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

NCT07330219 | Completed DMC

• 1 other identifier: 2024-1-1
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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),

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Childhood Autism Rating Scale (CARS) Total Score

  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 Outcomes (3)

• Change in Aberrant Behavior Checklist (ABC) Total Score

  Baseline and 12 weeks

• Change in Psychoeducational Profile-Third Edition (PEP-3) Total Score

  Baseline and 12 weeks

• Parental Satisfaction With Intervention

  12 weeks

Study Arms (2)

Fully Immersive Virtual Reality Combined With Psychological and Behavioral Intervention

EXPERIMENTAL

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.

Behavioral: Fully Immersive Virtual Reality Training; Behavioral: Psychological and Behavioral Intervention

Psychological and Behavioral Intervention Only

ACTIVE COMPARATOR

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.

Behavioral: Psychological and Behavioral Intervention

Interventions

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.

Fully Immersive Virtual Reality Combined With Psychological and Behavioral Intervention; Psychological and Behavioral Intervention Only

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.

Fully Immersive Virtual Reality Combined With Psychological and Behavioral Intervention

Eligibility Criteria

• Age: 2 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province: lead

Study Sites (1)

Hongxinkang New Traditional Chinese Medicine Hospital, Tongren

Tongren, Guizhou, 554300, China

Location

Related Publications (1)

• Li N, Tian M, Yang Y, Liu Z, Sun L, Li B. The effect of fully immersive virtual reality technology combined with psychological and behavioral intervention on autism spectrum disorder. BMC Psychol. 2025 Oct 9;13(1):1120. doi: 10.1186/s40359-025-03460-y.

  PMID: 41068944 RESULT

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 26, 2025
• First Posted: January 9, 2026
• Study Start: February 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CN (1)