NCT04317547

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 4, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 23, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

September 28, 2020

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

3.3 years

First QC Date

March 4, 2020

Last Update Submit

August 21, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Frequency of Parent-teen communications

    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

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

    Six months/study period

  • Recidivism

    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

    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

    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

    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

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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)Behavioral: Driving Feedback Technology.

Interventions

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).

Also known as: STS
Intervention Group

The driving feedback technology will include the Azūga™ in-vehicle device and smartphone app.

Also known as: Azuga device
Intervention Group

Eligibility Criteria

Age16 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (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;
  • Ward of the State;
  • Non-English speaking parent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43215, United States

Location

Related Publications (31)

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    BACKGROUND
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    PMID: 24342150BACKGROUND
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    PMID: 12971925BACKGROUND
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    PMID: 23859422BACKGROUND
  • 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: 26112737BACKGROUND
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    PMID: 11289724BACKGROUND
  • Hartos J, Eitel P, Simons-Morton B. Parenting practices and adolescent risky driving: a three-month prospective study. Health Educ Behav. 2002 Apr;29(2):194-206. doi: 10.1177/109019810202900205.

    PMID: 11942714BACKGROUND
  • Simons-Morton B. Parent involvement in novice teen driving: rationale, evidence of effects, and potential for enhancing graduated driver licensing effectiveness. J Safety Res. 2007;38(2):193-202. doi: 10.1016/j.jsr.2007.02.007. Epub 2007 Mar 26.

    PMID: 17478190BACKGROUND
  • Simons-Morton BG, Ouimet MC, Catalano RF. Parenting and the young driver problem. Am J Prev Med. 2008 Sep;35(3 Suppl):S294-303. doi: 10.1016/j.amepre.2008.06.018.

    PMID: 18702985BACKGROUND
  • Zakrajsek JS, Shope JT, Greenspan AI, Wang J, Bingham CR, Simons-Morton BG. Effectiveness of a brief parent-directed teen driver safety intervention (Checkpoints) delivered by driver education instructors. J Adolesc Health. 2013 Jul;53(1):27-33. doi: 10.1016/j.jadohealth.2012.12.010. Epub 2013 Mar 6.

    PMID: 23481298BACKGROUND
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    PMID: 24641793BACKGROUND
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    PMID: 24925492BACKGROUND
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    PMID: 24957844BACKGROUND
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    PMID: 15727975BACKGROUND
  • Ramirez M, Yang J, Young T, Roth L, Garinger A, Snetselaar L, Peek-Asa C. Implementation evaluation of steering teens safe: engaging parents to deliver a new parent-based teen driving intervention to their teens. Health Educ Behav. 2013 Aug;40(4):426-34. doi: 10.1177/1090198112459517. Epub 2012 Oct 4.

    PMID: 23041706BACKGROUND
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    PMID: 25082132BACKGROUND
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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: 29483239BACKGROUND
  • Franklin County Court of Common Pleas. Meet the Magistrate. [Accessed 2018 Jan 4]. https://drj.fccourts.org/DRJ.aspx?PN=Susan_House.htm

    BACKGROUND
  • Peek-Asa C, Reyes M, Hamman C, Butcher B, Cavanaugh J. In-vehicle video feedback systems and parent engagement: a randomized trial to improve safe teen driving. Transportation Research Board. January 2016. Washington D.C.

    BACKGROUND

MeSH Terms

Conditions

Adolescent BehaviorRisk-Taking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Jingzhen (Ginger) Yang, PhD, MPH

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
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

January 31, 2024

Study Completion

July 31, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Starting 6 months after the summary data are published.
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.

Locations