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DrivePhase 3projectDRIVENCT04317664

Intervention to Improve Driving Practices Among High-Risk Teen Drivers

A Phase 3 study testing Parent Communication in people with Drive and Recidivism, run by Ginger Yang at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Drive, Recidivism, Communication
What is being tested?
Parent Communication
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
1 siteUnited States
Study dates
28 Sep 2020to 31 Dec 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Adults unable to consent
  • Pregnant women
  • Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Nationwide Children's Hospital

    Columbus, Ohio, 43205

Other trials in United States

About this study

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.

Read the 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.

Being tested
In-vehicle device, Parent Communication
Medical subject headings
Recidivism, Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In-vehicle deviceCombination product

    Also called Azuga device, In-vehicle Driving Feedback Technology

    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.

  • Parent CommunicationBehavioural

    Also called Motivational Interviewing, Steering Teens Safe, Parent Training

    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.

Study groups in NCT04317664
Study groupRoleWhat they receive
Control GroupNo interventionThe Control Group will have the in-vehicle device installed in the teen's car, but all feedback features will be disabled.
Feedback Only GroupExperimentalThe 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.
Receives: Combination Product: In-vehicle device
Feedback and Parent Communication GroupExperimentalThe 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.
Receives: Combination Product: In-vehicle device; Behavioral: Parent Communication

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Risky Driving Events

    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.

    Measured: Six months/study period

  2. Unsafe Behaviors

    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.

    Measured: Six months/study period

Secondary outcomes (2)

  1. Recidivism

    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.

    Measured: Up to one year post-study period

  2. Parent-Teen Communication

    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.

    Measured: at baseline, three months, and six months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study start28 Sep 2020
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317664
Sponsor's protocol ID
1
Acronym
projectDRIVE
Status last verified
Feb 2026
First submitted
4 Mar 2020
Last updated
23 Feb 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: 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.

Publications

  • Centers for Disease Control and Prevention. Data and Statistics (WISQARS). www.cdc.gov/injury/wisqars. Accessed February 1, 2016.

  • Insurance Institute for Highway Safety (IIHS). Fatality facts: teenagers 2013. Arlington, VA: http://www.iihs.org/iihs/topics/t/teenagers/fatalityfacts/teenagers. Accessed February 1, 2016.

  • Williams AF. Teenage drivers: patterns of risk. J Safety Res. 2003 Jan;34(1):5-15. doi: 10.1016/s0022-4375(02)00075-0.

    PubMed 12535901

  • Mayhew DR, Simpson HM, Pak A. Changes in collision rates among novice drivers during the first months of driving. Accid Anal Prev. 2003 Sep;35(5):683-91. doi: 10.1016/s0001-4575(02)00047-7.

    PubMed 12850069

  • McCartt AT, Shabanova VI, Leaf WA. Driving experience, crashes and traffic citations of teenage beginning drivers. Accid Anal Prev. 2003 May;35(3):311-20. doi: 10.1016/s0001-4575(02)00006-4.

    PubMed 12643948

  • Jonah BA, and Dawson NE. Youth and risk: age differences in risky driving, risk perception, and risk utility. Alcohol, Drugs and Driving. 1987;3(3):13-29.

  • Summala H, Rajalin S, Radun I. Risky driving and recorded driving offences: a 24-year follow-up study. Accid Anal Prev. 2014 Dec;73:27-33. doi: 10.1016/j.aap.2014.08.008. Epub 2014 Aug 27.

    PubMed 25171522

  • Alver Y, Demirel MC, Mutlu MM. Interaction between socio-demographic characteristics: traffic rule violations and traffic crash history for young drivers. Accid Anal Prev. 2014 Nov;72:95-104. doi: 10.1016/j.aap.2014.06.015. Epub 2014 Jul 12.

    PubMed 25019690

  • Ayuso M, Guillen M, Alcaniz M. The impact of traffic violations on the estimated cost of traffic accidents with victims. Accid Anal Prev. 2010 Mar;42(2):709-17. doi: 10.1016/j.aap.2009.10.020. Epub 2009 Nov 22.

    PubMed 20159098

  • Factor R. The effect of traffic tickets on road traffic crashes. Accid Anal Prev. 2014 Mar;64:86-91. doi: 10.1016/j.aap.2013.11.010. Epub 2013 Dec 2.

    PubMed 24342150

  • Gebers MA, Peck RC. Using traffic conviction correlates to identify high accident-risk drivers. Accid Anal Prev. 2003 Nov;35(6):903-12. doi: 10.1016/s0001-4575(02)00098-2.

    PubMed 12971925

  • Goldenbeld C, Reurings M, Van Norden Y, Stipdonk H. Crash involvement of motor vehicles in relationship to the number and severity of traffic offenses. An exploratory analysis of Dutch traffic offenses and crash data. Traffic Inj Prev. 2013;14(6):584-91. doi: 10.1080/15389588.2012.743125.

    PubMed 23859422

  • Chen W, Cooper P, and Pinili M. Driver accident risk in relation to the penalty point system in British Columbia. J Safety Res. 1995;26:9-18.

  • Cooper PJ. The relationship between speeding behaviour (as measured by violation convictions) and crash involvement. J Safety Res. 1997;28:83-95.

  • Rajalin S. The connection between risky driving and involvement in fatal accidents. Accid Anal Prev. 1994 Oct;26(5):555-62. doi: 10.1016/0001-4575(94)90017-5.

    PubMed 7999200

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Parent Communication in people with Drive and Recidivism, run by Ginger Yang at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Risky Driving Events (time frame: Six months/study period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317664, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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