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

Last updated: January 2, 2025
Sponsor: Floreo, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Asperger's Disorder

Williams Syndrome

Treatment

VR Control

VR Control Crossover

Floreo VR

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: VR Control
Phase:
Study Start date:
May 31, 2024
Estimated Completion Date:
June 15, 2025

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

    Active - Recruiting

  • Cortica- Glendale

    Glendale, California 91203
    United States

    Active - Recruiting

  • Cortica- Irvine

    Irvine, California 92705
    United States

    Active - Recruiting

  • Cortica- Laguna Niguel

    Laguna Niguel, California 92677
    United States

    Active - Recruiting

  • Cortica- San Diego

    San Diego, California 92121
    United States

    Active - Recruiting

  • Cortica- Marin

    San Rafael, California 94903
    United States

    Active - Recruiting

  • Cortica- Torrance

    Torrance, California 90503
    United States

    Active - Recruiting

  • Cortica- Westlake Village

    Westlake Village, California 91361
    United States

    Active - Recruiting

  • Cortica- Ridgefield

    Ridgefield, Connecticut 06877
    United States

    Completed

  • Cortica- Trumbull

    Trumbull, Connecticut 06611
    United States

    Active - Recruiting

  • Cortica- Naperville

    Naperville, Illinois 60564
    United States

    Active - Recruiting

  • Cortica- Westchester

    Westchester, Illinois 60154
    United States

    Active - Recruiting

  • Cortica- Burlington

    Burlington, Massachusetts 01830
    United States

    Active - Recruiting

  • Cortica- Dedham

    Dedham, Massachusetts 20815
    United States

    Active - Recruiting

  • Cortica- Shrewsbury

    Shrewsbury, Massachusetts 01545
    United States

    Active - Recruiting

  • Cortica- West Springfield

    West Springfield, Massachusetts 01089
    United States

    Active - Recruiting

  • Cortica- Plano

    Plano, Texas 75093
    United States

    Active - Recruiting

  • Cortica- The Woodlands

    The Woodlands, Texas 77381
    United States

    Active - Recruiting

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