Translation Study of a Safe Teen Driving Intervention

August 21, 2024 updated by: Ginger Yang

A Hybrid Effectiveness-Implementation Trial to Improve Safe Driving Among Teen Drivers With Traffic Violations

Steering Teens Safe (STS) is an evidence-based and parent-focused intervention developed by the investigators, which aims to improve safe teen driving practices by enhancing parental communication skills. The objective of this translation study is to assess the effect of STS on driving outcomes among teen drivers who have committed a traffic violation, and to assess the adoption and implementation fidelity of STS in a county court setting and among these high-risk teen drivers and their parents. The investigators will test the following specific aims: Aim 1: Determine the effects of the intervention on parent-teen communications and risky driving outcomes (risky driving events, unsafe driving behaviors, and recidivism) among teen drivers with a traffic violation(s). Aim 2: Assess the adoption of the intervention and implementation fidelity We will enroll 90 parent-teen dyads, comprised a teen driver (16 to 17 years) who committed a moving violation and a parent/legal guardian, from the Ohio Franklin County Juvenile Traffic Court following the teens' mandatory court hearing. Enrolled dyads will be randomly assigned to 1 of 2 study groups (n=45/group): 1) Control, device installation only with no feedback to nor communication training for parents, or 2) Intervention, device feedback to teens and parents, and parents will also receive individualized virtual communication training. The expected outcome is to establish the effectiveness of STS augmented with driving feedback technology, and to establish the implementation fidelity of STS in a court setting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Motor vehicle collisions (MVCs) are the leading cause of death among teenagers in the United States. Teen drivers who have committed a traffic violation are at an even greater risk for MVCs than their counterparts. While parent-focused interventions are an effective strategy to improve teen driving safety, most of these interventions target teen drivers are implemented as universal interventions (for teens of all risk profiles). Evidence on the effectiveness of these evidence-based interventions when translated and implemented among high-risk teen drivers such as those with a traffic citation is lacking.

The current project is significant because it will translate the STS program to the needs of high-risk teen drivers who have committed a traffic violation and their parents. This study is innovative because it partners with the local court system, and utilizes novel and cutting-edge in-vehicle technology. The findings of the current study will have a significant impact on juvenile traffic court's practices and policies aimed to improve teen driving safety by reducing MVC-related crashes, injuries, and deaths.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

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, 43215
        • 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

12 years to 13 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;
  • Ward of the State;
  • Non-English speaking parent.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
The Azūga™ in-vehicle driving feedback technology will be installed.32 This driving feedback technology consists of a pager-sized device plugged into the vehicle's on-board diagnostic (OBD) port (installed in the teen's car) and a smartphone app (downloaded on the teen's smartphone). All feedback features will be disabled. Control dyads will receive no driving feedback. The parent will not receive STS. Additionally, a wireless mini-camera will be installed on the dashboard in teen's car to identify the participating driver using facial verification technology.
Experimental: Intervention Group
Parents will receive STS, which will include 1) Individualized virtual communication training and a booster session delivered by a traffic safety communication specialist; and 2) An online parent-teen safe driving communication guide. In addition, the Azūga™ in-vehicle device and app will be installed as described above and all feedback features will be enabled. Three types of feedback will be provided to teens: 1) Direct audio feedback; 2) Detailed cumulative driving data; and 3) A customized weekly driving summary report. Parents in this group will receive access to the teen's cumulative driving data and a weekly driving summary report. Additionally, a wireless mini-camera will be installed on the dashboard in teen's car to identify the participating driver using facial verification technology.
Behavioral: Steering Teens Safe (STS)
The goal of STS is to provide intervention parents with guidance and communication skills, which will enable parents to effectively communicate with their teens about specific driving safety topics (e.g., speeding, seatbelt use, distracted driving). Our proposed parent training has two components: an individualized virtual communication training (provided to parents via Skype by a trained research team member) and a parent-teen safe driving communication guide (available online).
Other Names:
  • STS
Behavioral: Driving Feedback Technology.
The driving feedback technology will include the Azūga™ in-vehicle device and smartphone app.
Other Names:
  • Azuga device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of Parent-teen communications
Time Frame: 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 the topic with their teen on driving topics.
Six months/study period
Number of Risky driving events and unsafe behavior rates
Time Frame: Six months/study period
Events of hard braking, sudden acceleration, speeding, distracted driving, and no seatbelt use.
Six months/study period
Recidivism
Time Frame: Up to one year post-study period
Recidivism will be measured among teens in both 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
Up to one year post-study period
Adoption of the intervention
Time Frame: Six months/study period
Adoption of the intervention by using publicly available court data from Franklin County Juvenile Traffic Court and compare it to all other juvenile traffic courts in Ohio. We will also use participant characteristic data and compare it to non-participating teens with a moving violation in Ohio.
Six months/study period
Implementation fidelity
Time Frame: Six months/study period
Engagement with community training via a self-report questionnaire, engagement with device feedback via Google Analytics, and a fidelity checklist will be combined to report implementation fidelity
Six months/study period
Quality of Parent-teen communication
Time Frame: 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.
Six 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

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)

January 31, 2024

Study Completion (Actual)

July 31, 2024

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)

August 22, 2024

Last Update Submitted That Met QC Criteria

August 21, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 3

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 the current 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 collected 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

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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