VR Intervention to Improve Police Safety

NCT03605368 | Completed Results DMC

• 2 other identifiers: 17-0143871R42MH115539-01
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder; Autism

Keywords

Intervention; Technology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Police Interaction Knowledge

  Baseline and immediately post-intervention (~2 weeks apart)

Study Arms (2)

Phase IIA - in-person

ACTIVE COMPARATOR

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; Behavioral: Video Modeling Intervention

Phase IIB - remote

ACTIVE COMPARATOR

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; Behavioral: No intervention

Interventions

Virtual Reality Intervention BEHAVIORAL

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.

Phase IIA - in-person; Phase IIB - remote

Video Modeling Intervention BEHAVIORAL

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 IIA - in-person

No intervention BEHAVIORAL

Participants will follow all study procedures with the exception of the VR-based intervention including assessments.

Phase IIB - remote

Eligibility Criteria

• Age: 12 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Floreo, Inc.: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Julia Parish-Morris
• Organization: Children's Hospital of Philadelphia

parishmorrisj@chop.edu

267-426-7540

Study Officials

• Julia Parish-Morris, PhD

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

• Vijay Ravindran

  Floreo, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2018
• First Posted: July 30, 2018
• Study Start: November 17, 2017
• Primary Completion: October 12, 2022
• Study Completion: October 12, 2022
• Last Updated: March 27, 2024
• Results First Posted: March 27, 2024

Record last verified: 2024-02

Locations

US (1)