Virtual Reality Intervention for Skill Acquisition Support in Autism Spectrum Disorder (ASD)

Floreo

Status and phase: Completed; Phase 2

Conditions: Autism Spectrum Disorder

Treatments: Device: Floreo VR Building Social Connections; Device: Sham

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05791071

Floreo Cortica Protocol

Details and patient eligibility

About

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)

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 4 to 10 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

Floreo VR Building Social Connections

Experimental group

Description:

Participants will receive Floreo VR Building Social Connections lessons approximately 3 times a week for no more than 15 minutes per session.

Treatment:

Device: Floreo VR Building Social Connections

Sham

Sham Comparator group

Description:

Participants will receive non-interventional active VR videos approximately 3 times a week for no more than 15 minutes per session.

Treatment:

Device: Sham