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

February 4, 2026 updated by: Ginger Yang
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Description

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 1996) 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report.
Other Names:
  • Azuga 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) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report.
Other Names:
  • Azuga 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, including includes three motivational interviewing technique demonstration videos and 26 safe driving lessons.
Other Names:
  • Motivational Interviewing
  • Parent Training
  • Steering Teens Safe

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risky Driving Events
Time Frame: Six months/study period
Risky driving events are continuously monitored for teens (240) across all three groups using an in-vehicle device and smartphone app. The system automatically detects and records driving events, including hard braking (≤ -0.45 g-force) sudden acceleration (> 0.35 g-force), speeding (>10 miles over the posted speed limit), and speed >75 mph. Event rates are calculated as the number of risky driving events per 1,000 miles driven.
Six months/study period
Unsafe Behaviors
Time Frame: Six months/study period
Unsafe driving behaviors among teens (N = 240) are continuously monitored across all three study groups using an in-vehicle device and a smartphone app. The system automatically records behaviors such as speeding, and seatbelt nonuse (for selected vehicle makes and model years only), as well as the distance traveled while these behaviors occur. Unsafe behavior rates are calculated as the number of miles involving an unsafe behavior per 1,000 miles driven. Survey data supplement these measures by capturing self-reported distracted driving and seatbelt use for vehicles that are not fully compatible with the in-vehicle device.
Six months/study period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recidivism
Time Frame: Up to one year post-study period
Recidivism is assessed by linking traffic citation and court disposition records to participants' driver's license numbers. Data collected include violation dates, types, and intervals between the index and subsequent violations.
Up to one year post-study period
Parent-Teen Communication
Time Frame: at baseline, three months, and six months
Parent-teen communication is assessed using REDCap surveys. Teens and parents rate the frequency (0-3) and success (1-10) of discussions about 26 driving skills and safety principles from the past month. Frequency scores range from 0-78, with higher scores indicating more frequent communication, and quality scores are weighted averages expressed as percentages (1-100%), with higher scores indicating higher quality communication. Additionally, one voice-recorded conversation per survey is also coded by trained raters for active listening, OARS (i.e.,open questions, affirmations, reflective listening, and summary reflections) use solicitation of the teen's perspective, focus on behaviors, and emotional expression, with each behavior scored 0-3 to generate a summary quality score, with higher scores indicating higher quality communication.
at baseline, three months, and six months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Engagement With Parent Communication Training
Time Frame: Six months/study period
Engagement with the parent communication training is measured among parents in the Feedback and Parent Communication Group using a self-report questionnaire and online tracking.
Six months/study period
Engagement With Device Feedback
Time Frame: 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.
Six months/study period
Communication Training Delivery
Time Frame: Three months/study period
Communication training delivery is measured among parents in the Feedback and Parent Communication Group and communication specialist via participant and trainer surveys completed immediately after each training session using the Behavior Change Counseling Index.
Three months/study period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ginger Yang

Collaborators

University of Iowa
Ohio State University
University of Nebraska

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2020

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

March 4, 2020

First Submitted That Met QC Criteria

March 19, 2020

First Posted (Actual)

March 23, 2020

Study Record Updates

Last Update Posted (Actual)

February 23, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1 (Other Identifier: Mobile Health and Wellness Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data used and/or analyzed during this study, along with detailed study protocol, are available from the PI, Dr. Jingzhen Yang, on reasonable request. The data are not publicly available due to privacy restrictions.

IPD Sharing Time Frame

Starting 6 months after the summary data are published.

IPD Sharing Access Criteria

De-identified data for the study and a data dictionary will be made available to other researchers following approval of a study proposal by the PI, Dr. Jingzhen Yang (ginger.yang@nationwidechildrens.org). The study protocol and statistical analysis plan are also available from the PI, Dr. Jingzhen Yang.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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