NCT06453629

RCT to Evaluate Social Skills in Children With Autism Using VR Technology (SoCaVR)

A Randomized Controlled Study to Evaluate Social Skill Treatment Options in Children With Autism Using VR Technology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Floreo, Inc. · Industry
• Sex: All
• Age: 5 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this study is to find out if Floreo's VR clinical program can help with autism symptoms such as social communication skills in autistic children. Recent advances in VR technology offers a new way to improve these types of skills in children with autism in an immersive and controlled environment. Questionnaires answered by adult caregivers will be used to assess the child's behaviors during the time of treatment. Clinician observations will also be conducted as a part of this study.

Conditions

• Autism Spectrum Disorder
• Social Communication

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-05-31
• Primary completion: 2025-11-30
• Completion: 2026-04-03
• First posted: 2024-06-11
• Last updated: 2026-04-06

Locations

17 sites across 1 country: United States

Regulatory

• FDA-regulated device study