Impact of Helmet Use in Preschool Children

Study Overview
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Brief Summary
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To test the hypothesis if provision of helmet education and free helmet distribution will significantly increase helmet use in preschool children of low-income families compared to those children receiving helmet education without free helmet distribution; To test the hypothesis if helmet users in preschool children will significantly reduce head and facial injuries compared to those non-helmet users

Detailed Description
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Current literature review shows that there were no definite prospective research studies that indicate the effectiveness of helmet promotion and wearing in injury prevention/reduction particularly to head and facial injuries among preschool children of low-income families. The magnitude and seriousness of the injury problem in these children in the community could be high. Many injuries may occur that are not treated in emergency departments. Even the occurrence of a minor injury in the face is undesirable. These ages are learning periods to ride, are liable to fall, and are prone to injuries by using, not only, bicycles but also tricycles, scooters, roller skates/roller blades and other riding toys (vehicles).

Official Title
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The Impact of Helmet Use in Preschool Children From Low-income Families in Northeastern Indiana

Conditions
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Head Injuries, Facial Injuries

Intervention / Treatment
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* Other: Bicycle helmet from Bell Sports Inc.
* Other: Bicycle helmet education only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 3-5 year olds and their siblings, registered at the Community Action of Northeast Indiana (CANI) Head Start Program The child must possess a bicycle or a riding toy to ride The child's caregiver speaks English or Spanish Exclusion Criteria: Age less than two or greater than 5-year olds 3-5 year old children that do not own a bicycle or a riding toy to ride The child's caregiver does not speak English or Spanish.

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Helmet and helmet education<br>Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers. | Other: Bicycle helmet from Bell Sports Inc.<br>* As described under the respective arm<br>* Other names: Bell bicycle helmets;|
| Active Comparator: Helmet education<br>Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above. | Other: Bicycle helmet education only<br>* As described under the respective arm<br>* Other names: Bicycle helmet education;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Wearing Helmet |  | Baseline (Survey 1) and 5 months (Survey 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence Rate of Head and Facial Injuries by Helmet Wearing Status in Helmet Owners | Number of injuries by helmet wearing status as reported | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bicycle helmet