Web-based Intervention to Prevent Risky Driving

October 3, 2017 updated by: University of Pennsylvania

Promoting Teen Health: A Web-based Intervention to Prevent Risky Driving

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.

Study Overview

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

Interventional

Enrollment (Actual)

60

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, 19104-4217
        • Children's Hospital of Philadelphia
      • Philadelphia, Pennsylvania, United States, 19104-4217
        • 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

No

Genders Eligible for Study

All

Description

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

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: 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.
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)
Adherence
Time Frame: Baseline (Study Visit 1) through completion of the intervention.
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
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.
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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Catherine C McDonald, PhD, RN, University of Pennsylvania

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

April 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

July 31, 2017

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 17, 2014

First Posted (Estimate)

December 18, 2014

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 3, 2017

Last Verified

October 1, 2017

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.

Clinical Trials on Adolescent

Clinical Trials on Risky driving prevention

Subscribe