projectDRIVE: Intervention to Improve Driving Practices Among High-Risk Teen Drivers

Sponsor
Ginger Yang (Other)
Overall Status
Recruiting
CT.gov ID
NCT04317664
Collaborator
University of Iowa (Other), Ohio State University (Other), University of Nebraska (Other)
480
1
3
36.5
13.1

Study Details

Study Description

Brief Summary

The purpose of this study is to test the effects of an in-vehicle driving feedback technology, with and without parent communication training, on risky driving events, unsafe driving behaviors, and subsequent traffic violations among teens who have recently received a moving traffic violation.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: In-vehicle device
  • Behavioral: Parent Communication
Phase 3

Detailed Description

For this study, 240 teen and parent/guardian dyads will be randomized into one of three study groups for six months. Teens will be aged 16-17 who committed a moving-related traffic violation and their parent/legal guardian who is most involved with their driving. Researchers will aim to determine the effects of the intervention on teens' risky driving events, unsafe driving behaviors, and traffic violation recidivism. Additionally, researchers will aim to determine the effects of the intervention on frequency and quality of parent-teen communications about safe driving practices.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
480 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Intervention to Improve Driving Practices Among High-Risk Teen Drivers
Actual Study Start Date :
Sep 28, 2020
Anticipated Primary Completion Date :
Apr 15, 2023
Anticipated Study Completion Date :
Oct 15, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control Group

The Control Group will have the in-vehicle device installed in the teen's car, but all feedback features will be disabled.

Experimental: Feedback Only Group

The Feedback Only Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens can review their driving data. Teens will also receive biweekly cumulative driving reports.

Combination Product: In-vehicle device
The Azūga™ in-vehicle driving feedback technology, which consists of a pager-sized device plugged into the vehicle's on-board diagnostic port (installed in the teen's car) and a smartphone app (downloaded on the teen's smartphone), will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Detailed cumulative driving data; and 3) A customized biweekly driving summary report.
Other Names:
  • Azuga device
  • OBDII device
  • In-vehicle Driving Feedback Technology
  • Experimental: Feedback and Parent Communication Group

    The Feedback and Parent Communication Group will have the in-vehicle devices in the teen's car and download the smartphone app on the teen's smartphone. Researchers will provide instructions on how teens and parents can review their driving data. The parent will also receive communication training on how to motivate their teen to adopt safe driving habits via online modules and a video call with a motivational interviewing professional. A second booster session will also occur two months after the initial training. Both teens and parents will receive a biweekly cumulative driving report.

    Combination Product: In-vehicle device
    The Azūga™ in-vehicle driving feedback technology, which consists of a pager-sized device plugged into the vehicle's on-board diagnostic port (installed in the teen's car) and a smartphone app (downloaded on the teen's smartphone), will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Detailed cumulative driving data; and 3) A customized biweekly driving summary report.
    Other Names:
  • Azuga device
  • OBDII device
  • In-vehicle Driving Feedback Technology
  • Behavioral: Parent Communication
    An individualized virtual training in communication strategies about driving safety along with a booster session will be delivered by a traffic safety communication specialist to subjects in the Feedback and Parent Communication Group. Intervention parents in this group will also be provided with access to an online parent-teen safe driving communication guide.
    Other Names:
  • Motivational Interviewing
  • Steering Teens Safe
  • Parent Training
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Risky Driving Events [Six months/study period]

      Events of hard braking and sudden acceleration.

    2. Number of Unsafe Driving Behaviors [Six months/study period]

      Events of speeding, distracted driving, and no seatbelt use.

    3. Frequency of Parent-teen Communication [Six months/study period]

      Frequency of parent-teen communication about driving safety. This will be measured through a survey asking parents how often they discussed a driving topic with their teen.

    4. Recidivism [Up to one year post-study period]

      Recidivism will be measured among teens in all three groups by linking traffic citations and court disposition data with the participating teen's driver's license number. Recidivism during the 12 months following enrollment, including date and type of violation, and days from index violation to subsequent violation will be analyzed.

    5. Quality of Parent-teen Communication [Six months/study period]

      The quality of parent-teen communication about driving safety will be measured through an average rating of each driving topic which is recorded by the parent and teen.

    Other Outcome Measures

    1. Engagement with Parent Communication Training [Six months/study period]

      Engagement with the parent communication training will be measured among parents in the Feedback and Parent Communication Group using online measurements.

    2. Engagement with Device Feedback [Six months/study period]

      Engagement with device feedback will be measured among teens in the Feedback Only Group and the Feedback and Parent Communication Group and parents in the Feedback and Parent Communication Group via online tracking of the participant's web interface using Google Analytics.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Age 16-17 years at time of violation

    • Convicted of a moving violation

    • Possess a valid intermediate driver's license issued by the state of Ohio, with proof of car insurance

    • Access to a vehicle with an On-board Diagnostics II system port (i.e. cars made after

    1. in which he/she is the primary driver
    • Smartphone with Bluetooth capabilities

    • At least one legal guardian

    Exclusion Criteria:
    • Unable to drive due to injury, license suspension, or car damage

    • Vehicle already has an in-vehicle driving feedback system installed

    • Extremely low average weekly drive time (e.g. <1 hour per week)

    • Currently enrolled in another driving-related study

    • War of the State

    • Non-English speaking parent

    • Adults unable to consent

    • Pregnant women

    • Prisoners

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nationwide Children's Hospital Columbus Ohio United States 43205

    Sponsors and Collaborators

    • Ginger Yang
    • University of Iowa
    • Ohio State University
    • University of Nebraska

    Investigators

    • Principal Investigator: Jingzhen (Ginger) Yang, PhD, MPH, Nationwide Children's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ginger Yang, Principal Investigator, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT04317664
    Other Study ID Numbers:
    • 1
    First Posted:
    Mar 23, 2020
    Last Update Posted:
    Jul 29, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes

    Study Results

    No Results Posted as of Jul 29, 2021