Virtual Reality for Autism
(SoCaVR Trial)
Recruiting in Palo Alto (17 mi)
+16 other locations
Age: < 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Floreo, Inc.
Disqualifiers: Epilepsy, Migraine, Vertigo, others
No Placebo Group
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Floreo VR for autism?
Research shows that virtual reality (VR) can be a safe and effective tool for teaching social skills to individuals with autism. Studies indicate that VR is motivating and feasible for use, helping users learn important life skills and improve social interactions.
12345Is virtual reality safe for people with autism?
Research shows that virtual reality (VR) is generally safe for people with autism. Studies found no major negative effects, and most participants reported no discomfort or issues while using VR devices.
12467How is the Floreo VR treatment different from other autism treatments?
Floreo VR is unique because it uses virtual reality to create interactive, three-dimensional simulations of real-world settings, helping individuals with autism develop social and interaction skills in a safe and controlled environment. This approach is different from traditional therapies as it provides an immersive experience that can be both engaging and effective for learning practical life skills.
12458Eligibility Criteria
This trial is for children with autism, including those diagnosed with Autism Spectrum Disorder or Social Communication Disorder. They'll use VR technology twice a week for twelve weeks to see if it helps improve their social skills.Inclusion Criteria
I can complete and pass a VR orientation test.
I go to the clinic at least twice a week for treatments.
My legal guardian can sign the consent for me and I understand what the study involves.
+2 more
Exclusion Criteria
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.
I do not have any health issues like uncontrolled epilepsy, severe migraines, balance disorders, blindness, deafness, or eye movement problems that would stop me from safely participating in the study.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants engage with the VR product twice a week for twelve weeks, randomized to either the Floreo Clinical Product or a VR Control group experience
12 weeks
24 visits (virtual)
Follow-up
Participants are monitored for safety and effectiveness after treatment, with assessments at 16, 20, and 24 weeks
12 weeks
VR Control Crossover
Participants who opt in will run the 12 week Floreo VR program
12 weeks
Participant Groups
The study tests the effectiveness of a Virtual Reality (VR) program called Floreo VR against a control VR experience. Children will be randomly placed in one of these two groups to compare skill and behavior development.
3Treatment groups
Experimental Treatment
Active Control
Group I: VR Control CrossoverExperimental Treatment2 Interventions
For participants who opt in, they will run the 12 week Floreo VR program
Group II: Floreo VRExperimental Treatment1 Intervention
Floreo VR is a 12 week program
Group III: VR ControlActive Control1 Intervention
VR Control is a 12 week program that matches the Floreo VR interactions
Floreo VR is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Floreo VR for:
- Autism Spectrum Disorder (ASD) therapy
- Social skills training
- Communication skills training
🇪🇺 Approved in European Union as Floreo VR for:
- Autism Spectrum Disorder (ASD) therapy
- Social skills training
- Communication skills training
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Cortica- GlendaleGlendale, CA
Cortica- IrvineIrvine, CA
Cortica- TorranceTorrance, CA
Cortica- Westlake VillageWestlake Village, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Floreo, Inc.Lead Sponsor
References
Virtual Reality Support for Joint Attention Using the Floreo Joint Attention Module: Usability and Feasibility Pilot Study. [2023]Advances in virtual reality (VR) technology offer new opportunities to design supports for the core behaviors associated with autism spectrum disorder (ASD) that promote progress toward optimal outcomes. Floreo has developed a novel mobile VR platform that pairs a user receiving instruction on target skills with an adult monitor.
Safety and Feasibility of an Immersive Virtual Reality Intervention Program for Teaching Police Interaction Skills to Adolescents and Adults with Autism. [2021]Low-cost, wireless immersive virtual reality (VR) holds significant promise as a flexible and scalable intervention tool to help individuals with autism spectrum disorder (ASD) learn and develop critical practical life skills, including interacting safely and effectively with police officers. Previous research suggests that VR is a motivating intervention platform, but many individuals with ASD also exhibit anxiety and sensory sensitivities which might make it difficult to tolerate VR experiences. Here, we describe the results of a relatively large-scale, National Institutes of Health-funded systematic examination of the safety, feasibility, and usability of an immersive VR training program in adolescents and adults with ASD, aged 12 and older. Sixty verbally fluent individuals with no personal or immediate family history of seizures or migraines participated in either one (n = 30) or three 45-min (n = 30) VR sessions using a lightweight wireless headset, and were monitored for side effects. Participants also reported on system usability, enjoyment, and willingness to engage in further VR sessions. Results confirm that immersive VR is safe, feasible, and highly usable for verbally fluent adolescents and adults with ASD. LAY SUMMARY: Immersive virtual reality (VR) holds promise as a means to provide social skills interventions for individuals with autism spectrum disorder (ASD), but it is unclear whether associated anxiety and sensory symptoms might limit feasibility. Here, we report data that indicate that immersive VR is both safe and feasible for use in verbally fluent adolescents and adults with ASD, for up to three 45-min sessions. Autism Res 2020, 13: 1418-1424. © 2020 International Society for Autism Research, Wiley Periodicals, Inc.
Effects of a Nonwearable Digital Therapeutic Intervention on Preschoolers With Autism Spectrum Disorder in China: Open-Label Randomized Controlled Trial. [2023]Autism spectrum disorder (ASD) is a neurodevelopmental disorder that can cause difficulty with communication and social interactions as well as complicated family dynamics. Digital health interventions can reduce treatment costs and promote healthy lifestyle changes. These therapies can be adjunctive or replace traditional treatments. However, issues with cooperation and compliance prevent preschool patients with ASD from applying these tools. In this open-label, randomized controlled trial, we developed a nonwearable digital therapy called virtual reality-incorporated cognitive behavioral therapy (VR-CBT).
Brief Report: A Pilot Study of the Use of a Virtual Reality Headset in Autism Populations. [2019]The application of virtual reality technologies (VRTs) for users with autism spectrum disorder (ASD) has been studied for decades. However, a gap remains in our understanding surrounding VRT head-mounted displays (HMDs). As newly designed HMDs have become commercially available (in this study the Oculus Rift™) the need to investigate newer devices is immediate. This study explored willingness, acceptance, sense of presence and immersion of ASD participants. Results revealed that all 29 participants (mean age = 32; 33 % with IQ
Virtual Reality Technology as an Educational and Intervention Tool for Children with Autism Spectrum Disorder: Current Perspectives and Future Directions. [2022]The worldwide rising trend of autism spectrum disorder (ASD) calls for innovative and efficacious techniques for assessment and treatment. Virtual reality (VR) technology gains theoretical support from rehabilitation and pedagogical theories and offers a variety of capabilities in educational and interventional contexts with affordable products. VR is attracting increasing attention in the medical and healthcare industry, as it provides fully interactive three-dimensional simulations of real-world settings and social situations, which are particularly suitable for cognitive and performance training, including social and interaction skills. This review article offers a summary of current perspectives and evidence-based VR applications for children with ASD, with a primary focus on social communication, including social functioning, emotion recognition, and speech and language. Technology- and design-related limitations, as well as disputes over the application of VR to autism research and therapy, are discussed, and future directions of this emerging field are highlighted with regards to application expansion and improvement, technology enhancement, linguistic diversity, and the development of theoretical models and brain-based research.
Safety and Lack of Negative Effects of Wearable Augmented-Reality Social Communication Aid for Children and Adults with Autism. [2023]There is a growing interest in the use of augmented reality (AR) to assist children and adults with autism spectrum disorders (ASD); however, little investigation has been conducted into the safety of AR devices, such as smartglasses. The objective of this report was to assess the safety and potential negative effects of the Empowered Brain system, a novel AR smartglasses-based social communication aid for people with ASD. The version of the Empowered Brain in this report utilized Google Glass (Google, Mountain View, CA, USA) as its hardware platform. A sequential series of 18 children and adults, aged 4.4 to 21.5 years (mean 12.2 years), with clinically diagnosed ASD of varying severity used the system. Users and caregivers were interviewed about the perceived negative effects and design concerns. Most users were able to wear and use the Empowered Brain (n = 16/18, 89%), with most of them reporting no negative effects (n = 14/16, 87.5%). Caregivers observed no negative effects in users (n = 16/16, 100%). Most users (77.8%) and caregivers (88.9%) had no design concerns. This report found no major negative effects in using an AR smartglasses-based social communication aid across a wide age and severity range of people with ASD. Further research is needed to explore longer-term effects of using AR smartglasses in this population.
Brief report: two case studies using virtual reality as a learning tool for autistic children. [2019]The children complied with most requests. Some of our teaching goals were limited by technology or space while others were limited by the difficulty of presenting a task to the children in a way that was understandable within their environment. However, the opportunity to introduce this technology to children was an important first step in exploring the potential VR offers to understanding the perceptual processes involved in autism. Our results indicate that the will accept a VR helmet and wear it, identify familiar objects and qualities of these objects in their environment while using the helmet, and locate and move toward objects in their environment while wearing the helmet. More research is necessary to verify the potential in this area, especially to discover if learning experiences through VR generalize to other environments, but it appears virtual reality may provide a useful tool for furthering our understanding of autism and guiding efforts at treatment and intervention.
Using virtual environments for teaching social understanding to 6 adolescents with autistic spectrum disorders. [2018]Six teenagers with Autistic Spectrum Disorders (ASDs) experienced a Virtual Environment (VE) of a café. They also watched three sets of videos of real cafés and buses and judged where they would sit and explained why. Half of the participants received their VE experience between the first and second sets of videos, and half experienced it between the second and third. Ten naïve raters independently coded participants' judgments and reasoning. In direct relation to the timing of VE use, there were several instances of significant improvement in judgments and explanations about where to sit, both in a video of a café and a bus. The results demonstrate the potential of Virtual Reality for teaching social skills.