VR Intervention to Improve Police Safety

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03605368
• Other study ID #: 17-014387
• Secondary ID: 1R42MH115539-01
• Status: Completed
• Phase: N/A
• Start date: November 17, 2017
• Est. completion date: October 12, 2022

Study information

• Verified date: February 2024
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: October 12, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism
• Autism Spectrum Disorder
• Autistic Disorder

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.
• 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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Floreo, Inc., National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment	The primary efficacy endpoint is the change in live in-person (Phase IIA) or virtual (Phase IIB) Police Interaction Assessment Scores between the Floreo PSM Virtual Reality Intervention and BE SAFE Video-Based intervention (Phase IIA) or treatment-as-usual (Phase IIB) from pre-treatment to post-treatment. Greater pre-treatment to post-treatment scores indicate better 3rd party ratings of social skills in that domain. The range of possible scores for the Police Interaction Assessment is -3 (performance got significantly worse from pre-treatment to post-treatment) to 3 (performance improved significantly from pre-treatment to post-treatment) on each variable (overall behavior, appropriate response, orienting, and fidgeting).	The Police Interaction Assessment was administered pre- and post-intervention (~2 weeks apart). Outcome measure data represent the difference in Police Interaction Assessment scores (post-intervention minus pre-intervention.)
Secondary	Change in Police Interaction Knowledge	The secondary endpoint includes changes in Police Interaction Knowledge Questionnaire Scores from Pre-Treatment to Post-Treatment or Pre-TAU to Post-TAU. Before and after the in-person Floreo VR intervention, participants completed a 10-question survey that asked about their feelings of comfort and safety when interacting with police officers. The scale for each question ranged from 1-7, with 7 indicating greater feelings of safety, comfort, and knowledge and 1 indicating fewer feelings of safety, comfort, and knowledge. Scores were summed to create a total score, which ranged from 10 to 70, and then subtracted to calculate a change score (post-intervention minus pre-intervention). Change scores, which had a possible range of -60 to +60, were compared between groups. Greater change scores after intervention or TAU indicate greater feelings of safety, comfort, and knowledge when interacting with police.	Baseline and immediately post-intervention (~2 weeks apart)