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Improving Driving in Young People With Autism Spectrum Disorders

Primary Purpose

Autism Spectrum Disorder

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Buspirone

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring Autism Spectrum Disorder, ASD, Anxiety

Eligibility Criteria

18 Years - 24 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Buspirone

Unmedicated

Arm Description

These subjects will receive buspirone prior to engaging in the driving simulation.

These subjects will take no medication prior to engaging in the driving simulation

Outcomes

Primary Outcome Measures

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.

Heart Rate

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03538431

First Posted

May 14, 2018

Last Updated

March 17, 2021

Sponsor

Massachusetts General Hospital

Collaborators

Massachusetts Institute of Technology

1. Study Identification

Unique Protocol Identification Number

NCT03538431

Brief Title

Improving Driving in Young People With Autism Spectrum Disorders

Official Title

Improving Driving in Young People With Autism Spectrum Disorders

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

October 31, 2018 (Actual)

Primary Completion Date

December 16, 2019 (Actual)

Study Completion Date

December 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Massachusetts General Hospital

Collaborators

Massachusetts Institute of Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Autism Spectrum Disorder

Keywords

Autism Spectrum Disorder, ASD, Anxiety

7. Study Design

Primary Purpose

Other

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Buspirone

Arm Type

Experimental

Arm Description

These subjects will receive buspirone prior to engaging in the driving simulation.

Arm Title

Unmedicated

Arm Type

Experimental

Arm Description

These subjects will take no medication prior to engaging in the driving simulation

Intervention Type

Drug

Intervention Name(s)

Buspirone

Intervention Description

Buspirone is an atypical anxiolytic medication.

Primary Outcome Measure Information:

Title

Driving Performance - Measured by Mean Off-Road Glance Duration

Description

Time Frame

Up to 6 weeks

Title

Heart Rate

Description

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

Time Frame

Up to 6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

24 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Improving Driving in Young People With Autism Spectrum Disorders

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