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Clinical Trials/NCT05696353
NCT05696353
Recruiting
Phase 3

Adoption and Implementation of an Evidence-based Safe Driving Program for High-Risk Teen Drivers

Ginger Yang1 site in 1 country580 target enrollmentNovember 17, 2022

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Drive
Sponsor
Ginger Yang
Enrollment
580
Locations
1
Primary Endpoint
Unsafe driving behaviors
Status
Recruiting
Last Updated
9 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 17, 2022
End Date
August 31, 2026
Last Updated
9 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Ginger Yang
Responsible Party
Sponsor Investigator
Principal Investigator

Ginger Yang

Principal Investigator

Nationwide Children's Hospital

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

Outcomes

Primary Outcomes

Unsafe driving behaviors

Time Frame: Daily overtime for six months following enrollment

Using the Azūga™ in-vehicle device and smart phone app, the investigators will collect data in both intervention groups and the control group on teen's unsafe driving behaviors (speeding, distracted driving, no seatbelt use). The duration (e.g., miles driven) and type of driving behaviors, including speeding (\>10 miles over the posted speed limit), and no seatbelt use, will be automatically coded and counted in the system. The proportions will be calculated by dividing by miles driven then multiplying by 1000 (e.g., proportion of 1,000 miles in which a seatbelt was not worn).

Change in Reach

Time Frame: Yearly for 3 years

Reach will be measured by comparing characteristics of teens who enrolled in the study to those who declined participation (e.g., demographics, residence location, citation history). The investigators will assess the number of eligible participants who are offered participation on each recruitment day, the number of those who were offered participation and declined as well as participation and drop-out rates.

Adoption - Courts: 3 Years

Time Frame: 3 years

Adoption will be measured by comparing characteristics of participating county courts (Franklin, Greene, Perry, and Wyandot Juvenile Traffic Courts) to county courts in the rest of Ohio (e.g., court hours, location, the number of staff, the number of cases). The investigators will also conduct interviews with participating court officials to identify facilitators and barriers to program adoption.

Implementation Fidelity - Fidelity Checklist

Time Frame: After completion of each intervention session, up to three years

Implementation fidelity will be measured among the expert and peer trainers immediately after the intervention using a fidelity checklist. The fidelity checklist will measure intervention fidelity including conceptual accuracy and adherence, and responsiveness to the needs of participants. Trained Raters will review a sample of recorded training and booster sessions and complete the fidelity checklist.

Direct Costs: 3 Years

Time Frame: 3 years

Direct costs refer to the personnel and non-personnel costs that can be assigned to the intervention (i.e., STS+). Personnel costs include service time and the proportion of staff time allocated to implement STS+ and non-personnel costs refer to other items needed for delivering STS+, such as equipment, supplies and materials. Examples of direct costs include staff time required to 1) deliver the intervention, 2) train the peer trainers, 3) install, manage, and maintain the driving feedback technology, 4) manage the STS+ website platform, and 5) train participants to use the driving feedback technology and STS+ website platform. Direct cost data will be collected yearly from all dyads using a cost data collection protocol and template that includes annual costs for personnel, technology, training requirements, supplies, and infrastructure.

Risky driving events

Time Frame: Daily overtime for six months following enrollment

Risky driving events (hard braking, sudden acceleration) will be collected among teens in the intervention groups and control group using the Azūga™ in-vehicle device. The number and type of driving event, including hard breaking (≤ -0.45 g-force) and sudden acceleration (\> 0.35 g-force), will be automatically coded and counted in the system. The rates will be computed by dividing events by miles driven then multiplying by 1000.

Adoption - Participants

Time Frame: At 6-month follow-up

The investigators will also conduct interviews with a randomly selected sample of dyads in each intervention group (n=116, 58 dyads for each intervention group) to identify facilitators and barriers to program adoption.

Implementation Fidelity - BECCI

Time Frame: After completion of each intervention session, up to three years

Implementation fidelity will be measured among parents in both intervention groups, and among the expert and peer trainers immediately after the intervention using the Behavior Change Counseling Index (BECCI). The BECCI measures the degree to which the intervention is delivered as intended and involves 11 items rated on a scale of 0 to 4. The average of all items will be calculated, with higher scores representing greater fidelity.

Secondary Outcomes

  • Parent-teen communications about driving safety(During 6 months of enrollment)
  • Motor Vehicle Collision(At 12 months following enrollment)
  • Traffic Violation Recidivism(At 12 months following enrollment)
  • Maintenance(At 6-month follow-up)
  • Indirect Costs: 3 Years(3 years)

Study Sites (1)

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