Clinical trial NCT02848092: Improving ADHD Teen Driving
Official title: Improving ADHD Teen Driving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Disorder
Attention Deficit Disorder With Hyperactivity
Keywords: Visual Attention
Automobile Driving
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: St. Louis University
name: University of Massachusetts, Amherst
First posted: 2016-07-28
Enrollment: 152
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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).

Primary outcomes:
measure: Number of Extended Glances Away From Roadway During Driving Simulation
timeFrame: 1-month post-training
measure: Standard Deviation of Lateral Position During Driving Simulation
timeFrame: 1-month post-training
measure: Number of Extended Glances Away From Roadway During Driving Simulation
timeFrame: 6-months post-training
measure: Standard Deviation of Lateral Position During Driving Simulation
timeFrame: 6-months post-training
Secondary outcomes:
measure: Number of Incidents, Crashes, and Near-crashes Recorded With DriveCam
timeFrame: 12 months
measure: Number of DriveCam Events That Are Preceded by a 2 Second or Greater Glance Away From the Roadway
timeFrame: 12 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Center for ADHD, Cincinnati Childrens Hospital Medical Center
state: Ohio
Study officials:
affiliation: Cincinnati Childrens Hospital Medical Center
name: Jeff Epstein, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: