Autism Spectrum Disorder High-FunctioningNCT07678333
Effectiveness of a Virtual Reality Social Skills Intervention in Autism
A study testing MyRakan Autism in people with Autism Spectrum Disorder High-Functioning and Young Adults, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
The goal of this clinical trial is to evaluate whether the MyRAKAN Autism module, which integrates video modelling and spherical video-based virtual reality (SVVR), can improve social communication skills in autistic young adults. Read more about this study
- Who is it for?
- Ages 18 to 24 years
- Conditions the study is for
- Autism Spectrum Disorder High-Functioning, Young Adults
- What is being tested?
- MyRakan Autism
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Jun 2023to 10 Jan 2025
- 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 18 to 24 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) diagnosed with Mild Autism Spectrum Disorder (Level 1) by a mental health professional or developmental pediatrician; 2) aged between 18 to 24; 3) capable of conversing in English or Malay.
Who cannot join
- 1) no official diagnosis by a mental health professional or developmental pediatrician
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of an Integrated Video Modelling and Spherical Video-Based Virtual Reality Intervention for Social Communication in Autistic Young Adults: A Randomized Controlled Trial
The goal of this clinical trial is to evaluate whether the MyRAKAN Autism module, which integrates video modelling and spherical video-based virtual reality (SVVR), can improve social communication skills in autistic young adults.
The main questions it aims to answer are:
Read more
Does the MyRAKAN Autism module improve social responsiveness and social communication skills in autistic young adults? Does the MyRAKAN Autism module improve autism-related characteristics, anxiety, and quality of life?
Researchers will compare participants who receive the MyRAKAN Autism intervention immediately with participants in a delayed-treatment control group to determine whether the intervention leads to greater improvements in these outcomes.
Participants will:
Complete baseline assessments of autism characteristics, social communication, anxiety, and quality of life.
Be randomly assigned to either the immediate treatment group or the delayed-treatment control group.
Attend eight intervention sessions over five weeks, consisting of video modelling and spherical video-based virtual reality (SVVR) social skills practice (treatment group), or wait six weeks before receiving the same intervention (control group).
Complete post-intervention assessments and a questionnaire on any side effects.
Read the detailed description
Detailed Description
Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by persistent difficulties in social communication and interaction, alongside restricted and repetitive patterns of behaviour. Although conventional social skills training programs have demonstrated benefits, many require substantial therapist involvement and opportunities for repeated practice remain limited. Advances in video-based instruction and immersive technologies provide new opportunities to deliver standardized, engaging, and accessible social skills interventions.
The MyRAKAN Autism module was developed to improve social communication skills among autistic young adults by integrating video modelling (VM) and spherical video-based virtual reality (SVVR). The intervention is grounded in social learning theory and incorporates cognitive and behavioural techniques, including psychoeducation, modelling, first-person and third-person perspectives, and behavioural rehearsal. Participants first learn targeted social communication skills through structured video modelling sessions before practising these skills in realistic 360-degree virtual social environments using a virtual reality headset.
This study is a randomized controlled trial designed to evaluate the efficacy of the MyRAKAN Autism module in autistic young adults aged 18 to 24 years. Eligible participants are randomly assigned to either an immediate treatment group or a delayed-treatment control group. The treatment group receives the intervention immediately, whereas the control group undergoes a six-week waiting period before receiving the same intervention.
The intervention consists of eight face-to-face sessions delivered over five weeks, including five sessions of video modelling and three sessions of virtual reality-based behavioural rehearsal. The module covers foundational social communication skills such as deep breathing, smiling, maintaining appropriate physical boundaries, eye contact, voice volume, initiating conversations, interpreting others' responses, handling rejection, maintaining two-way conversations, and ending conversations appropriately.
Participants complete assessments at baseline and post-intervention using validated outcome measures, including the Social Responsiveness Scale-2 (SRS-2), Autism Spectrum Quotient (AQ), Beck Anxiety Inventory (BAI), and the Quality of Life Questionnaire for High-Functioning Autism Spectrum Disorder (QoLY). The primary outcome is improvement in social responsiveness and social communication. Secondary outcomes include changes in autism-related characteristics, anxiety symptoms, and quality of life. Safety and tolerability of the intervention are also evaluated through a post-intervention side effects questionnaire.
- Being tested
- MyRakan Autism
- Keywords
- Autism Level 1, Social Communication, Social Skills Training, Video Modelling, Spherical Video-Based Virtual Reality (SVVR)
- Medical subject headings
- Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyRakan AutismBehavioural
Participants receive the MyRAKAN Autism social communication training module over five weeks, comprising eight face-to-face sessions (five video modelling sessions and three spherical video-based virtual reality [SVVR] practice sessions). The intervention integrates cognitive and behavioural techniques, including psychoeducation, modelling, first-person and third-person perspectives, deep breathing, and behavioural rehearsal.
The module teaches and allows participants to practise key social communication skills, including smiling, maintaining appropriate physical boundaries, eye contact, voice volume, initiating conversations, interpreting others' responses, handling rejection, maintaining two-way conversations, and appropriately ending conversations. Video modelling is delivered on a desktop computer, while behavioural rehearsal is conducted using a Meta Quest 2 virtual reality headset with immersive 360-degree social scenarios. Each session lasts approximately one hour and is delive
| Study group | Role | What they receive |
|---|---|---|
| MyRakan Autism Module Intervention | Experimental | The MyRakan Autism group went through 5 physical sessions of watching videos (VM) and 3 physical sessions of skill rehearsals using SVVR. They watched videos on a PC Desktop Intel(R) Core i7 Dell HP, Full HD 1920 x 1080 screen. They experienced the SVVR by wearing Meta Quest 2 VR headset. Each participant came once a week, one hour each session, for 5 consecutive weeks to complete all the sessions. Receives: Behavioral: MyRakan Autism |
| Waitlist Control Group | Active comparator | The control group went through pre-test, waited for treatment for six weeks and administered the post-test at the seventh week. At the eighth week, they underwent the training in the same procedure to those in the TX group for five weeks. Receives: Behavioral: MyRakan Autism |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Social Responsiveness
Social responsiveness refers to an individual's ability to perceive, interpret, and respond appropriately to social cues during interpersonal interactions. It encompasses the reciprocal aspects of social behaviour required for successful communication and relationship building, including social awareness, social cognition, social communication, social motivation, and the regulation of restricted and repetitive behaviours that affect social functioning.
In autism research, social responsiveness is commonly measured using the Social Responsiveness Scale, Second Edition (SRS-2), with higher scores indicating greater impairment in reciprocal social behaviour.
Measured: Baseline and immediately after completion of the 5-week intervention (Week 5).
Changes in Social Communication Skills
Social communication skills refer to the ability to effectively use verbal and non-verbal communication to initiate, maintain, and appropriately conclude social interactions. These skills involve understanding and responding to social cues, interpreting others' thoughts and emotions, engaging in reciprocal conversations, and adapting communication according to different social contexts and interpersonal relationships.
In this study, social communication skills encompass a range of practical behaviours taught through the MyRAKAN Autism module, including appropriate eye contact, smiling, maintaining physical boundaries, regulating voice volume, initiating conversations, interpreting others' responses, handling rejection, maintaining two-way conversations, and ending conversations appropriately. Social communication skills are primarily assessed using the Social Communication subscale of the Social Responsiveness Scale, Second Edition (SRS-2).
Measured: Baseline and immediately after completion of the 5-week intervention (Week 5).
Secondary outcomes (2)
Changes in Anxiety
Levels of anxiety measured by Beck Anxiety Inventory
Measured: Baseline and immediately after completion of the 5-week intervention (Week 5).
Changes in Quality of Life
In this study, quality of life refers to the overall well-being of autistic young adults across multiple domains of daily functioning, beyond improvements in social communication alone. It reflects participants' perceptions of how autism affects their psychological, social, family, environmental, and spiritual well-being.
Quality of life is measured using the Quality of Life Questionnaire for High-Functioning Autism Spectrum Disorder Youth (QoLY).
Measured: Baseline and immediately after completion of the 5-week intervention (Week 5).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Jun 2023
- Primary completion15 Sep 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum Disorder High-FunctioningStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- They were randomized into two groups: treatment (TX; n=26) and delayed treatment control (DTC; n=26) using Microsoft Excel witnessed by 4 members of the research group. The treatment group went through 5 physical sessions of watching videos (VM) and 3 physical sessions of skill rehearsals using SVVR. They watched videos on a PC Desktop Intel(R) Core i7 Dell HP, Full HD 1920 x 1080 screen. They experienced the SVVR by wearing Meta Quest 2 VR headset. Each participant came once a week, one hour each session, for 5 consecutive weeks to complete all the sessions.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678333
- Sponsor's protocol ID
- UKM PPI/111/8/JEP-2021-092
- Status last verified
- Jun 2026
- First submitted
- 25 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rieske, R. D., Babbitt, S. C., Neal, J. H. & Spencer, J. A. 2017. Informed Consent. In J. Matson (Ed.), Handbook of Treatments for Autism Spectrum Disorder. Autism and Child Psychopathology Series. Cham: Springer. https://doi.org/10.1007/978-3-319-61738-1_5
Pallant, J. 2011. SPSS Survival Manual: A Step-By-Step Guide to Data Analysis Using the SPSS Program. Berkshire: Allen & Unwin.
Grisso, T. & Appelbaum, P. S. 1998. Assessing Competence to Consent to Treatment. Oxford: Oxford University Press. (Note: the reference list in your document spells the author as "Applebaum," but the correct spelling is "Appelbaum.")
Constantino, J. N. 2012. Social Responsiveness Scale, Second Edition (SRS™-2). Torrance, CA: WPS Publication
Bruni, T. P. 2014. Test Review: Social Responsiveness Scale-Second Edition (SRS-2). Journal of Psychoeducational Assessment 32(4): 365-369. https://doi.org/10.1177/0734282913517525
American Psychiatric Association. 2000. Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.). Washington, DC: American Psychiatric Association.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of an Integrated Video Modelling and Spherical Video-Based Virtual Reality Intervention for Social Communication in Autistic Young Adults: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07678333
- Acronym / sponsor ID
- UKM PPI/111/8/JEP-2021-092
- Keywords
- Autism Level 1, Social Communication, Social Skills Training, Video Modelling, Spherical Video-Based Virtual Reality (SVVR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Collaborators
- Ministry of Higher Education, Malaysia
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 15 Sep 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 1 Jul 2026 (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 goal of this clinical trial is to evaluate whether the MyRAKAN Autism module, which integrates video modelling and spherical video-based virtual reality (SVVR), can improve social communication skills in autistic young adults.
The main questions it aims to answer are:
Does the MyRAKAN Autism module improve social responsiveness and social communication skills in autistic young adults? Does the MyRAKAN Autism module improve autism-related characteristics, anxiety, and quality of life?
Researchers will compare participants who receive the MyRAKAN Autism intervention immediately with participants in a delayed-treatment control group to determine whether the intervention leads to greater improvements in these outcomes.
Participants will:
Complete baseline assessments of autism characteristics, social communication, anxiety, and quality of life.
Be randomly assigned to either the immediate treatment group or the delayed-treatment control group.
Attend eight intervention sessions over five weeks, consisting of video modelling and spherical video-based virtual reality (SVVR) social skills practice (treatment group), or wait six weeks before receiving the same intervention (control group).
Complete post-intervention assessments and a questionnaire on any side effects.
Detailed description
Detailed Description
Autism spectrum disorder (ASD) is a neurodevelopmental condition characterized by persistent difficulties in social communication and interaction, alongside restricted and repetitive patterns of behaviour. Although conventional social skills training programs have demonstrated benefits, many require substantial therapist involvement and opportunities for repeated practice remain limited. Advances in video-based instruction and immersive technologies provide new opportunities to deliver standardized, engaging, and accessible social skills interventions.
The MyRAKAN Autism module was developed to improve social communication skills among autistic young adults by integrating video modelling (VM) and spherical video-based virtual reality (SVVR). The intervention is grounded in social learning theory and incorporates cognitive and behavioural techniques, including psychoeducation, modelling, first-person and third-person perspectives, and behavioural rehearsal. Participants first learn targeted social communication skills through structured video modelling sessions before practising these skills in realistic 360-degree virtual social environments using a virtual reality headset.
This study is a randomized controlled trial designed to evaluate the efficacy of the MyRAKAN Autism module in autistic young adults aged 18 to 24 years. Eligible participants are randomly assigned to either an immediate treatment group or a delayed-treatment control group. The treatment group receives the intervention immediately, whereas the control group undergoes a six-week waiting period before receiving the same intervention.
The intervention consists of eight face-to-face sessions delivered over five weeks, including five sessions of video modelling and three sessions of virtual reality-based behavioural rehearsal. The module covers foundational social communication skills such as deep breathing, smiling, maintaining appropriate physical boundaries, eye contact, voice volume, initiating conversations, interpreting others' responses, handling rejection, maintaining two-way conversations, and ending conversations appropriately.
Participants complete assessments at baseline and post-intervention using validated outcome measures, including the Social Responsiveness Scale-2 (SRS-2), Autism Spectrum Quotient (AQ), Beck Anxiety Inventory (BAI), and the Quality of Life Questionnaire for High-Functioning Autism Spectrum Disorder (QoLY). The primary outcome is improvement in social responsiveness and social communication. Secondary outcomes include changes in autism-related characteristics, anxiety symptoms, and quality of life. Safety and tolerability of the intervention are also evaluated through a post-intervention side effects questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- They were randomized into two groups: treatment (TX; n=26) and delayed treatment control (DTC; n=26) using Microsoft Excel witnessed by 4 members of the research group. The treatment group went through 5 physical sessions of watching videos (VM) and 3 physical sessions of skill rehearsals using SVVR. They watched videos on a PC Desktop Intel(R) Core i7 Dell HP, Full HD 1920 x 1080 screen. They experienced the SVVR by wearing Meta Quest 2 VR headset. Each participant came once a week, one hour each session, for 5 consecutive weeks to complete all the sessions.
| Arm | Type | Receives |
|---|---|---|
| MyRakan Autism Module Intervention | Experimental | Behavioral: MyRakan AutismThe MyRakan Autism group went through 5 physical sessions of watching videos (VM) and 3 physical sessions of skill rehearsals using SVVR. They watched videos on a PC Desktop Intel(R) Core i7 Dell HP, Full HD 1920 x 1080 screen. They experienced the SVVR by wearing Meta Quest 2 VR headset. Each participant came once a week, one hour each session, for 5 consecutive weeks to complete all the sessions. |
| Waitlist Control Group | Active comparator | Behavioral: MyRakan AutismThe control group went through pre-test, waited for treatment for six weeks and administered the post-test at the seventh week. At the eighth week, they underwent the training in the same procedure to those in the TX group for five weeks. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1) diagnosed with Mild Autism Spectrum Disorder (Level 1) by a mental health professional or developmental pediatrician; 2) aged between 18 to 24; 3) capable of conversing in English or Malay.
Key exclusion criteria (1 listed)
- 1) no official diagnosis by a mental health professional or developmental pediatrician
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 |
|---|---|---|
| MyRakan AutismParticipants receive the MyRAKAN Autism social communication training module over five weeks, comprising eight face-to-face sessions (five video modelling sessions and three spherical video-based virtual reality [SVVR] practice sessions). The intervention integrates cognitive and behavioural techniques, including psychoeducation, modelling, first-person and third-person perspectives, deep breathing, and behavioural rehearsal. The module teaches and allows participants to practise key social communication skills, including smiling, maintaining appropriate physical boundaries, eye contact, voice volume, initiating conversations, interpreting others' responses, handling rejection, maintaining two-way conversations, and appropriately ending conversations. Video modelling is delivered on a desktop computer, while behavioural rehearsal is conducted using a Meta Quest 2 virtual reality headset with immersive 360-degree social scenarios. Each session lasts approximately one hour and is delive | Behavioural | MyRakan Autism Module Intervention, Waitlist Control Group |
Primary outcome
Changes in Social Responsiveness
Time frame: Baseline and immediately after completion of the 5-week intervention (Week 5).
Social responsiveness refers to an individual's ability to perceive, interpret, and respond appropriately to social cues during interpersonal interactions. It encompasses the reciprocal aspects of social behaviour required for successful communication and relationship building, including social awareness, social cognition, social communication, social motivation, and the regulation of restricted and repetitive behaviours that affect social functioning. In autism research, social responsiveness is commonly measured using the Social Responsiveness Scale, Second Edition (SRS-2), with higher scores indicating greater impairment in reciprocal social behaviour.
Changes in Social Communication Skills
Time frame: Baseline and immediately after completion of the 5-week intervention (Week 5).
Social communication skills refer to the ability to effectively use verbal and non-verbal communication to initiate, maintain, and appropriately conclude social interactions. These skills involve understanding and responding to social cues, interpreting others' thoughts and emotions, engaging in reciprocal conversations, and adapting communication according to different social contexts and interpersonal relationships. In this study, social communication skills encompass a range of practical behaviours taught through the MyRAKAN Autism module, including appropriate eye contact, smiling, maintaining physical boundaries, regulating voice volume, initiating conversations, interpreting others' responses, handling rejection, maintaining two-way conversations, and ending conversations appropriately. Social communication skills are primarily assessed using the Social Communication subscale of the Social Responsiveness Scale, Second Edition (SRS-2).
2 secondary outcomes
Changes in Anxiety
Time frame: Baseline and immediately after completion of the 5-week intervention (Week 5).
Changes in Quality of Life
Time frame: Baseline and immediately after completion of the 5-week intervention (Week 5).
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 1 Jul 2026.
- BackgroundRieske, R. D., Babbitt, S. C., Neal, J. H. & Spencer, J. A. 2017. Informed Consent. In J. Matson (Ed.), Handbook of Treatments for Autism Spectrum Disorder. Autism and Child Psychopathology Series. Cham: Springer. https://doi.org/10.1007/978-3-319-61738-1_5
- BackgroundPallant, J. 2011. SPSS Survival Manual: A Step-By-Step Guide to Data Analysis Using the SPSS Program. Berkshire: Allen & Unwin.
- BackgroundGrisso, T. & Appelbaum, P. S. 1998. Assessing Competence to Consent to Treatment. Oxford: Oxford University Press. (Note: the reference list in your document spells the author as "Applebaum," but the correct spelling is "Appelbaum.")
- BackgroundConstantino, J. N. 2012. Social Responsiveness Scale, Second Edition (SRS™-2). Torrance, CA: WPS Publication
- BackgroundBruni, T. P. 2014. Test Review: Social Responsiveness Scale-Second Edition (SRS-2). Journal of Psychoeducational Assessment 32(4): 365-369. https://doi.org/10.1177/0734282913517525
- BackgroundAmerican Psychiatric Association. 2000. Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.). Washington, DC: American Psychiatric Association.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyRakan Autism in people with Autism Spectrum Disorder High-Functioning and Young Adults, 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 1 inclusion and 1 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 1 Jul 2026. 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?
Changes in Social Responsiveness (time frame: Baseline and immediately after completion of the 5-week intervention (Week 5).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07678333, which also lists 6 linked publications.
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 1 Jul 2026.