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Prevention of Traumatic Brain Injury in Youth and Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vernon Barnes, Georgia Health Sciences University
ClinicalTrials.gov Identifier:
NCT01629121
First received: June 19, 2012
Last updated: June 26, 2012
Last verified: June 2012
History of Changes

June 19, 2012
June 26, 2012
September 2010
August 2011   (final data collection date for primary outcome measure)
parental report of bicycle helmet use [ Time Frame: change for baseline in bicycle helmet wearing at 1 and 3 months ] [ Designated as safety issue: No ]
A series of mixed model univariate analyses were used to determine group differences across the follow-ups on helmet wearing.
Same as current
Complete list of historical versions of study NCT01629121 on ClinicalTrials.gov Archive Site
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Prevention of Traumatic Brain Injury in Youth and Adolescents
Prevention of Traumatic Brain Injury in Youth and Adolescents

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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Compliance With Bicycle Helmet Wearing
Behavioral: Brain injury prevention education intervention.

The educational 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.
  • Active Comparator: bicycle helmet education
    The educational intervention included case scenarios as well as education about the benefits of bicycle helmet use.
    Intervention: Behavioral: Brain injury prevention education intervention.
  • No Intervention: Control
    All subjects received a bicycle helmet and educational materials, including those in the control group.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2011
August 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Hospitalized in-patients in the CMC;
  • 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.
Both
5 Years to 18 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01629121
GHSF11085
No
Vernon Barnes, Georgia Health Sciences University
Georgia Regents University
Not Provided
Principal Investigator: Vernon A Barnes, PhD Georgia Regents University
Georgia Regents University
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP