The Effectiveness of the REAL™, a School-based, Virtual Reality-integrated Social Emotional Learning Intervention to Promote Mental Health for Early Malaysian Adolescents

NCT ID: NCT06849154

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2023-12-11

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety Depression Disorders Emotional Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This study uses a parallel assignment design, where participants are randomly assigned to either the intervention group, receiving the REAL™ module, or the control group, following the standard school curriculum. The intervention group undergoes structured sessions incorporating social-emotional learning (SEL) strategies and virtual reality (VR) components, while the control group receives no additional intervention. Outcomes are measured at four time points (baseline, immediate post-test, 3-month follow-up, and 6-month follow-up) to assess the effectiveness of the intervention.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
This study used a single-blind design where participants and the outcomes assessor were initially masked to group assignments. Participants were not informed of their assignment at the beginning of the study to reduce expectancy effects. However, due to the nature of the intervention, participants eventually became aware of their group allocation. The outcomes assessor remained blinded throughout data collection and analysis, with all data coded to maintain objectivity and minimize bias.

Study Groups

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Standard School Curriculum (Control Group)

Participants in this group will continue with their usual school activities and will not receive the REAL™ Module intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

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).

Group Type EXPERIMENTAL

REAL™ SEL Intervention Group

Intervention Type BEHAVIORAL

A structured intervention using virtual reality (VR) components to improve emotional regulation in early adolescents

Interventions

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REAL™ SEL Intervention Group

A structured intervention using virtual reality (VR) components to improve emotional regulation in early adolescents

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. Malaysian citizens who are Form 1 and Form 2 students (ages 13-14).
2. Students who provide assent and obtain parental consent to participate.
3. Students enrolled in daily government secondary schools in Malaysia.
4. Students who can attend all four intervention sessions consecutively.

Exclusion Criteria

1. Students from boarding-based schools, religious-based schools, or private schools.
2. Students with physical impairments that may hinder participation.
3. Students with intellectual deficits that may affect comprehension of the intervention.
4. Students diagnosed with severe mental illness.
5. Students currently receiving professional psychological treatment.
Minimum Eligible Age

13 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University of Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nik Ruzyanei Nik Jaafar Prof. Dr., Master of Medicine Psychiatry

Role: STUDY_DIRECTOR

Department of Psychiatry, Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)

Locations

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Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)

Cheras, Kuala Lumpur, Malaysia

Site Status

Countries

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Malaysia

Other Identifiers

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TRGS/1/2020/UKM/01/4/4

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UKM PPI/111/8/JEP-2023-111

Identifier Type: -

Identifier Source: org_study_id

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