Recruiting

Driving Intervention

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT06960980

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Sex: All

Age: 16 - 19

Healthy Volunteers: Not accepted

Interventions

FOCAL+

VR-FOCAL+

Study Details

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). 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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Study ID

NCT06960980

Start date

Sep 11, 2025

Status verified date

Feb, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 19

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Aged 16-19.
2. Teens will meet DSM 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 Kauffman Brief Intelligence Scale - Second Edition (KBIT-2).
5. Parent willing to participate.

Exclusion Criteria:

1. On ADHD medication that cannot be washed out on assessment days.
2. Drug or alcohol dependence based on self-report on the Simple Screening Instrument for Alcohol and Other Drugs survey.
3. On psychotropic or neuroleptic medications.
4. At-risk for motion sickness in the driving simulator or in virtual reality.
5. History of moderate to severe head trauma, neurological disorder, or any other organic disorder that could possibly affect brain function.
6. Cannot see the secondary task stimuli without the use of glasses (contacts acceptable).

Study Design

Enrollment

204 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: FOCAL+ Training

Enhanced FOcused Concentration and Attention Learning driver training using desktop computer and fixed base driving simulator

experimental: Virtual Reality - FOCAL+

Enhanced FOcused Concentration and Attention Learning driver training using virtual reality

no intervention: Wait-list Control

Teens will wait approximately 1 year to receive FOCAL+ training. In order to control for experience with the driving simulator across groups, teens in this group will attend 5 weekly sessions where they will experience five 5-minute drives in the 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. Teens in this group will not receive feedback regarding eye glances during these drives.

Interventions

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.

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 measure

  • Number of extended glances away from the roadway during simulated driving [ Time Frame: 1-month post-training ]
  • Number of extended glances away from the roadway during simulated driving [ Time Frame: 6-months post-training ]

Central Contacts and Locations

Central contacts

Clinical Research Coordinator

513-636-0007ADHDdriving@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Jeff Epstein, Ph.D.

513-636-8296jeff.epstein@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Feb 23, 2026

Last verified

Feb, 2026

Keywords

  • Visual attention
  • Automobile Driving

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-02-23.