Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD) (NCT05791071) | Clinical Trial Compass
CompletedPhase 2
Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD)
United States30 participantsStarted 2023-02-15
Plain-language summary
A Randomized Controlled Phase II study to assess the efficacy of Floreo VR (Virtual reality) Building Social Connections as treatment for social skills in children with Autism Spectrum Disorder (ASD)
Who can participate
Age range4 Years – 10 Years
SexALL
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Inclusion Criteria:
* Males and females aged 4 years to 10 years 11 months of age (up to 11th birthday at randomization).
* 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 receive ABA therapy at Cortica, with scheduled ABA sessions in clinic at least 3 times per week.
* Participants must be able to tolerate VR therapy in the judgement of parent or caregiver and study staff
Exclusion Criteria:
* A history of photosensitive epilepsy, or photoparoxysmal response on electroencephalogram (EEG)
* Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome), not adequately controlled
* History of balance disorder including vertigo, motion sensitivity, or balance disorder
* Primary sensory impairment (blindness, deafness)
* Motor disorder that would interfere with VR engagement
What they're measuring
1
Autism Impact Measure (AIM) Assessment
Timeframe: The AIM takes approximately 30 minutes to complete.