Study Results
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View full resultsBasic Information
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COMPLETED
NA
152 participants
INTERVENTIONAL
2016-12-21
2021-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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 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.
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 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.
Interventions
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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 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.
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 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.
Eligibility Criteria
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Inclusion Criteria
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
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).
16 Years
19 Years
ALL
No
Sponsors
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St. Louis University
OTHER
University of Massachusetts, Amherst
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Jeff Epstein, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Cincinnati Childrens Hospital Medical Center
Locations
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Center for ADHD, Cincinnati Childrens Hospital Medical Center
Cincinnati, Ohio, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form: Parent Permission Form
Document Type: Informed Consent Form: Adult Consent Form
Other Identifiers
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