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DriveNCT04317547

Translation Study of a Safe Teen Driving Intervention

A study testing Steering Teens Safe (STS) and Driving Feedback Technology. in people with Drive and Adolescent Behavior, run by Ginger Yang at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Drive, Adolescent Behavior, Risk Behavior
What is being tested?
Steering Teens Safe (STS) and Driving Feedback Technology.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
1 siteUnited States
Study dates
28 Sep 2020to 31 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Nationwide Children's Hospital

    Columbus, Ohio, 43215

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Steering Teens Safe (STS), Driving Feedback Technology.
Medical subject headings
Adolescent Behavior, Risk-Taking

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Steering Teens Safe (STS)Behavioural

    Also called 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).

  • Driving Feedback Technology.Behavioural

    Also called Azuga device

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

Study groups in NCT04317547
Study groupRoleWhat they receive
Control GroupNo interventionThe 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 GroupExperimentalParents 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.
Receives: Behavioral: Steering Teens Safe (STS); Behavioral: Driving Feedback Technology.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Six months/study period

  2. Number of Risky driving events and unsafe behavior rates

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

    Measured: Six months/study period

  3. 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

    Measured: Up to one year post-study period

  4. 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.

    Measured: Six months/study period

  5. 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

    Measured: Six months/study period

  6. 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.

    Measured: Six months/study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Mar 2020
  2. Study start28 Sep 2020
  3. Primary completion31 Jan 2024
  4. Study completion31 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
Single blind
Who is masked
Participant
Enrolment
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04317547
Sponsor's protocol ID
3
Status last verified
Aug 2024
First submitted
4 Mar 2020
Last updated
22 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Masten SV, Foss RD, Marshall SW. Graduated driver licensing and fatal crashes involving 16- to 19-year-old drivers. JAMA. 2011 Sep 14;306(10):1098-103. doi: 10.1001/jama.2011.1277.

    PubMed 21917580

  • Simons-Morton BG, Ouimet MC, Zhang Z, Klauer SE, Lee SE, Wang J, Albert PS, Dingus TA. Crash and risky driving involvement among novice adolescent drivers and their parents. Am J Public Health. 2011 Dec;101(12):2362-7. doi: 10.2105/AJPH.2011.300248. Epub 2011 Oct 20.

    PubMed 22021319

  • Mayhew DR, Simpson HM, Pak A. Changes in collision rates among novice drivers during the first months of driving. Accid Anal Prev. 2003 Sep;35(5):683-91. doi: 10.1016/s0001-4575(02)00047-7.

    PubMed 12850069

  • 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.

    PubMed 12643948

  • Insurance Institute for Highway Safety (IIHS). Fatality Facts: Teenagers 2015. Arlington (VA): The Institute; 2017 [cited 2018 Jan 4]. http://www.iihs.org/iihs/topics/t/teenagers/fatalityfacts/teenagers

  • 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.

    PubMed 7999200

  • 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.

    PubMed 25171522

  • 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.

    PubMed 25019690

  • Ayuso M, Guillen M, Alcaniz M. The impact of traffic violations on the estimated cost of traffic accidents with victims. Accid Anal Prev. 2010 Mar;42(2):709-17. doi: 10.1016/j.aap.2009.10.020. Epub 2009 Nov 22.

    PubMed 20159098

  • Factor R. The effect of traffic tickets on road traffic crashes. Accid Anal Prev. 2014 Mar;64:86-91. doi: 10.1016/j.aap.2013.11.010. Epub 2013 Dec 2.

    PubMed 24342150

  • 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.

    PubMed 12971925

  • 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.

    PubMed 23859422

  • 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.

    PubMed 26112737

  • Beck KH, Shattuck T, Raleigh R. Parental predictors of teen driving risk. Am J Health Behav. 2001 Jan-Feb;25(1):10-20. doi: 10.5993/ajhb.25.1.2.

    PubMed 11289724

  • 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.

    PubMed 11942714

Questions about this trial

What is this clinical trial studying?

A study testing Steering Teens Safe (STS) and Driving Feedback Technology. in people with Drive and Adolescent Behavior, run by Ginger Yang at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of Parent-teen communications (time frame: Six months/study period). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04317547, which also lists 31 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2024.

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