The Effect of Fully Immersive Virtual Reality Technology Combined With Psychological and Behavioral Intervention on Autism Spectrum Disorder

To explore the effects of immersive virtual reality technology combined with psychological and behavioral intervention on children with autism. Methods: A retrospective study was conducted on the clinical data of 120 children with autism admitted to our hospital from January 2024 to October 2024. 58 children received psychological and behavioral intervention alone (control group), while 62 children received psychological and behavioral intervention combined with immersive virtual reality technology (study group). Disease severity (CARS),

Study Overview

Detailed Description

This is a single-center, retrospective interventional study evaluating the effects of fully immersive virtual reality combined with psychological and behavioral intervention in children with autism spectrum disorder. Clinical data were retrospectively collected from February 2024 to October 2024. Outcomes were assessed using standardized behavioral and developmental scales.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Guizhou
      • Tongren, Guizhou, China, 554300
        • Hongxinkang New Traditional Chinese Medicine Hospital, Tongren

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinical diagnosis of autism spectrum disorder (ASD) according to DSM-5 criteria;
  • Age between 2 and 12 years;
  • Complete clinical and assessment data available.

Exclusion Criteria:

  • Diagnosis of schizophrenia or other psychotic disorders;
  • Severe intellectual disability preventing completion of assessments;
  • History of epilepsy or uncontrolled seizure disorders;
  • Significant visual or auditory impairment;
  • History of intracranial surgery or implantation of metallic foreign bodies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fully Immersive Virtual Reality Combined With Psychological and Behavioral Intervention
Participants receive fully immersive virtual reality (FIVR) training combined with standard psychological and behavioral intervention (PBI). The intervention lasts for 12 weeks. FIVR is delivered 3-5 times per week in addition to routine PBI.
Fully immersive virtual reality (FIVR) training is delivered using head-mounted display devices. The training includes structured virtual scenarios targeting social interaction, communication skills, and sensory regulation. Each session lasts 20-60 minutes, delivered 3-5 times per week for 12 weeks, with individualized adjustment based on participant tolerance and performance.
Psychological and behavioral intervention (PBI) includes language training, sensory integration training, group-based activities, individualized behavioral training, family-based training, and psychological support. Sessions are conducted multiple times per week over a 12-week period according to a standardized rehabilitation protocol.
Active Comparator: Psychological and Behavioral Intervention Only
Participants receive standard psychological and behavioral intervention (PBI) alone for 12 weeks, including language training, sensory integration training, group activities, individualized training, family-based training, and psychological support.
Psychological and behavioral intervention (PBI) includes language training, sensory integration training, group-based activities, individualized behavioral training, family-based training, and psychological support. Sessions are conducted multiple times per week over a 12-week period according to a standardized rehabilitation protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Childhood Autism Rating Scale (CARS) Total Score
Time Frame: Baseline and 12 weeks after initiation of intervention

The Childhood Autism Rating Scale (CARS) is a clinician-rated assessment consisting of 15 items, each scored from 1 to 4, with a total score range from 15 to 60.

Higher scores indicate more severe autism-related symptoms (worse outcome). The outcome is defined as the change in total CARS score from baseline to the end of the 12-week intervention period.

Baseline and 12 weeks after initiation of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Aberrant Behavior Checklist (ABC) Total Score
Time Frame: Baseline and 12 weeks

The Aberrant Behavior Checklist (ABC) is a standardized caregiver-rated scale assessing problem behaviors in children with autism spectrum disorder across five domains.

The total score ranges from 0 to 158, with higher scores indicating more severe behavioral problems (worse outcome).

The outcome is defined as the change in ABC total score from baseline to 12 weeks.

Baseline and 12 weeks
Change in Psychoeducational Profile-Third Edition (PEP-3) Total Score
Time Frame: Baseline and 12 weeks

The Psychoeducational Profile-Third Edition (PEP-3) is a standardized developmental assessment evaluating cognitive, language, and adaptive functioning in children with autism spectrum disorder.

Higher scores indicate better developmental functioning (better outcome). The outcome is defined as the change in PEP-3 total score from baseline to 12 weeks.

Baseline and 12 weeks
Parental Satisfaction With Intervention
Time Frame: 12 weeks

Parental satisfaction with the intervention is assessed using the Newcastle Satisfaction with Nursing Scales (NSNS).

The scale measures satisfaction across multiple domains, with higher scores indicating greater satisfaction (better outcome).

Overall satisfaction is assessed at the end of the 12-week intervention period.

12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

October 30, 2024

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

January 9, 2026

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 25, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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