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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
  Purpose

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 Intervention Phase
Compliance With Bicycle Helmet Wearing
 Behavioral: Brain injury prevention education intervention.
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Traumatic Brain Injury in Youth and Adolescents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Georgia Regents University:

Primary Outcome Measures:
  • 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.


Enrollment: 120
Study Start Date: September 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: bicycle helmet education
The educational intervention included case scenarios as well as education about the benefits of bicycle helmet use.
 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.
No Intervention: Control
All subjects received a bicycle helmet and educational materials, including those in the control group.

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.

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01629121

Locations
United States, Georgia
Georgia Health Sciences University, Children's Medical Center
Augusta, Georgia, United States, 30912
Sponsors and Collaborators
Georgia Regents University
Investigators
Principal Investigator: Vernon A Barnes, PhD Georgia Regents University
  More Information

No publications provided

Responsible Party: Vernon Barnes, Assistant Professor, Georgia Health Sciences University
ClinicalTrials.gov Identifier: NCT01629121     History of Changes
Other Study ID Numbers: GHSF11085
Study First Received: June 19, 2012
Last Updated: June 26, 2012
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on May 19, 2013