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VR for Joint Attention Support in ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04016701
Recruitment Status : Withdrawn (limited recruitment within study timeline)
First Posted : July 11, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Floreo, Inc.

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: Floreo Joint Attention Module Behavioral: Regularly Scheduled Therapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Immersive VR as a Tool to Support Joint Attention Skills in Children With Autism Spectrum Disorder
Actual Study Start Date : July 20, 2018
Actual Primary Completion Date : July 16, 2019
Actual Study Completion Date : July 16, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: VR Intervention
Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week
Device: Floreo Joint Attention Module
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

Active Comparator: Treatment as Usual
Regularly scheduled therapy
Behavioral: Regularly Scheduled Therapy
therapy as regularly scheduled at therapy center




Primary Outcome Measures :
  1. Change from Baseline Joint Attention Protocol score at 12 weeks [ Time Frame: immediately before and 4 weeks after intervention or control period of the study ]
    A measure developed to rate child behaviors on 16 items involving response to joint attention and initiation of joint attention


Secondary Outcome Measures :
  1. Change from Baseline Joint Attention Assessment score at 12 weeks [ Time Frame: immediately before and 4 weeks after intervention or control period of the study ]
    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.

  2. Change from Baseline Vineland Adaptive Behavior Scales, Third Edition total score [ Time Frame: immediately before and 4 weeks after intervention or control period of the study ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • History of seizures, migraines, vertigo, psychosis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016701


Locations
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United States, Maryland
Children's SPOT
Columbia, Maryland, United States, 21045
Sponsors and Collaborators
Floreo, Inc.

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Responsible Party: Floreo, Inc.
ClinicalTrials.gov Identifier: NCT04016701     History of Changes
Other Study ID Numbers: Floreo Salus Protocol 1
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders