A Randomized Controlled Study to Evaluate Social Skill Treatment Options in Children With Autism Using VR Technology

Status: Recruiting
Location: See all (18) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Maximum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
California
Cortica- Carlsbad
RECRUITING
Carlsbad
Cortica- Glendale
RECRUITING
Glendale
Cortica- Irvine
RECRUITING
Irvine
Cortica- Laguna Niguel
RECRUITING
Laguna Niguel
Cortica- San Diego
RECRUITING
San Diego
Cortica- Marin
ACTIVE_NOT_RECRUITING
San Rafael
Cortica- Torrance
RECRUITING
Torrance
Cortica- Westlake Village
ACTIVE_NOT_RECRUITING
Westlake Village
Connecticut
Cortica- Ridgefield
COMPLETED
Ridgefield
Cortica- Trumbull
RECRUITING
Trumbull
Illinois
Cortica- Naperville
ACTIVE_NOT_RECRUITING
Naperville
Cortica- Westchester
ACTIVE_NOT_RECRUITING
Westchester
Massachusetts
Cortica- Burlington
RECRUITING
Burlington
Cortica- Dedham
RECRUITING
Dedham
Cortica- Shrewsbury
ACTIVE_NOT_RECRUITING
Shrewsbury
Cortica- West Springfield
WITHDRAWN
West Springfield
Texas
Cortica- Plano
ACTIVE_NOT_RECRUITING
Plano
Cortica- The Woodlands
ACTIVE_NOT_RECRUITING
The Woodlands
Contact Information
Primary
Shirley Mak-Parisi, MA
shirley@floreovr.com
7817893034
Backup
Liz Pascual
liz@floreovr.com
Time Frame
Start Date: 2024-05-31
Estimated Completion Date: 2026-03-15
Participants
Target number of participants: 100
Treatments
Experimental: Floreo VR
Floreo VR is a 12 week program
Active_comparator: VR Control
VR Control is a 12 week program that matches the Floreo VR interactions
Other: VR Control Crossover
For participants who opt in, they will run the 12 week Floreo VR program
Related Therapeutic Areas
Sponsors
Leads: Floreo, Inc.

This content was sourced from clinicaltrials.gov