VR Intervention to Improve Police Safety

Children's Hospital of Philadelphia (CHOP)

Status: Completed

Conditions: Autism Spectrum Disorder; Autism

Treatments: Behavioral: No intervention; Behavioral: Video Modeling Intervention; Behavioral: Virtual Reality Intervention

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03605368

17-014387

1R42MH115539-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 158 patients

Sex: All

Ages: 12 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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158 participants in 2 patient groups

Phase IIA - in-person

Active Comparator group

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).

Treatment:

Behavioral: Virtual Reality Intervention

Behavioral: Video Modeling Intervention

Phase IIB - remote

Active Comparator group

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.

Treatment:

Behavioral: No intervention

Behavioral: Virtual Reality Intervention