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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
Sponsor:
Collaborators:
St. Louis University
University of Massachusetts, Amherst
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Brief Summary:
Teens with Attention-Deficit/Hyperactivity Disorder (ADHD) have high rates of negative driving outcomes, including motor vehicle crashes, which may be caused by visual inattention (i.e., looking away from the roadway to perform secondary tasks). A driving intervention that trains teens to reduce instances of looking away from the roadway will be tested in teens with ADHD.

Condition or disease Intervention/treatment Phase
Attention Deficit Disorder Attention Deficit Disorder With Hyperactivity Behavioral: FOCAL+ Other: Rules of The road Not Applicable

Detailed Description:
Operating a motor vehicle requires a complex set of skills, the most important of which is the ability to continuously visually attend to the roadway. Glances away from the roadway significantly increase one's risk for a motor vehicle crash (MVC). Teen drivers evidence far more extended glances away from the roadway than experienced drivers. Further, teens with a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) emit 3-times more extended glances away from the roadway than typical teens. There is a clear need for interventions, particularly one that targets extended glances away from the roadway, to address the driving deficits of teens with ADHD. The proposed research will test the efficacy of the FOcused Concentration and Attention Learning (FOCAL) intervention, which targets reducing the number of extended glances away from the roadway, among teens with ADHD. The PC-based FOCAL training provides teens with an operational understanding of the dangers of extended glances away from the roadway and trains them on limiting the length of the teens' glances. The investigators have enhanced the FOCAL intervention (now termed FOCAL+) to include multiple training sessions and to integrate practice on a driving simulator with immediate feedback regarding extended glance behavior. In this randomized trial, teens with ADHD will be randomly assigned to receive either FOCAL+ or a sham placebo group. Immediately after 1 month of training sessions and 6-months post-training, teens' driving skills will be assessed using a driving simulator. In addition, teens will have cameras installed in their cars for 12-months which record driver behavior and road conditions during irregular events (e.g., hard-braking, swerving). Using data from driving simulation, cameras installed in the teen's car, and teen driving records, the investigators will examine the short- and long-term efficacy of the FOCAL+ intervention on 1) decreasing rates of extended glances away from the roadway among teens with ADHD, and 2) improving driving performance among teens with ADHD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Improving ADHD Teen Driving
Study Start Date : May 2016
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FOCAL+Training Behavioral: 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 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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Aged 16-19.
  2. Must meet DSM-5 ADHD criteria for ADHD-Predominantly Inattentive Presentation or ADHD-Combined Presentation based on the K-SADS interview.
  3. Possess a valid driver's license and regularly spend at least 3 hours per week engaged in unsupervised driving.
  4. IQ ≥80 as measured by the Wechsler Abbreviated Intelligence Scale-II (WASI-II)
  5. Parent willing to participate..

Exclusion Criteria:

  1. On ADHD medication that cannot be washed out on assessment days.
  2. Drug or alcohol dependence according to K-SADS interview.
  3. On psychotropic or neuroleptic medications.
  4. Require eye glasses (contacts acceptable) for driving (corrective vision restriction on driver's license).

Information from the National Library of Medicine

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


Contacts
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Contact: Jeff Epstein, Ph.D. 513-636-8296 jeff.epstein@cchmc.org

Locations
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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    elissar.elsabbaugh@cchmc.org   
Principal Investigator: Jeffery N Epstein, Ph.D.         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
St. Louis University
University of Massachusetts, Amherst
Investigators
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Principal Investigator: Jeff Epstein, Ph.D Cincinnati Childrens Hospital Medical Center

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02848092     History of Changes
Other Study ID Numbers: R01HD084430 ( U.S. NIH Grant/Contract )
First Posted: July 28, 2016    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Visual Attention
Automobile Driving
Additional relevant MeSH terms:
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Disease
Attention Deficit Disorder with Hyperactivity
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders