Clinical trial NCT04317547: Translation Study of a Safe Teen Driving Intervention
Official title: A Hybrid Effectiveness-Implementation Trial to Improve Safe Driving Among Teen Drivers With Traffic Violations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drive
Adolescent Behavior
Risk Behavior
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Iowa
First posted: 2020-03-23
Enrollment: 180
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of Parent-teen communications
timeFrame: Six months/study period
measure: Number of Risky driving events and unsafe behavior rates
timeFrame: Six months/study period
measure: Recidivism
timeFrame: Up to one year post-study period
measure: Adoption of the intervention
timeFrame: Six months/study period
measure: Implementation fidelity
timeFrame: Six months/study period
measure: Quality of Parent-teen communication
timeFrame: Six months/study period
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Jingzhen (Ginger) Yang, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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