Clinical trial NCT04016701: 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
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Autism Spectrum Disorder
Lead sponsor: Floreo, Inc.
Sponsor class: INDUSTRY
First posted: 2019-07-11
Enrollment: 0
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* History of seizures, migraines, vertigo, psychosis

Primary outcomes:
measure: Change from Baseline Joint Attention Protocol score at 12 weeks
timeFrame: immediately before and 4 weeks after intervention or control period of the study
Secondary outcomes:
measure: Change from Baseline Joint Attention Assessment score at 12 weeks
timeFrame: immediately before and 4 weeks after intervention or control period of the study
measure: Change from Baseline Vineland Adaptive Behavior Scales, Third Edition total score
timeFrame: immediately before and 4 weeks after intervention or control period of the study
Other outcomes:
Locations:
city: Columbia
country: United States
facility: Children's SPOT
state: Maryland
Study officials:
References: