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

NCT ID: NCT07330219

Last Updated: 2026-01-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2024-10-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autism Spectrum Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Fully Immersive Virtual Reality Training

Intervention Type 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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Fully Immersive Virtual Reality Training

Intervention Type 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

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fully 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.

Intervention Type BEHAVIORAL

Psychological 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Meets the diagnostic criteria for autism, is under 12 years old, and has complete clinical data.

Exclusion Criteria

* Individuals with Asperger's syndrome; individuals with schizophrenia; individuals with intellectual disability; individuals with epilepsy; individuals with visual or auditory impairment; individuals with a history of intracranial surgery or implantation of metallic foreign bodies.
Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

lining

lining

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hongxinkang New Traditional Chinese Medicine Hospital, Tongren

Tongren, Guizhou, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 41068944 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2024-1-1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

VR for Joint Attention Support in ASD
NCT04016701 WITHDRAWN PHASE2