Prevention of Traumatic Brain Injury in Youth and Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01629121
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : June 21, 2013
Information provided by (Responsible Party):
Vernon Barnes, Augusta University

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.

Condition or disease Intervention/treatment Phase
Focus of Study: Bicycle Helmet Wearing Compliance Behavioral: education intervention Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
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
Study Start Date : September 2010
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01629121

United States, Georgia
Georgia Regents University, Children's Medical Center
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Augusta University
Principal Investigator: Vernon A Barnes, PhD Augusta University

Publications of Results:
Barnes VA, Maria B, Caldwell AL, Hopkins I, Nguyen K, Shenbagarajan VP: Prevention of traumatic brain injury in youth and adolescents. Ann Behav Med 2012; 43(Supplement 1): s198.

Responsible Party: Vernon Barnes, Assistant Professor, Augusta University Identifier: NCT01629121     History of Changes
Other Study ID Numbers: GHSF11085
First Posted: June 27, 2012    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: June 2013

Additional relevant MeSH terms:
Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries