Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453629
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-31
Brief Title:
RCT to Evaluate Social Skills in Children with Autism Using VR Technology SoCaVR
Sponsor:
Floreo Inc
Organization:
Floreo Inc
Study Overview
Official Title:
A Randomized Controlled Study to Evaluate Social Skill Treatment Options in Children with Autism Using VR Technology
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SoCaVR
Brief Summary:
The goal of this randomized clinical trial is to compare and learn about Virtual Reality VR in children with autismAutistic 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
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
Detailed Description:
The purpose of this study is to find out if Floreos VR clinical program can help with autism symptoms such as social communication skills in autistic children Recent advances in VR technology offers a new way to improve these types of skills in children with autism in an immersive and controlled environment
Questionnaires answered by adult caregivers will be used to assess the childs behaviors during the time of treatment
Clinician observations will also be conducted as a part of this study
Questionnaires answered by adult caregivers will be used to assess the childs behaviors during the time of treatment
Clinician observations will also be conducted as a part of this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None