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Prevention of Traumatic Brain Injury in Youth and Adolescents

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Augusta University

Status and phase

Completed
Phase 1

Conditions

Focus of Study: Bicycle Helmet Wearing Compliance

Treatments

Behavioral: education intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT01629121
GHSF11085

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

5 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 2 patient groups

education intervention
Experimental group
Description:
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.
Treatment:
Behavioral: education intervention
control
No Intervention group
Description:
Printed materials were given to the control group, along with a helmet for each participant.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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