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VR for Joint Attention Support in ASD

Primary Purpose

Autism Spectrum Disorder

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Floreo Joint Attention Module
Regularly Scheduled Therapy
Sponsored by
Floreo, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

7 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Documented ASD diagnosis, between 7 and 17 years of age

Exclusion Criteria:

  • History of seizures, migraines, vertigo, psychosis

Sites / Locations

  • Children's SPOT

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

VR Intervention

Treatment as Usual

Arm Description

Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week

Regularly scheduled therapy

Outcomes

Primary Outcome Measures

Change from Baseline Joint Attention Protocol score at 12 weeks
A measure developed to rate child behaviors on 16 items involving response to joint attention and initiation of joint attention

Secondary Outcome Measures

Change from Baseline Joint Attention Assessment score at 12 weeks
an in-person, videotaped, play-based measure to rate frequency of joint attention skills in school-aged children. Instances of each joint attention behavior observed are summed to provide a total Joint Attention Assessment score, with higher numbers reflecting more frequent joint attention behaviors.
Change from Baseline Vineland Adaptive Behavior Scales, Third Edition total score
a parent-reported measure of adaptive skills, commonly used for assessment of individuals with developmental disabilities. The Vineland provides an Adaptive Behavior Composite (ABC) score, which can be compared to a normative mean score of 100 with a normative standard deviation of 15.

Full Information

First Posted
July 8, 2019
Last Updated
July 16, 2019
Sponsor
Floreo, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04016701
Brief Title
VR for Joint Attention Support in ASD
Official Title
Immersive VR as a Tool to Support Joint Attention Skills in Children With Autism Spectrum Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Withdrawn
Why Stopped
limited recruitment within study timeline
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Floreo, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall objective of this study is to determine the effectiveness of the Floreo VR Joint Attention Module in improving social communication skills in children with ASD. An additional objective is ongoing investigation of the tolerability of the product and the extent of potential adverse effects of Floreo VR, if any.
Detailed Description
The study will be a Phase II randomized controlled trial in which the Floreo VR Joint Attention Module is the intervention being evaluated. Floreo is a mobile application that offers a supervised virtual reality experience for individuals with ASD. The application provides a 3D immersive scene for Google Cardboard-compatible smartphones and a WiFi paired supervisory overview that can run on smartphones or tablets. The therapeutic content will consist of a Learning Module focused on Joint Attention. This Joint Attention Learning Module will include separate Learning Cards (LCs) that address specific subskills necessary to develop appropriate joint attention. Each Learning Card will consist of a virtual reality environment in a safari-themed setting, complete with animals designed to draw the learner's attention when necessary. The product will be implemented at The Children's SPOT by a therapist working with a client during the course of a therapy session. The intervention arm participant would engage in one or two VR episodes during a scheduled session. Each episode would last no more than 5 minutes. If two episodes are done in a day, there is a mandatory break of at least 3 minutes in between them. The sessions would occur two days per week, with at least two days in between sessions to allow the eyes time to rest. There are 15 total VR sessions in the protocol, and completion of all study sessions would take 8 weeks. The control condition is treatment as usual, that is, regularly scheduled therapy.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VR Intervention
Arm Type
Experimental
Arm Description
Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Regularly scheduled therapy
Intervention Type
Device
Intervention Name(s)
Floreo Joint Attention Module
Intervention Description
Two sessions per week for eight weeks of the Floreo VR Joint Attention Module, delivered via a Google Cardboard compatible VR headset. Each session includes one or two 5-minute VR episodes and an intermission that is at least 3 minutes long
Intervention Type
Behavioral
Intervention Name(s)
Regularly Scheduled Therapy
Intervention Description
therapy as regularly scheduled at therapy center
Primary Outcome Measure Information:
Title
Change from Baseline Joint Attention Protocol score at 12 weeks
Description
A measure developed to rate child behaviors on 16 items involving response to joint attention and initiation of joint attention
Time Frame
immediately before and 4 weeks after intervention or control period of the study
Secondary Outcome Measure Information:
Title
Change from Baseline Joint Attention Assessment score at 12 weeks
Description
an in-person, videotaped, play-based measure to rate frequency of joint attention skills in school-aged children. Instances of each joint attention behavior observed are summed to provide a total Joint Attention Assessment score, with higher numbers reflecting more frequent joint attention behaviors.
Time Frame
immediately before and 4 weeks after intervention or control period of the study
Title
Change from Baseline Vineland Adaptive Behavior Scales, Third Edition total score
Description
a parent-reported measure of adaptive skills, commonly used for assessment of individuals with developmental disabilities. The Vineland provides an Adaptive Behavior Composite (ABC) score, which can be compared to a normative mean score of 100 with a normative standard deviation of 15.
Time Frame
immediately before and 4 weeks after intervention or control period of the study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Documented ASD diagnosis, between 7 and 17 years of age Exclusion Criteria: History of seizures, migraines, vertigo, psychosis
Facility Information:
Facility Name
Children's SPOT
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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VR for Joint Attention Support in ASD

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