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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02319317
Other study ID # R00NR013548
Secondary ID R00NR01354814-01
Status Completed
Phase N/A
First received December 8, 2014
Last updated October 3, 2017
Start date April 2015
Est. completion date July 31, 2017

Study information

Verified date October 2017
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date July 31, 2017
Est. primary completion date August 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. 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 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.
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.

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
University of Pennsylvania Children's Hospital of Philadelphia, National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retention of Participants 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 Proportion of Participants Randomized Proportion of participants screened, enrolled and randomized Baseline (Study Visit 1)
Secondary Adherence Adherence among the intervention and control group to the intervention. Baseline (Study Visit 1) through completion of the intervention.
Secondary Simulated Driving Performance 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
Secondary Self-report Driving Behaviors 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).
Secondary Driving Citations and Crashes Difference between the intervention and control group on driving citations and crashes. Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
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