- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01498575
An Evaluation of a Web-based Intervention Program for Parents and Teens to Promote Safe Driving
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Motor vehicle crashes remain the number one cause of death among teens in the United States. Teen drivers (ages 16 to 19) are four times more likely to be involved in fatal crashes than adult drivers (ages 25 to 69). Inexperience is a fundamental factor in the high crash rate for novice teens. Safe and skilled driving is a complex task that involves behaviors (e.g., skills and actions) that vary and become increasingly challenging with increasing speed, unsafe road conditions and other hazards of the driving environment. Because teens are at their lowest lifetime risk of crashing when accompanied by an adult, adult-supervised practice provides a safe way for teens to gain needed experience under a variety of driving conditions. Unfortunately, few teens receive sufficient quantity, quality and diversity of adult-supervised practice prior to licensure.
The objective of the proposed research is to compare how the driving training process and the results of that training process differ between a group of young learning permit holders in families that have access to TDP (the intervention group) from the training process and the results of that process in an otherwise similar group of teens in families with no TDP access (the control group). The investigators hypothesize that teens given access to TDP will demonstrate greater competence and safety in a standardized on-road driving assessment than teens with no TDP access.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Children's Hospital of Philadelphia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Teen 16 or 17 years of age who holds a Pennsylvania (PA) learner permit, or plans to obtain a learner permit in < 1 month.
- Parent(s) or legal guardian(s) of a teen with his or her learner permit.
- Internet connection at home and other technical requirements to launch web program if needed.
Exclusion Criteria:
- Non-English speaking.
- Teen has practiced more than 5 hours behind the wheel or has taken more than 5 practice drives with a supervising adult prior to enrollment.
- Teen has received formal behind-the-wheel driver education instruction prior to enrollment with a certified driving instructor at a professional driver education company or in his/her school.
- Pregnant female teen subjects.
- Teen requires handicapped placard or license plate in order to drive.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Teen Driving Plan
Access to web-based driving intervention
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Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver.
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No Intervention: Usual practice
Use of typical supervised practice driving resources
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Late Driving Performance in On-road Assessment (ODA) Test
Time Frame: 24 weeks after enrollment
|
The primary outcome was driving performance as measured by the teens completion of the standardized and validated ODA 24 weeks after enrollment.
Certified professional driving evaluators blinded to randomization status terminated the ODA if they determined that the teen could not safely complete it.
Criteria for termination included: (1) a driver action or inaction requiring evaluator intervention to prevent a collision; (2) a driving task requiring assistance from the evaluator to be performed safely; (3) violation of a traffic law; (4) evasive action needed by another vehicle or a pedestrian to avoid a collision; or (5) a subjective assessment by the evaluator that the teenager could not continue safely.
We examined the teens ability to complete the ODA as measured by the number of terminations.
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24 weeks after enrollment
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Collaborators and Investigators
Investigators
- Principal Investigator: Dennis R Durbin, MD, MSCE, Chidlren's Hospital of Philadelphia
Publications and helpful links
General Publications
- Mirman JH, Curry AE, Winston FK, Wang W, Elliott MR, Schultheis MT, Fisher Thiel MC, Durbin DR. Effect of the teen driving plan on the driving performance of teenagers before licensure: a randomized clinical trial. JAMA Pediatr. 2014 Aug;168(8):764-71. doi: 10.1001/jamapediatrics.2014.252.
- Winston FK, Mirman JH, Curry AE, Pfeiffer MR, Elliott MR, Durbin DR. Engagement with the TeenDrivingPlan and diversity of teens' supervised practice driving: lessons for internet-based learner driver interventions. Inj Prev. 2015 Feb;21(1):4-9. doi: 10.1136/injuryprev-2014-041212. Epub 2014 Jun 10.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 11-008203
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.
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