Improving ADHD Teen Driving
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|ClinicalTrials.gov Identifier: NCT02848092|
Recruitment Status : Recruiting
First Posted : July 28, 2016
Last Update Posted : July 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Disorder Attention Deficit Disorder With Hyperactivity||Behavioral: FOCAL+ Other: Rules of The road||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Improving ADHD Teen Driving|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||March 2021|
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 two 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.
|Sham Comparator: Rules of the Road Training||
Other: 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 two 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 [ Time Frame: Immediate post-training ]Participants will complete a simulated drive in a driving simulator with an integrated eye-tracking system. After acclimating to the driving simulator, participants will complete two 15-minute drives. During each drive, the participant will engage in one secondary task per minute for a total of 28 secondary tasks. The secondary task will consist of searching for streets on a GPS map. Eye gaze, driving speed and lateral position will be sampled continuously. Eye gaze data will be summarized by calculating the number of extended (≥2 secs) glances away from the roadway, which will be the primary outcome for visual behavior during driving.
- Standard Deviation of Lateral Position during Driving Simulation [ Time Frame: Immediate post-training ]Participants will complete a simulated drive in a driving simulator with an integrated eye-tracking system. After acclimating to the driving simulator, participants will complete two 15-minute drives. During each drive, the participant will engage in one secondary task per minute for a total of 28 secondary tasks. The secondary task will consist of searching for streets on a GPS map. Eye gaze, driving speed and lateral position will be sampled continuously. Using driving simulator data, the investigators will calculate the standard deviation of lane position.
- Number of incidents, crashes, and near-crashes recorded with DriveCam [ Time Frame: 12 months ]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 three primary codings: 1) incidents (i.e., a threshold exceedance in which the driver's action, either intentional or unintentional, was responsible for a safety-relevant event), 2) crashes (i.e., collision with another vehicle or object), and 3) near-crashes (i.e., an evasive maneuver performed to avoid a MVC). The primary outcomes will include the number of incidents, crashes, and near-crashes per hour driven.
- Number of incidents, crashes, and near-crashes recorded with DriveCam that are preceded by a greater than 2 second glance away from the roadway [ Time Frame: 12 months ]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 recordings of the driver will be coded for whether an extended glance away from the roadway preceded the recorded event, along with the length of the glance away from the roadway and the temporal proximity of that glance to the actual event. Using these codings, the investigators will be able to determine the number of incidents preceded by ≥ 2 sec glance away from roadway.
- Number of motor vehicle crashes [ Time Frame: 12 months ]Participants' driving records from the Bureau of Motor Vehicles for the 1 year of the study will be obtained. The number of motor vehicle crashes will be recorded from these records.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02848092
|Contact: Jeff Epstein, Ph.D.||email@example.com|
|United States, Ohio|
|Center for ADHD, Cincinnati Childrens Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|Contact: Elissar ElSabbaugh, B.A 513-803-1345 firstname.lastname@example.org|
|Principal Investigator: Jeffery N Epstein, Ph.D.|
|Principal Investigator:||Jeff Epstein, Ph.D||Cincinnati Childrens Hospital Medical Center|