VR Intervention to Improve Police Safety
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03605368|
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : June 25, 2019
|Condition or disease||Intervention/treatment||Phase|
|Autism Spectrum Disorder Autism||Behavioral: Virtual Reality Intervention Behavioral: Video Modeling Intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||96 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Immersive Virtual Reality as a Tool to Improve Police Safety in Adolescents and Adults With ASD|
|Actual Study Start Date :||November 28, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
|Active Comparator: Video Modeling||
Behavioral: 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.
|Experimental: Virtual Reality Intervention||
Behavioral: 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.
- Change in Live Police Interaction Assessment Scores from Pre-to-Post treatment [ Time Frame: Baseline and immediately post-intervention ]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.
- Change in Police Interaction Knowledge [ Time Frame: Baseline and immediately post-intervention ]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.
- Learned skill improvements - Phase IIb only [ Time Frame: 10 weeks post-intervention ]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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03605368
|Contact: Ashley Zitteremail@example.com|
|Contact: Jennifer Swope, MSfirstname.lastname@example.org|
|United States, Pennsylvania|
|Children's Hospital of Philadelphia||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Julia Parish-Morris, PhD||Children's Hospital of Philadelphia|
|Principal Investigator:||Vijay Ravindran||Floreo, Inc.|