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OpenTrials
Completed

NCT Number: NCT03538431

Improving Driving in Young People With Autism Spectrum Disorders

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.

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Key information

Conditions

Autism Spectrum Disorder Anxiety Disorders Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

18 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Buspirone

Drug

Buspirone is an atypical anxiolytic medication.

Primary outcomes

  1. Driving Performance - Measured by Mean Off-Road Glance Duration

    Time frame: 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.

  2. Heart Rate

    Time frame: Up to 6 weeks

    Hyperarousal will be measured by heart rate during participants' time in the driving simulation.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Massachusetts Institute of Technology

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
May 29, 2018
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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