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Behavioural Intervention

Virtual Reality for Autism (SoCaVR Trial)

N/A
Recruiting
Led By Suzanne Goh, MD
Research Sponsored by Floreo, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Receiving therapies at least two times per week in a clinic setting
Five to ten years old (inclusive) at the time of consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 16, 20, and 24 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to see if using a Virtual Reality (VR) product called Floreo can help improve symptoms of autism in children. Participants will use the VR product twice a week for twelve weeks and will

Who is the study for?
This trial is for children with autism, including those diagnosed with Autism Spectrum Disorder or Social Communication Disorder. They'll use VR technology twice a week for twelve weeks to see if it helps improve their social skills.
What is being tested?
The study tests the effectiveness of a Virtual Reality (VR) program called Floreo VR against a control VR experience. Children will be randomly placed in one of these two groups to compare skill and behavior development.
What are the potential side effects?
Since this trial involves non-invasive VR technology, side effects are minimal but may include temporary discomfort like dizziness, nausea, or eye strain from using the VR headset.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I go to the clinic at least twice a week for treatments.
Select...
I am between 5 and 10 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 16, 20, and 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 16, 20, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Autism Impact Measure (AIM)
Secondary study objectives
Assessment of Functional Living Skills (AFLS)
Child and Family Quality of Life (CFQL-2)
Total Autism Impact Measure (AIM) Score
Other study objectives
Childhood Autism Rating Scale (CARS-2)
Floreo Skills Acquisition and Observations
Rate of Skills Acquisition
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: VR Control CrossoverExperimental Treatment2 Interventions
For participants who opt in, they will run the 12 week Floreo VR program
Group II: Floreo VRExperimental Treatment1 Intervention
Floreo VR is a 12 week program
Group III: VR ControlActive Control1 Intervention
VR Control is a 12 week program that matches the Floreo VR interactions

Find a Location

Who is running the clinical trial?

Floreo, Inc.Lead Sponsor
3 Previous Clinical Trials
188 Total Patients Enrolled
3 Trials studying Autism Spectrum Disorder
188 Patients Enrolled for Autism Spectrum Disorder
Suzanne Goh, MDPrincipal InvestigatorCortica
Emily Newton, PsyDPrincipal InvestigatorCortica
~17 spots leftby Dec 2024
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