Teen Driving Translation Study (NIH)

NCT05696353 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: STUDY00001081
• Study Type: interventional
• Target: 580
• Locations: 1 country
• Sites: 1

Brief Summary

To translate our evidence-based, parent-engagement safe teen driving intervention to a high-risk, rural and urban teen drivers with a traffic violation, and to test the implementation, effectiveness, and cost-effectiveness of the proposed intervention.

Conditions

Drive; Recidivism; Feedback, Psychological; Communication

Outcome Measures

Primary Outcomes (2)

• Risky Driving Events

  Risky driving events are continuously monitored for teens 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 Driving Behaviors

  Unsafe driving behaviors among teens 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)

• Traffic Violation Recidivism

  Up to one-year post-study period

• Parent-Teen Communication

  At Baseline, Three months, and Six months

Other Outcomes (9)

• Engagement with communication training and booster session

  Six months/study period

• Engagement with Device Feedback

  Six months/study period

• Motor Vehicle Collision

  By 12 months following study completion

Study Arms (3)

Control Group

NO INTERVENTION

The Control Group will have an in-vehicle device installed in the teen's car, but all feedback features will be disabled. Parents assigned into this group will receive no communication training on how to motivate their teen to adopt safe driving habits.

Feedback and Expert-Delivered Parent Communication Intervention Group

EXPERIMENTAL

Teens will have an in-vehicle device installed in their car and the smart phone app downloaded on their smart phone. Teens will receive real-time and cumulative driving feedback generated by the in-vehicle device and app; parents will have access to their teen's cumulative driving data at any time via study web portal. Parents 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 teen driving safety communication expert. A second booster session will occur two months after the initial training. Both teens and parents will also receive a biweekly summary report of the teen's driving events prepared by the research team.

Combination Product: In-vehicle Device; Behavioral: Expert-Delivered Parent Communication Training

Feedback and Peer-Delivered Parent Communication Intervention Group

EXPERIMENTAL

Teens will have an in-vehicle device installed in their car and the smart phone app download on their smart phone. Teens will receive real-time and cumulative driving feedback generated by the in-vehicle device and app; parents will have access to their teen's cumulative driving data at any time via study web portal. Parents 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 peer trainer who is a parent of teen with a traffic violation and who has received the Expert-delivered Intervention and met the defined peer trainer criteria. A second booster session delivered by the peer trainer will also occur two months after the initial training. Both teens and parents will also receive a biweekly summary report of the teen's driving events prepared by the research team.

Combination Product: In-vehicle Device; Behavioral: Peer-Delivered Parent Communication Training

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 smart phone app (downloaded on the teen's smart phone), 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 via the smart phone app and study website; 3) A customized biweekly driving summary report via study website; and 4) Push notification on the phone screen when a trip ends.

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

Feedback and Expert-Delivered Parent Communication Intervention Group; Feedback and Peer-Delivered Parent Communication Intervention Group

Expert-Delivered Parent Communication Training BEHAVIORAL

An individualized virtual training in communication strategies about teen driving safety along with a booster session will be delivered by a traffic safety communication specialist to parents in the Feedback and Expert-Delivered Parent Communication Intervention Group. Intervention parents in this group will also be provided with access to an online parent-teen safe driving communication guide.

Also known as: Expert-Delivered Parent Training, Steering Teens Safe (Expert), Expert-Delivered Motivational Interviewing Training

Feedback and Expert-Delivered Parent Communication Intervention Group

Peer-Delivered Parent Communication Training BEHAVIORAL

An individualized virtual training in communication strategies about teen driving safety along with a booster session will be delivered by a peer trainer who is a parent of teen with traffic citation and has participated in the Feedback and Expert-Delivered Parent Communication Intervention Group. Intervention parents in this group will also be provided with access to an online parent-teen safe driving communication guide.

Also known as: Peer-Delivered Parent Training, Steering Teens Safe (Peer), Peer-Delivered Motivational Interviewing Training

Feedback and Peer-Delivered Parent Communication Intervention Group

Eligibility Criteria

• Age: 16 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Teen must be 16 or 17 years old at the time of the moving-related violation
• Teen must be found guilty of committing the violation
• Teen must possess a valid Ohio provisional driver's license and proof of car insurance
• Teen must have access to a vehicle with an On-board Diagnostics II system port (i.e., cars made after 1996) in which they are the primary driver
• Teen must have a smart phone with Bluetooth capabilities

You may not qualify if:

• Teen is unable to drive due to injury, has a suspended driver's license, and/or car damage
• Teen has previously received a traffic citation
• Vehicle already has an in-vehicle driving feedback system installed
• Teen has non-English speaking parents
• Teen is currently enrolled in another driving-related study
• Teen is a ward of the State
• 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

RECRUITING

Related Publications (29)

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  BACKGROUND

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• Peek-Asa C, Reyes ML, Hamann CJ, Butcher BD, Cavanaugh JE. A randomized trial to test the impact of parent communication on improving in-vehicle feedback systems. Accid Anal Prev. 2019 Oct;131:63-69. doi: 10.1016/j.aap.2019.06.006. Epub 2019 Jun 21.

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• Gielen AC, Frattaroli S, Pollack KM, Peek-Asa C, Yang JG. How the science of injury prevention contributes to advancing home fire safety in the USA: successes and opportunities. Inj Prev. 2018 Jun;24(Suppl 1):i7-i13. doi: 10.1136/injuryprev-2017-042356. Epub 2018 Feb 26.

  PMID: 29483239 BACKGROUND

MeSH Terms

Conditions

Recidivism; Communication

Condition Hierarchy (Ancestors)

Criminal Behavior; Behavior

Study Officials

• Jingzhen (Ginger) Yang, PhD, MPH

  Nationwide Children's Hospital - Center for Injury Research and Policy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingzhen (Ginger) Yang, PhD, MPH

CONTACT

614-355-5852; ginger.yang@nationwidechildrens.org

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 7, 2022
• First Posted: January 25, 2023
• Study Start: November 17, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

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)