Clinical trial NCT04317664: Intervention to Improve Driving Practices Among High-Risk Teen Drivers
Official title: Intervention to Improve Driving Practices Among High-Risk Teen Drivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Drive
Recidivism
Communication
Feedback, Psychological
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Iowa
name: Ohio State University
name: University of Nebraska
First posted: 2020-03-23
Enrollment: 480
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to test the effects of an in-vehicle driving feedback technology, with and without parent communication training, on risky driving events, unsafe driving behaviors, and subsequent traffic violations among teens who have recently received a moving traffic violation.

Detailed description: For this study, 240 teen and parent/guardian dyads will be randomized into one of three study groups for six months. Teens will be aged 16-17 who committed a moving-related traffic violation and their parent/legal guardian who is most involved with their driving. Researchers will aim to determine the effects of the intervention on teens' risky driving events, unsafe driving behaviors, and traffic violation recidivism. Additionally, researchers will aim to determine the effects of the intervention on frequency and quality of parent-teen communications about safe driving practices.

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
* War of the State
* Non-English speaking parent
* Adults unable to consent
* Pregnant women
* Prisoners

Primary outcomes:
measure: Number of Risky Driving Events
timeFrame: Six months/study period
measure: Number of Unsafe Driving Behaviors
timeFrame: Six months/study period
measure: Frequency of Parent-teen Communication
timeFrame: Six months/study period
measure: Recidivism
timeFrame: Up to one year post-study period
measure: Quality of Parent-teen Communication
timeFrame: Six months/study period
Secondary outcomes:
Other outcomes:
measure: Engagement with Parent Communication Training
timeFrame: Six months/study period
measure: Engagement with Device Feedback
timeFrame: Six months/study period
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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