Intervention to Improve Driving Practices Among High-Risk Teen Drivers

NCT04317664 | Completed Phase 3 Results DMC FDA Device

• 1 other identifier: 1
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Drive; Recidivism; Communication; Feedback, Psychological

Outcome Measures

Primary Outcomes (2)

• 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.

  Six months/study period

• 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.

  Six months/study period

Secondary Outcomes (2)

• Recidivism

  Up to one year post-study period

• Parent-Teen Communication

  at baseline, three months, and six months

Other Outcomes (3)

• Engagement With Parent Communication Training

  Six months/study period

• Engagement With Device Feedback

  Six months/study period

• Communication Training Delivery

  Three months/study period

Study Arms (3)

Control Group

NO INTERVENTION

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

Feedback Only Group

EXPERIMENTAL

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

Feedback and Parent Communication Group

EXPERIMENTAL

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; Behavioral: Parent Communication

Interventions

In-vehicle device COMBINATION_PRODUCT

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.

Also known as: Azuga device, In-vehicle Driving Feedback Technology

Feedback Only Group; Feedback and Parent Communication Group

Parent Communication BEHAVIORAL

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.

Also known as: Motivational Interviewing, Steering Teens Safe, Parent Training

Feedback and Parent Communication Group

Eligibility Criteria

• Age: 16 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ginger Yang: lead
• University of Iowa: collaborator
• Ohio State University: collaborator
• University of Nebraska: collaborator

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (22)

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  BACKGROUND

• 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.

  BACKGROUND

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

  PMID: 12535901 BACKGROUND

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  PMID: 12850069 BACKGROUND

• 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.

  PMID: 12643948 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 25171522 BACKGROUND

• 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.

  PMID: 25019690 BACKGROUND

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  PMID: 20159098 BACKGROUND

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  PMID: 24342150 BACKGROUND

• 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.

  PMID: 12971925 BACKGROUND

• 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.

  PMID: 23859422 BACKGROUND

• 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.

  BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 7999200 BACKGROUND

• Carney C, McGehee DV, Lee JD, Reyes ML, Raby M. Using an event-triggered video intervention system to expand the supervised learning of newly licensed adolescent drivers. Am J Public Health. 2010 Jun;100(6):1101-6. doi: 10.2105/AJPH.2009.165829. Epub 2010 Apr 15.

  PMID: 20395588 BACKGROUND

• Farmer CM, Kirley BB, McCartt AT. Effects of in-vehicle monitoring on the driving behavior of teenagers. J Safety Res. 2010 Feb;41(1):39-45. doi: 10.1016/j.jsr.2009.12.002. Epub 2010 Jan 29.

  PMID: 20226949 BACKGROUND

• McGehee DV, Raby M, Carney C, Lee JD, Reyes ML. Extending parental mentoring using an event-triggered video intervention in rural teen drivers. J Safety Res. 2007;38(2):215-27. doi: 10.1016/j.jsr.2007.02.009. Epub 2007 Mar 28.

  PMID: 17478192 BACKGROUND

• McCartt AT, Farmer CM, Jenness JW. Perceptions and experiences of participants in a study of in-vehicle monitoring of teenage drivers. Traffic Inj Prev. 2010 Aug;11(4):361-70. doi: 10.1080/15389588.2010.486428.

  PMID: 20730683 BACKGROUND

• Curry AE, Peek-Asa C, Hamann CJ, Mirman JH. Effectiveness of Parent-Focused Interventions to Increase Teen Driver Safety: A Critical Review. J Adolesc Health. 2015 Jul;57(1 Suppl):S6-14. doi: 10.1016/j.jadohealth.2015.01.003.

  PMID: 26112737 BACKGROUND

• Farah H, Musicant O, Shimshoni Y, Toledo T, Grimberg E, Omer H, Lotan T. Can providing feedback on driving behavior and training on parental vigilant care affect male teen drivers and their parents? Accid Anal Prev. 2014 Aug;69:62-70. doi: 10.1016/j.aap.2013.11.005. Epub 2013 Nov 27.

  PMID: 24331278 BACKGROUND

• Yang J, Peek-Asa C, Zhang Y, Hamann C, Zhu M, Wang Y, Kaur A, Recker R, Rose D, Roth L. ProjectDRIVE: study protocol for a randomized controlled trial to improve driving practices of high-risk teen drivers with a traffic violation. Inj Epidemiol. 2024 Mar 29;11(1):12. doi: 10.1186/s40621-024-00494-5.

  PMID: 38553746 DERIVED

MeSH Terms

Conditions

Recidivism; Communication

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Criminal Behavior; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Jingzhen Yang
• Organization: Nationwide Children's Hospital

Ginger.Yang@nationwidechildrens.org

614-355-5852

Study Officials

• Jingzhen (Ginger) Yang, PhD, MPH

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 23, 2020
• Study Start: September 28, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: February 23, 2026
• Results First Posted: February 23, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Starting 6 months after the summary data are published.
• 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.

Locations

US (1)