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

NCT06453629 | Active Not Recruiting FDA Device

• 1 other identifier: FLO-CL-2023-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 17

Brief 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

Autism Spectrum Disorder; Social Communication

Keywords

Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Assessment of Functional Living Skills (AFLS)

  Baseline-12 weeks

• Child and Family Quality of Life (CFQL-2)

  Baseline-12 weeks

• Assessment of Functional Living Skills (AFLS)

  baseline, 16 weeks, 20 weeks, 24 weeks

• Total Autism Impact Measure (AIM) Score

  baseline, 16 weeks, 20 weeks, 24 weeks

• Child and Family Quality of Life (CFQL-2)

  baseline, 16, 20, and 24 weeks

Other Outcomes (9)

• Childhood Autism Rating Scale (CARS-2)

  baseline, 12 weeks, 24 weeks

• Floreo Skills Acquisition and Observations

  baseline, 12 weeks, 24 weeks

• Rate of Skills Acquisition

  baseline, 12 weeks, 24 weeks

Study Arms (3)

Floreo VR

EXPERIMENTAL

Floreo VR is a 12 week program

Device: Floreo VR

VR Control

ACTIVE COMPARATOR

VR Control is a 12 week program that matches the Floreo VR interactions

Device: VR Control

VR Control Crossover

OTHER

For participants who opt in, they will run the 12 week Floreo VR program

Device: Floreo VR; Device: VR Control Crossover

Interventions

Floreo VR DEVICE

12 week VR program to help children with ASD to reduce the core symptoms of Autism

Floreo VR; VR Control Crossover

VR Control DEVICE

12 week program administered in VR

VR Control

VR Control Crossover DEVICE

If opt in, this group will crossover at the end of 12 weeks to the Floreo VR program

Also known as: Crossover group

VR Control Crossover

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Floreo, Inc.: lead

Study Sites (17)

Cortica- Carlsbad

Carlsbad, California, 92008, United States

Location

Cortica- Glendale

Glendale, California, 91203, United States

Location

Cortica- Irvine

Irvine, California, 92705, United States

Location

Cortica- Laguna Niguel

Laguna Niguel, California, 92677, United States

Location

Cortica- San Diego

San Diego, California, 92121, United States

Location

Cortica- Marin

San Rafael, California, 94903, United States

Location

Cortica- Torrance

Torrance, California, 90503, United States

Location

Cortica- Westlake Village

Westlake Village, California, 91361, United States

Location

Cortica- Ridgefield

Ridgefield, Connecticut, 06877, United States

Location

Cortica- Trumbull

Trumbull, Connecticut, 06611, United States

Location

Cortica- Naperville

Naperville, Illinois, 60564, United States

Location

Cortica- Westchester

Westchester, Illinois, 60154, United States

Location

Cortica- Burlington

Burlington, Massachusetts, 01830, United States

Location

Cortica- Dedham

Dedham, Massachusetts, 20815, United States

Location

Cortica- Shrewsbury

Shrewsbury, Massachusetts, 01545, United States

Location

Cortica- Plano

Plano, Texas, 75093, United States

Location

Cortica- The Woodlands

The Woodlands, Texas, 77381, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Communication

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Suzanne Goh, MD

  Cortica

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant and their adult caregiver will be blinded. The Outcomes Assessor (Clinician) with the adult caregiver will also be blinded.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Experimental: Floreo VR- 12 week with follow up Active Comparator: VR Control- 12 week with ability to crossover or follow up Other: VR Control Crossover- 12 week of Floreo VR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 11, 2024
• Study Start: May 31, 2024
• Primary Completion: December 30, 2025
• Study Completion: March 15, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)