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Teen Driving Translation Study (NIH)

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05696353
Enrollment
588
Registered
2023-01-25
Start date
2022-11-17
Completion date
2027-06-30
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Communication, Drive, Feedback, Psychological, Recidivism

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.

Interventions

COMBINATION_PRODUCTIn-vehicle Device

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.

BEHAVIORALExpert-Delivered Parent Communication Training

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.

BEHAVIORALPeer-Delivered Parent Communication Training

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.

Sponsors

Ginger Yang
Lead SponsorOTHER
University of Iowa
CollaboratorOTHER
Ohio State University
CollaboratorOTHER
University of Nebraska
CollaboratorOTHER
Dayton Children's Hospital
CollaboratorOTHER
Wright State University
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Hybrid Type II

Eligibility

Sex/Gender
ALL
Age
16 Years to 18 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Risky Driving EventsSix months/study periodRisky 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.
Unsafe Driving BehaviorsSix months/study periodUnsafe 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

MeasureTime frameDescription
Traffic Violation RecidivismUp to one-year post-study periodRecidivism 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.
Parent-Teen CommunicationAt Baseline, Three months, and Six monthsParent-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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORJingzhen (Ginger) Yang, PhD, MPH

Nationwide Children's Hospital - Center for Injury Research and Policy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026