Improving ADHD Teen Driving - Virtual Reality

Part of paid clinical trials in Cincinnati, Ohio.

Sponsor
Children's Hospital Medical Center, Cincinnati
Study ID
NCT06960980
Status
Recruiting

Conditions

  • Attention Deficit Hyperactivity Disorder (ADHD)

Eligibility Criteria

Sex
ALL
Age
16 Years - 19 Years
Healthy Volunteers
Not accepted

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. 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+ — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Sep 11, 2025
Status verified
Feb 2026
Primary completion
Aug 31, 2029
Completion
Aug 31, 2029

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Cincinnati Children's Hospital Medical CenterCincinnatiOhio45229
Jeff Epstein, Ph.D.
513-636-8296

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