94 - Virtual Bonds, Real Connections: Floreo's Immersive Virtual Reality Helps Build Social Skills in Children with Autism

Publication Number: 1086.94

Georgia Barbayannis, George Washington University School of Medicine and Health Sciences, Washington, DC, United States; Kevin A. Shapiro, Cortica Healthcare, Glendale, CA, United States; Vijay Ravindran, Floreo, Washington, DC, United States; Gregory J. Downing, Innovation Horizons, Inc, WASHINGTON, DC, United States; Shirley Mak-Parisi, floreo VR, Woburn, MA, United States; Rita Solórzano, Floreo, Inc., Washington, DC, United States; Sinan Turnacioglu, Children's National Health System, Washington, DC, United States

Background: Evidence-based early interventions for autism spectrum disorder (ASD), such as Applied Behavior Analysis (ABA), may be beneficial but are often limited by socioeconomic, geographic, and other barriers. Immersive virtual reality (VR) offers a promising, scalable, and cost-effective way to complement established therapies by providing interactive, strength-based environments that foster social communication, connection, and self-directed learning tailored to each child's needs and comfort level.

Objective: This study evaluated the feasibility and preliminary efficacy of integrating Floreo's Building Social Connections (BSC) VR module into behavioral therapy to support social and behavioral outcomes in preschool- and school-age children with ASD.

Design/Methods: In this randomized controlled phase 2 trial (NCT05791071), 14 children with ASD, aged 4-14 years old, received either the Floreo BSC VR intervention (n=8) or a VR control (n=6). Participants completed 36 sessions (15 minutes each, up to 3 times weekly for 12-15 weeks) within an ABA therapy setting. Outcomes were measured using the caregiver-reported Autism Impact Measure (AIM), which provides composite and subdomain scores for communication, social reciprocity, peer interaction, repetitive behavior, and atypical behavior. Items were rated on 5-point Linkert scales assessing frequency and impact. The primary outcome measure was the change in scores from baseline as a function of treatment.

Results: Floreo's VR intervention was well-tolerated and easily incorporated into clinical sessions, with no serious adverse events or participant dropouts due to side effects. Children with ASD who received the BSC VR intervention demonstrated a clinically meaningful improvement in the AIM composite score (-25) compared with controls (-0.84), although this difference did not achieve statistical significance (Figure 1). Similar trends of clinically meaningful improvements were also observed in the Floreo BSC group across the subdomains of social reciprocity (-1.75 vs. 0), peer interaction (-4 vs. -3.5), repetitive behavior (-2.75 vs. 0.83), and atypical behavior (-4.88 vs. -2.33; Figure 1). Notably, children in the BSC group showed both clinically and statistically significant improvement in communication (-5.12 vs 3.33; p=0.02, Figure 1).

Conclusion(s): Floreo's Building Social Connections VR module is a safe, well-tolerated intervention with the potential to support social communication in children with ASD, demonstrating the emerging promise of immersive VR as an innovative, accessible approach to enhance therapeutic engagement and outcomes.

Figure 1. Autism Impact Measure Outcomes: Floreo Building Social Connections VR Treatment vs. Control
Autism Impact Measure (AIM) outcomes comparing the Floreo Building Social Connections (BSC) VR intervention with control. Children receiving the BSC VR module demonstrated both statistically and clinically meaningful improvements in communication scores as well as clinically meaningful improvements in atypical behavior, peer interaction, repetitive behavior, and social reciprocity scores.