Immersive Virtual Reality as a Tool to Improve Police Safety in Adolescents and Adults With ASD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 158
- 试验地点
- 2
- 主要终点
- Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in Live or Virtual Police Interaction Assessment Scores From Pre-to-Post Treatment
时间窗: 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).
次要结局
- Change in Police Interaction Knowledge(Baseline and immediately post-intervention (~2 weeks apart))