- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07505901
Virtual Reality-Based Self-Modeling Intervention for Children With Autism Spectrum Disorder (OSB-VR)
Effects of a Virtual Reality-Based Self-Modeling Intervention on Social Communication Skills in Children With Autism Spectrum Disorder
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impairments in social communication and interaction, as well as restricted and repetitive behaviors. Behavioral and educational interventions are considered the most effective approaches to improve functional outcomes in children with ASD. However, access to these interventions may be disrupted in extraordinary situations such as natural disasters or limited access to specialized rehabilitation services.
The aim of this study is to develop and evaluate a virtual reality (VR)-based intervention program using a self-modeling approach to improve core social communication skills in children with ASD. The program will focus on core social communication behaviors including eye contact, initiating joint attention, responding to joint attention, and gesture use.
The study will include 75 children aged 6-11 years diagnosed with ASD without intellectual disability. Participants will be randomly assigned to three groups. The intervention group will receive a 12-week VR-based training program designed according to evidence-based behavioral principles and self-modeling scenarios. In the VR environment, children will observe themselves performing target behaviors and subsequently practice these behaviors within the same environment, with virtual reinforcement provided for successful performance.
One control group will receive conventional rehabilitation training delivered by a special education teacher for the same duration, while another control group will not receive any additional intervention.
Participants will be evaluated using standardized clinical assessment scales, behavioral observation methods, and eye-tracking measurements to assess changes in social communication skills and visual attention patterns.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by persistent deficits in social communication and social interaction, accompanied by restricted and repetitive patterns of behavior. Difficulties in eye contact, joint attention, gesture use, and social interaction are among the core features of the disorder and significantly affect children's functional outcomes and quality of life.
Evidence-based behavioral and educational interventions are widely used to improve social communication skills in children with ASD. Approaches based on Applied Behavior Analysis and other structured behavioral techniques have demonstrated positive effects on social and communication outcomes. However, these interventions often require trained professionals and structured environments, which may limit accessibility in certain situations. In extraordinary conditions such as natural disasters, pandemics, or limited access to specialized educational services, the continuity of rehabilitation programs for children with ASD may be disrupted.
Virtual reality (VR) technologies provide an opportunity to deliver structured and interactive interventions in a controlled and repeatable environment. VR allows the simulation of real-life situations while reducing social anxiety and environmental distractions. Previous research suggests that VR-based interventions may improve social interaction, emotional recognition, and daily living skills in individuals with ASD.
Self-modeling is a behavioral intervention technique in which individuals observe themselves successfully performing a target behavior. Based on social learning theory, self-modeling increases learning efficiency because individuals are more likely to imitate behaviors demonstrated by models who resemble themselves. Video-based self-modeling interventions have been shown to improve various social behaviors in children with ASD. However, the use of self-modeling within immersive VR environments remains limited in the current literature.
The present study aims to develop and evaluate a virtual reality-based intervention program using a self-modeling approach to improve core social communication skills in children with ASD. The VR program will include interactive scenarios targeting eye contact, initiating joint attention, responding to joint attention, and gesture use. The intervention will incorporate evidence-based behavioral principles and reinforcement mechanisms within the virtual environment.
A total of 75 children aged 6-11 years diagnosed with ASD without intellectual disability will be included in the study. Participants will be randomly assigned to one of three groups (25 participants per group). The intervention group will receive a VR-based self-modeling training program for 12 weeks, with two sessions per week. During the sessions, children will observe avatar-based representations of themselves demonstrating target behaviors and will subsequently practice these behaviors in the virtual environment. Successful behavioral responses will be reinforced through virtual rewards.
The first control group will receive conventional rehabilitation training targeting similar social skills delivered by a special education teacher. The second control group will not receive any additional intervention during the study period.
Participants will be evaluated before and after the intervention using standardized clinical scales, structured behavioral observation methods, and eye-tracking technology. Eye-tracking measurements will provide objective data on visual attention patterns related to eye contact and social stimuli. The study aims to determine whether a virtual reality-based self-modeling intervention can improve social communication skills in children with ASD and whether technology-based interventions can complement existing evidence-based rehabilitation programs.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Malatya, Turkey (Türkiye)
- Inonu University Turgut Ozal Medical Center Department of Child and Adolescent Psychiatry
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Trabzon, Turkey (Türkiye)
- Trabzon Kanuni Training and Research Hospital Department of Child and Adolescent Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Children aged 6-11 years
- Diagnosis of Autism Spectrum Disorder according to DSM-5 criteria
- Meeting ASD classification on the Autism Diagnostic Observation Schedule-2 (ADOS-2)
- Ability to produce simple sentence-level speech
- Eye contact score of 2 on ADOS-2 assessment
- Gesture use score ≥1 on ADOS-2 assessment
- Written informed consent obtained from parents or legal guardians
Exclusion Criteria:
- Presence of epilepsy or other chronic neurological disorders
- Presence of significant medical conditions that may interfere with participation in the intervention
- Intellectual disability (IQ ≤70 on WISC-R assessment)
- Known visual or hearing impairment that may affect participation in the assessments
- Presence of physical disabilities that interfere with gesture use or participation in the intervention
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: VR Self-Modeling Intervention
Participants will receive a virtual reality-based self-modeling intervention program designed to improve core social communication skills.
The intervention will be conducted twice weekly for 12 weeks and will target eye contact, initiating joint attention, responding to joint attention, and gesture use.
Behavioral responses will be reinforced using virtual reward mechanisms within the virtual environment.
|
Participants will receive a virtual reality-based self-modeling intervention designed to improve core social communication skills in children with autism spectrum disorder.
The program will be delivered twice weekly for 12 weeks.
In the virtual environment, participants will observe avatar-based representations of themselves demonstrating target behaviors such as eye contact, initiating joint attention, responding to joint attention, and gesture use.
Participants will then practice these behaviors within the same virtual environment.
Successful behavioral responses will be reinforced using virtual reward mechanisms.
|
|
Active Comparator: Conventional Rehabilitation
Participants will receive conventional rehabilitation training delivered by a special education teacher using evidence-based behavioral approaches targeting social communication skills, including eye contact, joint attention, and gesture use.
The intervention will be conducted twice weekly for 12 weeks.
|
Participants will receive conventional rehabilitation training delivered by a trained special education teacher using evidence-based behavioral approaches commonly used in autism interventions.
The program will target social communication skills including eye contact, joint attention, and gesture use.
Sessions will be conducted twice weekly for 12 weeks and will follow structured behavioral teaching strategies typically used in special education programs for children with autism spectrum disorder.
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|
No Intervention: No-Intervention Control
Participants assigned to this group will not receive any additional intervention during the 12-week study period but will complete the same assessment procedures as the other groups.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in parent-reported social communication score measured by the Social Communication Questionnaire
Time Frame: Baseline to Week 12
|
Change in parent-reported social communication skills assessed using the Social Communication Questionnaire (SCQ).
The unit of measure will be the total SCQ score.
The total score ranges from 0 to 39, with higher scores indicating greater impairment in social communication and therefore a worse outcome.
|
Baseline to Week 12
|
|
Change in autism symptom severity measured by the Autism Diagnostic Observation Schedule, Second Edition calibrated severity score
Time Frame: Baseline to Week 12
|
Change in autism symptom severity assessed using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2) calibrated severity score.
The unit of measure will be the calibrated severity score, which ranges from 1 to 10, with higher scores indicating greater autism symptom severity and therefore a worse outcome.
|
Baseline to Week 12
|
|
Change in joint attention performance score measured by the Attention-Following and Initiating Joint Attention Protocol
Time Frame: Baseline to Week 12
|
Change in joint attention performance assessed using the Attention-Following and Initiating Joint Attention Protocol.
The unit of measure will be the total performance score.
Higher scores indicate better joint attention performance and therefore a better outcome.
|
Baseline to Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in gaze duration to social stimuli measured by eye-tracking
Time Frame: Baseline to Week 12
|
Change in visual attention to social stimuli assessed using eye-tracking technology.
The unit of measure will be gaze duration in seconds within predefined areas of interest corresponding to social stimuli.
Higher gaze duration to relevant social stimuli indicates greater visual attention to social information and therefore a better outcome.
|
Baseline to Week 12
|
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Change in fixation count on social stimuli measured by eye-tracking
Time Frame: Baseline to Week 12
|
Change in visual attention to social stimuli assessed using eye-tracking technology.
The unit of measure will be fixation count within predefined areas of interest corresponding to social stimuli.
Higher fixation count on relevant social stimuli indicates greater visual attention to social information and therefore a better outcome.
|
Baseline to Week 12
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 323S275 (Other Grant/Funding Number: TUBITAK/TURKEY)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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