Attention Deficit Disorder, Attention Deficit Disorder With Hyperactivity
Conditions
Keywords
Visual Attention, Automobile Driving
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). A driving intervention that trains teens to reduce instances of looking away from the roadway will be tested in teens with ADHD.
Detailed description
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.
Interventions
BEHAVIORALFOCAL+
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.
OTHERRules 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 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.
Sponsors
St. Louis University
University of Massachusetts, Amherst
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 16-19. 2. Must meet DSM-5 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 Wechsler Abbreviated Intelligence Scale-II (WASI-II) 5. Parent willing to participate..
Exclusion criteria
1. On ADHD medication that cannot be washed out on assessment days. 2. Drug or alcohol dependence according to K-SADS interview. 3. On psychotropic or neuroleptic medications. 4. Require eye glasses (contacts acceptable) for driving (corrective vision restriction on driver's license).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Extended Glances Away From Roadway During Driving Simulation | 1-month post-training | 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. |
| Standard Deviation of Lateral Position During Driving Simulation | 1-month post-training | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Incidents, Crashes, and Near-crashes Recorded With DriveCam | 12 months | 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. |
| Number of DriveCam Events That Are Preceded by a 2 Second or Greater Glance Away From the Roadway | 12 months | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 76 |
| 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. | 76 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-month Naturalistic Driving | Did not have DriveCam installed in car | 3 | 2 |
| 1-month Post-training Follow-up | Adverse Event | 2 | 1 |
| 1-month Post-training Follow-up | fatigue | 0 | 1 |
| 1-month Post-training Follow-up | Lost to Follow-up | 8 | 3 |
| 1-month Post-training Follow-up | received new diagnosis of epilepsy | 1 | 0 |
| 1-month Post-training Follow-up | Withdrawal by Subject | 1 | 0 |
| 6-month Post-training Follow-up | Adverse Event | 1 | 1 |
| 6-month Post-training Follow-up | frustrated with task | 1 | 0 |
| 6-month Post-training Follow-up | Lost to Follow-up | 9 | 3 |
| 6-month Post-training Follow-up | new diagnosis of epilepsy | 1 | 0 |
| 6-month Post-training Follow-up | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | Rules of the Road Training | FOCAL+Training |
|---|---|---|---|
| Age, Continuous | 17.4 years STANDARD_DEVIATION 0.9 | 17.5 years STANDARD_DEVIATION 0.9 | 17.3 years STANDARD_DEVIATION 0.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 3 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 147 Participants | 72 Participants | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Number of Extended Glances Away from Roadway during Driving Simulation | 22.43 number of long glances STANDARD_DEVIATION 13.06 | 23.1 number of long glances STANDARD_DEVIATION 12.28 | 21.5 number of long glances STANDARD_DEVIATION 13.82 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 4 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 5 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 134 Participants | 69 Participants | 65 Participants |
| Region of Enrollment United States | 152 participants | 76 participants | 76 participants |
| Sex: Female, Male Female | 58 Participants | 30 Participants | 28 Participants |
| Sex: Female, Male Male | 94 Participants | 46 Participants | 48 Participants |
| Standard Deviation of Lateral Position during Driving Simulation | 1.15 feet STANDARD_DEVIATION 0.32 | 1.20 feet STANDARD_DEVIATION 0.31 | 1.11 feet STANDARD_DEVIATION 0.33 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 76 |
| other Total, other adverse events | 8 / 76 | 6 / 76 |
| serious Total, serious adverse events | 0 / 76 | 0 / 76 |
Outcome results
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.
Time frame: 1-month post-training
Population: Missing data were handled with the use of 100 imputed data sets that were based on fully conditional specification imputation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FOCAL+Training | Number of Extended Glances Away From Roadway During Driving Simulation | 16.5 number of long glances |
| Rules of the Road Training | Number of Extended Glances Away From Roadway During Driving Simulation | 28.0 number of long glances |
p-value: <0.000195% CI: [0.52, 0.76]Generalized Estimating Equation
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.
Time frame: 6-months post-training
Population: Missing data were handled with the use of 100 imputed data sets that were based on fully conditional specification imputation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FOCAL+Training | Number of Extended Glances Away From Roadway During Driving Simulation | 15.7 number of long glances |
| Rules of the Road Training | Number of Extended Glances Away From Roadway During Driving Simulation | 27.0 number of long glances |
p-value: <0.000195% CI: [0.52, 0.76]Generalized Estimating Equation
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.
Time frame: 1-month post-training
Population: Missing data were handled with the use of 100 imputed data sets that were based on model-based imputation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FOCAL+Training | Standard Deviation of Lateral Position During Driving Simulation | .98 feet |
| Rules of the Road Training | Standard Deviation of Lateral Position During Driving Simulation | 1.20 feet |
p-value: <0.000195% CI: [-0.29, -0.13]Generalized Estimating Equation
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.
Time frame: 6-months post-training
Population: Missing data were handled with the use of 100 imputed data sets that were based on model-based imputation.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| FOCAL+Training | Standard Deviation of Lateral Position During Driving Simulation | .98 feet |
| Rules of the Road Training | Standard Deviation of Lateral Position During Driving Simulation | 1.20 feet |
p-value: <0.000195% CI: [-0.31, -0.13]Generalized Estimating Equation
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| FOCAL+Training | Number of DriveCam Events That Are Preceded by a 2 Second or Greater Glance Away From the Roadway | 588 DriveCam events |
| Rules of the Road Training | Number of DriveCam Events That Are Preceded by a 2 Second or Greater Glance Away From the Roadway | 674 DriveCam events |
95% CI: [0.61, 0.92]
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.
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| FOCAL+Training | Number of Incidents, Crashes, and Near-crashes Recorded With DriveCam | 110 DriveCam events |
| Rules of the Road Training | Number of Incidents, Crashes, and Near-crashes Recorded With DriveCam | 159 DriveCam events |
95% CI: [0.41, 0.89]