Sun Protection for Florida's Children

Study Overview
=================
Brief Summary
-----------------
Purpose of the project is to develop a school-based intervention aimed at increasing hat use when children are outside at home and at school. The intervention is targeted to fourth grade children in Hillsborough County, Florida and is based on Theory of Reasoned Action and Planned Behavior. It is structured to accomplish the following goals: (a) increase sun protection knowledge of children in regards to hat use,(b) foster more positive attitudes in regard to wearing hats,(c) change the subjective norms of wearing hats (d) target persons that children perceive as controlling their behavior of wearing hats(parents,teachers) and increase the use of hats when children are outdoors at school(primary outcome) and when outdoors at times other than school(secondary outcome).

Detailed Description
-----------------
Intervention is aimed at encouraging students to use a wide brim hat when participating in outdoor activities. To accomplish this goal our approach will be multifaceted and will include: individual sessions with school principals to facilitate a school policy that encourages hat use when children are outdoors. sessions with fourth grade teachers that explains the importance of sun protection and hat use, and that addresses potential concerns by teachers. classroom sessions with fourth grade children that improves sun protection knowledge, fosters more positive attitudes about hat use. and that changes the subjective norm of wearing hats when at school. follow-up sessions in which children are provided free hats with a customized design that represents their school. sun protection educational materials that are mailed to the parents of targeted children.

Official Title
-----------------
Sun Protection for Florida's Children

Conditions
-----------------
Skin Cancer

Intervention / Treatment
-----------------
* Behavioral: Increasing hat use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One fourth/one fifth grade class. 20 students minimum. 25% of students are Caucasian. Principle/teachers agree to participate. Majority of parents agree to participate. Majority of 4th grade students provide written assent. One outdoor session lasting 20 minutes once per week where children are directly exposed to the sun. Outdoor session in an area observable by data monitors. School can accommodate intervention components of study. School environment stable over the intervention period. Randomized control school delay sun protection initiatives until project is completed. Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sun Protection Intervention<br>School based sun protection education, provision of free hats. | Behavioral: Increasing hat use<br>* Sun protection intervention that address sun protection knowledge, attitudes, social norms, and perceived behavioral controls. Intervention also provides free wide brimmed hats<br>|
| No Intervention: Control arm<br>Usual sun protection practices | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase the use of hats when children are outside at school |  | june 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase the hat use when children are outside at times other than school |  | june 2008 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Children's behavior towards hat use