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Behavioral Intervention

VR Social Skills Training for Autism Spectrum Disorder

N/A

Waitlist Available

Led By Krestin Radonovich, PhD

Research Sponsored by West Virginia University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Be younger than 18 years old

Must not have

Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome) which is not adequately controlled by medication or other therapy.

Motor disorder that would interfere with VR engagement.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 week post final treatment visit

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how VR training can help parents and caregivers of kids with ASD improve their social skills. It will evaluate effects on core symptoms, social skills, and adaptive skills. Participants will use the VR program in clinic and at home.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from wearing VR equipment, temporary disorientation or dizziness after use, eye strain or headache due to prolonged screen exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with autism by a qualified clinician.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 1 week post final treatment visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 1 week post final treatment visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 week post final treatment visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Autism Impact Measure (AIM)

Childhood Autism Rating Scale, 2nd Edition (CARS-2)

Vineland Scales of Adaptive Behavior, 3rd Edition (Vineland 3)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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).

0 / 3Eligibility criteria met