Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2018-07-20
2019-07-16
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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VR Intervention
Eight weeks of training with Floreo's VR Joint Attention Module with two sessions per week
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
Treatment as Usual
Regularly scheduled therapy
Regularly Scheduled Therapy
therapy as regularly scheduled at therapy center
Interventions
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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
Regularly Scheduled Therapy
therapy as regularly scheduled at therapy center
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
7 Years
17 Years
ALL
No
Sponsors
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Floreo, Inc.
INDUSTRY
Responsible Party
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Locations
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Children's SPOT
Columbia, Maryland, United States
Countries
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Other Identifiers
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Floreo Salus Protocol 1
Identifier Type: -
Identifier Source: org_study_id
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