Back to resultsPrevention of Traumatic Brain Injury in Youth and Adolescents
Primary Purpose
Focus of Study: Bicycle Helmet Wearing Compliance
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
education intervention
Sponsored by
About this trial
This is an interventional prevention trial for Focus of Study: Bicycle Helmet Wearing Compliance
Eligibility Criteria
Inclusion Criteria:
- Hospitalized in-patients in the Children's Medical Center;
- Projected length of stay >24 hours;
- Mentally and physically fit to complete the educational program;
- History of regular (>1x per week) bicycle riding;
- All racial/ethnic groups.
Sites / Locations
- Georgia Regents University, Children's Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
education intervention
control
Arm Description
The intervention delivered education about the benefits of bicycle helmet use and safety and was designed to be sensitive to the age and educational level of the study participant.
Printed materials were given to the control group, along with a helmet for each participant.
Outcomes
Primary Outcome Measures
parental report of bicycle helmet use
A series of mixed model univariate analyses were used to determine group differences across the follow-ups on helmet wearing.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01629121
Brief Title
Prevention of Traumatic Brain Injury in Youth and Adolescents
Official Title
Prevention of Traumatic Brain Injury in Youth and Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Augusta University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The hypothesis was that the implementation of a Safe Kids East Central brain injury prevention program targeting children and caregivers admitted to the Georgia Health Sciences University Children's Medical Center is feasible and that short-term treatment effects of injury prevention education on the child or adolescent and the caregiver will increase bicycle helmet use.
Detailed Description
The overarching goal of this project is to reduce traumatic brain injury in children and adolescents by promoting bicycle helmet use via an inpatient educational program. The Safe Kids East Central injury prevention educational program was customized for hospitalized subjects and their caregivers. The investigators hypothesized that this program would increase bicycle helmet use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focus of Study: Bicycle Helmet Wearing Compliance
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
education intervention
Arm Type
Experimental
Arm Description
The intervention delivered education about the benefits of bicycle helmet use and safety and was designed to be sensitive to the age and educational level of the study participant.
Arm Title
control
Arm Type
No Intervention
Arm Description
Printed materials were given to the control group, along with a helmet for each participant.
Intervention Type
Behavioral
Intervention Name(s)
education intervention
Intervention Description
The brain injury prevention education intervention included case scenarios as well as education about the benefits of bicycle helmet use. The intervention was designed to be sensitive to the age and educational level of the study participant and his or her parents. Educational materials were chosen to provide use of the five senses to enhance the learning experience. The intervention took place in the privacy of the patient's hospital room. The study was designed so as not to interfere with the hospital standard of care.
The proper way to fit the bicycle helmet was demonstrated.
Primary Outcome Measure Information:
Title
parental report of bicycle helmet use
Description
A series of mixed model univariate analyses were used to determine group differences across the follow-ups on helmet wearing.
Time Frame
change for baseline in bicycle helmet wearing at 1 and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Hospitalized in-patients in the Children's Medical Center;
Projected length of stay >24 hours;
Mentally and physically fit to complete the educational program;
History of regular (>1x per week) bicycle riding;
All racial/ethnic groups.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vernon A Barnes, PhD
Organizational Affiliation
Augusta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgia Regents University, Children's Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23143720
Citation
Barnes VA, Maria BL, Caldwell AL, Hopkins I. Prevention of Traumatic Brain Injury in Youth and Adolescents. J Child Neurol. 2013 Nov;28(11):1412-1417. doi: 10.1177/0883073812464272. Epub 2012 Nov 8.
Results Reference
result
Learn more about this trial
Prevention of Traumatic Brain Injury in Youth and Adolescents
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