Improving Driving in Young People With Autism Spectrum Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Improving Driving in Young People With Autism Spectrum Disorders

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Drug: Buspirone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females, ages 18-24, with a diagnosis of DSM-V Autism Spectrum Disorder Has a valid Driver's License Exclusion Criteria: 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 Pregnant

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 24 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buspirone<br>These subjects will receive buspirone prior to engaging in the driving simulation. | Drug: Buspirone<br>* Buspirone is an atypical anxiolytic medication.<br>|
| Experimental: Unmedicated<br>These subjects will take no medication prior to engaging in the driving simulation | Drug: Buspirone<br>* Buspirone is an atypical anxiolytic medication.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Driving Performance - Measured by Mean Off-Road Glance Duration | 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. | Up to 6 weeks | 
| Heart Rate | Hyperarousal will be measured by heart rate during participants' time in the driving simulation. | Up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism Spectrum Disorder, ASD, Anxiety