Clinical trial NCT02319317: Web-based Intervention to Prevent Risky Driving
Official title: Promoting Teen Health: A Web-based Intervention to Prevent Risky Driving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent
Accidents, Traffic
Attention
Motor Vehicles
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Children's Hospital of Philadelphia
First posted: 2014-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention of Participants
timeFrame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
Secondary outcomes:
measure: Proportion of Participants Randomized
timeFrame: Baseline (Study Visit 1)
measure: Adherence
timeFrame: Baseline (Study Visit 1) through completion of the intervention.
measure: Simulated Driving Performance
timeFrame: Baseline (Study Visit 1) through Study Visit 3
measure: Self-report Driving Behaviors
timeFrame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
measure: Driving Citations and Crashes
timeFrame: Baseline (Study Visit 1) through Study Visit 4 (around 6 months).
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Catherine C McDonald, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: McDonald CC, Sommers MS, Fargo JD, Seacrist T, Power T. Simulated Driving Performance, Self-Reported Driving Behaviors, and Mental Health Symptoms in Adolescent Novice Drivers. Nurs Res. 2018 May/Jun;67(3):202-211. doi: 10.1097/NNR.0000000000000270.