- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02695888
Mobile Technology Monitoring System to Assess a Web-based Intervention for Teen Risky Driving
October 17, 2018 updated by: University of Pennsylvania
A Pilot Study of a Mobile Technology Monitoring System to Assess a Web-based Intervention for Teen Risky Driving
This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This research study examines the feasibility of using an in-vehicle mobile technology monitoring system to measure teen secondary task engagement during on-road driving as the outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.
Approximately 20 teens who have been licensed for less than 90 days will be enrolled and evaluated at baseline, ~1 week and ~4 weeks.
Participants will complete an intervention after the ~1 week assessment.
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 cell phone use while driving.
Study Type
Interventional
Enrollment (Actual)
28
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
Yes
Genders Eligible for Study
All
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).
- Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan
- PA driver's license for 90 days or less at time of teen assent
- Personal email address and computer and internet access
- Ability to read and write English
- Primarily drives one vehicle with the ability to accommodate the DriveID device
- Parental consent and teen assent
Exclusion Criteria:
- Participation in a Center for Injury Research and Prevention at CHOP teen driving study within the past 6 months
- Unable to follow study procedures
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.
Other Names:
|
|
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 approximately 1- month (Study Visit 4)
|
Proportion of participants enrolled who complete Study Visit 1, Study Visit 2, Study Visit 3 and Study Visit 4.
|
Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
In-vehicle cell phone use
Time Frame: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
|
Difference between the intervention and control group on frequency of cell phone use while driving as monitored by an in-vehicle device
|
Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
|
|
Self-reported driving behaviors
Time Frame: Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
|
Difference between the intervention and control group on on self-report measures of driving behaviors
|
Baseline (Study Visit 1) through approximately 1- month (Study Visit 4)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
March 1, 2016
Primary Completion (Actual)
December 29, 2016
Study Completion (Actual)
December 29, 2016
Study Registration Dates
First Submitted
February 25, 2016
First Submitted That Met QC Criteria
February 25, 2016
First Posted (Estimate)
March 1, 2016
Study Record Updates
Last Update Posted (Actual)
October 18, 2018
Last Update Submitted That Met QC Criteria
October 17, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 15-012431
- 823913 (Other Identifier: University of Pennsylvania)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.