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OpenTrials
Active, Not Recruiting

NCT Number: NCT05696353

Teen Driving Translation Study (NIH)

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

16 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Teen must be 16 or 17 years old at the time of the moving-related violation
  • Teen must 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

Treatment and study plan

In-vehicle device

Combination Product

The Azūga™ in-vehicle driving feedback technology, which consists of a pager-sized device plugged into the vehicle's on-board diagnostic port (installed in the teen's car) and a smart phone app (downloaded on the teen's smart phone), will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Detailed cumulative driving data via the smart phone app and study website; 3) A customized biweekly driving summary report via study website; and 4) Push notification on the phone screen when a trip ends.

Other names: Azuga Device, In-vehicle Driving Feedback Technology

Expert-Delivered Parent Communication Training

Behavioral

An individualized virtual training in communication strategies about teen driving safety along with a booster session will be delivered by a traffic safety communication specialist to parents in the Feedback and Expert-Delivered Parent Communication Intervention Group. Intervention parents in this group will also be provided with access to an online parent-teen safe driving communication guide.

Other names: Expert-Delivered Parent Training, Steering Teens Safe (Expert), Expert-Delivered Motivational Interviewing Training

Peer-Delivered Parent Communication Training

Behavioral

An individualized virtual training in communication strategies about teen driving safety along with a booster session will be delivered by a peer trainer who is a parent of teen with traffic citation and has participated in the Feedback and Expert-Delivered Parent Communication Intervention Group. Intervention parents in this group will also be provided with access to an online parent-teen safe driving communication guide.

Other names: Peer-Delivered Parent Training, Steering Teens Safe (Peer), Peer-Delivered Motivational Interviewing Training

Primary outcomes

  1. Risky Driving Events

    Time frame: Six months/study period

    Risky driving events are continuously monitored for teens across all three groups using an in-vehicle device and smartphone app. The system automatically detects and records driving events, including hard braking (≤ -0.45 g-force) sudden acceleration (> 0.35 g-force), speeding (>10 miles over the posted speed limit), and speed >75 mph. Event rates are calculated as the number of risky driving events per 1,000 miles driven.

  2. Unsafe Driving Behaviors

    Time frame: Six months/study period

    Unsafe driving behaviors among teens are continuously monitored across all three study groups using an in-vehicle device and a smartphone app. The system automatically records behaviors such as speeding, and seatbelt nonuse (for selected vehicle makes and model years only), as well as the distance traveled while these behaviors occur. Unsafe behavior rates are calculated as the number of miles involving an unsafe behavior per 1,000 miles driven. Survey data supplement these measures by capturing self-reported distracted driving and seatbelt use for vehicles that are not fully compatible with the in-vehicle device.

Secondary outcomes

  1. Traffic Violation Recidivism

    Time frame: Up to one-year post-study period

    Recidivism is assessed by linking traffic citation and court disposition records to participants' driver's license numbers. Data collected include violation dates, types, and intervals between the index and subsequent violations.

  2. Parent-Teen Communication

    Time frame: At Baseline, Three months, and Six months

    Parent-teen communication is assessed using REDCap surveys. Teens and parents rate the frequency (0-3) and success (1-10) of discussions about 26 driving skills and safety principles from the past month. Frequency scores range from 0-78, with higher scores indicating more frequent communication, and quality scores are weighted averages expressed as percentages (1-100%), with higher scores indicating higher quality communication. Additionally, one voice-recorded conversation per survey is also coded by trained raters for active listening, OARS (i.e.,open questions, affirmations, reflective listening, and summary reflections) use solicitation of the teen's perspective, focus on behaviors, and emotional expression, with each behavior scored 0-3 to generate a summary quality score, with higher scores indicating higher quality communication.

Other outcomes

  1. Engagement with communication training and booster session

    Time frame: Six months/study period

    Engagement with communication training and the booster session will be measured among parents in the intervention groups using a self-report questionnaire and online tracking.

  2. Engagement with Device Feedback

    Time frame: Six months/study period

    Engagement with device feedback will be measured among teens and parents in the intervention groups via online tracking of the participant's web interface using Google Analytics.

  3. Motor Vehicle Collision

    Time frame: By 12 months following study completion

    Motor vehicle collision (MVC) will be measured among teens in both intervention groups and the control group by linking crash report data with the participating teen's driver's license number. Motor vehicle collision (MVC) during the 12 months following enrollment, including date and type of crash will be analyzed. The time of MVC may not be observed when the 12-month study participation is completed and thus, it will be considered as censored at month 12 (end of study participation).

  4. Adoption - Participants and Courts

    Time frame: At 6-month follow-up

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

    Courts Adoption will also 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.

  5. Implementation Fidelity

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

    BECCI 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.

    Fidelity Checklist Implementation fidelity will also 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.

  6. Reach

    Time frame: At three months and six months follow up

    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.

  7. Maintenance

    Time frame: At 6-month follow-up

    Maintenance will be measured by assessing parents' intention to continue using the STS+ program and teens' intention to continue using the in-vehicle device and app. The investigators will interview court officials, peer trainers, and parent-teen dyads in each intervention group (approximately 50% of intervention dyads) at the end of the study to explore perceived facilitators and barriers to program implementation and sustainability in their community.

  8. Direct Costs

    Time frame: At baseline, and at three months and six months follow up

    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.

  9. Indirect Costs

    Time frame: At baseline, and at three months and six months follow up

    Indirect costs are those costs that are not directly associated with the intervention but that support the delivery of the intervention (e.g., provide private space in court house for the recruitment). For indirect costs, staff interviews will be used to determine the percent of their time and resources needed to support the delivery of the intervention.

Sponsors and collaborators

Lead sponsor

Ginger Yang

Other

Collaborators

  • Dayton Children's Hospital
  • Ohio State University
  • University of Iowa
  • University of Nebraska
  • Wright State University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jan 25, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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