Prevention of Traumatic Brain Injury in Youth and Adolescents

NCT ID: NCT01629121

Last Updated: 2013-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Focus of Study: Bicycle Helmet Wearing Compliance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

education intervention

Intervention Type BEHAVIORAL

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.

control

Printed materials were given to the control group, along with a helmet for each participant.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Augusta University

OTHER

Sponsor Role lead

Responsible Party

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Vernon Barnes

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vernon A Barnes, PhD

Role: PRINCIPAL_INVESTIGATOR

Augusta University

Locations

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Georgia Regents University, Children's Medical Center

Augusta, Georgia, United States

Site Status

Countries

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United States

References

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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. doi: 10.1177/0883073812464272. Epub 2012 Nov 8.

Reference Type RESULT
PMID: 23143720 (View on PubMed)

Other Identifiers

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GHSF11085

Identifier Type: -

Identifier Source: org_study_id

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