Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD)
- Conditions
- Autism Spectrum Disorder
- Interventions
- Device: Floreo VR Building Social ConnectionsDevice: Sham
- Registration Number
- NCT05791071
- Lead Sponsor
- Floreo, Inc.
- Brief Summary
A Randomized Controlled Phase II study to assess the efficacy of Floreo VR (Virtual reality) Building Social Connections as treatment for social skills in children with Autism Spectrum Disorder (ASD)
- Detailed Description
In this randomized controlled phase II study, 30 eligible subjects aged 4-10 years old with documented ASD diagnoses will be enrolled and randomized in a 1:1 ratio intervention vs control group.
The Floreo VR Building Social Connections intervention is designed to be administered for 12 weeks, with three treatment visits per week, for a total of 36 treatment visits.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Males and females aged 4 years to 10 years 11 months of age (up to 11th birthday at randomization).
- Patients or legally authorized representatives must provide written informed consent and be willing and able to comply with study procedures. Participants must provide informed assent as clinically appropriate.
- A diagnosis of autism spectrum disorder on the basis of the clinical judgement of a qualified clinician according to DSM-5 criteria, supported by either the Autism Diagnostic Observation Schedule or the Autism Diagnostic Interview-Revised.
- Participants must receive ABA therapy at Cortica, with scheduled ABA sessions in clinic at least 3 times per week.
- Participants must be able to tolerate VR therapy in the judgement of parent or caregiver and study staff
- A history of photosensitive epilepsy, or photoparoxysmal response on electroencephalogram (EEG)
- Active diagnosis of migraine headache or migraine variant (abdominal migraine, cyclic vomiting syndrome), not adequately controlled
- History of balance disorder including vertigo, motion sensitivity, or balance disorder
- Primary sensory impairment (blindness, deafness)
- Motor disorder that would interfere with VR engagement
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Floreo VR Building Social Connections Floreo VR Building Social Connections Participants will receive Floreo VR Building Social Connections lessons approximately 3 times a week for no more than 15 minutes per session. Sham Sham Participants will receive non-interventional active VR videos approximately 3 times a week for no more than 15 minutes per session.
- Primary Outcome Measures
Name Time Method Autism Impact Measure (AIM) Assessment The AIM takes approximately 30 minutes to complete. The AIM is a 25-item parent questionnaire targeting sensitivity to change of core ASD symptoms. The questionnaire uses a 2-week recall period with items rated on two corresponding 5-point scales (frequency and impact). The items cover distinct sub-domains of ASD symptoms including Repetitive Behavior, Atypical Behavior, Social Reciprocity, and Peer Interaction. A composite score is also calculated.
- Secondary Outcome Measures
Name Time Method CARS-2 The CARS-3 takes approximately 5-10 minutes to complete after the information needed to make the ratings is collected The CARS-2 is a 15-item rating scale used to identify children with autism and determine overall symptom severity. The scale is completed by a clinician familiar with the assessment of ASD after collecting information by direct interview and observation. The rater will also make use of supplemental collected using an unscored Parent/Caregiver Questionnaire. Only the CARS-2 Standard rating scale will be used for the purposes of this study.
Trial Locations
- Locations (1)
Cortica
🇺🇸Thousand Oaks, California, United States