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Behavioral Intervention

Driving Safety Intervention for Teen Drivers

Phase 3

Recruiting

Led By Jingzhen (Ginger) Yang, PhD, MPH

Research Sponsored by Ginger Yang

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after completion of each intervention session, up to three years

Awards & highlights

Study Summary

This trial tests an intervention that helps keep teen drivers safe in rural and urban areas, and could reduce traffic violations.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

There may not be traditional medical side effects; however, participants might experience increased stress or anxiety from constant monitoring by the in-vehicle device or changes in family dynamics due to parent communication training.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adoption - Courts: 3 Years

Adoption - Participants

Change in Reach

+5 more

Secondary outcome measures

Indirect Costs: 3 Years

Maintenance

Motor Vehicle Collision

+2 more

Other outcome measures

Engagement with communication training and booster session

Engagement with device feedback

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Feedback and Peer-Delivered Parent Communication Intervention GroupExperimental Treatment2 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 GroupExperimental Treatment2 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 GroupActive Control1 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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Ginger YangLead Sponsor

2 Previous Clinical Trials

660 Total Patients Enrolled

1 Trials studying Psychological Feedback

480 Patients Enrolled for Psychological Feedback

University of IowaOTHER

447 Previous Clinical Trials

879,142 Total Patients Enrolled

1 Trials studying Psychological Feedback

480 Patients Enrolled for Psychological Feedback

Ohio State UniversityOTHER

830 Previous Clinical Trials

505,040 Total Patients Enrolled

1 Trials studying Psychological Feedback

480 Patients Enrolled for Psychological Feedback

Media Library

Expert-Delivered Parent Communication Training (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05696353 — Phase 3

Psychological Feedback Research Study Groups: Feedback and Expert-Delivered Parent Communication Intervention Group, Feedback and Peer-Delivered Parent Communication Intervention Group, Control Group

Psychological Feedback Clinical Trial 2023: Expert-Delivered Parent Communication Training Highlights & Side Effects. Trial Name: NCT05696353 — Phase 3

Expert-Delivered Parent Communication Training (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05696353 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the eligibility criterion for this study restricted to individuals aged 45 or younger?

"This research program requires enrollees to be between 16 and 18 years of age. The study involves 13 participants younger than 18, with another 29 adults above the senior threshold."

Answered by AI

Has Feedback and Expert-Delivered Parent Communication Intervention Group gained regulatory authorization?

"Our team at Power rated Feedback and Expert-Delivered Parent Communication Intervention Group a 3 out of 3 on safety because it has undergone several phases of clinical trials, resulting in evidence for both efficacy and protection."

Answered by AI

Are researchers currently enrolling participants for this clinical experiment?

"Indeed. According to the clinicaltrials.gov website, this medical trial is recruiting patients for enrollment and began on November 1st 2022. The last update was made on January 12th 2023 with a need for 580 participants from one site."

Answered by AI

How many participants is this investigation accommodating?

"Affirmative. Per the information displayed on clinicaltrials.gov, this study is currently recruiting patients as of 1/12/2023 and has been since 11/1/2020 with a goal to enroll 580 participants from one location."

Answered by AI

Are there certain characteristics that make individuals more suitable candidates for this research?

"This clinical trial necessitates the recruitment of 580 adolescents, between the ages 16 and 18, who have a driving record. In addition to those criteria, potential participants must be at least 16 years old when they commit their first traffic violation; hold an Ohio provisional driver's license with valid car insurance; drive a vehicle manufactured after 1996 which contains an On-board Diagnostics II system port; as well possess a smartphone that is Bluetooth compatible."

Answered by AI

What goals are investigators hoping to accomplish with this experiment?

"The purpose of this 6-month clinical trial is to assess the effect of risky driving events. Secondary objectives include evaluating Motor Vehicle Collisions (MVCs) and Traffic Violation Recidivism among all groups, as well as assessing Indirect Costs over a three year period. Participant data for MVC and recidivism will be collected through linked crash report and court disposition information alongside driver's license numbers. At the conclusion study participation, any uncaptured data regarding MVC or recidivism shall be considered censored."

Answered by AI

Recent research and studies

JamaJournal

Graduated Driver Licensing and Fatal Crashes Involving 16- to 19-year-old Drivers

Masten, Scott V., Robert D. Foss, and Stephen W. Marshall. 2011. “Graduated Driver Licensing and Fatal Crashes Involving 16- to 19-year-old Drivers”. Jama. American Medical Association (AMA). doi:10.1001/jama.2011.1277.

Accident Analysis & PreventionJournal

Risky Driving and Recorded Driving Offences: A 24-year Follow-up Study

Summala, Heikki, Sirpa Rajalin, and Igor Radun. 2014. “Risky Driving and Recorded Driving Offences: A 24-year Follow-up Study”. Accident Analysis & Prevention. Elsevier BV. doi:10.1016/j.aap.2014.08.008.

Accident Analysis & PreventionJournal

Interaction Between Socio-demographic Characteristics: Traffic Rule Violations and Traffic Crash History for Young Drivers

Alver, Y., M.C. Demirel, and M.M. Mutlu. 2014. “Interaction Between Socio-demographic Characteristics: Traffic Rule Violations and Traffic Crash History for Young Drivers”. Accident Analysis & Prevention. Elsevier BV. doi:10.1016/j.aap.2014.06.015.

Accident Analysis & PreventionJournal