Attention Deficit Hyperactivity Disorder (ADHD)NCT06960980
Improving ADHD Teen Driving - Virtual Reality
A study testing FOCAL+ and VR-FOCAL+ in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 19 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- FOCAL+ and VR-FOCAL+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2025to 31 Aug 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Jeff Epstein, Ph.D., 513-636-8296, jeff.epstein@cchmc.org
About this study
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.
Read the 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.
- Being tested
- FOCAL+, VR-FOCAL+
- Keywords
- Visual attention, Automobile Driving
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOCAL+Behavioural
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+Behavioural
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 group | Role | What they receive |
|---|---|---|
| FOCAL+ Training | Experimental | Enhanced FOcused Concentration and Attention Learning driver training using desktop computer and fixed base driving simulator Receives: Behavioral: FOCAL+ |
| Virtual Reality - FOCAL+ | Experimental | Enhanced FOcused Concentration and Attention Learning driver training using virtual reality Receives: Behavioral: VR-FOCAL+ |
| Wait-list Control | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6-months post-training
Secondary outcomes (2)
Standard Deviation of Lateral Position 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. Lateral position will be sampled continuously. Standard deviation of lane position will be calculated for the 14 secondary task periods per drive. 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.
Measured: 1-month post-training
Standard Deviation of Lateral Position 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. Lateral position will be sampled continuously. Standard deviation of lane position will be calculated for the 14 secondary task periods per drive. 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.
Measured: 6-months post-training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start11 Sep 2025
- Primary completion31 Aug 2029 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Jeff N Epstein, Ph.D., Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960980
- Sponsor's protocol ID
- 2025-0273
- Other IDs
- R01HD084430-06A1
- Status last verified
- Feb 2026
- First submitted
- 29 Apr 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36449421
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving ADHD Teen Driving - Virtual Reality
- ClinicalTrials.gov ID
- NCT06960980
- Acronym / sponsor ID
- 2025-0273
- Keywords
- Visual attention, Automobile Driving
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- 31 Aug 2029 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| FOCAL+ Training | Experimental | Behavioral: FOCAL+Enhanced FOcused Concentration and Attention Learning driver training using desktop computer and fixed base driving simulator |
| Virtual Reality - FOCAL+ | Experimental | Behavioral: VR-FOCAL+Enhanced FOcused Concentration and Attention Learning driver training using virtual reality |
| Wait-list Control | No intervention | –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. |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | FOCAL+ Training |
| 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. | Behavioural | Virtual Reality - FOCAL+ |
Primary outcome
Number of extended glances away from the roadway during simulated driving
Time frame: 1-month post-training
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.
Number of extended glances away from the roadway during simulated driving
Time frame: 6-months post-training
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.
2 secondary outcomes
Standard Deviation of Lateral Position during simulated driving
Time frame: 1-month post-training
Standard Deviation of Lateral Position during simulated driving
Time frame: 6-months post-training
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 36449421Epstein 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeff N Epstein, Ph.D. principal investigator
Children's Hospital Medical Center, Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FOCAL+ and VR-FOCAL+ in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Children's Hospital Medical Center, Cincinnati at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Coordinator (513-636-0007, ADHDdriving@cchmc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of extended glances away from the roadway during simulated driving (time frame: 1-month post-training). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06960980, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.