Trial Outcomes & Findings for Improving ADHD Teen Driving (NCT NCT02848092)
NCT ID: NCT02848092
Last Updated: 2023-03-03
Results Overview
Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Eye gaze was sampled continuously. Eye gaze data was summarized by calculating the number of extended (≥2 secs) glances away from the roadway during the 14 secondary task periods per drive. This was our primary outcome for visual behavior during driving. Descriptive estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable.
COMPLETED
NA
152 participants
1-month post-training
2023-03-03
Participant Flow
Teens 16 to 19 years of age with ADHD who had a valid driver's license were recruited at the Cincinnati Children's Hospital Medical Center by means of radio, social media, and print advertisements.
Participant milestones
| Measure |
FOCAL+Training
FOCAL+: Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
|
Rules of the Road Training
Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
|
|---|---|---|
|
1-month Post-training Follow-up
STARTED
|
76
|
76
|
|
1-month Post-training Follow-up
COMPLETED
|
64
|
71
|
|
1-month Post-training Follow-up
NOT COMPLETED
|
12
|
5
|
|
6-month Post-training Follow-up
STARTED
|
76
|
76
|
|
6-month Post-training Follow-up
COMPLETED
|
63
|
72
|
|
6-month Post-training Follow-up
NOT COMPLETED
|
13
|
4
|
|
12-month Naturalistic Driving
STARTED
|
76
|
76
|
|
12-month Naturalistic Driving
COMPLETED
|
73
|
74
|
|
12-month Naturalistic Driving
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
FOCAL+Training
FOCAL+: Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
|
Rules of the Road Training
Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
|
|---|---|---|
|
1-month Post-training Follow-up
Lost to Follow-up
|
8
|
3
|
|
1-month Post-training Follow-up
Adverse Event
|
2
|
1
|
|
1-month Post-training Follow-up
Withdrawal by Subject
|
1
|
0
|
|
1-month Post-training Follow-up
received new diagnosis of epilepsy
|
1
|
0
|
|
1-month Post-training Follow-up
fatigue
|
0
|
1
|
|
6-month Post-training Follow-up
Lost to Follow-up
|
9
|
3
|
|
6-month Post-training Follow-up
Adverse Event
|
1
|
1
|
|
6-month Post-training Follow-up
Withdrawal by Subject
|
1
|
0
|
|
6-month Post-training Follow-up
frustrated with task
|
1
|
0
|
|
6-month Post-training Follow-up
new diagnosis of epilepsy
|
1
|
0
|
|
12-month Naturalistic Driving
Did not have DriveCam installed in car
|
3
|
2
|
Baseline Characteristics
Improving ADHD Teen Driving
Baseline characteristics by cohort
| Measure |
FOCAL+Training
n=76 Participants
FOCAL+: Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
|
Rules of the Road Training
n=76 Participants
Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
|
Total
n=152 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
17.3 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
17.5 years
STANDARD_DEVIATION 0.9 • n=7 Participants
|
17.4 years
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
75 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
76 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Number of Extended Glances Away from Roadway during Driving Simulation
|
21.5 number of long glances
STANDARD_DEVIATION 13.82 • n=5 Participants
|
23.1 number of long glances
STANDARD_DEVIATION 12.28 • n=7 Participants
|
22.43 number of long glances
STANDARD_DEVIATION 13.06 • n=5 Participants
|
|
Standard Deviation of Lateral Position during Driving Simulation
|
1.11 feet
STANDARD_DEVIATION .33 • n=5 Participants
|
1.20 feet
STANDARD_DEVIATION .31 • n=7 Participants
|
1.15 feet
STANDARD_DEVIATION .32 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1-month post-trainingPopulation: Missing data were handled with the use of 100 imputed data sets that were based on fully conditional specification imputation.
Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Eye gaze was sampled continuously. Eye gaze data was summarized by calculating the number of extended (≥2 secs) glances away from the roadway during the 14 secondary task periods per drive. This was our primary outcome for visual behavior during driving. Descriptive estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable.
Outcome measures
| Measure |
FOCAL+Training
n=76 Participants
FOCAL+: Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
|
Rules of the Road Training
n=76 Participants
Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
|
|---|---|---|
|
Number of Extended Glances Away From Roadway During Driving Simulation
|
16.5 number of long glances
Interval 14.0 to 19.1
|
28.0 number of long glances
Interval 26.0 to 30.2
|
PRIMARY outcome
Timeframe: 1-month post-trainingPopulation: Missing data were handled with the use of 100 imputed data sets that were based on model-based imputation.
Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Lateral position was sampled continuously. Standard deviation of lane position was calculated for the 14 secondary task periods per drive. Estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable.
Outcome measures
| Measure |
FOCAL+Training
n=76 Participants
FOCAL+: Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
|
Rules of the Road Training
n=76 Participants
Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
|
|---|---|---|
|
Standard Deviation of Lateral Position During Driving Simulation
|
.98 feet
Interval 0.92 to 1.04
|
1.20 feet
Interval 1.14 to 1.25
|
PRIMARY outcome
Timeframe: 6-months post-trainingPopulation: Missing data were handled with the use of 100 imputed data sets that were based on fully conditional specification imputation.
Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Eye gaze was sampled continuously. Eye gaze data was summarized by calculating the number of extended (≥2 secs) glances away from the roadway during the 14 secondary task periods per drive. This was our primary outcome for visual behavior during driving. Descriptive estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable.
Outcome measures
| Measure |
FOCAL+Training
n=76 Participants
FOCAL+: Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
|
Rules of the Road Training
n=76 Participants
Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
|
|---|---|---|
|
Number of Extended Glances Away From Roadway During Driving Simulation
|
15.7 number of long glances
Interval 13.2 to 18.2
|
27.0 number of long glances
Interval 24.9 to 29.1
|
PRIMARY outcome
Timeframe: 6-months post-trainingPopulation: Missing data were handled with the use of 100 imputed data sets that were based on model-based imputation.
Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Lateral position was sampled continuously. Standard deviation of lane position was calculated for the 14 secondary task periods per drive. Estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable.
Outcome measures
| Measure |
FOCAL+Training
n=76 Participants
FOCAL+: Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
|
Rules of the Road Training
n=76 Participants
Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
|
|---|---|---|
|
Standard Deviation of Lateral Position During Driving Simulation
|
.98 feet
Interval 0.92 to 1.05
|
1.20 feet
Interval 1.14 to 1.27
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: These analyses were conducted in the as-treated population, which involved participants for whom data from the in-vehicle recording device were available. Three teens (1 in the intervention group and 2 in the control group) had no g-force events during the 1-year follow-up for the evaluation of secondary outcomes.
The DriveCam device is an event-triggered palm sized pair of cameras that are mounted to the rear view mirror of the participant's car. The device has a forward-road facing camera and another camera that faces the driver. Both cameras continuously record but only save to memory when a built-in accelerometer exceeds a set g force threshold. Any g-force event that exceeds .6 g-force will be coded using codings of crashes (i.e., collision with another vehicle or object) or near-crashes (i.e., an evasive maneuver performed to avoid a MVC). This outcome will include the rate of crashes or near-crashes.
Outcome measures
| Measure |
FOCAL+Training
n=3213 DriveCam events
FOCAL+: Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
|
Rules of the Road Training
n=2818 DriveCam events
Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
|
|---|---|---|
|
Number of Incidents, Crashes, and Near-crashes Recorded With DriveCam
|
110 DriveCam events
|
159 DriveCam events
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: These analyses were conducted in the as-treated population, which involved participants for whom data from the in-vehicle recording device were available. Three teens (1 in the intervention group and 2 in the control group) had no g-force events during the 1-year follow-up for the evaluation of secondary outcomes.
The DriveCam device has a forward-road facing camera and another camera that faces the driver. Both cameras record when a built-in accelerometer exceeds a set g force threshold of .6. Video event recordings of the driver were be coded for whether a 2-second or longer glance away from the roadway occurred during the recorded event. Using these codings, the number of events that included a 2-second or longer glance away from the roadway was determined for each group.
Outcome measures
| Measure |
FOCAL+Training
n=3213 DriveCam events
FOCAL+: Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
|
Rules of the Road Training
n=2818 DriveCam events
Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
|
|---|---|---|
|
Number of DriveCam Events That Are Preceded by a 2 Second or Greater Glance Away From the Roadway
|
588 DriveCam events
|
674 DriveCam events
|
Adverse Events
FOCAL+Training
Rules of the Road Training
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FOCAL+Training
n=76 participants at risk
FOCAL+: Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
|
Rules of the Road Training
n=76 participants at risk
Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
|
|---|---|---|
|
Nervous system disorders
Simulator sickness during assessment
|
0.00%
0/76 • 5-weeks of training, 1-month post-training assessment, 6-month post-training assessment
Anticipated AE and possible precautions and responses to these events include: 1) Simulator sickness including nausea and headache. 2) Frustration with simulator training.
|
2.6%
2/76 • Number of events 2 • 5-weeks of training, 1-month post-training assessment, 6-month post-training assessment
Anticipated AE and possible precautions and responses to these events include: 1) Simulator sickness including nausea and headache. 2) Frustration with simulator training.
|
|
Nervous system disorders
Simulator sickness during training
|
7.9%
6/76 • Number of events 6 • 5-weeks of training, 1-month post-training assessment, 6-month post-training assessment
Anticipated AE and possible precautions and responses to these events include: 1) Simulator sickness including nausea and headache. 2) Frustration with simulator training.
|
5.3%
4/76 • Number of events 4 • 5-weeks of training, 1-month post-training assessment, 6-month post-training assessment
Anticipated AE and possible precautions and responses to these events include: 1) Simulator sickness including nausea and headache. 2) Frustration with simulator training.
|
|
Psychiatric disorders
Frustration during training
|
2.6%
2/76 • Number of events 2 • 5-weeks of training, 1-month post-training assessment, 6-month post-training assessment
Anticipated AE and possible precautions and responses to these events include: 1) Simulator sickness including nausea and headache. 2) Frustration with simulator training.
|
0.00%
0/76 • 5-weeks of training, 1-month post-training assessment, 6-month post-training assessment
Anticipated AE and possible precautions and responses to these events include: 1) Simulator sickness including nausea and headache. 2) Frustration with simulator training.
|
Additional Information
Jeff Epstein, Ph.D.
Cincinnati Children's Hospital Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place