Clinical trial NCT05696353: Teen Driving Translation Study (NIH)
Official title: Adoption and Implementation of an Evidence-based Safe Driving Program for 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: 2023-01-25
Enrollment: 580
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To translate our evidence-based, parent-engagement safe teen driving intervention to a high-risk, rural and urban teen drivers with a traffic violation, and to test the implementation, effectiveness, and cost-effectiveness of the proposed intervention.

Detailed description: For this study, 290 teen and parent/guardian dyads will be randomized into one of three study groups for 12 months with 6 months of active data collection. 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. Dyads will be recruited from both urban and rural counties in Ohio following the teen's moving violation conviction. The study will determine the effectiveness and cost-effectiveness of the intervention on teens' risky driving events, unsafe driving behaviors, traffic violation recidivism, and motor vehicle collisions (MVCs), as well as frequency and quality of parent-teen communications about safe driving practices. Additionally, the study will determine the effectiveness and cost-effectiveness of the peer-delivered intervention vs. expert-delivered intervention on the outcomes of the interest. Finally, the study will assess the barriers/facilitators to the adoption and implementation of the intervention in rural and urban families.

Eligibility criteria: Inclusion Criteria:

* Teen must be 16 or 17 years old at the time of the moving-related violation
* Teen must be a first-time offender and be found guilty of committing the violation
* Teen must possess a valid Ohio provisional driver's license and proof of car insurance
* Teen must have access to a vehicle with an On-board Diagnostics II system port (i.e., cars made after 1996) in which they are the primary driver
* Teen must have a smart phone with Bluetooth capabilities

Exclusion Criteria:

* Teen is unable to drive due to injury, has a suspended driver's license, and/or car damage
* Teen has previously received a traffic citation
* Vehicle already has an in-vehicle driving feedback system installed
* Teen has non-English speaking parents
* Teen is currently enrolled in another driving-related study
* Teen is a ward of the State
* Adults unable to consent
* Pregnant women
* Prisoners

Primary outcomes:
measure: Risky driving events
timeFrame: Daily overtime for six months following enrollment
measure: Unsafe driving behaviors
timeFrame: Daily overtime for six months following enrollment
measure: Direct Costs: 3 Years
timeFrame: 3 years
measure: Adoption - Courts: 3 Years
timeFrame: 3 years
measure: Adoption - Participants
timeFrame: At 6-month follow-up
measure: Change in Reach
timeFrame: Yearly for 3 years
measure: Implementation Fidelity - BECCI
timeFrame: After completion of each intervention session, up to three years
measure: Implementation Fidelity - Fidelity Checklist
timeFrame: After completion of each intervention session, up to three years
Secondary outcomes:
measure: Parent-teen communications about driving safety
timeFrame: During 6 months of enrollment
measure: Traffic Violation Recidivism
timeFrame: At 12 months following enrollment
measure: Motor Vehicle Collision
timeFrame: At 12 months following enrollment
measure: Indirect Costs: 3 Years
timeFrame: 3 years
measure: Maintenance
timeFrame: At 6-month follow-up
Other outcomes:
measure: Engagement with communication training and booster session
timeFrame: After completion of each intervention session, up to three years
measure: Engagement with device feedback
timeFrame: During 6 months of enrollment
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital - Center for Injury Research and Policy
name: Jingzhen (Ginger) Yang, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
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