Improving ADHD Teen Driving - Virtual Reality
2 other identifiers
interventional
204
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2025
CompletedFirst Posted
Study publicly available on registry
May 7, 2025
CompletedStudy Start
First participant enrolled
September 11, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2029
February 23, 2026
February 1, 2026
4 years
April 29, 2025
February 20, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of extended glances away from the roadway during simulated driving
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.
1-month post-training
Number of extended glances away from the roadway during simulated driving
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.
6-months post-training
Secondary Outcomes (2)
Standard Deviation of Lateral Position during simulated driving
1-month post-training
Standard Deviation of Lateral Position during simulated driving
6-months post-training
Other Outcomes (1)
Rate of crashes and near-crashes recorded with DriveCam
12-months post-training
Study Arms (3)
FOCAL+ Training
EXPERIMENTALEnhanced FOcused Concentration and Attention Learning driver training using desktop computer and fixed base driving simulator
Virtual Reality - FOCAL+
EXPERIMENTALEnhanced FOcused Concentration and Attention Learning driver training using virtual reality
Wait-list Control
NO INTERVENTIONTeens 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
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Related Publications (1)
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.
PMID: 36449421BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeff N Epstein, Ph.D.
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2025
First Posted
May 7, 2025
Study Start
September 11, 2025
Primary Completion (Estimated)
August 31, 2029
Study Completion (Estimated)
August 31, 2029
Last Updated
February 23, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- The study team will submit an initial batch of processed and cleaned data to the NICHD Data and Specimen Hub (DASH) after the first 50 participants have been enrolled in order to develop a pipeline for submitting study data to DASH. Along with these data, the investigators will develop and submit any data dictionaries and codebooks for these data. All remaining data will be submitted within 1 year of the last patient's last study visit, 4 months prior to any publication date, or 6 months before the end of the performance period, whichever is sooner.
- Access Criteria
- Clinical data will be shared with controlled access in NICHD Data and Specimen Hub (DASH) for general research use, as allowed by the participant's informed consents and the institutional certification. To access study data within DASH, users must submit a Data Request Checklist to DASH, sign the NICHD DASH Data Use Agreement, and submit proof of IRB approval.
Clinical data that will be preserved and shared are demographic data, diagnostic data and intelligence testing results, among other data pertinent to the study. Research data that will be shared include the driving history, driving simulation, eyetracking data, and driving event codings.