Trauma PreventionNCT02437149
Effectiveness of Distracted Driving Campaign
A study testing Video, Power Point and Brochure in people with Trauma Prevention, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma Prevention
- What is being tested?
- Video, Power Point and Brochure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 273 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Adolescents between the ages of 15 to 18 years
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
Miami, Florida, 33155
About this study
Official title: 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.
Read the 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.
- Conditions
- Trauma Prevention
- Being tested
- Video, Power Point, Brochure
- Keywords
- Texting and driving, Teenager and driving, Distracted Driving Campaign
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
Real stories video presentation about distracted driving. Produced by the National Highway Traffic Safety Administration.
Power PointBehavioural
Brief power point presentation with information about distracted driving. Produced by the National Highway Traffic Safety Administration.
BrochureBehavioural
Brochure with the National Highway Traffic Safety Administration information about distracting driving.
| Study group | Role | What they receive |
|---|---|---|
| Video and Brochure | Experimental | Real stories video presentation and a brochure with information about distracted driving will be given to the participant. Receives: Behavioral: Video; Behavioral: Brochure |
| Power Point and Brochure | Experimental | Brief power point presentation and a brochure with information about distracted driving will be given to the participant. Receives: Behavioral: Power Point; Behavioral: Brochure |
| Brochure Only | Experimental | Only a brochure with information about distracting driving will be given to the participant. Receives: Behavioral: Brochure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Previous knowledge and attitudes towards distracted driving
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.
Measured: 6 months
Secondary outcomes (2)
Short Term Effectiveness of the Distracted Driving Campaign
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.
Measured: 6 months
Long Term Effectiveness of the Distracted Driving Campaign
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Blumstein, MD, Principal investigator, Nicklaus Children's Hospital f/k/a Miami Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02437149
- Sponsor's protocol ID
- 20150548
- Status last verified
- May 2017
- First submitted
- 23 Apr 2015
- Last updated
- 5 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Distracted Driving Campaign for Teenagers in the Emergency Department
- ClinicalTrials.gov ID
- NCT02437149
- Acronym / sponsor ID
- 20150548
- Conditions
- Trauma Prevention
- Keywords
- Texting and driving, Teenager and driving, Distracted Driving Campaign
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 273 participants (estimated)
- Lead sponsor
- Nicklaus Children's Hospital f/k/a Miami Children's HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 7 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Video and Brochure | Experimental | Behavioral: Video, Behavioral: BrochureReal stories video presentation and a brochure with information about distracted driving will be given to the participant. |
| Power Point and Brochure | Experimental | Behavioral: Power Point, Behavioral: BrochureBrief power point presentation and a brochure with information about distracted driving will be given to the participant. |
| Brochure Only | Experimental | Behavioral: BrochureOnly a brochure with information about distracting driving will be given to the participant. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adolescents between the ages of 15 to 18 years
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VideoReal stories video presentation about distracted driving. Produced by the National Highway Traffic Safety Administration. | Behavioural | Video and Brochure |
| Power PointBrief power point presentation with information about distracted driving. Produced by the National Highway Traffic Safety Administration. | Behavioural | Power Point and Brochure |
| BrochureBrochure with the National Highway Traffic Safety Administration information about distracting driving. | Behavioural | Brochure Only, Power Point and Brochure, Video and Brochure |
Primary outcome
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.
2 secondary outcomes
Short Term Effectiveness of the Distracted Driving Campaign
Time frame: 6 months
Long Term Effectiveness of the Distracted Driving Campaign
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Blumstein, MD principal investigator
Nicklaus Children's Hospital f/k/a Miami Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video, Power Point and Brochure in people with Trauma Prevention, run by Nicklaus Children's Hospital f/k/a Miami Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Previous knowledge and attitudes towards distracted driving (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.