Improving ADHD Teen Driving

Attention Deficit Disorder With Hyperactivity Clinical Trial

Official title:

Improving ADHD Teen Driving

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02848092
• Other study ID #: R01HD084430
• Status: Completed
• Phase: N/A
• Start date: December 21, 2016
• Est. completion date: December 1, 2021

Study information

• Verified date: February 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 19 Years

Eligibility

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).

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder With Hyperactivity
• Disease

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Center for ADHD, Cincinnati Childrens Hospital Medical Center	Cincinnati	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	St. Louis University, University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Extended Glances Away From Roadway During Driving Simulation	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.	1-month post-training
Primary	Standard Deviation of Lateral Position During Driving Simulation	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.	1-month post-training
Primary	Number of Extended Glances Away From Roadway During Driving Simulation	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.	6-months post-training
Primary	Standard Deviation of Lateral Position During Driving Simulation	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.	6-months post-training
Secondary	Number of Incidents, Crashes, and Near-crashes Recorded With DriveCam	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.	12 months
Secondary	Number of DriveCam Events That Are Preceded by a 2 Second or Greater Glance Away From the Roadway	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.	12 months