Autism Spectrum DisorderOSB-VRNCT07505901
Virtual Reality-Based Self-Modeling Intervention for Children With Autism Spectrum Disorder
A study testing Virtual Reality Self-Modeling Training and Conventional Behavioral Rehabilitation in people with Autism Spectrum Disorder, run by Inonu University at 2 sites in Turkey (Türkiye).
Trial summary
Autism Spectrum Disorder (ASD) is a neurodevelopmental condition characterized by impairments in social communication and interaction, as well as restricted and repetitive behaviors. Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Virtual Reality Self-Modeling Training and Conventional Behavioral Rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 15 Jun 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites
Inonu University Turgut Ozal Medical Center Department of Child and Adolescent Psychiatry
Malatya
Trabzon Kanuni Training and Research Hospital Department of Child and Adolescent Psychiatry
Trabzon
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Virtual Reality Self-Modeling Training, Conventional Behavioral Rehabilitation
- Keywords
- Autism Spectrum Disorder, Virtual Reality, Self-Modeling, Eye Tracking, Joint Attention
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Self-Modeling TrainingBehavioural
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.
Conventional Behavioral RehabilitationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 12
Secondary outcomes (2)
Change in gaze duration to social stimuli measured by eye-tracking
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.
Measured: Baseline to Week 12
Change in fixation count on social stimuli measured by eye-tracking
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.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start15 Jun 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Ilknur Ucuz, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07505901
- Sponsor's protocol ID
- 323S275
- Other IDs
- 323S275
- Acronym
- OSB-VR
- Status last verified
- Mar 2026
- First submitted
- 16 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Virtual Reality-Based Self-Modeling Intervention on Social Communication Skills in Children With Autism Spectrum Disorder
- ClinicalTrials.gov ID
- NCT07505901
- Acronym / sponsor ID
- OSB-VR / 323S275
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Virtual Reality, Self-Modeling, Eye Tracking, Joint Attention
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| VR Self-Modeling Intervention | Experimental | Behavioral: Virtual Reality Self-Modeling TrainingParticipants 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. |
| Conventional Rehabilitation | Active comparator | Behavioral: Conventional Behavioral RehabilitationParticipants 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. |
| 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. |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Self-Modeling TrainingParticipants 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. | Behavioural | VR Self-Modeling Intervention |
| Conventional Behavioral RehabilitationParticipants 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. | Behavioural | Conventional Rehabilitation |
Primary outcome
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.
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.
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Inonu University - Department of Child and Adolescent Psychiatry URL:Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Self-Modeling Training and Conventional Behavioral Rehabilitation in people with Autism Spectrum Disorder, run by Inonu University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in parent-reported social communication score measured by the Social Communication Questionnaire (time frame: Baseline to Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.