VR Social Skills Training for Autism Spectrum Disorder

Palo Alto (17 mi)

Overseen byKrestin Radonovich, PhD

Age: < 18

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: N/A

Waitlist Available

Sponsor: West Virginia University

No Placebo Group

Trial Summary

What is the purpose of this trial?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 effects of treatment with Floreo Building Social Connections (BSC) on the AIM, a parent report survey that assesses core symptoms of ASD. The secondary objective is to explore the changes in social skills over time by using a multimethod outcomes battery. The Investigators will evaluate the effect of treatment with Floreo BSC on the Childhood Autism Rating Scales (CARS-2) in the study patient population. Additional secondary objectives include evaluation of the effects of treatment on adaptive skills as measured by the Vineland-3. Participants will be asked to complete questionnaires and utilize the VR program at clinic and at home.

Eligibility Criteria

This trial is for children with Autism Spectrum Disorder (ASD) who can handle VR therapy, as judged by their parents and study staff. They must have a confirmed diagnosis of ASD and be able to follow the study's procedures. Girls who can get pregnant must use birth control or not be able to become pregnant.

Inclusion Criteria

I have been diagnosed with autism by a qualified clinician.

Exclusion Criteria

My migraines or related conditions are not well-managed with current treatments.

I do not have a motor disorder that affects my ability to use VR.

Treatment Details

The trial tests a VR social skills training program led by parents for kids with ASD. It checks if the program helps improve social connections using surveys like AIM, CARS-2, and Vineland-3. The training happens at clinics and home, with progress tracked over time.

1Treatment groups

Experimental Treatment

Group I: Floreo BSCExperimental Treatment1 Intervention

Subjects and their caregiver will engage in the Floreo VR Building Social Connections VR sessions: three sessions per week, for 12 weeks. Each session will consist of 2 VR (Floreo BSC) lessons separated by a brief break, for a total of approximately 15 minutes of direct VR time over a 30-minute period. Treatment sessions will be scheduled over a 12-week period, with an allowance of up to 15 weeks for make-up sessions (e.g., illness or travel).