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OpenTrials
Completed

NCT Number: NCT06453629

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

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.

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Key information

Conditions

Autism Spectrum Disorder Behavior Child Development Disorders, Pervasive Communication Mental Disorders Neurodevelopmental Disorders Social Communication

Age range

5 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cortica- Carlsbad, Carlsbad, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Floreo VR

Device

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

VR Control

Device

12 week program administered in VR

VR Control Crossover

Device

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

Other names: Crossover group

Primary outcomes

  1. Autism Impact Measure (AIM)

    Time frame: Baseline-12 weeks

    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.

Secondary outcomes

  1. Assessment of Functional Living Skills (AFLS)

    Time frame: Baseline-12 weeks

    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)

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

    Time frame: Baseline-12 weeks

    Change from baseline to 12 weeks in scores of the Child and Family Quality of Life (CFQL-2)

  3. Assessment of Functional Living Skills (AFLS)

    Time frame: baseline, 16 weeks, 20 weeks, 24 weeks

    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)

  4. Total Autism Impact Measure (AIM) Score

    Time frame: baseline, 16 weeks, 20 weeks, 24 weeks

    Responder rate at 16, 20, and 24 weeks for the Total AIM score

  5. Child and Family Quality of Life (CFQL-2)

    Time frame: baseline, 16, 20, and 24 weeks

    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)

Other outcomes

  1. Childhood Autism Rating Scale (CARS-2)

    Time frame: baseline, 12 weeks, 24 weeks

    Change from baseline,12, and 24 weeks in scores on the Childhood Autism Rating Scales-2 (CARS-2)

  2. Floreo Skills Acquisition and Observations

    Time frame: baseline, 12 weeks, 24 weeks

    Floreo specific skills scores

  3. Rate of Skills Acquisition

    Time frame: baseline, 12 weeks, 24 weeks

    Social Skills goals

  4. Subdomain 1 of the Autism Impact Measure in Repetitive Behaviors

    Time frame: baseline, 12 weeks, 24 weeks

    Subdomain of the Autism Impact Measure in Repetitive Behaviors

  5. Subdomain 2 of the Autism Impact Measure in Communications

    Time frame: baseline, 12 weeks, 24 weeks

    Subdomain of the Autism Impact Measure in Communications

  6. Subdomain 3 of the Autism Impact Measure in Atypical Behavior

    Time frame: baseline, 12 weeks, 24 weeks

    Subdomain of the Autism Impact Measure in Atypical Behavior

  7. Subdomain 4 of the Autism Impact Measure in Social Reciprocity

    Time frame: baseline, 12 weeks, 24 weeks

    Subdomain of the Autism Impact Measure in Social Reciprocity

  8. Subdomain 5 of the Autism Impact Measure in Peer Interaction

    Time frame: baseline, 12 weeks, 24 weeks

    Subdomain of the Autism Impact Measure in Peer Interaction

  9. Subdomain 6 of the Autism Impact Measure in questions not related to other subdomains

    Time frame: baseline, 12 weeks, 24 weeks

    Subdomain of the Autism Impact Measure in questions not related to other subdomains

Sponsors and collaborators

Lead sponsor

Floreo, Inc.

Industry

Registry information

Official study title

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

Acronym: SoCaVR

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 11, 2024
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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