RCT to Evaluate Social Skills in Children With Autism Using VR Technology (SoCaVR)
NCT06453629 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 117
Last updated 2026-04-06
Summary
The goal of this randomized clinical trial is to compare and learn about Virtual Reality (VR) in children with autism/Autistic children.
The main question it aims to answer is:
• Does the Floreo VR clinical product show clinical improvement in autism symptoms?
Participants will engage the VR product for twice a week for twelve weeks.
They will be randomized to either the Floreo Clinical Product or a VR Control group experience.
Researchers will compare the two groups to see if there is an effect on learning specific skills and behaviors.
Conditions
- Autism Spectrum Disorder
- Social Communication
Interventions
- DEVICE
-
Floreo VR
12 week VR program to help children with ASD to reduce the core symptoms of Autism
- DEVICE
-
VR Control
12 week program administered in VR
- DEVICE
-
VR Control Crossover
If opt in, this group will crossover at the end of 12 weeks to the Floreo VR program
Sponsors & Collaborators
-
Floreo, Inc.
lead INDUSTRY
Principal Investigators
-
Suzanne Goh, MD · Cortica
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 5 Years
- Max Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-31
- Primary Completion
- 2025-11-30
- Completion
- 2026-04-03
- FDA Device
- Yes
Countries
- United States
Study Locations
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