Trial Outcomes & Findings for Improving Driving in Young People With Autism Spectrum Disorders (NCT NCT03538431)
NCT ID: NCT03538431
Last Updated: 2021-03-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
26 participants
Primary outcome timeframe
Up to 6 weeks
Results posted on
2021-03-18
Participant Flow
Participant milestones
| Measure |
Buspirone Before Simulation 1, Then no Buspirone Before Simulation 2
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.
|
No Buspirone Before Simulation 1, Then Buspirone Before Simulation 2
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.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
13
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Buspirone Before Simulation 1, Then no Buspirone Before Simulation 2
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.
|
No Buspirone Before Simulation 1, Then Buspirone Before Simulation 2
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.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Improving Driving in Young People With Autism Spectrum Disorders
Baseline characteristics by cohort
| Measure |
Buspirone
n=26 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
27.8 Years
STANDARD_DEVIATION 8.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 6 weeksDriving 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.
Outcome measures
| Measure |
Buspirone
n=21 Participants
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.
|
Unmedicated
n=21 Participants
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.
|
|---|---|---|
|
Driving Performance - Measured by Mean Off-Road Glance Duration
|
0.85 Seconds
Standard Deviation 0.17
|
0.90 Seconds
Standard Deviation 0.27
|
PRIMARY outcome
Timeframe: Up to 6 weeksHyperarousal will be measured by heart rate during participants' time in the driving simulation.
Outcome measures
| Measure |
Buspirone
n=24 Participants
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.
|
Unmedicated
n=24 Participants
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.
|
|---|---|---|
|
Heart Rate
|
81.78 Beats Per Minute
Standard Deviation 10.67
|
82.74 Beats Per Minute
Standard Deviation 11.70
|
Adverse Events
Buspirone
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Unmedicated
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Buspirone
n=26 participants at risk
These subjects received buspirone either before driving simulation visit 1 or before driving simulation 2.
|
Unmedicated
n=26 participants at risk
These subjects received no medication either before driving simulation visit 1 or before driving simulation 2.
|
|---|---|---|
|
Immune system disorders
Mild allergic reaction to medication prescribed not related to the study
|
3.8%
1/26 • Number of events 1 • 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.
|
0.00%
0/26 • 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.
|
|
Musculoskeletal and connective tissue disorders
Concussion
|
3.8%
1/26 • Number of events 1 • 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.
|
0.00%
0/26 • 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.
|
|
Cardiac disorders
Chest Tightness, mild excitement, and nausea
|
3.8%
1/26 • Number of events 1 • 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.
|
0.00%
0/26 • 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.
|
|
Gastrointestinal disorders
Mild nausea
|
3.8%
1/26 • Number of events 1 • 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.
|
0.00%
0/26 • 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.
|
|
Infections and infestations
Head Cold
|
3.8%
1/26 • Number of events 1 • 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.
|
0.00%
0/26 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place