Prevention of Traumatic Brain Injury in Youth and Adolescents

Phase 1

Completed

• Conditions: Focus of Study: Bicycle Helmet Wearing Compliance
• Interventions: Behavioral: education intervention

• Registration Number: NCT01629121
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-09
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2012-06-19
• Study First Submitted QC: 2012-06-26
• Study First Posted: 2012-06-27
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
education intervention	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.

Primary Outcome Measures

Name	Time	Method
parental report of bicycle helmet use	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.

Trial Locations

Locations (1)

Georgia Regents University, Children's Medical Center; 🇺🇸 Augusta, Georgia, United States