Clinical trial NCT03605368: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Autism
Keywords: Intervention
Technology
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: Floreo, Inc.
name: National Institute of Mental Health (NIMH)
First posted: 2018-07-30
Enrollment: 158
Sex: ALL
Minimum age (years): 12
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment
timeFrame: 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:
measure: Change in Police Interaction Knowledge
timeFrame: Baseline and immediately post-intervention (~2 weeks apart)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Julia Parish-Morris, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Floreo, Inc.
name: Vijay Ravindran
role: PRINCIPAL_INVESTIGATOR
References: