RCT to Evaluate Social Skills in Children With Autism Using VR Technology (SoCaVR)

Autism Spectrum Disorder Clinical Trial

— SoCaVR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06453629
• Other study ID #: FLO-CL-2023-001
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: January 15, 2025

Study information

• Verified date: May 2024
• Source: Floreo, Inc.
• Contact: Shirley Mak-Parisi, MA
• Phone: 7817893034
• Email: shirley[@]floreovr.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

The purpose of this study is to find out if Floreo's 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 child's behaviors during the time of treatment. Clinician observations will also be conducted as a part of this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 15, 2025
• Est. primary completion date: October 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 10 Years

Eligibility

Inclusion Criteria:

• Five to ten 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

Exclusion Criteria:

• 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
• Participants are enrolled in another clinical study
• Participation in this study is not in the best interest of the child, at the discretion of the treating clinician and the primary investigator.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Device:
• Floreo VR
12 week VR program to help children with ASD to reduce the core symptoms of Autism
• VR Control
12 week program administered in VR
• VR Control Crossover
If opt in, this group will crossover at the end of 12 weeks to the Floreo VR program

Locations

Country	Name	City	State
United States	Cortica- Carlsbad	Carlsbad	California
United States	Cortica- Glendale	Glendale	California
United States	Cortica- Irvine	Irvine	California
United States	Cortica- Laguna Niguel	Laguna Niguel	California
United States	Cortica- Ridgefield	Ridgefield	Connecticut
United States	Cortica- San Diego	San Diego	California
United States	Cortica- Marin	San Rafael	California
United States	Cortica- Torrance	Torrance	California
United States	Cortica- Trumbull	Trumbull	Connecticut
United States	Cortica- Westlake Village	Westlake Village	California

Sponsors (1)

Lead Sponsor	Collaborator
Floreo, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Childhood Autism Rating Scale (CARS-2)	Change from baseline,12, and 24 weeks in scores on the Childhood Autism Rating Scales-2 (CARS-2)	baseline, 12 weeks, 24 weeks
Other	Floreo Skills Acquisition and Observations	Floreo specific skills scores	baseline, 12 weeks, 24 weeks
Other	Rate of Skills Acquisition	Social Skills goals	baseline, 12 weeks, 24 weeks
Other	Subdomain 1 of the Autism Impact Measure in Repetitive Behaviors	Subdomain of the Autism Impact Measure in Repetitive Behaviors	baseline, 12 weeks, 24 weeks
Other	Subdomain 2 of the Autism Impact Measure in Communications	Subdomain of the Autism Impact Measure in Communications	baseline, 12 weeks, 24 weeks
Other	Subdomain 3 of the Autism Impact Measure in Atypical Behavior	Subdomain of the Autism Impact Measure in Atypical Behavior	baseline, 12 weeks, 24 weeks
Other	Subdomain 4 of the Autism Impact Measure in Social Reciprocity	Subdomain of the Autism Impact Measure in Social Reciprocity	baseline, 12 weeks, 24 weeks
Other	Subdomain 5 of the Autism Impact Measure in Peer Interaction	Subdomain of the Autism Impact Measure in Peer Interaction	baseline, 12 weeks, 24 weeks
Other	Subdomain 6 of the Autism Impact Measure in questions not related to other subdomains	Subdomain of the Autism Impact Measure in questions not related to other subdomains	baseline, 12 weeks, 24 weeks
Primary	Autism Impact Measure (AIM)	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.	Baseline-12 weeks
Secondary	Assessment of Functional Living Skills (AFLS)	Change from baseline to 12 weeks in scores on the subdomains of social skills and basic communications in the Assessment of Functional Living Skills (AFLS)	Baseline-12 weeks
Secondary	Child and Family Quality of Life (CFQL-2)	Change from baseline to 12 weeks in scores of the Child and Family Quality of Life (CFQL-2)	Baseline-12 weeks
Secondary	Assessment of Functional Living Skills (AFLS)	Change from 16, 20, 24 weeks in scores on the subdomains of social skills and basic communications in the Assessment of Functional Living Skills (AFLS)	baseline, 16 weeks, 20 weeks, 24 weeks
Secondary	Total Autism Impact Measure (AIM) Score	Responder rate at 16, 20, and 24 weeks for the Total AIM score	baseline, 16 weeks, 20 weeks, 24 weeks
Secondary	Child and Family Quality of Life (CFQL-2)	Change from baseline to 24 weeks in scores on the subdomains of social skills and basic communications in the Assessment of Functional Living Skills (AFLS)	baseline, 16, 20, and 24 weeks