- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07678333
Effectiveness of a Virtual Reality Social Skills Intervention in Autism
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:
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.
연구 개요
상세 설명
**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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Kuala Lumpur, 말레이시아, 56000
- Hospital Chancellor Tuanku Muhriz
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
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.
Exclusion Criteria:
1) no official diagnosis by a mental health professional or developmental pediatrician
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: MyRakan Autism Module Intervention
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.
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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 |
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활성 비교기: Waitlist Control Group
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.
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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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Social Responsiveness
기간: Baseline and immediately after completion of the 5-week intervention (Week 5).
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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).
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Changes in Social Communication Skills
기간: Baseline and immediately after completion of the 5-week intervention (Week 5).
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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).
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in Anxiety
기간: Baseline and immediately after completion of the 5-week intervention (Week 5).
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Levels of anxiety measured by Beck Anxiety Inventory
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Baseline and immediately after completion of the 5-week intervention (Week 5).
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Changes in Quality of Life
기간: Baseline and immediately after completion of the 5-week intervention (Week 5).
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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). |
Baseline and immediately after completion of the 5-week intervention (Week 5).
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- UKM PPI/111/8/JEP-2021-092
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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