- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03639753
Transportation Safety in Adolescence
August 4, 2026 updated by: Catherine McDonald, University of Pennsylvania
Promoting Transportation Safety in Adolescence
The proposed project will focus on improving teen driver safety as motor vehicle crashes are the leading cause of death and injury to adolescents.
If successful, research findings will lead to clear strategies to reduce motor vehicle crashes.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2216
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- UNIVERSITY of PENNSYLVANIA
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 17 years (Child)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Teens between 16 and 17 years and 4 months (17.33 years) of age
- Pennsylvania state learner's permits
- Will have their Pennsylvania state learner's permit for at least 6 months (self-report)
- Self-report of less than 10 hours of behind-the-wheel driving experience.
- Teen and parent/caregiver fluent in written and spoken English
- Access to at least one practice vehicle
- Email address and internet access to complete study procedures
Exclusion Criteria:
- Teens with self-reported or parent reported (of teen's) visual, medical, or physical impairments that would require a handicap placard or assistive device to drive.
- Teens with pervasive developmental delays
- Have a sibling enrolled in this study
- Enrolled in other teen driving studies
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Parent-Teen Intervention
Parent health coaching session and supportive materials, teen on road driver assessment with feedback.
|
Parent health coaching and resources + teen on-road driver experience + safe driving eLearning Modules
|
|
Other: Usual Practice
|
Standard care for teens who get licensed in the state of PA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Police-reported motor vehicle crashes
Time Frame: Licensure to 12 months after licensure
|
Time to first motor vehicle crash
|
Licensure to 12 months after licensure
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Self-reported motor vehicle crashes
Time Frame: First 6 months of licensure
|
First 6 months of licensure
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantity of Practice Driving
Time Frame: At baseline, +3 months, and at driver licensure
|
Hours of driving practice by driving environment (1-5, higher score indicates more diversity)
|
At baseline, +3 months, and at driver licensure
|
|
Frequency of parent-teen communication about traffic safety driving topics Scale (e.g., GDL)
Time Frame: At driver licensure
|
0-3, higher scores indicate more communication
|
At driver licensure
|
|
Parental limit-setting on post-license driving Scale
Time Frame: At driver licensure and at 3, 6, and 12 months of driver licensure
|
1-5, higher score indicates stronger limit-setting
|
At driver licensure and at 3, 6, and 12 months of driver licensure
|
|
Risky driving behavior scale
Time Frame: At 3, 6, and 12 months of driver licensure
|
1-5, higher score indicates riskier driving
|
At 3, 6, and 12 months of driver licensure
|
|
Driving Avoidance
Time Frame: At 3, 6, and 12 months of driver licensure
|
Driving Habits Questionnaire, 1-5 higher score indicates more avoidance
|
At 3, 6, and 12 months of driver licensure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Catherine McDonald, PhD, RN, FAAN, UNIVERSITY of PENNSYLVANIA
- Principal Investigator: Jessica Mirman, PhD, University of Edinburgh
- Principal Investigator: Leann Long, PhD, Wake Forest University Health Sciences
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 18, 2021
Primary Completion (Actual)
March 18, 2026
Study Completion (Estimated)
August 31, 2026
Study Registration Dates
First Submitted
August 17, 2018
First Submitted That Met QC Criteria
August 17, 2018
First Posted (Actual)
August 21, 2018
Study Record Updates
Last Update Posted (Actual)
August 7, 2026
Last Update Submitted That Met QC Criteria
August 4, 2026
Last Verified
October 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IRB-834765
- R01HD095248 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.