N/A
N=112
VR Intervention to Improve Police Safety
Autism Spectrum Disorder · Autism
Bottom Line
View on ClinicalTrials.gov: NCT03605368 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment — .13; .29; -.28; .02 Change from baseline - units on a scale — p=.23
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Virtual Reality Intervention (Behavioral); Video Modeling Intervention (Behavioral); No intervention (Behavioral)
- Age
- Pediatric, Adult · 12+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment |
.13; .29; -.28; .02; .04; .21 | .23 |
| SECONDARY Change in Police Interaction Knowledge |
8.09; 9.71; 8.11; 2.70 | .55 |
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.
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
Data sourced from ClinicalTrials.gov (NCT03605368). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.