Driving Safety Intervention for Teen Drivers

Overseen By Robyn Feiss, PhD

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Ginger Yang

Disqualifiers: Non-English speaking parents, others

No Placebo Group All 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 Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

580 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help teen drivers become safer by involving their parents in communication training. It tests two approaches: one where a communication expert trains parents (Expert-Delivered Parent Communication Training) and another where a peer parent provides the training (Peer-Delivered Parent Communication Training). The focus is on teens aged 16 or 17 who have committed a traffic violation and can drive a car with a diagnostic port (common in cars made after 1996). Teens must also have a smartphone with Bluetooth. The goal is to determine which training method is more effective and cost-efficient in promoting safe driving habits. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially impactful safety program.

Will I have to stop taking my current medications?

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

What prior data suggests that this intervention is safe for teen drivers?

Research shows that programs focused on helping parents communicate with their teen drivers, such as the Expert-Delivered Parent Communication Training, receive positive feedback. These programs improve parent-teen communication, reducing risky driving. Reports indicate no major negative effects.

Similarly, the Peer-Delivered Parent Communication Training has demonstrated good results. Reviews highlight its success in helping parents guide their teens to drive more safely, without major safety issues.

Both training methods aim to encourage safe driving among teens, and evidence suggests they are safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative strategies for improving teen driving safety. Unlike existing driving safety programs that primarily focus on educating teens, this trial emphasizes parent involvement through unique communication training. One group receives training from a communication expert, while the other benefits from a peer parent's experience, offering distinct approaches to motivate teens to adopt safer driving habits. Both methods integrate technology by providing real-time feedback and detailed driving reports, potentially making these interventions more effective than traditional educational programs.

What evidence suggests that this trial's interventions could be effective for improving teen driving safety?

Research shows that programs focused on parents can greatly improve teen driving safety. In this trial, one group of parents will receive expert-delivered communication training, which past studies have shown helps reduce risky driving among teens who had broken traffic rules. Teens whose parents received expert advice demonstrated better driving habits and were less likely to drive unsafely. Another group will receive peer-delivered training, where parents learn to promote safe driving by sharing experiences with others who have faced similar issues. This peer approach has been linked to better communication between parents and teens, leading to safer driving. Both methods are being tested in this trial to evaluate their effectiveness in making roads safer for young drivers. ^{2 6 7 8 9}

Who Is on the Research Team?

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.

Exclusion Criteria

I am a teen who cannot drive because of an injury, a suspended license, or car damage.

Teen has previously received a traffic citation

Teen is a ward of the State

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?

Group I: Feedback and Peer-Delivered Parent Communication Intervention Group Experimental Treatment 2 Interventions

Teens will have an in-vehicle device installed in their car and the smart phone app download on their smart phone. Teens will receive real-time and cumulative driving feedback generated by the in-vehicle device and app; parents will have access to their teen's cumulative driving data at any time via study web portal. Parents will also receive communication training on how to motivate their teen to adopt safe driving habits via online modules and a video call with a peer trainer who is a parent of teen with a traffic violation and who has received the Expert-delivered Intervention and met the defined peer trainer criteria. A second booster session delivered by the peer trainer will also occur two months after the initial training. Both teens and parents will also receive a biweekly summary report of the teen's driving events prepared by the research team.

Group II: Feedback and Expert-Delivered Parent Communication Intervention Group Experimental Treatment 2 Interventions

Teens will have an in-vehicle device installed in their car and the smart phone app downloaded on their smart phone. Teens will receive real-time and cumulative driving feedback generated by the in-vehicle device and app; parents will have access to their teen's cumulative driving data at any time via study web portal. Parents will also receive communication training on how to motivate their teen to adopt safe driving habits via online modules and a video call with a teen driving safety communication expert. A second booster session will occur two months after the initial training. Both teens and parents will also receive a biweekly summary report of the teen's driving events prepared by the research team.

Group III: Control Group Active Control 1 Intervention

The Control Group will have an in-vehicle device installed in the teen's car, but all feedback features will be disabled. Parents assigned into this group will receive no communication training on how to motivate their teen to adopt safe driving habits.

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

Teenage drivers experience significantly higher crash rates compared to adults, and parents play a crucial role in managing their driving risks by supervising practice and setting limits on driving privileges.

Delaying licensure and imposing restrictions on high-risk driving conditions, such as night driving and having teenage passengers, are the most effective strategies parents can use to reduce the risk of accidents among new drivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenting and the young driver problem. Simons-Morton, BG., Ouimet, MC., Catalano, RF.[2021]

The study found that family communication patterns (FCPs) significantly influence the effectiveness of parent-focused interventions on teen driving safety, particularly highlighting that families with a laissez-faire communication style benefited more from the intervention.

By targeting interventions like in-vehicle event recorder feedback and parent communication training to families with laissez-faire patterns, the study suggests a more efficient approach to reducing risky driving behaviors among teens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Family Communication Patterns and Teen Driving Intervention Effectiveness. Hamann, C., Schwab-Reese, L., O'Neal, EE., et al.[2020]

Integrating a parent communication intervention with an in-vehicle video feedback system significantly reduced unsafe driving events among young drivers, with the combined intervention group showing a 79% reduction in unsafe driving compared to the control group.

The study involved 150 parent-teen dyads and demonstrated that teaching parents effective communication strategies further enhanced the effectiveness of the in-vehicle feedback system, leading to even safer driving behaviors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial to test the impact of parent communication on improving in-vehicle feedback systems. Peek-Asa, C., Reyes, ML., Hamann, CJ., et al.[2020]

The Talking with Teens about Traffic Safety Program was successfully implemented with 54 parent-teen dyads, showing that it is feasible and acceptable for promoting discussions about teen driver safety during annual well-child visits.

Parents in the treatment group reported significantly more frequent conversations about safe driving topics compared to the control group, particularly on less commonly discussed topics, indicating preliminary efficacy of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Talking with teens about traffic safety: Initial feasibility, acceptability, and efficacy of a parent-targeted intervention for primary care settings. Mirman, JH., Goodman, ES., Friedrich, E., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Teaching physicians how to break bad news: a 1-day workshop using standardized parents. Vaidya, VU., Greenberg, LW., Patel, KM., et al.[2022]

The Steering Teens Safe program effectively engaged 83 parents in teaching their teens safe driving skills, with parents reporting a median of 101.5 minutes spent discussing driving safety over three months.

Despite some barriers like time constraints and teen resistance, parents felt comfortable and benefited from the program, indicating its high acceptability and potential for real-world application in reducing teen driving risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation evaluation of steering teens safe: engaging parents to deliver a new parent-based teen driving intervention to their teens. Ramirez, M., Yang, J., Young, T., et al.[2013]

Most salespeople at car dealerships mentioned their brand's teen-specific safety systems, but only after receiving specific prompts from researchers posing as parents, indicating a lack of proactive communication about these features.

Salespeople generally provided vague information about the teen safety features, and none reported receiving specific training on these systems, suggesting that parents may leave dealerships without a clear understanding of available safety options for their teen drivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salesperson knowledge of teen-specific vehicle safety features. Weast, RA., Jenness, JW., De Leonardis, D.[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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

A communication skills training program for experienced pediatric physicians significantly improved their performance in Objective Structured Clinical Examinations (OSCE), particularly in building relationships with parents and addressing their concerns.

The training also enhanced the physicians' self-efficacy regarding communication, demonstrating that even seasoned clinicians can benefit from structured training to improve their interaction skills with patients' parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome of parent-physician communication skills training for pediatric residents. Nikendei, C., Bosse, HM., Hoffmann, K., et al.[2022]

Effective communication is crucial in pediatric oncology for discussing serious diagnoses and treatment options, yet there are significant communication gaps reported by parents, patients, and healthcare providers.

The review highlights the need for improved communication skills training for pediatric oncologists, as current methods may not adequately prepare them to handle the complexities of patient and family interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Communication Skills Training in Pediatric Oncology: Moving Beyond Role Modeling. Feraco, AM., Brand, SR., Mack, JW., et al.[2022]

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/588395

Teen Driving Translation Study (NIH) Behavioral. Expert-Delivered Parent Communication Training. An individualized virtual training in communication strategies about teen driving safety along ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04317547

Translation Study of a Safe Teen Driving Intervention The objective of this translation study is to assess the effect of STS on driving outcomes among teen drivers who have committed a traffic violation, and to ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4483193/

Effectiveness of Parent-Focused Interventions to Increase ... We critically reviewed recent parent-directed teen driving interventions in order to summarize their success in meeting stated goals.

4. clinicaltrial.be clinicaltrial.be/en/details/189511?per_page=20&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Teen Driving Translation Study (NIH) - Clinical Trial Dis... The study will determine the effectiveness and cost-effectiveness of the intervention on teens' risky driving events, unsafe driving behaviors, traffic ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7738003/

Design and implementation of a parent guide for coaching ... Effectiveness of a brief parent-directed teen driver safety intervention (Checkpoints) delivered by driver education instructors. Journal of Adolescent ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7654442/

Family Communication Patterns and Teen Driving ... In this study, we examined how family communication patterns (FCPs) impact teen risky driving and the effectiveness of a parent-focused teen driving ...

7. researchgate.net researchgate.net/publication/335537424_Family_Communication_Patterns_and_Teen_Driving_Intervention_Effectiveness

Family Communication Patterns and Teen Driving ... In this study, we examined how family communication patterns (FCPs) impact teen risky driving and the effectiveness of a parent-focused teen driving ...

8. rosap.ntl.bts.gov rosap.ntl.bts.gov/view/dot/56541/dot_56541_DS1.pdf

A Comprehensive Program to Support Parents of New ... Effectiveness of a brief parent-directed teen driver safety intervention (Checkpoints) delivered by driver education instructors. Journal of ...

9. roadsafety.unc.edu roadsafety.unc.edu/wp-content/uploads/2021/04/CSCRS_Report_R8-Final.pdf

A Comprehensive Program to Support Parents of New ... Effectiveness of a brief parent-directed teen driver safety intervention (Checkpoints) delivered by driver education instructors. Journal of ...