580 Participants Needed

Driving Safety Intervention for Teen Drivers

J(
RF
Overseen ByRobyn Feiss, PhD
Age: < 65
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

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

Is the Driving Safety Intervention for Teen Drivers safe for participants?

The studies reviewed focus on improving communication between parents and teens to enhance driving safety, using tools like in-vehicle video systems and parent training. These interventions are generally safe, as they involve non-invasive methods like feedback and communication strategies to reduce risky driving behaviors.12345

How does the Parent Communication Training treatment differ from other treatments for improving teen driving safety?

The Parent Communication Training treatment is unique because it involves teaching parents effective communication strategies to discuss and reinforce safe driving behaviors with their teens, which enhances the impact of in-vehicle feedback systems. This approach leverages the influential role of parents in shaping teen driving habits, making it more effective than feedback systems alone.12346

What data supports the effectiveness of the treatment Expert-Delivered Parent Communication Training and similar interventions for improving driving safety in teens?

Research on communication skills training in healthcare settings shows that such training can significantly improve communication confidence and skills, which are crucial for effective parent-teen interactions. This suggests that similar training for parents could enhance their ability to communicate with their teen drivers, potentially improving driving safety.7891011

Who Is on the Research Team?

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Jingzhen (Ginger) Yang, PhD, MPH

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for 16 or 17-year-old first-time traffic violators with a valid Ohio provisional driver's license and car insurance. They must be the primary driver of a vehicle made after 1996, have a smartphone with Bluetooth, and English-speaking parents. Teens who can't drive due to injury, have prior citations, non-English speaking parents, or are in another study cannot join.

Inclusion Criteria

Teen must have a smart phone with Bluetooth capabilities
I am a teen with a valid Ohio provisional driver's license and car insurance.
I drive a car made after 1996 that has an OBD II port.
See 2 more

Exclusion Criteria

I am a teen who cannot drive because of an injury, a suspended license, or car damage.
Pregnant women
Teen has previously received a traffic citation
See 6 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 randomized into intervention groups, receive in-vehicle devices, and participate in communication training sessions.

6 months
Biweekly summary reports and booster sessions

Follow-up

Participants are monitored for safety and effectiveness after the intervention, including assessment of driving behaviors and communication.

6 months

Long-term Monitoring

Ongoing assessment of implementation fidelity, cost-effectiveness, and program adoption.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Expert-Delivered Parent Communication Training
  • In-vehicle Device
  • Peer-Delivered Parent Communication Training
Trial Overview The study tests an intervention for safe teen driving among high-risk teens with violations. It includes an in-vehicle device that gives feedback on driving habits and training programs for parents on effective communication about safe driving practices.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Feedback and Peer-Delivered Parent Communication Intervention GroupExperimental Treatment2 Interventions
Group II: Feedback and Expert-Delivered Parent Communication Intervention GroupExperimental Treatment2 Interventions
Group III: Control GroupActive Control1 Intervention

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

A brief intervention for pediatric and internal medicine residents significantly improved their use of effective communication skills with parents, leading to better interactions during patient visits.
Following the intervention, parent satisfaction with care increased, particularly in areas of distress relief and communication, indicating that enhancing communication skills can positively impact the quality of pediatric care.
Enhancing parent-provider communication in ambulatory pediatric practice.Hart, CN., Drotar, D., Gori, A., et al.[2022]
A training program using standardized parents (SPs) significantly improved pediatric intensive care fellows' ability to communicate bad news, with an average score increase of 18.1 points after the training (P = .007).
This study is the first to show that a short, 1-day workshop can lead to immediate enhancements in communication skills for physicians in a high-stress pediatric intensive care environment.
Teaching physicians how to break bad news: a 1-day workshop using standardized parents.Vaidya, VU., Greenberg, LW., Patel, KM., et al.[2022]
A pilot communication skills training (CST) program for 50 healthcare professionals in adolescent oncology showed significant improvements in confidence for 6 out of 19 communication areas after training, indicating its effectiveness.
Participants reported that while the training was practical and intense, the benefits diminished over time, highlighting the need for follow-up booster sessions to maintain communication skills.
Communication Skills Training for Professionals Working with Adolescent Patients with Cancer Based on Participants' Needs: A Pilot.Essig, S., Steiner, C., Kühne, T., et al.[2020]

Citations

Enhancing parent-provider communication in ambulatory pediatric practice. [2022]
Teaching physicians how to break bad news: a 1-day workshop using standardized parents. [2022]
Communication Skills Training for Professionals Working with Adolescent Patients with Cancer Based on Participants' Needs: A Pilot. [2020]
Outcome of parent-physician communication skills training for pediatric residents. [2022]
Communication Skills Training in Pediatric Oncology: Moving Beyond Role Modeling. [2022]
Family Communication Patterns and Teen Driving Intervention Effectiveness. [2020]
A randomized trial to test the impact of parent communication on improving in-vehicle feedback systems. [2020]
Talking with teens about traffic safety: Initial feasibility, acceptability, and efficacy of a parent-targeted intervention for primary care settings. [2020]
Implementation evaluation of steering teens safe: engaging parents to deliver a new parent-based teen driving intervention to their teens. [2013]
Salesperson knowledge of teen-specific vehicle safety features. [2022]
Parenting and the young driver problem. [2021]
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