Skip to main content
OpenTrials
Completed

NCT Number: NCT07330219

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),

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hongxinkang New Traditional Chinese Medicine Hospital, Tongren

Tongren, Guizhou, 554300, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fully Immersive Virtual Reality Training

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 9, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.