NCT05791071

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

A Randomized Controlled Phase II Study to Assess the Efficacy of Floreo VR Building Social Connections vs. Active VR Exposure Control as Treatment for Social Skills in Autistic Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Floreo, Inc. · Industry
• Sex: All
• Age: 4 Years – 10 Years
• Healthy volunteers: Not accepted

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)

Detailed description

In this randomized controlled phase II study, 30 eligible subjects aged 4-10 years old with documented ASD diagnoses will be enrolled and randomized in a 1:1 ratio intervention vs control group. The Floreo VR Building Social Connections intervention is designed to be administered for 12 weeks, with three treatment visits per week, for a total of 36 treatment visits.

Conditions

• Autism Spectrum Disorder

Interventions

Type	Name	Description
DEVICE	Floreo VR Building Social Connections	Floreo's VR platform consists of a VR headset and wireless tethered VR screens (iPhones) and tablets (iPads) that are seamlessly linked in real time, allowing the therapist (or monitor) to set up lessons, change the interactive environment, and provide live verbal and VR-based guidance, feedback, and rewards to users. The lessons that will be implemented in this intervention are aimed at targeting social skills such as communication, joint attention, and social interactions.
DEVICE	Sham	This condition will contain the same VR headset and wireless tethered VR screens (iPhones) and tablets (iPads) as the intervention condition, but instead of social skill lessons, only non-intervention, active VR videos such as underwater fish swimming will be shown.

Timeline

• Start date: 2023-02-15
• Primary completion: 2023-06-29
• Completion: 2023-06-29
• First posted: 2023-03-30
• Last updated: 2025-02-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study