Skip to content

Prevention of Traumatic Brain Injury in Youth and Adolescents

Prevention of Traumatic Brain Injury in Youth and Adolescents

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01629121
Enrollment
120
Registered
2012-06-27
Start date
2010-09-30
Completion date
2011-08-31
Last updated
2013-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focus of Study: Bicycle Helmet Wearing Compliance

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.

Interventions

BEHAVIORALeducation 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.

Sponsors

Augusta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
parental report of bicycle helmet usechange for baseline in bicycle helmet wearing at 1 and 3 monthsA series of mixed model univariate analyses were used to determine group differences across the follow-ups on helmet wearing.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026