NCT06453629Completed
RCT to Evaluate Social Skills in Children With Autism Using VR Technology (SoCaVR)
A Randomized Controlled Study to Evaluate Social Skill Treatment Options in Children With Autism Using VR Technology
Source: ClinicalTrials.gov · Last updated 6 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 117 (actual)
- First submitted
- 31 May 2024
- Start date
- 31 May 2024
- Primary completion date
- 30 Nov 2025
- Lead sponsor
- Floreo, Inc.
- Diseases
- Autism
- NCT number
- NCT06453629
What you commit to
- Study type: Interventional
- Participants enrolled: 117
- From 31 May 2024 to the primary completion date, 30 Nov 2025
- 17 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 5 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (17)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cortica- Burlington Coordinator of this site? Confirm its status | Burlington | United States | Unknown status |
| Cortica- Carlsbad Coordinator of this site? Confirm its status | Carlsbad | United States | Unknown status |
| Cortica- Dedham Coordinator of this site? Confirm its status | Dedham | United States | Unknown status |
| Cortica- Glendale Coordinator of this site? Confirm its status | Glendale | United States | Unknown status |
| Cortica- Irvine Coordinator of this site? Confirm its status | Irvine | United States | Unknown status |
| Cortica- Laguna Niguel Coordinator of this site? Confirm its status | Laguna Niguel | United States | Unknown status |
| Cortica- Naperville Coordinator of this site? Confirm its status | Naperville | United States | Unknown status |
| Cortica- Plano Coordinator of this site? Confirm its status | Plano | United States | Unknown status |
| Cortica- Ridgefield Coordinator of this site? Confirm its status | Ridgefield | United States | Unknown status |
| Cortica- San Diego Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Cortica- Marin Coordinator of this site? Confirm its status | San Rafael | United States | Unknown status |
| Cortica- Shrewsbury Coordinator of this site? Confirm its status | Shrewsbury | United States | Unknown status |
| Cortica- The Woodlands Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Cortica- Torrance Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
| Cortica- Trumbull Coordinator of this site? Confirm its status | Trumbull | United States | Unknown status |
| Cortica- Westchester Coordinator of this site? Confirm its status | Westchester | United States | Unknown status |
| Cortica- Westlake Village Coordinator of this site? Confirm its status | Westlake Village | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.