Improving ADHD Teen Driving

NCT02848092 | Completed Results

• 1 other identifier: R01HD084430
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder; Attention Deficit Disorder With Hyperactivity

Keywords

Visual Attention; Automobile Driving

Outcome Measures

Primary Outcomes (4)

• 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.

  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

Secondary Outcomes (2)

• Number of Incidents, Crashes, and Near-crashes Recorded With DriveCam

  12 months

• Number of DriveCam Events That Are Preceded by a 2 Second or Greater Glance Away From the Roadway

  12 months

Study Arms (2)

FOCAL+Training

EXPERIMENTAL

Behavioral: FOCAL+

Rules of the Road Training

SHAM COMPARATOR

Other: Rules of The road

Interventions

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.

FOCAL+Training

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.

Rules of the Road Training

Eligibility Criteria

• Age: 16 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Aged 16-19.
• Must meet DSM-5 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 Wechsler Abbreviated Intelligence Scale-II (WASI-II)
• Parent willing to participate..

You may not qualify if:

• On ADHD medication that cannot be washed out on assessment days.
• Drug or alcohol dependence according to K-SADS interview.
• On psychotropic or neuroleptic medications.
• Require eye glasses (contacts acceptable) for driving (corrective vision restriction on driver's license).

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• St. Louis University: collaborator
• University of Massachusetts, Amherst: collaborator

Study Sites (1)

Center for ADHD, Cincinnati Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (1)

• 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.

  PMID: 36449421 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Jeff Epstein, Ph.D.
• Organization: Cincinnati Children's Hospital Medical Center

jeff.epstein@cchmc.org

513-636-8296

Study Officials

• Jeff Epstein, Ph.D

  Cincinnati Childrens Hospital Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2016
• First Posted: July 28, 2016
• Study Start: December 21, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: March 3, 2023
• Results First Posted: March 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)