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| Name | Class |
|---|---|
| St. Louis University | OTHER |
| University of Massachusetts, Amherst | OTHER |
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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). A driving intervention that trains teens to reduce instances of looking away from the roadway will be tested in teens with ADHD.
Operating a motor vehicle requires a complex set of skills, the most important of which is the ability to continuously visually attend to the roadway. Glances away from the roadway significantly increase one's risk for a motor vehicle crash (MVC). Teen drivers evidence far more extended glances away from the roadway than experienced drivers. Further, teens with a diagnosis of Attention Deficit/Hyperactivity Disorder (ADHD) emit 3-times more extended glances away from the roadway than typical teens. There is a clear need for interventions, particularly one that targets extended glances away from the roadway, to address the driving deficits of teens with ADHD. The proposed research will test the efficacy of the FOcused Concentration and Attention Learning (FOCAL) intervention, which targets reducing the number of extended glances away from the roadway, among teens with ADHD. The PC-based FOCAL training provides teens with an operational understanding of the dangers of extended glances away from the roadway and trains them on limiting the length of the teens' glances. The investigators have enhanced the FOCAL intervention (now termed FOCAL+) to include multiple training sessions and to integrate practice on a driving simulator with immediate feedback regarding extended glance behavior. In this randomized trial, teens with ADHD will be randomly assigned to receive either FOCAL+ or a sham placebo group. Immediately after 1 month of training sessions and 6-months post-training, teens' driving skills will be assessed using a driving simulator. In addition, teens will have cameras installed in their cars for 12-months which record driver behavior and road conditions during irregular events (e.g., hard-braking, swerving). Using data from driving simulation, cameras installed in the teen's car, and teen driving records, the investigators will examine the short- and long-term efficacy of the FOCAL+ intervention on 1) decreasing rates of extended glances away from the roadway among teens with ADHD, and 2) improving driving performance among teens with ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FOCAL+Training | Experimental |
| |
| Rules of the Road Training | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. 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. After each session of computerized FOCAL training, teens will complete two 5-minute simulated drives. 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Extended Glances Away From Roadway During Driving Simulation | Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Eye gaze was sampled continuously. Eye gaze data was summarized by calculating the number of extended (≥2 secs) glances away from the roadway during the 14 secondary task periods per drive. This was our primary outcome for visual behavior during driving. Descriptive estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable. | 1-month post-training |
| Standard Deviation of Lateral Position During Driving Simulation | Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Lateral position was sampled continuously. Standard deviation of lane position was calculated for the 14 secondary task periods per drive. Estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable. | 1-month post-training |
| Number of Extended Glances Away From Roadway During Driving Simulation | Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Eye gaze was sampled continuously. Eye gaze data was summarized by calculating the number of extended (≥2 secs) glances away from the roadway during the 14 secondary task periods per drive. This was our primary outcome for visual behavior during driving. Descriptive estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Incidents, Crashes, and Near-crashes Recorded With DriveCam | The DriveCam device is an event-triggered palm sized pair of cameras that are mounted to the rear view mirror of the participant's car. The device has a forward-road facing camera and another camera that faces the driver. Both cameras continuously record but only save to memory when a built-in accelerometer exceeds a set g force threshold. Any g-force event that exceeds .6 g-force will be coded using codings of crashes (i.e., collision with another vehicle or object) or near-crashes (i.e., an evasive maneuver performed to avoid a MVC). This outcome will include the rate of crashes or near-crashes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Epstein, Ph.D | Cincinnati Childrens Hospital Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for ADHD, Cincinnati Childrens Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36449421 | Derived | 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. |
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Teens 16 to 19 years of age with ADHD who had a valid driver's license were recruited at the Cincinnati Children's Hospital Medical Center by means of radio, social media, and print advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | FOCAL+Training | 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. 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. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. 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. |
| FG001 | Rules of the Road Training | Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1-month Post-training Follow-up |
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| |||||||||||||||||||||
| 6-month Post-training Follow-up |
| ||||||||||||||||||||||
| 12-month Naturalistic Driving |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FOCAL+Training | 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. 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. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Extended Glances Away From Roadway During Driving Simulation | Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Eye gaze was sampled continuously. Eye gaze data was summarized by calculating the number of extended (≥2 secs) glances away from the roadway during the 14 secondary task periods per drive. This was our primary outcome for visual behavior during driving. Descriptive estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable. | Missing data were handled with the use of 100 imputed data sets that were based on fully conditional specification imputation. | Posted | Mean | 95% Confidence Interval | number of long glances | 1-month post-training |
|
5-weeks of training, 1-month post-training assessment, 6-month post-training assessment
Anticipated AE and possible precautions and responses to these events include: 1) Simulator sickness including nausea and headache. 2) Frustration with simulator training.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FOCAL+Training | 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. 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. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Simulator sickness during assessment | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeff Epstein, Ph.D. | Cincinnati Children's Hospital Medical Center | 513-636-8296 | jeff.epstein@cchmc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2022 | Jan 6, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Parent Permission Form | Mar 2, 2019 | Jan 6, 2023 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Adult Consent Form | Mar 2, 2019 | Jan 6, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Rules of The road | Other | Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete two 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving. |
|
| 6-months post-training |
| Standard Deviation of Lateral Position During Driving Simulation | Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Lateral position was sampled continuously. Standard deviation of lane position was calculated for the 14 secondary task periods per drive. Estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable. | 6-months post-training |
| 12 months |
| Number of DriveCam Events That Are Preceded by a 2 Second or Greater Glance Away From the Roadway | The DriveCam device has a forward-road facing camera and another camera that faces the driver. Both cameras record when a built-in accelerometer exceeds a set g force threshold of .6. Video event recordings of the driver were be coded for whether a 2-second or longer glance away from the roadway occurred during the recorded event. Using these codings, the number of events that included a 2-second or longer glance away from the roadway was determined for each group. | 12 months |
| Withdrawal by Subject |
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| received new diagnosis of epilepsy |
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| fatigue |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| BG001 | Rules of the Road Training | Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Extended Glances Away from Roadway during Driving Simulation | Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Eye gaze was sampled continuously. Eye gaze data was summarized by calculating the number of extended (≥2 secs) glances away from the roadway during the 14 secondary task periods per drive. Estimates reflect averages across the 2 drives. | Mean | Standard Deviation | number of long glances |
|
| Standard Deviation of Lateral Position during Driving Simulation | Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Lateral position was sampled continuously. Standard deviation of lane position was calculated for the 14 secondary task periods per drive. Estimates reflect averages across the 2 drives. | Mean | Standard Deviation | feet |
|
| FOCAL+Training |
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. 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. After each session of computerized FOCAL training, teens will complete up to five 5-minute simulated drives. 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. |
| OG001 | Rules of the Road Training | Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving. |
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| Primary | Standard Deviation of Lateral Position During Driving Simulation | Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Lateral position was sampled continuously. Standard deviation of lane position was calculated for the 14 secondary task periods per drive. Estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable. | Missing data were handled with the use of 100 imputed data sets that were based on model-based imputation. | Posted | Mean | 95% Confidence Interval | feet | 1-month post-training |
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| Primary | Number of Extended Glances Away From Roadway During Driving Simulation | Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Eye gaze was sampled continuously. Eye gaze data was summarized by calculating the number of extended (≥2 secs) glances away from the roadway during the 14 secondary task periods per drive. This was our primary outcome for visual behavior during driving. Descriptive estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable. | Missing data were handled with the use of 100 imputed data sets that were based on fully conditional specification imputation. | Posted | Mean | 95% Confidence Interval | number of long glances | 6-months post-training |
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| Primary | Standard Deviation of Lateral Position During Driving Simulation | Participants completed a simulated drive in a driving simulator with an integrated eye-tracking system. Participants completed two 15-minute drives. During each drive, participants engaged in 14 secondary tasks. The secondary task consisted of searching for streets on a GPS map and lasted for 30 seconds. Lateral position was sampled continuously. Standard deviation of lane position was calculated for the 14 secondary task periods per drive. Estimates reflect averages across the 2 drives. However, for analyses, estimates for each drive were statistically modeled with a two-level drive variable. | Missing data were handled with the use of 100 imputed data sets that were based on model-based imputation. | Posted | Mean | 95% Confidence Interval | feet | 6-months post-training |
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| Secondary | Number of Incidents, Crashes, and Near-crashes Recorded With DriveCam | The DriveCam device is an event-triggered palm sized pair of cameras that are mounted to the rear view mirror of the participant's car. The device has a forward-road facing camera and another camera that faces the driver. Both cameras continuously record but only save to memory when a built-in accelerometer exceeds a set g force threshold. Any g-force event that exceeds .6 g-force will be coded using codings of crashes (i.e., collision with another vehicle or object) or near-crashes (i.e., an evasive maneuver performed to avoid a MVC). This outcome will include the rate of crashes or near-crashes. | These analyses were conducted in the as-treated population, which involved participants for whom data from the in-vehicle recording device were available. Three teens (1 in the intervention group and 2 in the control group) had no g-force events during the 1-year follow-up for the evaluation of secondary outcomes. | Posted | Count of Units | DriveCam events | 12 months | DriveCam events | DriveCam events |
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| Secondary | Number of DriveCam Events That Are Preceded by a 2 Second or Greater Glance Away From the Roadway | The DriveCam device has a forward-road facing camera and another camera that faces the driver. Both cameras record when a built-in accelerometer exceeds a set g force threshold of .6. Video event recordings of the driver were be coded for whether a 2-second or longer glance away from the roadway occurred during the recorded event. Using these codings, the number of events that included a 2-second or longer glance away from the roadway was determined for each group. | These analyses were conducted in the as-treated population, which involved participants for whom data from the in-vehicle recording device were available. Three teens (1 in the intervention group and 2 in the control group) had no g-force events during the 1-year follow-up for the evaluation of secondary outcomes. | Posted | Count of Units | DriveCam events | 12 months | DriveCam events | DriveCam events |
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|
| 0 |
| 76 |
| 0 |
| 76 |
| 8 |
| 76 |
| EG001 | Rules of the Road Training | Rules of The road: Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete up to five 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving. | 0 | 76 | 0 | 76 | 6 | 76 |
| Simulator sickness during training | Nervous system disorders | Non-systematic Assessment |
|
| Frustration during training | Psychiatric disorders | Non-systematic Assessment |
|
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