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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

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Cortica- Burlington
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BurlingtonUnited StatesUnknown status
Cortica- Carlsbad
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CarlsbadUnited StatesUnknown status
Cortica- Dedham
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DedhamUnited StatesUnknown status
Cortica- Glendale
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GlendaleUnited StatesUnknown status
Cortica- Irvine
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IrvineUnited StatesUnknown status
Cortica- Laguna Niguel
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Laguna NiguelUnited StatesUnknown status
Cortica- Naperville
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NapervilleUnited StatesUnknown status
Cortica- Plano
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PlanoUnited StatesUnknown status
Cortica- Ridgefield
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RidgefieldUnited StatesUnknown status
Cortica- San Diego
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San DiegoUnited StatesUnknown status
Cortica- Marin
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San RafaelUnited StatesUnknown status
Cortica- Shrewsbury
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ShrewsburyUnited StatesUnknown status
Cortica- The Woodlands
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The WoodlandsUnited StatesUnknown status
Cortica- Torrance
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TorranceUnited StatesUnknown status
Cortica- Trumbull
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TrumbullUnited StatesUnknown status
Cortica- Westchester
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WestchesterUnited StatesUnknown status
Cortica- Westlake Village
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Westlake VillageUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.