AnxietyREAL™NCT06849154
The Effectiveness of the REAL™, a School-based, Virtual Reality-integrated Social Emotional Learning Intervention to Promote Mental Health for Early Malaysian Adolescents
A study testing REAL™ SEL Intervention Group in people with Anxiety and Depression Disorders, run by National University of Malaysia at 1 site in Malaysia.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression Disorders, Emotional Regulation
- What is being tested?
- REAL™ SEL Intervention Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteMalaysia
- Study dates
- 3 May 2023to 11 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)
Cheras, Kuala Lumpur, 56000
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Anxiety, Depression Disorders, Emotional Regulation
- Being tested
- REAL™ SEL Intervention Group
- Keywords
- Adolescent mental health, Emotion regulation, School-based intervention, Virtual reality
- Medical subject headings
- Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REAL™ SEL Intervention GroupBehavioural
A structured intervention using virtual reality (VR) components to improve emotional regulation in early adolescents
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: REAL™ SEL Intervention Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)
Secondary outcomes (1)
Depression and Anxiety Scores
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.
Measured: Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2025
- Study start3 May 2023
- Primary completion24 Nov 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nik Ruzyanei Nik Jaafar Prof. Dr., Master of Medicine Psychiatry, Study director, Department of Psychiatry, Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06849154
- Sponsor's protocol ID
- UKM PPI/111/8/JEP-2023-111
- Other IDs
- TRGS/1/2020/UKM/01/4/4
- Acronym
- REAL™
- Status last verified
- Feb 2025
- First submitted
- 16 Feb 2025
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to ethical considerations and privacy regulations regarding research involving minors.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06849154
- Acronym / sponsor ID
- REAL™ / UKM PPI/111/8/JEP-2023-111
- Conditions
- Anxiety, Depression Disorders, Emotional Regulation
- Keywords
- Adolescent mental health, Emotion regulation, School-based intervention, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 24 Nov 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: REAL™ SEL Intervention GroupParticipants in this group will receive the REAL™ Module, a school-based social-emotional learning (SEL) intervention with virtual reality (VR). |
Who may qualify
- Ages
- 13 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REAL™ SEL Intervention GroupA structured intervention using virtual reality (VR) components to improve emotional regulation in early adolescents | Behavioural | REAL™ SEL Intervention Group |
Primary outcome
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.
1 secondary outcome
Depression and Anxiety Scores
Time frame: Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to ethical considerations and privacy regulations regarding research involving minors.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nik Ruzyanei Nik Jaafar Prof. Dr., Master of Medicine Psychiatry study director
Department of Psychiatry, Faculty of Medicine, Universiti Kebangsaan Malaysia (UKM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REAL™ SEL Intervention Group in people with Anxiety and Depression Disorders, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Emotional Regulation Score (time frame: Baseline (T0), Immediate Post-Test (T1), 3-Month Follow-Up (T2), 6-Month Follow-Up (T3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.