Autism Spectrum Disorder, Social Communication
Conditions
Keywords
Virtual Reality
Brief 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.
Detailed 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.
Interventions
DEVICEFloreo VR
12 week VR program to help children with ASD to reduce the core symptoms of Autism
DEVICEVR Control
12 week program administered in VR
DEVICEVR Control Crossover
If opt in, this group will crossover at the end of 12 weeks to the Floreo VR program
Sponsors
Floreo, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participant and their adult caregiver will be blinded. The Outcomes Assessor (Clinician) with the adult caregiver will also be blinded.
Intervention model description
Experimental: Floreo VR- 12 week with follow up Active Comparator: VR Control- 12 week with ability to crossover or follow up Other: VR Control Crossover- 12 week of Floreo VR
Eligibility
Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* 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
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 * Participants known to be pregnant * Participation in this study is not in the best interest of the child, at the discretion of the treating clinician and the primary investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Autism Impact Measure (AIM) | Baseline-12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Functional Living Skills (AFLS) | Baseline-12 weeks | 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) |
| Child and Family Quality of Life (CFQL-2) | Baseline-12 weeks | Change from baseline to 12 weeks in scores of the Child and Family Quality of Life (CFQL-2) |
| Total Autism Impact Measure (AIM) Score | baseline, 16 weeks, 20 weeks, 24 weeks | Responder rate at 16, 20, and 24 weeks for the Total AIM score |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSuzanne Goh, MD
Cortica
Outcome results
None listed