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Enrolling by invitation NCT07505901

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

No phase Interventional Autism Spectrum Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Virtual Reality Self-Modeling Training, Conventional Behavioral Rehabilitation.
Who it may be relevant to
Registry conditions: Autism Spectrum Disorder. Basic parameters: 6 years — 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of a Virtual Reality-Based Self-Modeling Intervention on Social Communication Skills in Children With Autism Spectrum Disorder

Overview

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.

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.

Interventions

  • Behavioral Virtual Reality Self-Modeling Training
    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 behavio
  • Behavioral Conventional Behavioral Rehabilitation
    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 disorde

Primary outcome measures

  • Change in parent-reported social communication score measured by the Social Communication Questionnaire [Time frame: 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 joint attention performance score measured by the Attention-Following and Initiating Joint Attention Protocol [Time frame: Baseline to Week 12]
Secondary outcome measures (2)
  • Change in gaze duration to social stimuli measured by eye-tracking [Time frame: Baseline to Week 12]
  • Change in fixation count on social stimuli measured by eye-tracking [Time frame: Baseline to Week 12]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 2 centers
  • Inonu University Turgut Ozal Medical Center Department of Child and Adolescent Psychiatry — Malatya
  • Trabzon Kanuni Training and Research Hospital Department of Child and Adolescent Psychiatr — Trabzon

Identifiers

NCT: NCT07505901 · 323S275 · 323S275

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗