Improving ADHD Teen Driving - Virtual Reality

NCT ID: NCT06960980

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2029-08-31

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.

Detailed Description

Motor vehicle crashes (MVC) are the leading causes of death among teens with eight teens dying per day in an MVC. Teens with Attention-Deficit Hyperactivity Disorder (ADHD) are at twice the risk of MVC compared to teen drivers without ADHD. A programmatic line of research by this investigative team has identified long (>2 secs) glances away from the roadway, particularly during engagement with secondary tasks, as being a key mechanism in ADHD teen driving risk. In the original research grant, the investigative team developed and tested a driver training program, enhanced FOcused Concentration and Attention Learning (FOCAL+), to specifically target reducing rates of extended glances away from the roadway in teens with ADHD. In a randomized controlled trial (RCT), teens with ADHD randomly assigned to FOCAL+ demonstrated 41% fewer long-glances and less variability in lane position during simulated driving assessments conducted immediately after the final training session, and 1- and 6-months post-training compared to teens assigned to modified driver's training. Moreover, during naturalistic driving over the course of a year of driving, FOCAL+ teens had 40% less risk of a crash/near-crash event than control teens. However, there are considerable barriers to disseminating FOCAL+ in its current format. FOCAL+, as implemented in the RCT, requires costly (~$90K) hardware and software that are quite complex to use. Though there has been much interest in offering this training since publication of our RCT results, key stakeholders have reported that the expense and complexity of the hardware and software requirements are barriers to adoption. In the proposed study, with input from relevant stakeholders, FOCAL+ training will be converted to an immersive virtual reality (iVR) platform. iVR-FOCAL+ will provide an affordable ($5K), single hardware, single software, easily-executable solution that implementation sites (i.e., driving schools, outpatient occupational therapy) will be able to afford, adopt, and offer to teens with ADHD. Using a hybrid effectiveness-implementation design, teens with ADHD will be randomly assigned to receive either iVR-FOCAL+, the original FOCAL+ or a wait-list control group. The iVR-FOCAL+ training will be implemented in real-world, non-research settings (i.e., driving schools, outpatient occupational therapy). At baseline and 1- and 6-months post-training, teens' driving skills will be assessed during driving simulation. Naturalistic driving will be assessed during the year after training using video event recorders installed in the teen's car. Training costs and implementation outcomes (e.g., barriers to implementation) for each training will be collected. Using these data, the investigators will examine the relative effectiveness and cost-effectiveness of iVR-FOCAL+ intervention compared to FOCAL+ training. Finally, implementation of iVR-FOCAL+ will be described. The proposed research has the potential to facilitate adoption and eventual dissemination of a training program that can prevent injuries and fatalities among a high-risk population of teens as well as among those who share their roadways.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

FOCAL+ Training

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

Group Type: EXPERIMENTAL

FOCAL+

Intervention Type: 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.

Virtual Reality - FOCAL+

Enhanced FOcused Concentration and Attention Learning driver training using virtual reality

Group Type: EXPERIMENTAL

VR-FOCAL+

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeff N Epstein, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clinical Research Coordinator

Role: CONTACT

ADHDdriving@cchmc.org

513-636-0007

Facility Contacts

Jeff Epstein, Ph.D.

Role: primary

jeff.epstein@cchmc.org

513-636-8296

References

Epstein JN, Garner AA, Kiefer AW, Peugh J, Tamm L, MacPherson RP, Simon JO, Fisher DL. Trial of Training to Reduce Driver Inattention in Teens with ADHD. N Engl J Med. 2022 Dec 1;387(22):2056-2066. doi: 10.1056/NEJMoa2204783.

Reference Type: BACKGROUND

PMID: 36449421 (View on PubMed)

Other Identifiers

R01HD084430-06A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025-0273

Identifier Type: -

Identifier Source: org_study_id