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Web-based Intervention to Prevent Risky Driving

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319317
Recruitment Status : Completed
First Posted : December 18, 2014
Results First Posted : October 4, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborators:
National Institute of Nursing Research (NINR)
Children's Hospital of Philadelphia
Information provided by (Responsible Party):
University of Pennsylvania

Brief Summary:
The specific aim of this study is to assess the feasibility of a web-based intervention to prevent risky driving with teen drivers licensed in the previous 90 days.

Condition or disease Intervention/treatment Phase
Adolescent Accidents, Traffic Attention Motor Vehicles Behavioral: Risky driving prevention Behavioral: Control group general health promotion Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Promoting Teen Health: A Web-based Intervention to Prevent Risky Driving
Study Start Date : April 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : July 31, 2017

Arm Intervention/treatment
Experimental: Risky driving prevention
Web-based behavioral intervention to promote teen driver attention to the roadway, addressing mobile technology and passengers.
Behavioral: Risky driving prevention
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.
Behavioral: Control group general health promotion
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Proportion of Participants Randomized [ Time Frame: Baseline (Study Visit 1) ]
    Proportion of participants screened, enrolled and randomized

  2. Adherence [ Time Frame: Baseline (Study Visit 1) through completion of the intervention. ]
    Adherence among the intervention and control group to the intervention.

  3. Simulated Driving Performance [ Time Frame: Baseline (Study Visit 1) through Study Visit 3 ]
    Difference between the intervention and control group on the simulated driving assessment (measures of driving performance during the simulated experimental drives).

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Males or females age 16-17 years at time of enrollment (i.e. can turn 18 while enrolled in research and still be eligible).
  2. Pennsylvania driver's license for 90 days or less at time of assent
  3. Personal email address and computer and internet access
  4. Willingness to travel to CHOP twice to complete simulated assessment
  5. Ability to read and write English

Exclusion Criteria:

  1. Self-reported of claustrophobia, migraine headaches, or motion sickness
  2. Self-reported current pregnancy
  3. . Participation in a Center for Injury Research and Prevention teen driving study with the past 6 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319317


Locations
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United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104-4217
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4217
Sponsors and Collaborators
University of Pennsylvania
National Institute of Nursing Research (NINR)
Children's Hospital of Philadelphia
Investigators
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Principal Investigator: Catherine C McDonald, PhD, RN University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02319317    
Other Study ID Numbers: R00NR013548 ( U.S. NIH Grant/Contract )
R00NR013548 ( U.S. NIH Grant/Contract )
14-011336 ( Other Identifier: Children's Hospital of Philadelphia IRB )
821064 ( Other Identifier: University of Pennsylvania IRB )
First Posted: December 18, 2014    Key Record Dates
Results First Posted: October 4, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017