Virtual Reality-Based Self-Modeling Intervention for Children With Autism Spectrum Disorder

NCT07505901 | Enrolling By Invitation

• 1 other identifier: 323S275
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder; Virtual Reality; Self-Modeling; Eye Tracking; Joint Attention

Outcome Measures

Primary Outcomes (3)

• Change in parent-reported social communication score measured by the Social Communication Questionnaire

  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

  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

  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 Outcomes (2)

• Change in gaze duration to social stimuli measured by eye-tracking

  Baseline to Week 12

• Change in fixation count on social stimuli measured by eye-tracking

  Baseline to Week 12

Study Arms (3)

VR Self-Modeling Intervention

EXPERIMENTAL

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.

Behavioral: Virtual Reality Self-Modeling Training

Conventional Rehabilitation

ACTIVE COMPARATOR

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.

Behavioral: Conventional Behavioral Rehabilitation

No-Intervention Control

NO INTERVENTION

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.

Interventions

Virtual Reality Self-Modeling Training BEHAVIORAL

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.

VR Self-Modeling Intervention

Conventional Behavioral Rehabilitation BEHAVIORAL

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.

Conventional Rehabilitation

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inonu University: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (2)

Inonu University Turgut Ozal Medical Center Department of Child and Adolescent Psychiatry

Malatya, Turkey (Türkiye)

Location

Trabzon Kanuni Training and Research Hospital Department of Child and Adolescent Psychiatry

Trabzon, Turkey (Türkiye)

Location

Related Links

• Inonu University - Department of Child and Adolescent Psychiatry URL:

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Participants and investigators will not be blinded to the assigned intervention because the study involves behavioral and virtual reality-based interventions that cannot be concealed.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. Dr.

Model Details: Participants will be randomly assigned to one of three parallel groups. The first group will receive a virtual reality-based self-modeling intervention for 12 weeks. The second group will receive conventional rehabilitation training delivered by a special education teacher, while the third group will serve as a no-intervention control group. Outcomes will be assessed before and after the intervention using clinical scales, behavioral observations, and eye-tracking measures.

Study Record Dates

• First Submitted: March 16, 2026
• First Posted: April 1, 2026
• Study Start: June 15, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

TU (2)