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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07330219
Enrollment
120
Registered
2026-01-09
Start date
2024-02-01
Completion date
2024-10-30
Last updated
2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder

Brief summary

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),

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.

Interventions

BEHAVIORALFully Immersive Virtual Reality Training

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.

BEHAVIORALPsychological and Behavioral Intervention

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.

Sponsors

Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in Childhood Autism Rating Scale (CARS) Total ScoreBaseline and 12 weeks after initiation of interventionThe 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

MeasureTime frameDescription
Change in Aberrant Behavior Checklist (ABC) Total ScoreBaseline and 12 weeksThe 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.
Change in Psychoeducational Profile-Third Edition (PEP-3) Total ScoreBaseline and 12 weeksThe 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.
Parental Satisfaction With Intervention12 weeksParental 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026