- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02319317
Web-based Intervention to Prevent Risky Driving
Promoting Teen Health: A Web-based Intervention to Prevent Risky Driving
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving teen drivers licensed in the previous 90 days. The intervention will focus on promoting teen driver attention to the roadway.
The investigators will use a randomized controlled trial (RCT) experimental design for this feasibility study, randomizing to the intervention or control group. The investigators will complete a baseline assessment and follow up with participants at 1-month, 3-months and 6-months post-intervention delivery.
This study will provide information on the feasibility of the web-based intervention to prevent risky driving and estimation of effect size of the intervention on simulated driving performance, self-reported driving behaviors, crash and citation data.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-4217
- Children's Hospital of Philadelphia
-
Philadelphia, Pennsylvania, United States, 19104-4217
- University of Pennsylvania
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Males or females age 16-17 years at time of enrollment (i.e. can turn 18 while enrolled in research and still be eligible).
- Pennsylvania driver's license for 90 days or less at time of assent
- Personal email address and computer and internet access
- Willingness to travel to CHOP twice to complete simulated assessment
- Ability to read and write English
Exclusion Criteria:
- Self-reported of claustrophobia, migraine headaches, or motion sickness
- Self-reported current pregnancy
- . Participation in a Center for Injury Research and Prevention teen driving study with the past 6 months
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: Risky driving prevention
Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.
|
The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.
|
|
Experimental: Control group
Web-based behavioral intervention for healthy lifestyles.
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The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Retention of Participants
Time Frame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
|
Number of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.
|
Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Participants Randomized
Time Frame: Baseline (Study Visit 1)
|
Proportion of participants screened, enrolled and randomized
|
Baseline (Study Visit 1)
|
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Adherence
Time Frame: Baseline (Study Visit 1) through completion of the intervention.
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Adherence among the intervention and control group to the intervention.
|
Baseline (Study Visit 1) through completion of the intervention.
|
|
Simulated Driving Performance
Time Frame: Baseline (Study Visit 1) through Study Visit 3
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Difference between the intervention and control group on the simulated driving assessment (measures of driving performance during the simulated experimental drives).
|
Baseline (Study Visit 1) through Study Visit 3
|
|
Self-report Driving Behaviors
Time Frame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
|
Difference between the intervention and control group on self-report measures of driving behaviors.
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Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
|
|
Driving Citations and Crashes
Time Frame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
|
Difference between the intervention and control group on driving citations and crashes.
|
Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Catherine C McDonald, PhD, RN, University of Pennsylvania
Publications and helpful links
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R00NR013548 (U.S. NIH Grant/Contract)
- 14-011336 (Other Identifier: Children's Hospital of Philadelphia IRB)
- 821064 (Other Identifier: University of Pennsylvania IRB)
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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