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Trial record 27 of 52 for:    Developmental Disabilities | Recruiting Studies | NIH

VR Intervention to Improve Police Safety

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ClinicalTrials.gov Identifier: NCT03605368
Recruitment Status : Recruiting
First Posted : July 30, 2018
Last Update Posted : June 25, 2019
Sponsor:
Collaborators:
Floreo, Inc.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Autism Behavioral: Virtual Reality Intervention Behavioral: Video Modeling Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females age 12 to 60 years.
  • Documented autism spectrum disorder (ASD) diagnosis
  • Verbal 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

Information from the National Library of Medicine

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


Contacts
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Contact: Ashley Zitter 267-425-1157 zittera@email.chop.edu
Contact: Jennifer Swope, MS 267-425-1118 swopej@email.chop.edu

Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Children's Hospital of Philadelphia
Floreo, Inc.
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Julia Parish-Morris, PhD Children's Hospital of Philadelphia
Principal Investigator: Vijay Ravindran Floreo, Inc.

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT03605368     History of Changes
Other Study ID Numbers: 17-014387
1R42MH115539-01 ( U.S. NIH Grant/Contract )
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: June 25, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Philadelphia:
Intervention
Technology
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders