Clinical trial NCT06413927: Driver Education Research Study
Official title: A Contemporary Look at Driver Training and Its Role in Reducing Crash Risk in Novice Adolescent Drivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Risk Reduction Behavior
Injuries
Accident, Traffic
Development, Adolescent
Keywords: Injury prevention
Adolescent development
Learner drivers
Crash risk reduction
Novice drivers
Risky Driving
Teens
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Pennsylvania
name: University of Michigan
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2024-05-14
Enrollment: 1300
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test the effectiveness of different types of driver training interventions for reducing young new driver crash risk early after licensure.

Detailed description: Motor vehicle crashes remain high in young drivers, despite graduated driver licensing laws that put restrictions on driving and delay licensure. Typically, data trends show that crash risk is highest right after licensure, in the early months of independent driving. Additional studies of different driver training interventions have shown some evidence that it is possible to improve skills and reduce crashes early in licensure for young drivers. However, Pennsylvania and many other states have no professional training requirements for young drivers.

This study will test the effectiveness of different types of driver training programs for reducing young new driver crash risk early after licensure.

A thousand adolescent learner drivers in Pennsylvania will be recruited through Primary Care Clinics at Children's Hospital of Philadelphia to take part in a study that will continue through the learner phase and for 6 months after licensure. Participants will give informed consent and be asked to complete some baseline surveys and cognitive tasks in-person during a clinical or other visit. All will receive care-as-usual.

Participants will also be followed through the learner phase with a smartphone app that monitors driving trips and monthly surveys that can be completed at home. In the learner phase, participants will randomly receive one of three interventions. One group of participants will receive professional behind-the-wheel training with a local driving school instructor. Another group will receive a modern online driver training course. Another group will receive an online vehicle and driver safety training course. Participants randomly assigned to the behind-the-wheel training group will be required to download and use an app to log and track their driving practice hours. Use of this app will be optional for participants randomly assigned to the other groups.

After the learner phase, participants will be given a state license examination and will be followed for 6 months after licensure, with online surveys at 2, 4, and 6 months after licensure, and with continued driver trip monitoring through the smartphone app.

Eligibility criteria: Inclusion Criteria:

* Adolescents ages 16-17 years old who reside in Pennsylvania
* Have an active Pennsylvania learner's permit
* Have \<30 hours of driving practice during permit phase
* Have never taken an on-road licensing exam, in any state
* Plan to get a license within the next 12 months in Pennsylvania
* Plan to have access to a vehicle to drive after licensure
* Have a personal cell phone and access to a smartphone/tablet/computer with internet access
* Download and use the RoadReady app (only required for participants randomized to the behind-the-wheel training arm; optional for participants randomized to the online vehicle and driver safety and online driver skills training arms)
* Are able to read/write in English
* Provide informed consent/assent
* Are not also taking part in another learner driver study

Exclusion Criteria:

* Non-Pennsylvania resident
* Participants who do not pass the license exam will not be able to complete the post-license monitoring until the license is obtained
* Enrolled in another learner driver study

Primary outcomes:
measure: Hard Braking Events
timeFrame: Measured over the 6 months post-licensure at the end of the study (about month 18-24).
measure: Pass rate on the licensure exam
timeFrame: Measured at the time of the license examination, post-intervention (in about month 8-18).
Secondary outcomes:
measure: Phone Use While Driving
timeFrame: Measured over the 6 months post-licensure at the end of the study (about month 18-24).
measure: Speeding
timeFrame: Measured over the 6 months post-licensure at the end of the study (about month 18-24).
measure: Crash Involvement
timeFrame: Measured at 2-, 4- and 6-month follow-up post-licensure (about month 18-24).
measure: Risky driving behavior
timeFrame: Measured at 2-, 4- and 6-month follow-up post-licensure (within about month 18-24).
measure: Virtual Driving Assessment performance
timeFrame: Measured at the time of the license examination, post-intervention (in about month 8-18).
measure: Change in Virtual Driving Assessment performance
timeFrame: Measured at the time of the license examination, post-intervention (in about month 8-18).
measure: Number of license exam attempts
timeFrame: Measured at the time of the license examination, post-intervention (in about month 8-18).
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Elizabeth A Walshe, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: Flaura Winston, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia/University of Pennsylvania
name: Dan Romer, PhD
role: PRINCIPAL_INVESTIGATOR
References: