CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 152 enrolled
Drug / intervention
FOCAL+ +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02848092
NCT02848092N/ACompleted

Improving ADHD Teen Driving

Children's Hospital Medical Center, Cincinnati·interventional·Posted Jul 28, 2016·Updated Mar 3, 2023

In Brief

A clinical study evaluating FOCAL+ and Rules of The road for Attention Deficit Disorder and Attention Deficit Disorder With Hyperactivity. Completed, enrolled 152 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJul 28, 2016
Enrollment StartDec 21, 2016
Primary CompletionDec 1, 2021
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 9.9 years ago

Interventions

FOCAL+behavioral

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.

Rules of The roadother

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.