Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD)

Completed · Phase 2 · Has a placebo group

Conditions studied: Autism Spectrum Disorder

In brief

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)

Key facts

Study ID

NCT05791071

Run by

Floreo, Inc.

People needed

30

Starts

2023-02-15

Expected to finish

2023-06-29

Last updated by the study team

2025-02-26

Who can join

Age: 4 and older, up to 10. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cortica — Thousand Oaks, California, United States

Full record on ClinicalTrials.gov

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