Status:
UNKNOWN
Parent Led Implementation of a VR Social Skills Training Program for Children With ASD
Lead Sponsor:
West Virginia University
Collaborating Sponsors:
Floreo
Conditions:
Autism Spectrum Disorder
Eligibility:
All Genders
4-131 years
Phase:
NA
Brief Summary
The goal of this interventional trial is to establish training protocols to show feasibility of training parents and caregivers to administer the VR protocol. The primary objective is to evaluate the ...
Eligibility Criteria
Inclusion
- Patients or legally authorized representatives must provide written informed consent and be willing and able to comply with study procedures. Participants must provide informed assent as clinically appropriate.
- A diagnosis of autism spectrum disorder on the basis of the clinical judgement of a qualified clinician according to DSM-5 criteria, supported by either the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
- Participants must be able to tolerate VR therapy in the judgement of parent or caregiver and study staff.
- Female participants must either be unable to become pregnant (e.g., premenarchal, surgically sterile, etc.) or agree to use a highly effective method of contraception (e.g., intrauterine device, oral contraceptives, condom or diaphragm with spermicides, contraceptive sponge) from 28 days before the Baseline Visit to 45 days after the last treatment session. Females of childbearing potential must have a negative urine human chorionic gonadotropin pregnancy test at the Screening Visit.
Exclusion
- History of photosensitive epilepsy or demonstrated photoparoxysmal response on prior electroencephalogram.
- Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome) which is not adequately controlled by medication or other therapy.
- History of balance disorder including vertigo, motion sensitivity, or ataxia. Vestibular sensory deficits are not necessarily exclusionary.
- Primary sensory impairment (blindness, deafness).
- Motor disorder that would interfere with VR engagement.
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2024
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06098768
Start Date
November 1 2023
End Date
June 1 2024
Last Update
October 25 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
West Virginia University
Morgantown, West Virginia, United States, 26508