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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02695888
Other study ID # 15-012431
Secondary ID 823913
Status Completed
Phase N/A
First received
Last updated
Start date March 2016
Est. completion date December 29, 2016

Study information

Verified date March 2018
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date December 29, 2016
Est. primary completion date December 29, 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 17 Years
Eligibility 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. Has their own iPhone 4S or newer or Android 4.3 or newer smartphone with data plan

3. PA driver's license for 90 days or less at time of teen assent

4. Personal email address and computer and internet access

5. Ability to read and write English

6. Primarily drives one vehicle with the ability to accommodate the DriveID device

7. Parental consent and teen assent

Exclusion Criteria:

1. Participation in a Center for Injury Research and Prevention at CHOP teen driving study within the past 6 months

2. Unable to follow study procedures

Study Design


Related Conditions & MeSH terms


Intervention

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.
Teen Healthy Living
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.

Locations

Country Name City State
United States Children's Hospital of Philadelphia Philadelphia Pennsylvania
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of Pennsylvania Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retention of participants 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 In-vehicle cell phone use 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)
Secondary Self-reported driving behaviors 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)
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