Prevention of Traumatic Brain Injury in Youth and Adolescents

Focus of Study: Bicycle Helmet Wearing Compliance Clinical Trial

Official title:

Prevention of Traumatic Brain Injury in Youth and Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01629121
• Other study ID #: GHSF11085
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2012
• Last updated: June 19, 2013
• Start date: September 2010
• Est. completion date: August 2011

Study information

• Verified date: June 2013
• Source: Georgia Regents University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Brain Injuries
• Focus of Study: Bicycle Helmet Wearing Compliance

Intervention

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.

Locations

Country	Name	City	State
United States	Georgia Regents University, Children's Medical Center	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Georgia Regents University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.

Barnes VA, Maria BL, Caldwell AL, Hopkins I. Prevention of Traumatic Brain Injury in Youth and Adolescents. J Child Neurol. 2013 Nov;28(11):1412-1417. Epub 2012 Nov 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	parental report of bicycle helmet use	A series of mixed model univariate analyses were used to determine group differences across the follow-ups on helmet wearing.	change for baseline in bicycle helmet wearing at 1 and 3 months	No