Improving Driving in Young People With Autism Spectrum Disorders
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Heart Rate
研究概览
简要总结
This study will examine the effects of treatment with the anti-anxiety medicine buspirone on driving performance (eye tracking) in individuals with high-functioning autism spectrum disorder (HF-ASD).
The study consists of an Assessment Visit at Massachusetts General Hospital (MGH), as well as two Driving Simulation visits that will take place at Massachusetts Institute of Technology (MIT). Subjects will be given buspirone and asked to take the medication for the two days preceding the Driving Simulation Visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 24 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder
- •Has a valid Driver's License
排除标准
- •Major sensorimotor handicaps (e.g. deafness, blindness)
- •Individuals who have never held a valid driver's license
- •Intellectual Deficiency (Verbal Comprehension Index < 80)
- •Inadequate command of the English language
- •Subjects with any clinically meaningful medical or psychiatric condition as determined by the investigator
- •Individuals who are currently taking a monoamine oxidase inhibitor (MAOI) for any reason
研究组 & 干预措施
Buspirone
These subjects will receive buspirone prior to engaging in the driving simulation.
干预措施: Buspirone (Drug)
Unmedicated
These subjects will take no medication prior to engaging in the driving simulation
干预措施: Buspirone (Drug)
结局指标
主要结局
Heart Rate
时间窗: Up to 6 weeks
Hyperarousal will be measured by heart rate during participants' time in the driving simulation.
Driving Performance - Measured by Mean Off-Road Glance Duration
时间窗: Up to 6 weeks
Driving performance will be analyzed using eye tracking in individuals with Autism Spectrum Disorder while on the anti-anxiety medication buspirone and while not on buspirone. Eye movement behavior (measured by glance duration) during the driving simulation was manually coded on a frame-by-frame basis from recorded video by trained coders for all cases where usable video recordings were available for both the medicated and non-medicated driving simulation sessions per participant.
次要结局
未报告次要终点
研究者
Joseph Biederman, MD
Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD
Massachusetts General Hospital