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
Official title: The Effectiveness of the REAL™, a School-based, Virtual Reality-integrated Social Emotional Learning Intervention to Promote Mental Health for Early Malaysian Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression Disorders
Emotional Regulation
Keywords: Adolescent mental health
Emotion regulation
School-based intervention
Virtual reality
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2025-02-27
Enrollment: 226
Sex: ALL
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Emotional Regulation Score
timeFrame: Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)
Secondary outcomes:
measure: Depression and Anxiety Scores
timeFrame: Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)
state: Kuala Lumpur
Study officials:
affiliation: Department of Psychiatry, Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)
name: Nik Ruzyanei Nik Jaafar Prof. Dr., Master of Medicine Psychiatry
role: STUDY_DIRECTOR
References: