Autism Spectrum DisorderNCT07330219

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

A study testing Fully Immersive Virtual Reality Training and Psychological and Behavioral Intervention in people with Autism Spectrum Disorder, run by Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou Province at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 to 12 years
Conditions the study is for: Autism Spectrum Disorder
What is being tested?: Fully Immersive Virtual Reality Training and Psychological and Behavioral Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteChina
Study dates: 1 Feb 2024to 30 Oct 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 2 to 12 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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),

Read the 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.

Conditions: Autism Spectrum Disorder
Being tested: Fully Immersive Virtual Reality Training, Psychological and Behavioral Intervention
Medical subject headings: Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fully Immersive Virtual Reality TrainingBehavioural
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 InterventionBehavioural
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.

Study groups in NCT07330219
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Psychological and Behavioral Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline and 12 weeks after initiation of intervention

Secondary outcomes (3)

Change in Aberrant Behavior Checklist (ABC) Total Score
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.
Measured: Baseline and 12 weeks
Change in Psychoeducational Profile-Third Edition (PEP-3) Total Score
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.
Measured: Baseline and 12 weeks
Parental Satisfaction With Intervention
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.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 202430 Oct 2024

First posted9 Jan 2026
Study start1 Feb 2024
Primary completion30 Oct 2024
Study completion30 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07330219
Sponsor's protocol ID: 2024-1-1
Status last verified: Jan 2026
First submitted: 26 Dec 2025
Last updated: 27 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 41068944

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Fully Immersive Virtual Reality Technology Combined With Psychological and Behavioral Intervention on Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT07330219
Acronym / sponsor ID: 2024-1-1
Conditions: Autism Spectrum Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Tongren Hongxin Kangxin Traditional Chinese Medicine Hospital, Guizhou ProvinceUniversity, hospital or other
Study start: 1 Feb 2024 (actual)
Primary completion: 30 Oct 2024 (actual)
Study completion: 30 Oct 2024 (actual)
First posted: 9 Jan 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fully Immersive Virtual Reality Combined With Psychological and Behavioral Intervention	Experimental	Behavioral: Fully Immersive Virtual Reality Training, Behavioral: Psychological and Behavioral InterventionParticipants 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.
Psychological and Behavioral Intervention Only	Active comparator	Behavioral: Psychological and Behavioral InterventionParticipants 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.

Who may qualify

Ages: 2 to 12 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fully Immersive Virtual Reality TrainingFully 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.	Behavioural	Fully Immersive Virtual Reality Combined With Psychological and Behavioral Intervention
Psychological and Behavioral InterventionPsychological 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.	Behavioural	Fully Immersive Virtual Reality Combined With Psychological and Behavioral Intervention, Psychological and Behavioral Intervention Only

Primary outcome

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.

3 secondary outcomes

Change in Aberrant Behavior Checklist (ABC) Total Score
Time frame: Baseline and 12 weeks
Change in Psychoeducational Profile-Third Edition (PEP-3) Total Score
Time frame: Baseline and 12 weeks
Parental Satisfaction With Intervention
Time frame: 12 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
Results publication: PubMed 41068944Li 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Childhood Autism Rating Scale (CARS) Total Score (time frame: Baseline and 12 weeks after initiation of intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07330219, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.