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

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder; Social Communication
• Intervention / Treatment: Device: Floreo VR; Device: VR Control; Device: VR Control Crossover

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.

• Study Type: Interventional
• Enrollment (Actual): 117
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Carlsbad, California, United States, 92008
      • Cortica- Carlsbad
    • Glendale, California, United States, 91203
      • Cortica- Glendale
    • Irvine, California, United States, 92705
      • Cortica- Irvine
    • Laguna Niguel, California, United States, 92677
      • Cortica- Laguna Niguel
    • San Diego, California, United States, 92121
      • Cortica- San Diego
    • San Rafael, California, United States, 94903
      • Cortica- Marin
    • Torrance, California, United States, 90503
      • Cortica- Torrance
    • Westlake Village, California, United States, 91361
      • Cortica- Westlake Village
  • Connecticut
    • Ridgefield, Connecticut, United States, 06877
      • Cortica- Ridgefield
    • Trumbull, Connecticut, United States, 06611
      • Cortica- Trumbull
  • Illinois
    • Naperville, Illinois, United States, 60564
      • Cortica- Naperville
    • Westchester, Illinois, United States, 60154
      • Cortica- Westchester
  • Massachusetts
    • Burlington, Massachusetts, United States, 01830
      • Cortica- Burlington
    • Dedham, Massachusetts, United States, 20815
      • Cortica- Dedham
    • Shrewsbury, Massachusetts, United States, 01545
      • Cortica- Shrewsbury
  • Texas
    • Plano, Texas, United States, 75093
      • Cortica- Plano
    • The Woodlands, Texas, United States, 77381
      • Cortica- The Woodlands

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Five to eighteen years old (inclusive) at the time of consent
• Legal guardian is able and willing to properly sign and date informed consent indicating that they have been informed about the study and able to complete all visits [If age appropriate, an assent will also be administered to the participant to inform them of the study and give them an opportunity to proceed or decline]
• Verified diagnosis of ASD documented by a qualified clinician according to DSM-V criteria
• Receiving therapies at least two times per week in a clinic setting
• Participant is able to complete and pass the VR orientation screening

Exclusion Criteria:

• Significant medical condition(s) [examples listed below] or other circumstances which, in the opinion of the treating clinician, would preclude compliance with the protocol, adequate cooperation in the study, or may prevent the participant from safely participating in the study:
• Uncontrolled neurological conditions such as epilepsy, migraine
• Current disorders affecting balance, such as vertigo
• Primary sensory impairment such as blindness or deafness
• Eye movement impairment, such as strabismus
• Participants are enrolled in another clinical study
• Participants known to be pregnant
• Participation in this study is not in the best interest of the child, at the discretion of the treating clinician and the primary investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Floreo VR; Floreo VR is a 12 week program	Device: Floreo VR; 12 week VR program to help children with ASD to reduce the core symptoms of Autism
Active Comparator: VR Control; VR Control is a 12 week program that matches the Floreo VR interactions	Device: VR Control; 12 week program administered in VR
Other: VR Control Crossover; For participants who opt in, they will run the 12 week Floreo VR program	Device: Floreo VR; 12 week VR program to help children with ASD to reduce the core symptoms of Autism; Device: VR Control Crossover; If opt in, this group will crossover at the end of 12 weeks to the Floreo VR program; Other Names: Crossover group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autism Impact Measure (AIM)	The primary objective of this study is to determine if administration of the Floreo VR compared to VR Control results in clinically significant improvement in autism symptoms as measured by the Autism Impact Measure (AIM) in the study participant population.	Baseline-12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Functional Living Skills (AFLS)	Change from baseline to 12 weeks in scores on the subdomains of social skills and basic communications in the Assessment of Functional Living Skills (AFLS)	Baseline-12 weeks
Child and Family Quality of Life (CFQL-2)	Change from baseline to 12 weeks in scores of the Child and Family Quality of Life (CFQL-2)	Baseline-12 weeks
Assessment of Functional Living Skills (AFLS)	Change from 16, 20, 24 weeks in scores on the subdomains of social skills and basic communications in the Assessment of Functional Living Skills (AFLS)	baseline, 16 weeks, 20 weeks, 24 weeks
Total Autism Impact Measure (AIM) Score	Responder rate at 16, 20, and 24 weeks for the Total AIM score	baseline, 16 weeks, 20 weeks, 24 weeks
Child and Family Quality of Life (CFQL-2)	Change from baseline to 24 weeks in scores on the subdomains of social skills and basic communications in the Assessment of Functional Living Skills (AFLS)	baseline, 16, 20, and 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Autism Rating Scale (CARS-2)	Change from baseline,12, and 24 weeks in scores on the Childhood Autism Rating Scales-2 (CARS-2)	baseline, 12 weeks, 24 weeks
Floreo Skills Acquisition and Observations	Floreo specific skills scores	baseline, 12 weeks, 24 weeks
Rate of Skills Acquisition	Social Skills goals	baseline, 12 weeks, 24 weeks
Subdomain 1 of the Autism Impact Measure in Repetitive Behaviors	Subdomain of the Autism Impact Measure in Repetitive Behaviors	baseline, 12 weeks, 24 weeks
Subdomain 2 of the Autism Impact Measure in Communications	Subdomain of the Autism Impact Measure in Communications	baseline, 12 weeks, 24 weeks
Subdomain 3 of the Autism Impact Measure in Atypical Behavior	Subdomain of the Autism Impact Measure in Atypical Behavior	baseline, 12 weeks, 24 weeks
Subdomain 4 of the Autism Impact Measure in Social Reciprocity	Subdomain of the Autism Impact Measure in Social Reciprocity	baseline, 12 weeks, 24 weeks
Subdomain 5 of the Autism Impact Measure in Peer Interaction	Subdomain of the Autism Impact Measure in Peer Interaction	baseline, 12 weeks, 24 weeks
Subdomain 6 of the Autism Impact Measure in questions not related to other subdomains	Subdomain of the Autism Impact Measure in questions not related to other subdomains	baseline, 12 weeks, 24 weeks

Collaborators and Investigators

• Sponsor: Floreo, Inc.
• Investigators: Principal Investigator: Suzanne Goh, MD, Cortica

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2024
• Primary Completion (Actual): November 30, 2025
• Study Completion (Actual): April 3, 2026

Study Registration Dates

• First Submitted: May 31, 2024
• First Submitted That Met QC Criteria: June 5, 2024
• First Posted (Actual): June 11, 2024

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Virtual Reality
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Behavior; Autism Spectrum Disorder; Communication
• Other Study ID Numbers: FLO-CL-2023-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plans to share

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No