Clinical trial NCT06960980: Improving ADHD Teen Driving - Virtual Reality
Official title: Improving ADHD Teen Driving - Virtual Reality
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Keywords: Visual attention
Automobile Driving
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2025-05-07
Enrollment: 204
Sex: ALL
Minimum age (years): 16
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Number of extended glances away from the roadway during simulated driving
timeFrame: 1-month post-training
measure: Number of extended glances away from the roadway during simulated driving
timeFrame: 6-months post-training
Secondary outcomes:
measure: Standard Deviation of Lateral Position during simulated driving
timeFrame: 1-month post-training
measure: Standard Deviation of Lateral Position during simulated driving
timeFrame: 6-months post-training
Other outcomes:
measure: Rate of crashes and near-crashes recorded with DriveCam
timeFrame: 12-months post-training
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jeff N Epstein, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.