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NCT06453629 · ClinicalTrials.gov registry record · NA
RCT to Evaluate Social Skills in Children With Autism Using VR Technology (SoCaVR)
A NA study of Autism Spectrum Disorder and Social Communication, sponsored by Floreo.
- Active
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 17
- Study locations
NCT06453629: Active NA study of Autism Spectrum Disorder and Social Communication, sponsored by Floreo.
NCT06453629 is a NA study of Autism Spectrum Disorder and Social Communication that is active but no longer recruiting, run by Floreo. The registered enrollment target is 100 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (26% lower). The trial reports 17 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06453629, a NA study of Autism Spectrum Disorder and Social Communication, is active but no longer recruiting, sponsored by Floreo.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 17
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Floreo VR
- DEVICE VR Control
- DEVICE VR Control Crossover
Study Locations (17)
California
- Cortica- Carlsbad - Carlsbad
- Cortica- Glendale - Glendale
- Cortica- Irvine - Irvine
- Cortica- Laguna Niguel - Laguna Niguel
- Cortica- San Diego - San Diego
- Cortica- Marin - San Rafael
- Cortica- Torrance - Torrance
- Cortica- Westlake Village - Westlake Village
Massachusetts
- Cortica- Burlington - Burlington
- Cortica- Dedham - Dedham
- Cortica- Shrewsbury - Shrewsbury
Connecticut
- Cortica- Ridgefield - Ridgefield
- Cortica- Trumbull - Trumbull
Illinois
- Cortica- Naperville - Naperville
- Cortica- Westchester - Westchester
Texas
- Cortica- Plano - Plano
- Cortica- The Woodlands - The Woodlands
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-05-31 |
| Est. Completion | 2026-03-15 |
| Phase | NA |
What the registry record for NCT06453629 still lists
NCT06453629 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (26% lower).
The record links to 2 conditions, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 3 interventions - of which Floreo VR is the first listed.
NCT06453629 lists 17 locations in 5 states (California, Massachusetts, Connecticut).
Frequently Asked Questions
What is clinical trial NCT06453629 about?
NCT06453629 is a clinical study titled "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 prod...
What is the current status of trial NCT06453629?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-05-31. Estimated completion is 2026-03-15.
What conditions does trial NCT06453629 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder, Social Communication.
What interventions are being tested in trial NCT06453629?
The interventions under investigation include: Floreo VR (DEVICE), VR Control (DEVICE), VR Control Crossover (DEVICE).
Who is sponsoring clinical trial NCT06453629?
This trial is sponsored by Floreo, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06453629 being conducted?
This trial has 17 study locations across California, Connecticut, Illinois, Massachusetts, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06453629's enrollment target sits among peer trials
100 71st of 224 higher than 147 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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