Prevention of Traumatic Brain Injury in Youth and Adolescents
|Focus of Study: Bicycle Helmet Wearing Compliance||Behavioral: education intervention||Phase 1|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
|Official Title:||Prevention of Traumatic Brain Injury in Youth and Adolescents|
- parental report of bicycle helmet use [ Time Frame: change for baseline in bicycle helmet wearing at 1 and 3 months ]A series of mixed model univariate analyses were used to determine group differences across the follow-ups on helmet wearing.
|Study Start Date:||September 2010|
|Study Completion Date:||August 2011|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Experimental: education intervention
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.
Behavioral: education intervention
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.
No Intervention: control
Printed materials were given to the control group, along with a helmet for each participant.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629121
|United States, Georgia|
|Georgia Regents University, Children's Medical Center|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Vernon A Barnes, PhD||Augusta University|