Web-based Intervention to Prevent Risky Driving

Adolescent Clinical Trial

Official title:

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

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
• 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

Related Conditions & MeSH terms

• Accidents, Traffic
• Adolescent
• Attention
• Motor Vehicles

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).