Prevention of Traumatic Brain Injury in Youth and Adolescents
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|ClinicalTrials.gov Identifier: NCT01629121|
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : June 21, 2013
|Condition or disease||Intervention/treatment||Phase|
|Focus of Study: Bicycle Helmet Wearing Compliance||Behavioral: education intervention||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Traumatic Brain Injury in Youth and Adolescents|
|Study Start Date :||September 2010|
|Actual Primary Completion Date :||August 2011|
|Actual Study Completion Date :||August 2011|
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629121
|United States, Georgia|
|Georgia Regents University, Children's Medical Center|
|Augusta, Georgia, United States, 30912|
|Principal Investigator:||Vernon A Barnes, PhD||Augusta University|