Improving Driving in Young People With Autism Spectrum Disorders

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03538431
• Collaborator: Massachusetts Institute of Technology (Other)
• Enrollment: 26
• Location: 1
• Arms: 2
• Actual Duration (Months): 13.5
• Patients Per Site Per Month: 1.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Autism Spectrum Disorder	Drug: Buspirone	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Improving Driving in Young People With Autism Spectrum Disorders
• Actual Study Start Date: Oct 31, 2018
• Actual Primary Completion Date: Dec 16, 2019
• Actual Study Completion Date: Dec 16, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Buspirone These subjects will receive buspirone prior to engaging in the driving simulation.	Drug: Buspirone; Buspirone is an atypical anxiolytic medication.
Experimental: Unmedicated These subjects will take no medication prior to engaging in the driving simulation	Drug: Buspirone; Buspirone is an atypical anxiolytic medication.

Outcome Measures

Primary Outcome Measures

1. Driving Performance - Measured by Mean Off-Road Glance Duration [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 [Up to 6 weeks]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 24 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• Massachusetts Institute of Technology

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 3, 2019

More Information

Publications

None provided.

• Responsible Party: Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT03538431
• Other Study ID Numbers: 2018-P-000900
• First Posted: May 29, 2018
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Joseph Biederman, MD, Chief, Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital: Autism Spectrum Disorder; ASD; Anxiety
• Additional relevant MeSH terms: Disease; Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Buspirone

Study Results

Participant Flow

Arm/Group Title	Buspirone Before Simulation 1, Then no Buspirone Before Simulation 2	No Buspirone Before Simulation 1, Then Buspirone Before Simulation 2
Arm/Group Description	These subjects will receive and be instructed to take the buspirone for the 2 days preceding their first driving simulation visit. They will not take buspirone before their 2nd driving simulation visit. Buspirone: Buspirone is an atypical anxiolytic medication.	These subjects will receive and be instructed to take the buspirone for the 2 days preceding their second driving simulation visit. They will not take buspirone before their 1st driving simulation visit. Buspirone: Buspirone is an atypical anxiolytic medication.
Period Title: Overall Study
STARTED	13	13
COMPLETED	12	12
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Buspirone
Arm/Group Description	These participants took buspirone either before driving simulation 1 or before driving simulation 2. Those who took the medication before driving simulation visit 1 took no medication before visit 2, and those who took the medication before driving simulation visit 2 took no medication before driving simulation 1. This study is a crossover design.
Overall Participants	26
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	26 100%
>=65 years	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	27.8 (8.4)
Sex: Female, Male (Count of Participants)
Female	5 19.2%
Male	21 80.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 7.7%
Not Hispanic or Latino	24 92.3%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	24 92.3%
More than one race	0 0%
Unknown or Not Reported	2 7.7%
Region of Enrollment (Count of Participants)
United States	26 100%

Outcome Measures

1. Primary Outcome

Title	Driving Performance - Measured by Mean Off-Road Glance Duration
Description	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.
Time Frame	Up to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Buspirone	Unmedicated
Arm/Group Description	Subjects will receive buspirone before 1 of 2 driving simulation visits. Half of the participants in the study completed Simulation 1 on buspirone, and the other half completed Simulation 2 on buspirone. These participants completed the driving simulation on buspirone. Buspirone: Buspirone is an atypical anxiolytic medication.	These participants completed the driving simulation unmedicated. Subjects will receive buspirone before 1 of 2 driving simulation visits. Half of the participants in the study completed Simulation 1 on unmedicated, and the other half completed Simulation 2 on unmedicated. Buspirone: Buspirone is an atypical anxiolytic medication.
Measure Participants	21	21
Mean (Standard Deviation) [Seconds]	0.85 (0.17)	0.90 (0.27)

2. Primary Outcome

Title	Heart Rate
Description	Hyperarousal will be measured by heart rate during participants' time in the driving simulation.
Time Frame	Up to 6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Buspirone	Unmedicated
Arm/Group Description	These participants completed the driving simulation on buspirone. Subjects will receive buspirone before 1 of 2 driving simulation visits. Half of the participants in the study completed Simulation 1 on buspirone, and the other half completed Simulation 2 on buspirone. Buspirone: Buspirone is an atypical anxiolytic medication.	These participants completed the driving simulation without buspirone. Subjects will receive buspirone before 1 of 2 driving simulation visits. Half of the participants in the study completed Simulation 1 unmedicated, and the other half completed Simulation 2 unmedicated. Buspirone: Buspirone is an atypical anxiolytic medication.
Measure Participants	24	24
Mean (Standard Deviation) [Beats Per Minute]	81.78 (10.67)	82.74 (11.70)

Adverse Events

Time Frame	Adverse event data was collected for each participant between the date the participant enrolled in the study and the date the participant completed the study. The precise time frame of this window differed by participant depending on their availability to schedule the driving simulations. On average, adverse event data were collected over a period of 7.2 weeks.
Arm/Group Title	Buspirone		Unmedicated
Arm/Group Description	These subjects received buspirone either before driving simulation visit 1 or before driving simulation 2.		These subjects received no medication either before driving simulation visit 1 or before driving simulation 2.
All Cause Mortality
	Buspirone		Unmedicated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Serious Adverse Events
	Buspirone		Unmedicated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Buspirone		Unmedicated
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/26 (19.2%)		0/26 (0%)
Cardiac disorders
Chest Tightness, mild excitement, and nausea	1/26 (3.8%)	1	0/26 (0%)	0
Gastrointestinal disorders
Mild nausea	1/26 (3.8%)	1	0/26 (0%)	0
Immune system disorders
Mild allergic reaction to medication prescribed not related to the study	1/26 (3.8%)	1	0/26 (0%)	0
Infections and infestations
Head Cold	1/26 (3.8%)	1	0/26 (0%)	0
Musculoskeletal and connective tissue disorders
Concussion	1/26 (3.8%)	1	0/26 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.