Skip to content

Intervention to Improve Driving Practices Among High-Risk Teen Drivers

Intervention to Improve Driving Practices Among High-Risk Teen Drivers

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04317664
Acronym
projectDRIVE
Enrollment
240
Registered
2020-03-23
Start date
2020-09-28
Completion date
2025-12-31
Last updated
2026-02-23

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

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.

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 smartphone app (downloaded on the teen's smartphone), will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Push notification on the phone screen when a trip ends, 3) Detailed cumulative driving data; and 4) A customized biweekly driving summary report.

An individualized virtual training in communication strategies about driving safety along with a booster session will be delivered by a traffic safety communication specialist to subjects in the Feedback and Parent Communication Group. Intervention parents in this group will also be provided with access to an online parent-teen safe driving communication guide, including includes three motivational interviewing technique demonstration videos and 26 safe driving lessons.

Sponsors

Ginger Yang
Lead SponsorOTHER
University of Iowa
CollaboratorOTHER
Ohio State University
CollaboratorOTHER
University of Nebraska
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 17 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Risky Driving EventsSix months/study periodRisky driving events are continuously monitored for teens (240) 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 BehaviorsSix months/study periodUnsafe driving behaviors among teens (N = 240) 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
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

Participant flow

Recruitment details

Parent and teen are enrolled as a dyad only if both agree to participate.

Pre-assignment details

Data listed below reflects number of parent-teen dyads.

Baseline characteristics

Characteristic
Age, Categorical
Parents
<=18 years
0 Participants
Age, Categorical
Parents
>=65 years
0 Participants
Age, Categorical
Parents
Between 18 and 65 years
80 Participants
Age, Categorical
Teens
<=18 years
240 Participants
Age, Categorical
Teens
>=65 years
0 Participants
Age, Categorical
Teens
Between 18 and 65 years
0 Participants
Ethnicity (NIH/OMB)
Parents
Hispanic or Latino
3 Participants
Ethnicity (NIH/OMB)
Parents
Not Hispanic or Latino
72 Participants
Ethnicity (NIH/OMB)
Parents
Unknown or Not Reported
6 Participants
Ethnicity (NIH/OMB)
Teens
Hispanic or Latino
5 Participants
Ethnicity (NIH/OMB)
Teens
Not Hispanic or Latino
206 Participants
Ethnicity (NIH/OMB)
Teens
Unknown or Not Reported
4 Participants
Race/Ethnicity, Customized
Parents
Black
7 Participants
Race/Ethnicity, Customized
Parents
Other
15 Participants
Race/Ethnicity, Customized
Parents
White
67 Participants
Race/Ethnicity, Customized
Teens
Black
4 Participants
Race/Ethnicity, Customized
Teens
Other
18 Participants
Race/Ethnicity, Customized
Teens
White
192 Participants
Region of Enrollment
United States
480 Participants
Sex: Female, Male
Parents
Female
180 Participants
Sex: Female, Male
Parents
Male
18 Participants
Sex: Female, Male
Teens
Female
41 Participants
Sex: Female, Male
Teens
Male
117 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 800 / 800 / 80
other
Total, other adverse events
3 / 803 / 803 / 80
serious
Total, serious adverse events
0 / 800 / 800 / 80

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 26, 2026