VR Intervention to Improve Police Safety

Study Overview
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Brief Summary
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The primary objective of this study is to demonstrate the efficacy of Floreo's police safety module (PSM) in adolescents and adults with autism spectrum disorder (ASD) by assessing improvement in police interaction skills as compared to a video modeling intervention.

Detailed Description
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Advances in virtual reality (VR) technology offer new opportunities to design interventions targeting the core deficits associated with autism spectrum disorder (ASD) and promote acquisition of skills necessary for effective navigation of challenging social situations, such as engagement with law enforcement. Researchers have explored the potential of virtual reality technology in targeting autism-related deficits, but at this time there are no evidence-based VR interventions for ASD. While most research labelled VR for the purposes of therapy has not been immersive, in recent years, the commercial introduction of head-mounted displays (HMD) and lower cost of virtual reality technology have led to greater interest in therapeutic applications of VR. As part of a mission to develop VR products for individuals with ASD, investigators will collaborate with a commercial tech start-up company, Floreo Technology, to study a mobile VR module for police safety skills. Investigators seek to evaluate the safety and feasibility of the mobile VR police safety module (PSM) and the effectiveness of the module in improving police interaction skills in adolescents and adults with ASD.

Official Title
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Immersive Virtual Reality as a Tool to Improve Police Safety in Adolescents and Adults With ASD

Conditions
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Autism Spectrum Disorder, Autism

Intervention / Treatment
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* Behavioral: Virtual Reality Intervention
* Behavioral: Video Modeling Intervention
* Behavioral: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males or females age 12 to 60 years. 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: Participation in pilot virtual reality (VR) study at the Children's Hospital of Philadelphia (CHOP) 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phase IIA<br>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). | Behavioral: Virtual Reality Intervention<br>* 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.<br>Behavioral: Video Modeling Intervention<br>* 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.<br>|
| Active Comparator: Phase IIB<br>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. | Behavioral: Virtual Reality Intervention<br>* 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.<br>Behavioral: No intervention<br>* Participants will follow all study procedures with the exception of the VR-based intervention including assessments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Live Police Interaction Assessment Scores from Pre-to-Post treatment | The primary efficacy endpoint will be the change in Live Police Interaction Assessment Scores between the Virtual Reality Intervention and BE SAFE Video-Based intervention from pre-treatment to post-treatment. | Baseline and immediately post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Police Interaction Knowledge | The secondary endpoint will include changes in Police Interaction Knowledge Questionnaire Scores from Pre-Treatment to Post-Treatment for the Virtual Reality Intervention and BE SAFE Video-Based intervention. | Baseline and immediately post-intervention | 
| Learned skill improvements - Phase IIb only | An additional Secondary endpoint is maintenance of learned skill improvements, indexed via the 10-week Follow-Up administration of the Live Police Interaction Assessment (Phase IIb only). | 10 weeks post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intervention, Technology