- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07330219
The Effect of Fully Immersive Virtual Reality Technology Combined With Psychological and Behavioral Intervention on Autism Spectrum Disorder
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Guizhou
-
Tongren, Guizhou, China, 554300
- Hongxinkang New Traditional Chinese Medicine Hospital, Tongren
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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 (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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline and 12 weeks after initiation of intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
Baseline and 12 weeks
|
|
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. |
Baseline and 12 weeks
|
|
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. |
12 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-1-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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