The Effectiveness of Car Seat Checks at Routine Pediatric Visits
| Tracking Information | |||||
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| First Received Date ICMJE | September 8, 2005 | ||||
| Last Updated Date | April 29, 2009 | ||||
| Start Date ICMJE | June 2001 | ||||
| Primary Completion Date | September 2003 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Car seat us [ Time Frame: median of 105.5 days ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00152568 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Proper car seat use [ Time Frame: 86.5 days ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effectiveness of Car Seat Checks at Routine Pediatric Visits | ||||
| Official Title ICMJE | The Effectiveness of Car Seat Checks at Routine Pediatric Visits | ||||
| Brief Summary | The purpose of this research is to evaluate the effectiveness of checking car seats during pediatric well-child visits on the use and properness of use of car seats for children 0-8 years. We are following up with families when they return for the next pediatric check up to see if they are appropriately using car seats for their children. |
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| Detailed Description | The purpose of this investigation is to evaluate the effectiveness of a car seat inspection at the time of a pediatric visit on the proper use of car seats 4-6 months later. Motor vehicle-related injury is the leading cause of death of children. Proper restraint in a motor vehicle reduces the risk of fatality in a crash by approximately 70%. However, multiple studies have found approximately 85% of car seats are misused. Urban poor and minority populations have been found to have higher child passenger death rates, and may have lower car seat usage rates than the rest of the population. Child passenger safety (CPS) technicians trained by the National Highway Traffic Safety Administration (NHTSA) and certified by the American Automobile Association (AAA) capably check proper car seat usage in "check up" events, and operate recently established "fitting stations." However, we are not aware of an attempt to provide the CPS technical services to families attending a routine checkup with their medical provider. This project will involve implementing and evaluating a program providing car seat checks at the time of routine pediatric visits at the Friend Family Health Center (FFHC). To determine if the car seat checks improve proper car seat use, children who receive the intervention will have their car seat use reassessed at the time of a scheduled return visit to their medical provider. The frequency of routinely scheduled health maintenance visits is greatest for the youngest children. Opportunities to collect follow up car seat use data therefore will be greatest for the youngest children. This evaluation will focus on 0 year olds. While we will also assess the older children and booster seat use, the sample size calculation for this study was determined for these younger children. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Behavioral: Car Seat Check (behavior)
At time of well child visit, family receives the services of a certified child passenger safety technician, including assessment, car seat distribution if needed and training. |
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| Study Arm (s) | Experimental: Child Passenger Safety Technician services
Intervention: Behavioral: Car Seat Check (behavior) |
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| Publications * | Grossman DC, Garcia CC. Effectiveness of health promotion programs to increase motor vehicle occupant restraint use among young children. Am J Prev Med. 1999 Jan;16(1 Suppl):12-22. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 364 | ||||
| Completion Date | December 2003 | ||||
| Primary Completion Date | September 2003 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 8 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00152568 | ||||
| Other Study ID Numbers ICMJE | 11119A | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Kyran Quinlan, MD, MPH Associate Professor, University of Chicago | ||||
| Study Sponsor ICMJE | University of Chicago | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Chicago | ||||
| Verification Date | April 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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