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Translation Study of a Safe Teen Driving Intervention

Sponsor
Ginger Yang (Other)
Overall Status
Recruiting
CT.gov ID
NCT04317547
Collaborator
University of Iowa (Other)
180
Enrollment
1
Location
2
Arms
28.1
Anticipated Duration (Months)
6.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Steering Teens Safe (STS)
  • Behavioral: Driving Feedback Technology.
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
We propose a hybrid, RCT to test the effectiveness and implementation of an evidence-based, parent-focused intervention among teen drivers with a moving violation. We aim to recruit 90 dyads (45 per group, totaling 180 study participants), comprised of one teen driver ages 16 or 17 who has committed a moving violation (e.g., speeding, failure to obey traffic signal) and the parent/legal guardian ('parent') who is most involved with the teen's driving. Recruitment will occur at the Franklin County Juvenile Traffic Court in Ohio following the parent-teen dyad's mandatory court appearance. After completing informed consent/assent and the baseline assessment, enrolled parent-teen dyads will be randomly assigned into either the Control or Intervention Group using a stratified block randomization. All enrolled dyads will be followed for a 6-month period.We propose a hybrid, RCT to test the effectiveness and implementation of an evidence-based, parent-focused intervention among teen drivers with a moving violation. We aim to recruit 90 dyads (45 per group, totaling 180 study participants), comprised of one teen driver ages 16 or 17 who has committed a moving violation (e.g., speeding, failure to obey traffic signal) and the parent/legal guardian ('parent') who is most involved with the teen's driving. Recruitment will occur at the Franklin County Juvenile Traffic Court in Ohio following the parent-teen dyad's mandatory court appearance. After completing informed consent/assent and the baseline assessment, enrolled parent-teen dyads will be randomly assigned into either the Control or Intervention Group using a stratified block randomization. All enrolled dyads will be followed for a 6-month period.
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
A Hybrid Effectiveness-Implementation Trial to Improve Safe Driving Among Teen Drivers With Traffic Violations
Actual Study Start Date :
Sep 28, 2020
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Frequency of Parent-teen communications [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.

    2. Number of Risky driving events and unsafe behavior rates [Six months/study period]

      Events of hard braking, sudden acceleration, speeding, distracted driving, and no seatbelt use.

    3. Recidivism [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

    4. Adoption of the intervention [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.

    5. Implementation fidelity [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

    6. Quality of Parent-teen communication [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    1. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nationwide Children's Hospital Columbus Ohio United States 43215

    Sponsors and Collaborators

    • Ginger Yang
    • University of Iowa

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ginger Yang, Principal Investigator, Nationwide Children's Hospital
    ClinicalTrials.gov Identifier:
    NCT04317547
    Other Study ID Numbers:
    • 3
    First Posted:
    Mar 23, 2020
    Last Update Posted:
    Apr 15, 2021
    Last Verified:
    Apr 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 15, 2021