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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06453629 on ClinicalTrials.gov