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

NCT06849154 | Completed

• 2 other identifiers: UKM PPI/111/8/JEP-2023-111TRGS/1/2020/UKM/01/4/4
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depression Disorders; Emotional Regulation

Keywords

Adolescent mental health; Emotion regulation; School-based intervention; Virtual reality

Outcome Measures

Primary Outcomes (1)

• Emotional Regulation Score

  : 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.

  Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)

Secondary Outcomes (1)

• Depression and Anxiety Scores

  Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)

Study Arms (2)

Standard School Curriculum (Control Group)

NO INTERVENTION

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

REAL™ SEL Intervention Group

EXPERIMENTAL

Participants in this group will receive the REAL™ Module, a school-based social-emotional learning (SEL) intervention with virtual reality (VR).

Behavioral: REAL™ SEL Intervention Group

Interventions

REAL™ SEL Intervention Group BEHAVIORAL

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

REAL™ SEL Intervention Group

Eligibility Criteria

• Age: 13 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Conditions

Anxiety Disorders; Emotional Regulation

Condition Hierarchy (Ancestors)

Mental Disorders; Self-Control; Social Behavior; Behavior

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 16, 2025
• First Posted: February 27, 2025
• Study Start: May 3, 2023
• Primary Completion: November 24, 2023
• Study Completion: December 11, 2023
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)