NCT07678333

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 25, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2026

Completed
Last Updated

July 1, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 25, 2026

Last Update Submit

June 25, 2026

Conditions

Keywords

Autism Level 1Social CommunicationSocial Skills TrainingVideo ModellingSpherical Video-Based Virtual Reality (SVVR)

Outcome Measures

Primary Outcomes (2)

  • 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.

    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).

    Baseline and immediately after completion of the 5-week intervention (Week 5).

Secondary Outcomes (2)

  • Changes in Anxiety

    Baseline and immediately after completion of the 5-week intervention (Week 5).

  • Changes in Quality of Life

    Baseline and immediately after completion of the 5-week intervention (Week 5).

Study Arms (2)

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.

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.

Behavioral: MyRakan Autism

Interventions

MyRakan AutismBEHAVIORAL

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

MyRakan Autism Module InterventionWaitlist Control Group

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \) 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.

You may not qualify if:

  • \) no official diagnosis by a mental health professional or developmental pediatrician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Chancellor Tuanku Muhriz

Kuala Lumpur, 56000, Malaysia

Location

Related Publications (6)

  • 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

    BACKGROUND
  • Pallant, J. 2011. SPSS Survival Manual: A Step-By-Step Guide to Data Analysis Using the SPSS Program. Berkshire: Allen & Unwin.

    BACKGROUND
  • 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.")

    BACKGROUND
  • Constantino, J. N. 2012. Social Responsiveness Scale, Second Edition (SRS™-2). Torrance, CA: WPS Publication

    BACKGROUND
  • 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

    BACKGROUND
  • American Psychiatric Association. 2000. Diagnostic and Statistical Manual of Mental Disorders (4th ed., text rev.). Washington, DC: American Psychiatric Association.

    BACKGROUND

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2026

First Posted

July 1, 2026

Study Start

June 1, 2023

Primary Completion

September 15, 2024

Study Completion

January 10, 2025

Last Updated

July 1, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations