Effectiveness of Distracted Driving Campaign

May 4, 2017 updated by: Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Effectiveness of Distracted Driving Campaign for Teenagers in the Emergency Department

The study will measure the effectiveness of a distracted driving campaign in the emergency department in teenagers, 15 to 18 years old, to determine if it changes their attitudes towards texting while driving. It will also assess previous knowledge and behaviors in this age group, regarding distracted driving and what educational tool (power point vs. videos vs. brochure) has the most impact changing the attitudes towards texting and driving.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Distracted driving is defined by the National Highway Safety Administration (NHTSA) as any activity that could withdraw a person's attention away from the primary task of driving. It includes, talking or texting on a cell phone, grooming, eating or drinking, changing radio stations, or talking to passengers. Of all these activities text messaging is by far the most alarming distraction because it requires visual, manual, and cognitive attention from the driver.

The NHTSA Research Note on distracted driving found that in 2011, 10% percent of fatal crashes were reported as distraction-affected crashes. This research also showed that teens between 15 to 19 years old are currently the largest group with distracted driving affected crashes, with 21% percent of them getting distracted while using their cell phones.

During the last few years, multiple public awareness campaigns have been launched in attempt to reduce this problem. These massive campaigns have included television, radio and internet campaigns, posters, billboards and brochures among others. Nevertheless, there are no studies assessing the success of these methods.

The research project will use visual and verbal educational tools to engage this population in order to maximize the learning process. The project will include brochures, video presentations and power point presentations. The investigators intend to test a potentially new and effective way to teach our teenagers about the dangers of distracted driving. The project primary goal is to assess if a distracting driving campaign in the emergency department is effective in changing the attitudes towards texting while driving. The investigator also intends to assess the current knowledge about distracted driving and to determine which tool (visual vs. verbal) is most effective to deliver this message.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
273

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Florida
      • Miami, Florida, United States, 33155
        • Nicklaus Children's Hospital f/k/a Miami Children's Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adolescents between the ages of 15 to 18 years

Exclusion Criteria:

  • Adolescents refusing to participate in the Distracted Driving Campaign.
  • Adolescents visiting the emergency department with a chief complaint related to mental illness, suicide ideation or attempt, or any complaint limiting the ability to complete the questionnaire.
  • Adolescents with diagnosis of developmental delay that could affect his or her ability to complete the questionnaire.
  • Adolescents that do not speak English (the videos about real people who have had accidents while texting and driving found at http://www.distraction.gov/faces/index.html are available only in English.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Video and Brochure
Real stories video presentation and a brochure with information about distracted driving will be given to the participant.
Behavioral: Video
Real stories video presentation about distracted driving. Produced by the National Highway Traffic Safety Administration.
Behavioral: Brochure
Brochure with the National Highway Traffic Safety Administration information about distracting driving.
Experimental: Power Point and Brochure
Brief power point presentation and a brochure with information about distracted driving will be given to the participant.
Behavioral: Brochure
Brochure with the National Highway Traffic Safety Administration information about distracting driving.
Behavioral: Power Point
Brief power point presentation with information about distracted driving. Produced by the National Highway Traffic Safety Administration.
Experimental: Brochure Only
Only a brochure with information about distracting driving will be given to the participant.
Behavioral: Brochure
Brochure with the National Highway Traffic Safety Administration information about distracting driving.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Previous knowledge and attitudes towards distracted driving
Time Frame: 6 months
A "Pre Campaign Survey" will be given to every participant before the intervention. The survey is a validated questionnaire that assess previous knowledge and attitudes towards distracted driving and demographic variables.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Short Term Effectiveness of the Distracted Driving Campaign
Time Frame: 6 months
A validated post campaign survey will be given, to each participant, immediately after the intervention. The "Post Campaign Survey 1" will assess the short term effectiveness of the campaign.
6 months
Long Term Effectiveness of the Distracted Driving Campaign
Time Frame: 6 months
A "Post Campaign Survey 2" will be obtain by phone call, at least one month after the intervention is done, to assess long term effectiveness of the campaign.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nicklaus Children's Hospital f/k/a Miami Children's Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michelle Blumstein, MD, Nicklaus Children's Hospital f/k/a Miami Children's Hospital

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 7, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20150548

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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