RCT to Evaluate Social Skills in Children with Autism Using VR Technology (SoCaVR)
- Conditions
- Social CommunicationAutism Spectrum Disorder
- Interventions
- Device: Floreo VRDevice: VR ControlDevice: VR Control Crossover
- Registration Number
- NCT06453629
- Lead Sponsor
- Floreo, Inc.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description VR Control Crossover VR Control Crossover For participants who opt in, they will run the 12 week Floreo VR program Floreo VR Floreo VR Floreo VR is a 12 week program VR Control VR Control VR Control is a 12 week program that matches the Floreo VR interactions VR Control Crossover Floreo VR For participants who opt in, they will run the 12 week Floreo VR program
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Assessment of Functional Living Skills (AFLS) baseline, 16 weeks, 20 weeks, 24 weeks 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)
Child and Family Quality of Life (CFQL-2) baseline, 16, 20, and 24 weeks 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)
Trial Locations
- Locations (18)
Cortica- Naperville
🇺🇸Naperville, Illinois, 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- San Diego
🇺🇸San Diego, California, United States
Cortica- Marin
🇺🇸San Rafael, California, United States
Cortica- Torrance
🇺🇸Torrance, California, United States
Cortica- Westlake Village
🇺🇸Westlake Village, California, United States
Cortica- Ridgefield
🇺🇸Ridgefield, Connecticut, United States
Cortica- Trumbull
🇺🇸Trumbull, Connecticut, United States
Cortica- Westchester
🇺🇸Westchester, Illinois, United States
Cortica- Burlington
🇺🇸Burlington, Massachusetts, United States
Cortica- Dedham
🇺🇸Dedham, Massachusetts, United States
Cortica- Shrewsbury
🇺🇸Shrewsbury, Massachusetts, United States
Cortica- West Springfield
🇺🇸West Springfield, Massachusetts, United States
Cortica- Plano
🇺🇸Plano, Texas, United States
Cortica- The Woodlands
🇺🇸The Woodlands, Texas, United States