480 Participants Needed

Driving Feedback Technology for High-Risk Teen Drivers

(projectDRIVE Trial)

AK
J(
Overseen ByJingzhen (Ginger) Yang, PhD, MPH
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Ginger Yang
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a driving feedback technology designed to help teens drive more safely. Researchers aim to determine if this technology, with or without parent involvement, can reduce risky behaviors and traffic violations among teens who have recently committed a driving offense. Participants will either have the in-vehicle device installed with no feedback, receive driving feedback through an app, or receive feedback plus parent communication training. Teens suitable for this trial have been convicted of a moving traffic violation, are the primary driver of a car made after 1996, and have a smartphone with Bluetooth. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking safety technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this in-vehicle driving feedback technology is safe for high-risk teen drivers?

Research has shown that using devices in cars to provide feedback to teen drivers is generally safe. The Teen Driver Support System (TDSS) offers real-time feedback, helping young drivers develop better habits without harm. Studies have found that these devices warn about speeding and other violations, with no reports of negative effects from their use.

Research also indicates that training parents to communicate better with their teen drivers is safe and beneficial. Studies show that parental involvement and training can lead to fewer risky driving events among teens. Specifically, teens whose parents received this training had fewer driving incidents compared to those who only received feedback.

Overall, both the in-car feedback device and parent communication training are well-tolerated and safe for teens, according to existing studies.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to improve teen driving safety using innovative feedback technology. Unlike traditional driving safety programs that rely on one-time education or passive monitoring, this trial actively engages teens and their parents with real-time driving feedback and communication training. The "Feedback Only" group allows teens to self-monitor and receive regular driving reports, while the "Feedback and Parent Communication" group adds a unique twist by involving parents in the process. This group receives additional training to help motivate their teens towards safer driving habits, creating a collaborative approach to improving safety. By integrating technology and parental involvement, the trial could offer a more effective way to reduce high-risk driving behaviors among teens.

What evidence suggests that this in-vehicle device is effective for reducing risky driving behaviors in teens?

Research shows that technology providing feedback while driving can help reduce risky driving in teens. In this trial, the Feedback Only Group will use devices like the Teen Driver Support System (TDSS) to receive real-time feedback, helping new drivers improve their habits. Teens in this group receive alerts and guidance while driving, which leads to safer driving. Another group in this trial, the Feedback and Parent Communication Group, combines this technology with parent communication training. Studies suggest that when parents communicate with their teens about driving, it encourages safer driving practices. This extra communication, supported by training, further reduces risky driving and traffic violations. Overall, both the feedback technology and parent involvement have shown promise in making teen driving safer.12346

Who Is on the Research Team?

J(

Jingzhen (Ginger) Yang, PhD, MPH

Principal Investigator

Nationwide Children's Hospital

Are You a Good Fit for This Trial?

This trial is for teens aged 16-17 in Ohio who have been convicted of a moving violation, hold a valid intermediate license with car insurance, and are the primary driver of a vehicle made after 1996. They need to have a legal guardian, smartphone with Bluetooth, and drive regularly. Teens can't join if they're unable to drive, enrolled in another driving study or don't speak English at home.

Inclusion Criteria

Smartphone with Bluetooth capabilities
Convicted of a moving violation
I was 16 or 17 years old at the time of the incident.
See 3 more

Exclusion Criteria

War of the State
I cannot drive because of an injury, suspended license, or car damage.
Pregnant women
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Teens and parents are assigned to one of three groups: Control, Feedback Only, or Feedback and Parent Communication. The intervention includes in-vehicle devices, smartphone apps, and communication training.

6 months
Biweekly virtual check-ins

Follow-up

Participants are monitored for recidivism and engagement with the intervention. Recidivism is tracked for 12 months post-study.

12 months

What Are the Treatments Tested in This Trial?

Interventions

  • In-vehicle device
  • Parent Communication
Trial Overview The study tests an in-car feedback device that monitors driving habits. It's looking at whether this tech reduces risky driving when used alone or combined with training parents on how to communicate about safe driving practices.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Feedback and Parent Communication GroupExperimental Treatment2 Interventions
Group II: Feedback Only GroupExperimental Treatment1 Intervention
Group III: Control GroupActive Control1 Intervention

In-vehicle device is already approved in United States, European Union for the following indications:

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Approved in United States as Teen Driver Technology for:
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Approved in European Union as In-vehicle Performance Monitoring and Feedback for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ginger Yang

Lead Sponsor

Trials
3
Recruited
1,200+

University of Iowa

Collaborator

Trials
486
Recruited
934,000+

Ohio State University

Collaborator

Trials
891
Recruited
2,659,000+

University of Nebraska

Collaborator

Trials
563
Recruited
1,147,000+

Published Research Related to This Trial

In a study involving 57 teens using a driving simulator, feedback based on peer social norms effectively reduced distraction engagement and improved driving performance among teen drivers.
The study found that there was no significant difference in effectiveness between same-gender and opposite-gender peer feedback, suggesting that any peer norm feedback can be beneficial without needing to tailor it by gender.
Mitigating Teen Driver Distraction: In-Vehicle Feedback Based on Peer Social Norms.Donmez, B., Merrikhpour, M., Nooshabadi, MH.[2022]
Young drivers are particularly vulnerable to distractions from new technologies like cell phones and infotainment systems, which can impair their ability to control vehicles and anticipate hazards, leading to higher crash rates.
While emerging technologies such as collision avoidance systems and electronic stability control can enhance safety, they must be tailored to the specific needs of young drivers, and collaboration among vehicle manufacturers, technology providers, and policymakers is essential to maximize their benefits.
Technology and teen drivers.Lee, JD.[2014]
A study involving 26 teen drivers used an event-triggered video device to capture risky driving behaviors, allowing for parental feedback through weekly reviews, which significantly reduced dangerous driving events among at-risk teens.
This innovative approach extends parental guidance beyond the initial learning phase, suggesting that technology can play a crucial role in improving teen driving safety even after they obtain their licenses.
Extending parental mentoring using an event-triggered video intervention in rural teen drivers.McGehee, DV., Raby, M., Carney, C., et al.[2007]

Citations

Effectiveness of Teenage Driver Support System (TDSS) ...The outcome of the study is expected to clarify the long-term effectiveness of an in-vehicle support system as well as promote future implementations with a ...
Teen Driver Support System Technology TransferThe Teen Driver Support System (TDSS) is a smartphone application designed to provide real-time, in-vehicle feedback to novice drivers about their driving ...
ProjectDRIVE: study protocol for a randomized controlled trial ...Using in-vehicle device and smartphone application technology, the study provides real-time and cumulative driving feedback to intervention ...
An Exploration of Vehicle-Based Monitoring of Novice ...Focus groups of teen drivers and their parents were conducted to explore issues of motivation, preference, and usability of teen monitoring systems and concepts ...
Study Finds Teens Driving Older Vehicles Have Increased ...Researchers found that driving vehicles 6-15 years old had a 19% greater risk of driver death in fatal crashes, and driving vehicles older than 15 years had a ...
Smartphone-Based Teen Driver Support SystemThe TDSS device, mounted on the vehicle's dashboard, provides visual and auditory warnings to the teen driver about speeding, stop sign violations, upcoming ...
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