Clinical trial NCT05791071: Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD)
Official title: A Randomized Controlled Phase II Study to Assess the Efficacy of Floreo VR Building Social Connections vs. Active VR Exposure Control as Treatment for Social Skills in Autistic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Keywords: ASD
Virtual Reality
VR
Social Communication
Applied Behavior Analysis Therapy
Lead sponsor: Floreo, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cortica
First posted: 2023-03-30
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The two parallel groups include an experimental group that will receive the Floreo VR Building Social Connections program and a control group that will receive non-interventional active VR programing.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Autism Impact Measure (AIM) Assessment
timeFrame: The AIM takes approximately 30 minutes to complete.
Secondary outcomes:
measure: CARS-2
timeFrame: The CARS-3 takes approximately 5-10 minutes to complete after the information needed to make the ratings is collected
Other outcomes:
measure: AIM sub-domain scores
timeFrame: The AIM takes approximately 30 minutes to complete.
measure: Vineland-3 Adaptive Behavior Composite and sub-domain scores
timeFrame: The Vineland-3 Comprehensive Interview Form takes approximately 60-90 minutes to complete
measure: Adverse events related to VR use
timeFrame: 5-10 minutes as needed to fill out AE form
Locations:
city: Thousand Oaks
country: United States
facility: Cortica
state: California
Study officials:
References:
citation: Kanne SM, Mazurek MO, Sikora D, Bellando J, Branum-Martin L, Handen B, Katz T, Freedman B, Powell MP, Warren Z. The Autism Impact Measure (AIM): initial development of a new tool for treatment outcome measurement. J Autism Dev Disord. 2014 Jan;44(1):168-79. doi: 10.1007/s10803-013-1862-3.