Using virtual reality to improve social skills in children with autism
A Randomized Controlled Study to Evaluate Social Skill Treatment Options in Children with Autism Using VR Technology
This study is testing if a virtual reality program can help improve social skills in children with autism aged 5 to 18.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 5 Years to 18 Years |
| Sex | All |
| Sponsor | Floreo, Inc. Industry-sponsored |
| Locations | 18 sites (Carlsbad, California and 17 other locations) |
| Trial ID | NCT06453629 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of the Floreo virtual reality (VR) program in improving social communication skills in children diagnosed with Autism Spectrum Disorder (ASD). Participants aged 5 to 18 will engage with the VR product twice a week for twelve weeks, while being randomized into either the Floreo VR group or a control group. The study will assess changes in autism symptoms through caregiver questionnaires and clinician observations, comparing the two groups to determine the impact of the VR intervention on skill development.
Who should consider this trial
Good fit: Ideal candidates are children aged 5 to 18 with a verified diagnosis of Autism Spectrum Disorder who are currently receiving therapy.
Not a fit: Patients with significant medical conditions or uncontrolled neurological issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic approach to enhance social skills in children with autism.
How similar studies have performed: Other studies have shown promise in using virtual reality for therapeutic purposes in autism, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Carlsbad, California and 17 other locations
- Cortica- Carlsbad — Carlsbad, California, United States (Recruiting)
- Cortica- Glendale — Glendale, California, United States (Recruiting)
- Cortica- Irvine — Irvine, California, United States (Recruiting)
- Cortica- Laguna Niguel — Laguna Niguel, California, United States (Recruiting)
- Cortica- San Diego — San Diego, California, United States (Recruiting)
- Cortica- Marin — San Rafael, California, United States (Recruiting)
- Cortica- Torrance — Torrance, California, United States (Recruiting)
- Cortica- Westlake Village — Westlake Village, California, United States (Recruiting)
- Cortica- Ridgefield — Ridgefield, Connecticut, United States (Completed)
- Cortica- Trumbull — Trumbull, Connecticut, United States (Recruiting)
- Cortica- Naperville — Naperville, Illinois, United States (Recruiting)
- Cortica- Westchester — Westchester, Illinois, United States (Recruiting)
- Cortica- Burlington — Burlington, Massachusetts, United States (Recruiting)
- Cortica- Dedham — Dedham, Massachusetts, United States (Recruiting)
- Cortica- Shrewsbury — Shrewsbury, Massachusetts, United States (Recruiting)
- Cortica- West Springfield — West Springfield, Massachusetts, United States (Recruiting)
- Cortica- Plano — Plano, Texas, United States (Recruiting)
- Cortica- The Woodlands — The Woodlands, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Suzanne Goh, MD — Cortica
- Study coordinator: Shirley Mak-Parisi, MA
- Email: shirley@floreovr.com
- Phone: 7817893034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.