NCT06960980 · Children's Hospital Medical Center, Cincinnati
Improving ADHD Teen Driving - Virtual Reality
What this study is about
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). Two versions of a driving intervention that trains teens to reduce instances of looking away from the roadway will be tested in teens with ADHD.
View original scientific description
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). Two versions of a driving intervention that trains teens to reduce instances of looking away from the roadway will be tested in teens with ADHD.
Interventions
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. During phase 1 of each training session, 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. During phase 2 of each training session, teens will complete five 5-minute simulated drives using a fixed-base driving simulator. 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.
BEHAVIORAL
VR-FOCAL+
Weekly for 5 weeks, teens complete a training program designed to train teens to limit the length of glances away from the roadway. The training has two phases, each of which will be administered using immersive virtual reality. The first phase will have teens switch between the upper half of a virtual reality screen which will play a simulated video drive while the bottom half 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. During the second phase of each session, teens will complete five 5-minute simulated drives in a virtual reality environment where teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
Primary outcome measures
Number of extended glances away from the roadway during simulated driving
Time frame: 1-month post-training
Participants will complete a simulated drive in a driving simulator with an integrated eye-tracking system. Participants will complete two 15-minute drives. During each drive, participants will engage in 14 secondary tasks. The secondary task consist of searching for streets on a GPS map for 20 seconds. Eye gaze will be sampled continuously. Eye gaze data will be summarized by calculating the number of extended (≥2 secs) glances away from the roadway during the 14 secondary task periods per drive. Descriptive estimates will reflect averages across the 2 drives. However, for analyses, estimates for each drive will be statistically modeled with a two-level drive variable.
Number of extended glances away from the roadway during simulated driving
Time frame: 6-months post-training
Participants will complete a simulated drive in a driving simulator with an integrated eye-tracking system. Participants will complete two 15-minute drives. During each drive, participants will engage in 14 secondary tasks. The secondary task consist of searching for streets on a GPS map for 20 seconds. Eye gaze will be sampled continuously. Eye gaze data will be summarized by calculating the number of extended (≥2 secs) glances away from the roadway during the 14 secondary task periods per drive. Descriptive estimates will reflect averages across the 2 drives. However, for analyses, estimates for each drive will be statistically modeled with a two-level drive variable.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Aged 16-19.
- Teens will meet DSM ADHD criteria for ADHD-Predominantly Inattentive Presentation or ADHD-Combined Presentation based on the K-SADS interview.
- Possess a valid driver's license and regularly spend at least 3 hours per week engaged in unsupervised driving.
- IQ ≥80 as measured by the Kauffman Brief Intelligence Scale - Second Edition (KBIT-2).
- Parent willing to participate.
Exclusion criteria
- On ADHD medication that cannot be washed out on assessment days.
- Drug or alcohol dependence based on self-report on the Simple Screening Instrument for Alcohol and Other Drugs survey.
- On psychotropic or neuroleptic medications.
- At-risk for motion sickness in the driving simulator or in virtual reality.
- History of moderate to severe head trauma, neurological disorder, or any other organic disorder that could possibly affect brain function.
- Cannot see the secondary task stimuli without the use of glasses (contacts acceptable).
Where
- Cincinnati, Ohio
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 23, 2026 · Source of record for eligibility and locations