Social Emotional Learning Intervention to Promote Mental Health for Early Malaysian Adolescents (REAL™)
The REAL™ (Read Emotions and Learn to Regulate) module is a school-based social-emotional learning (SEL) intervention designed for early adolescents in Malaysia. This study evaluates the effectiveness of the REAL™ intervention in improving emotional regulation skills and reducing depression and anxiety symptoms among secondary school students.
A randomized controlled trial (RCT) was conducted from February to November 2023, involving 226 students aged 13-14 years from four secondary schools in Selangor, Malaysia. The intervention integrates virtual reality (VR) components to enhance engagement and ensure that SEL skills are relatable within the students' sociocultural context.
Participants were assessed at four time points (baseline, immediate post-test, three-month follow-up, and six-month follow-up) using validated psychological measures, including the Difficulties in Emotion Regulation Scale (DERS), Beck Depression Inventory (BDI), and Beck Anxiety Inventory (BAI). The results showed that students in the intervention group demonstrated significant improvements in emotional regulation and reductions in depression and anxiety scores compared to the control group, with sustained benefits over time.
This study highlights the feasibility of implementing SEL programs in Malaysian schools and supports the integration of culturally adapted, VR-enhanced interventions to promote adolescent mental health.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The REAL™ (Read Emotions and Learn to Regulate) module was developed as a school-based social-emotional learning (SEL) intervention designed to help early adolescents in Malaysia enhance their emotional regulation skills and reduce symptoms associated with depression and anxiety. Adolescence is a critical stage of emotional development, yet many young individuals struggle with managing their emotions effectively, which can impact their mental well-being and academic performance. While SEL programs have been widely implemented in various countries, culturally adapted interventions tailored to the Malaysian socio-cultural context remain limited. To address this gap, the REAL™ intervention integrates virtual reality (VR) components to enhance engagement and provide students with realistic, immersive experiences to practice emotion regulation strategies.
This study aims to evaluate the effectiveness of the REAL™ intervention in improving emotional regulation skills among lower secondary school students in Malaysia. A randomized controlled trial (RCT) was conducted from February to November 2023, involving 226 students aged 13-14 years from four secondary schools in Selangor, Malaysia. These schools were selected through multistage cluster sampling, and participants were randomly assigned to either the intervention group, which received the REAL™ SEL module, or the control group, which continued with the standard school curriculum.
The intervention consists of multiple sessions focusing on different aspects of SEL, including understanding emotions, identifying emotional triggers, cognitive restructuring, and applying regulation strategies in daily life. To reinforce learning, the intervention incorporates VR simulations that allow students to practice these skills in a controlled, interactive environment. This approach is designed to make SEL strategies more engaging, relatable, and effective for Malaysian adolescents.
Data collection occurs at four time points: baseline (T0), immediate post-test (T1), three-month follow-up (T2), and six-month follow-up (T3). The primary outcome measures include the Difficulties in Emotion Regulation Scale (DERS) for emotional regulation, the Beck Depression Inventory (BDI) for depressive symptoms, and the Beck Anxiety Inventory (BAI) for anxiety symptoms.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kuala Lumpur
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Cheras, Kuala Lumpur, Malaysia, 56000
- FACULTY OF MEDICINE, UNIVERSITI KEBANGSAAN MALAYSIA (UKM)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Malaysian citizens who are Form 1 and Form 2 students (ages 13-14).
- Students who provide assent and obtain parental consent to participate.
- Students enrolled in daily government secondary schools in Malaysia.
- Students who can attend all four intervention sessions consecutively.
Exclusion Criteria:
- Students from boarding-based schools, religious-based schools, or private schools.
- Students with physical impairments that may hinder participation.
- Students with intellectual deficits that may affect comprehension of the intervention.
- Students diagnosed with severe mental illness.
- Students currently receiving professional psychological treatment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard School Curriculum (Control Group)
Participants in this group will continue with their usual school activities and will not receive the REAL™ Module intervention.
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Experimental: REAL™ SEL Intervention Group
Participants in this group will receive the REAL™ Module, a school-based social-emotional learning (SEL) intervention with virtual reality (VR).
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A structured intervention using virtual reality (VR) components to improve emotional regulation in early adolescents
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional Regulation Score
Time Frame: Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)
|
: Measured using the Difficulties in Emotion Regulation Scale (DERS).
Higher scores indicate greater difficulties in emotional regulation.
A reduction in scores post-intervention suggests improved emotional regulation.
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Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression and Anxiety Scores
Time Frame: Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)
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Measured using the Beck Depression Inventory (BDI) for depression and Beck Anxiety Inventory (BAI) for anxiety.
Higher scores indicate greater depressive and anxiety symptoms.
A reduction in scores post-intervention suggests improvement in mental health.
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Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Nik Ruzyanei Nik Jaafar Prof. Dr., Master of Medicine Psychiatry, Department of Psychiatry, Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UKM PPI/111/8/JEP-2023-111
- TRGS/1/2020/UKM/01/4/4 (Other Grant/Funding Number: Ministry of Education Malaysia)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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