Improving Driving in Young People With Autism Spectrum Disorders

Autism Spectrum Disorder Clinical Trial

Official title:

Improving Driving in Young People With Autism Spectrum Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538431
• Other study ID #: 2018-P-000900
• Status: Completed
• Phase: Phase 4
• Start date: October 31, 2018
• Est. completion date: December 16, 2019

Study information

• Verified date: March 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 16, 2019
• Est. primary completion date: December 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder
• Child Development Disorders, Pervasive
• Disease

Intervention

Drug:
• Buspirone
Buspirone is an atypical anxiolytic medication.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Heart Rate	Hyperarousal will be measured by heart rate during participants' time in the driving simulation.	Up to 6 weeks