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

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

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)

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: Floreo VR Building Social Connections; Device: Sham

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sinan Turnacioglu; Phone Number: 703-344-3738; Email: sinan@floreovr.com
• Study Contact Backup: Name: Monique Mahony; Email: monique@floreovr.com

Study Locations

• United States
  • California
    • Thousand Oaks, California, United States, 91361
      • Cortica

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Floreo VR Building Social Connections; Floreo's VR platform consists of a VR headset and wireless tethered VR screens (iPhones) and tablets (iPads) that are seamlessly linked in real time, allowing the therapist (or monitor) to set up lessons, change the interactive environment, and provide live verbal and VR-based guidance, feedback, and rewards to users. The lessons that will be implemented in this intervention are aimed at targeting social skills such as communication, joint attention, and social interactions.
Sham Comparator: Sham; Participants will receive non-interventional active VR videos approximately 3 times a week for no more than 15 minutes per session.	Device: Sham; This condition will contain the same VR headset and wireless tethered VR screens (iPhones) and tablets (iPads) as the intervention condition, but instead of social skill lessons, only non-intervention, active VR videos such as underwater fish swimming will be shown.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Autism Impact Measure (AIM) Assessment	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.	The AIM takes approximately 30 minutes to complete.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CARS-2	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.	The CARS-3 takes approximately 5-10 minutes to complete after the information needed to make the ratings is collected

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events related to VR use	Parents or caregivers will be asked about adverse events at the baseline visit (if this is separate from the screening visit), interim visits 1 and 2, and at the end of study visit. The occurrence or absence of AEs, and a description of any AEs, will be recorded on an Adverse Events Form.	5-10 minutes as needed to fill out AE form
AIM sub-domain scores	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.	The AIM takes approximately 30 minutes to complete.
Vineland-3 Adaptive Behavior Composite and sub-domain scores	The Vineland-3 evaluates adaptive behavior in five different domains: Social, Communication, Daily Living Skills, and Motor. In the context of this study, it will be administered using the Comprehensive Interview Form, for which a parent or caregiver is interviewed by a qualified rater familiar with the instrument. Based on the summarized scores in each domain, an Adaptive Behavior Composite (ABC) is also calculated. Items are scored on a scale of 0 (never), 1 (sometimes), or 2 (usually) for the level at which the child can independently perform a skill.	The Vineland-3 Comprehensive Interview Form takes approximately 60-90 minutes to complete

Collaborators and Investigators

• Sponsor: Floreo, Inc.
• Collaborators: Cortica

Publications and helpful links

General Publications

• 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.

Helpful Links

• Floreo Website
• Cortica Website

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2023
• Primary Completion (Actual): June 29, 2023
• Study Completion (Actual): June 29, 2023

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: March 17, 2023
• First Posted (Actual): March 30, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: ASD; Virtual Reality; Social Communication; VR; Applied Behavior Analysis Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: Floreo Cortica Protocol

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes