Improving ADHD Teen Driving - Virtual Reality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-19
SponsorChildren's Hospital Medical Center, Cincinnati
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
FOCAL+
BehavioralWeekly 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+
BehavioralWeekly 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.
Treatment groups
204 Participants
are divided into 3 treatment groupsGroup A: FOCAL+ TrainingExperimental treatment 1 intervention
Group B: Virtual Reality - FOCAL+Experimental treatment 1 intervention
Group C: Wait-list ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1-month post-training2
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.
Time frame
6-months post-trainingSecondary outcomes
1
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.
Time frame
1-month post-training2
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.
Time frame
6-months post-trainingOther outcomes
1
Rate of crashes and near-crashes recorded with DriveCam
DriveCam is an event-triggered device with a 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 post-trainingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Children's Hospital Medical Center, Cincinnati
Lead sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Source ClinicalTrials.gov