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

Completed · Not applicable

Conditions studied: Autism Spectrum Disorder, Social Communication

In brief

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.

Key facts

Study ID

NCT06453629

Run by

Floreo, Inc.

People needed

117

Starts

2024-05-31

Expected to finish

2026-04-03

Last updated by the study team

2026-04-06

Who can join

Age: 5 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Cortica- Carlsbad — Carlsbad, California, United States
• Cortica- Glendale — Glendale, California, United States
• Cortica- Irvine — Irvine, California, United States
• Cortica- Laguna Niguel — Laguna Niguel, California, United States
• Cortica- San Diego — San Diego, California, United States
• Cortica- Marin — San Rafael, California, United States
• Cortica- Torrance — Torrance, California, United States
• Cortica- Westlake Village — Westlake Village, California, United States
• Cortica- Ridgefield — Ridgefield, Connecticut, United States
• Cortica- Trumbull — Trumbull, Connecticut, United States
• Cortica- Naperville — Naperville, Illinois, United States
• Cortica- Westchester — Westchester, Illinois, United States
• Cortica- Burlington — Burlington, Massachusetts, United States
• Cortica- Dedham — Dedham, Massachusetts, United States
• Cortica- Shrewsbury — Shrewsbury, Massachusetts, United States
• Cortica- Plano — Plano, Texas, United States
• Cortica- The Woodlands — The Woodlands, Texas, United States

Full record on ClinicalTrials.gov

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