Study Results
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View full resultsBasic Information
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COMPLETED
NA
158 participants
INTERVENTIONAL
2017-11-17
2022-10-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Phase IIA - in-person
Participants will be assigned to either a) a virtual reality-based intervention or b) an video modeling intervention both aimed at improving police interaction skills. Assessments of police skills will occur before intervention and after intervention (three sessions of each).
Virtual Reality Intervention
Floreo's Police Safety Module (PSM) offers a supervised VR experience for people with ASD. The software is an application that provides a 3D immersive scene for headset-compatible smartphones. The person with ASD will use a smartphone capable of running the application with a dedicated headset providing the virtual environment. The PSM provides an immersive story-based intervention that shows a fully realized and intricately detailed urban environment designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person with ASD as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world.
Video Modeling Intervention
The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.
Phase IIB - remote
Participants will be assigned to either a) three sessions of virtual reality-based intervention aimed at improving police interaction skills or b) no intervention. Assessments of police skills will occur before intervention, after intervention, and 3-4 weeks follow up in the intervention group and at comparable timepoints in the no intervention group.
Virtual Reality Intervention
Floreo's Police Safety Module (PSM) offers a supervised VR experience for people with ASD. The software is an application that provides a 3D immersive scene for headset-compatible smartphones. The person with ASD will use a smartphone capable of running the application with a dedicated headset providing the virtual environment. The PSM provides an immersive story-based intervention that shows a fully realized and intricately detailed urban environment designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person with ASD as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world.
No intervention
Participants will follow all study procedures with the exception of the VR-based intervention including assessments.
Interventions
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Virtual Reality Intervention
Floreo's Police Safety Module (PSM) offers a supervised VR experience for people with ASD. The software is an application that provides a 3D immersive scene for headset-compatible smartphones. The person with ASD will use a smartphone capable of running the application with a dedicated headset providing the virtual environment. The PSM provides an immersive story-based intervention that shows a fully realized and intricately detailed urban environment designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person with ASD as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world.
Video Modeling Intervention
The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.
No intervention
Participants will follow all study procedures with the exception of the VR-based intervention including assessments.
Eligibility Criteria
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Inclusion Criteria
* Documented autism spectrum disorder (ASD) diagnosis
* Verbal Intelligence Quotient (IQ) \>/= 75 (verbal and non-verbal)
* Informed consent (if adult) or parental/guardian permission (if child or adult with diminished capacity) and, if applicable, assent
Exclusion Criteria
* Personal or family history of seizures or a seizure disorder
* Primary sensory impairment (e.g., blindness, deafness)
* Personal or family history of migraines
* History of vertigo
* History of strabismus, other eye muscle problems, or eye surgery
* History of concussion with hospitalization
* Diagnosis of a known genetic syndrome (e.g., Down syndrome, Fragile X syndrome)
* History of a medical condition which has affected/affects cognitive, sensory, or motor functioning (e.g., Fetal Alcohol Syndrome, brain injury, stroke, brain tumor)
* Non-English speaking
* Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
12 Years
60 Years
ALL
No
Sponsors
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Floreo, Inc.
INDUSTRY
National Institute of Mental Health (NIMH)
NIH
Children's Hospital of Philadelphia
OTHER
Responsible Party
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Principal Investigators
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Julia Parish-Morris, PhD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Vijay Ravindran
Role: PRINCIPAL_INVESTIGATOR
Floreo, Inc.
Locations
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Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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17-014387
Identifier Type: -
Identifier Source: org_study_id
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