- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04016701
VR for Joint Attention Support in ASD
Immersive VR as a Tool to Support Joint Attention Skills in Children With Autism Spectrum Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Maryland
-
Columbia, Maryland, United States, 21045
- Children's SPOT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Documented ASD diagnosis, between 7 and 17 years of age
Exclusion Criteria:
- History of seizures, migraines, vertigo, psychosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VR Intervention
Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week
|
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
|
therapy as regularly scheduled at therapy center
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
immediately before and 4 weeks after intervention or control period of the study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
immediately before and 4 weeks after intervention or control period of the study
|
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.
|
immediately before and 4 weeks after intervention or control period of the study
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Floreo Salus Protocol 1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Autism Spectrum Disorder
-
Stanford UniversityCalifornia Department of Developmental ServicesRecruitingAutism Spectrum Disorder | Autistic Disorder | Autism | Autism Spectrum Disorders | Autistic Disorders Spectrum | Autistic Spectrum Disorder | Autistic Spectrum DisordersUnited States
-
Hoffmann-La RocheCompletedAutism Spectrum Disorder (ASD)United States, Canada, Italy, Spain
-
Axial Therapeutics, Inc.Active, not recruitingAutism Spectrum Disorder (ASD)United States, Australia, New Zealand
-
Technion, Israel Institute of TechnologyCompleted
-
Stanford UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)CompletedAutism | Autism Spectrum Disorder (ASD)United States
-
Corporacion Parc TauliUnknown
-
Massachusetts General HospitalTerminatedAutism Spectrum Disorder (ASD)United States
-
Massachusetts General HospitalWithdrawnDouble-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum DisordersAutism Spectrum Disorder (ASD)United States
-
Institut de Recherches Internationales ServierADIR, a Servier Group companyTerminatedAutism Spectrum Disorder (ASD)Spain, United States, Hungary, Poland, Australia, United Kingdom, Brazil, Czechia, France, Italy, Portugal, Slovakia
-
Centre Hospitalier Intercommunal Robert BallangerRecruitingAutism Spectrum Disorder (ASD)France
Clinical Trials on Floreo Joint Attention Module
-
Ullevaal University HospitalCentre for Child and Adolescent Mental HealthCompleted
-
Health Resources and Services Administration (HRSA)Johns Hopkins University; University of California, Los Angeles; University of... and other collaboratorsCompletedAutism Spectrum DisorderUnited States
-
Eunice Kennedy Shriver National Institute of Child...National Institute of Mental Health (NIMH)Completed
-
University of CoimbraCompletedAutism Spectrum Disorder
-
University of California, Los AngelesEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsUnknown
-
University of California, Los AngelesBoston Children's HospitalCompletedTuberous Sclerosis ComplexUnited States
-
University of FloridaNational Cancer Institute (NCI)RecruitingColorectal CancerUnited States