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

Last updated: November 14, 2025
Sponsor: Floreo, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Autism

Williams Syndrome

Asperger's Disorder

Treatment

Floreo VR

VR Control Crossover

VR Control

Clinical Study ID

NCT06453629
FLO-CL-2023-001
  • Ages 5-18
  • All Genders

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.

Eligibility Criteria

Inclusion

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 consentindicating that they have been informed about the study and able to complete allvisits [If age appropriate, an assent will also be administered to the participantto 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-Vcriteria

  • Receiving therapies at least two times per week in a clinic setting

  • Participant is able to complete and pass the VR orientation screening

Exclusion

Exclusion Criteria:

  • Significant medical condition(s) [examples listed below] or other circumstanceswhich, in the opinion of the treating clinician, would preclude compliance with theprotocol, adequate cooperation in the study, or may prevent the participant fromsafely 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 thediscretion of the treating clinician and the primary investigator.

Study Design

Total Participants: 100
Treatment Group(s): 3
Primary Treatment: Floreo VR
Phase:
Study Start date:
May 31, 2024
Estimated Completion Date:
March 15, 2026

Study 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.

Connect with a study center

  • Cortica- Carlsbad

    Carlsbad, California 92008
    United States

    Site Not Available

  • Cortica- Glendale

    Glendale, California 91203
    United States

    Site Not Available

  • Cortica- Irvine

    Irvine, California 92705
    United States

    Site Not Available

  • Cortica- Laguna Niguel

    Laguna Niguel, California 92677
    United States

    Site Not Available

  • Cortica- San Diego

    San Diego, California 92121
    United States

    Site Not Available

  • Cortica- Marin

    San Rafael, California 94903
    United States

    Site Not Available

  • Cortica- Torrance

    Torrance, California 90503
    United States

    Site Not Available

  • Cortica- Westlake Village

    Westlake Village, California 91361
    United States

    Site Not Available

  • Cortica- Carlsbad

    Carlsbad 5334223, California 5332921 92008
    United States

    Site Not Available

  • Cortica- Glendale

    Glendale 5352423, California 5332921 91203
    United States

    Site Not Available

  • Cortica- Irvine

    Irvine 5359777, California 5332921 92705
    United States

    Site Not Available

  • Cortica- Laguna Niguel

    Laguna Niguel 5364329, California 5332921 92677
    United States

    Site Not Available

  • Cortica- San Diego

    San Diego 5391811, California 5332921 92121
    United States

    Site Not Available

  • Cortica- Marin

    San Rafael 5392567, California 5332921 94903
    United States

    Site Not Available

  • Cortica- Torrance

    Torrance 5403022, California 5332921 90503
    United States

    Site Not Available

  • Cortica- Westlake Village

    Westlake Village 5408395, California 5332921 91361
    United States

    Site Not Available

  • Cortica- Ridgefield

    Ridgefield, Connecticut 06877
    United States

    Site Not Available

  • Cortica- Trumbull

    Trumbull, Connecticut 06611
    United States

    Site Not Available

  • Cortica- Ridgefield

    Ridgefield 4841463, Connecticut 4831725 06877
    United States

    Site Not Available

  • Cortica- Trumbull

    Trumbull 4844459, Connecticut 4831725 06611
    United States

    Site Not Available

  • Cortica- Naperville

    Naperville, Illinois 60564
    United States

    Site Not Available

  • Cortica- Westchester

    Westchester, Illinois 60154
    United States

    Site Not Available

  • Cortica- Naperville

    Naperville 4903279, Illinois 4896861 60564
    United States

    Site Not Available

  • Cortica- Westchester

    Westchester 4916140, Illinois 4896861 60154
    United States

    Site Not Available

  • Cortica- Burlington

    Burlington, Massachusetts 01830
    United States

    Site Not Available

  • Cortica- Dedham

    Dedham, Massachusetts 20815
    United States

    Site Not Available

  • Cortica- Shrewsbury

    Shrewsbury, Massachusetts 01545
    United States

    Site Not Available

  • Cortica- West Springfield

    West Springfield, Massachusetts 01089
    United States

    Site Not Available

  • Cortica- Burlington

    Burlington 4931737, Massachusetts 6254926 01830
    United States

    Site Not Available

  • Cortica- Dedham

    Dedham 4934664, Massachusetts 6254926 20815
    United States

    Site Not Available

  • Cortica- Shrewsbury

    Shrewsbury 4950898, Massachusetts 6254926 01545
    United States

    Site Not Available

  • Cortica- Plano

    Plano, Texas 75093
    United States

    Site Not Available

  • Cortica- The Woodlands

    The Woodlands, Texas 77381
    United States

    Site Not Available

  • Cortica- Plano

    Plano 4719457, Texas 4736286 75093
    United States

    Site Not Available

  • Cortica- The Woodlands

    The Woodlands 4736476, Texas 4736286 77381
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.