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

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Floreo VR Building Social Connections

Sham

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring ASD, Virtual Reality, VR, Social Communication, Applied Behavior Analysis Therapy

Eligibility Criteria

4 Years - 10 Years (Child)All SexesDoes not accept 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

Sites / Locations

Cortica

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Floreo VR Building Social Connections

Sham

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05791071

First Posted

February 27, 2023

Last Updated

June 29, 2023

Sponsor

Floreo, Inc.

Collaborators

Cortica

1. Study Identification

Unique Protocol Identification Number

NCT05791071

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

February 15, 2023 (Actual)

Primary Completion Date

June 29, 2023 (Actual)

Study Completion Date

June 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Floreo, Inc.

Collaborators

Cortica

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

ASD, Virtual Reality, VR, Social Communication, Applied Behavior Analysis Therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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.

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Subjects and their parents/caregivers will be blinded to whether they are receiving Floreo VR therapy vs active VR exposure control. Research staff administering the therapy or control will not be blinded to the therapy; however, the clinicians doing pre/post assessments will be blinded.

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Floreo VR Building Social Connections

Arm Type

Experimental

Arm Description

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

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Floreo VR Building Social Connections

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham

Intervention Description

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.

Primary Outcome Measure Information:

Title

Autism Impact Measure (AIM) Assessment

Description

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.

Time Frame

The AIM takes approximately 30 minutes to complete.

Secondary Outcome Measure Information:

Title

CARS-2

Description

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.

Time Frame

The CARS-3 takes approximately 5-10 minutes to complete after the information needed to make the ratings is collected

Other Pre-specified Outcome Measures:

Title

AIM sub-domain scores

Description

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.

Time Frame

The AIM takes approximately 30 minutes to complete.

Title

Vineland-3 Adaptive Behavior Composite and sub-domain scores

Description

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.

Time Frame

The Vineland-3 Comprehensive Interview Form takes approximately 60-90 minutes to complete

Title

Adverse events related to VR use

Description

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.

Time Frame

5-10 minutes as needed to fill out AE form

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

No

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

Facility Information:

Facility Name

Cortica

City

Thousand Oaks

State/Province

California

ZIP/Postal Code

91361

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

23748386

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.

Results Reference

background

Links:

URL

http://floreotech.com

Description

Floreo Website

URL

http://corticacare.com

Description

Cortica Website

Autism Spectrum Disorder

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial