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VR Intervention to Improve Police Safety

Primary Purpose

Autism Spectrum Disorder, Autism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Intervention
Video Modeling Intervention
No intervention
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder focused on measuring Intervention, Technology

Eligibility Criteria

12 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Phase IIA

Phase IIB

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).

Full Information

First Posted
July 23, 2018
Last Updated
May 3, 2023
Sponsor
Children's Hospital of Philadelphia
Collaborators
Floreo, Inc., National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03605368
Brief Title
VR Intervention to Improve Police Safety
Official Title
Immersive Virtual Reality as a Tool to Improve Police Safety in Adolescents and Adults With ASD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
October 12, 2022 (Actual)
Study Completion Date
October 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Floreo, Inc., National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
Intervention, Technology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phase IIA
Arm Type
Active Comparator
Arm Description
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).
Arm Title
Phase IIB
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Video Modeling Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No intervention
Intervention Description
Participants will follow all study procedures with the exception of the VR-based intervention including assessments.
Primary Outcome Measure Information:
Title
Change in Live Police Interaction Assessment Scores from Pre-to-Post treatment
Description
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.
Time Frame
Baseline and immediately post-intervention
Secondary Outcome Measure Information:
Title
Change in Police Interaction Knowledge
Description
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.
Time Frame
Baseline and immediately post-intervention
Title
Learned skill improvements - Phase IIb only
Description
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).
Time Frame
10 weeks post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Parish-Morris, PhD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Vijay Ravindran
Organizational Affiliation
Floreo, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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VR Intervention to Improve Police Safety

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