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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06413927
Other study ID # 21-019445
Secondary ID 1R01HD108249-01A
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date June 2024
Est. completion date December 2027

Study information

Verified date June 2024
Source Children's Hospital of Philadelphia
Contact Elizabeth A Walshe, PhD
Phone 267-425-1583
Email walshee@chop.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1200
Est. completion date December 2027
Est. primary completion date December 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 17 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Online Vehicle and Driver Safety Training
This online video education program provides education in vehicle and driver safety (e.g. vehicle maintenance, adjusting car seats and seatbelts). This online training will take up to 2 hours to complete and will have a short quiz at the end to determine compliance with this online training.
Online Driver Skills Training
The online driver training is the Accelerated Curriculum to Create Effective Learning (ACCEL) is designed to enhance the ability to anticipate, recognize and respond to hazards and to maintain attention to the road. The training is delivered online via a computer and can be done from home or at a school or other site that has a computer with internet access. It requires up to two hours to complete, and will be hosted on a platform that will track progress and completion through the training (such as accuracy, duration in modules, time to complete) and a short quiz will be provided at the end to assess learning.
Behind-the-Wheel Driver Training
The professional behind-the-wheel training course will be conducted in-person, delivered by local driving school partner Driver Training Services. The curriculum consists of 6 hours of training with assigned practice between lessons, and meets Pennsylvania and national standards. Post-lesson forms completed by the instructors will record adherence and consistency (intervention fidelity).

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
Children's Hospital of Philadelphia Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), University of Michigan, University of Pennsylvania

Outcome

Type Measure Description Time frame Safety issue
Primary Hard Braking Events For Aim 1 and 3, the primary outcome is the number of hard braking events per 100 miles driven during, as measured via the Way-to-Drive App. Measured over the 6 months post-licensure at the end of the study (about month 18-24).
Primary Pass rate on the licensure exam The primary outcome in Aim 2 and 3 will be the pass rate on the first licensure exam attempt. Measured at the time of the license examination, post-intervention (in about month 8-18).
Secondary Phone Use While Driving For Aim 1 and 3: minutes of handheld phone use per hour of driving, as measured via the Way-to-Drive App. Measured over the 6 months post-licensure at the end of the study (about month 18-24).
Secondary Speeding For Aim 1 and 3: Proportion of drive time >10 miles over the posted speed limit, as measured via the Way-to-Drive App. Measured over the 6 months post-licensure at the end of the study (about month 18-24).
Secondary Crash Involvement For Aim 1 and 3: Self-reported involvement in crashes as a driver (binary yes/no) as captured by a question in our follow-up driver experience questionnaire: response options are 1) none; 2) one; 3) two; 4) more than 2. This item has been used in previous studies as part of the modified Driver Behavior Questionnaire (mDBQ). Measured at 2-, 4- and 6-month follow-up post-licensure (about month 18-24).
Secondary Risky driving behavior For Aim 1 and 3: Risky Driving factor score as captured through self-reported responses on the modified driver behavior questionnaire, in which participants rate how often they engage in 11 different risk-taking behaviors while driving on a 6-point scale from "Never" to "Nearly all the time." Measured at 2-, 4- and 6-month follow-up post-licensure (within about month 18-24).
Secondary Virtual Driving Assessment performance For Aim 2 and 3: the class of driving behavior assessed via performance on a virtual driving assessment. Measured at the time of the license examination, post-intervention (in about month 8-18).
Secondary Change in Virtual Driving Assessment performance For Aim 2 and 3: the change in virtual driving assessment performance class assessed via performance on a virtual driving assessment pre- and post-intervention. Measured at the time of the license examination, post-intervention (in about month 8-18).
Secondary Number of license exam attempts For Aim 2 and 3: the number of attempts taken to pass the licensure exam. Measured at the time of the license examination, post-intervention (in about month 8-18).
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