VR Intervention to Improve Police Safety

February 29, 2024 updated by: Children's Hospital of Philadelphia

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
158

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Phase IIA - in-person
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: 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.
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.
Active Comparator: Phase IIB - remote
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
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.
Behavioral: No intervention
Participants will follow all study procedures with the exception of the VR-based intervention including assessments.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment
Time Frame: 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.)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Police Interaction Knowledge
Time Frame: Baseline and immediately post-intervention (~2 weeks apart)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Children's Hospital of Philadelphia

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)
Floreo, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Julia Parish-Morris, PhD, Children's Hospital of Philadelphia
  • Principal Investigator: Vijay Ravindran, Floreo, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 17, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 12, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 30, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 27, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 29, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-014387
  • 1R42MH115539-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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