<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03243929</url>
  </required_header>
  <id_info>
    <org_study_id>5R01HD074416</org_study_id>
    <nct_id>NCT03243929</nct_id>
  </id_info>
  <brief_title>Translation of District Sun Safe Policies to Schools</brief_title>
  <acronym>SSS</acronym>
  <official_title>Translation of District Sun Safe Policies to Schools</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Claremont Graduate University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Claremont Graduate University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the Translation of District Sun Safe Policies to Schools study was to test&#xD;
      whether schools need assistance to facilitate the implementation of school district&#xD;
      board-approved sun safety policies by individual elementary schools. The intervention is&#xD;
      expected to produce a change in practices at the school level and to improve the sun safety&#xD;
      behavior of children attending the intervention schools compared to control schools. A group&#xD;
      of 40 school districts in Southern California that adopted board policy 5141.7 for sun safety&#xD;
      provided 118 schools that were randomized to a intervention condition or to an attention&#xD;
      control condition. The primary outcome is change in school-level sun safety practices based&#xD;
      on 10 Centers for Disease Control and Prevention (CDC) categories for policy change (i.e.,&#xD;
      sunscreen use, UV protective clothing, hats, student education, teacher education, provision&#xD;
      of shade, scheduling to avoid peak UV exposure, parent outreach, resource allocation for sun&#xD;
      safety, and an accountability system). This primary outcome was assessed by a survey of the&#xD;
      principal and one teacher at each school (N=118 principals and 113 teachers at pretest).&#xD;
      Parents (N=1770 at pretest) of children attending the schools completed a self-report measure&#xD;
      assessing the secondary outcomes of change in individual-level sun safety behavior of their&#xD;
      elementary school aged children and number of communications received from the school&#xD;
      regarding sun safety. Assessment of principals, teachers and parents occurred at pretest,&#xD;
      just prior to randomization, and at a posttest 20-months after the pretest. One Parent&#xD;
      Teacher Association (PTA) representative per school was contacted to assess PTA involvement&#xD;
      in intervention activities related to sun safety.&#xD;
&#xD;
      The primary hypothesis was stated for the effectiveness of the intervention condition at&#xD;
      increasing school-level sun safety practices consistent with the sun safety policies of the&#xD;
      school districts and read, H1: At follow-up, a greater percentage of schools in the&#xD;
      intervention condition will implement at least one component of the school district sun&#xD;
      safety policy compared to schools randomized to the attention-control condition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 13, 2014</start_date>
  <completion_date type="Actual">April 10, 2018</completion_date>
  <primary_completion_date type="Actual">March 21, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure of implementation of sun safety practices and policy at schools</measure>
    <time_frame>20 Months</time_frame>
    <description>Change in implementation of sun safety policy after intervention, through survey administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Students sun protection behavior</measure>
    <time_frame>20 Months</time_frame>
    <description>Change in sun safety behaviors after intervention, through survey administration</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">118</enrollment>
  <condition>Sun Safety</condition>
  <condition>Sun Safe Schools</condition>
  <condition>Prevention of Skin Cancer</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants in the Translation of District Sun Safe Policies to Schools arm received 1) initial coaching meeting that guided principals through an evaluation of current sun safety practices, the selection of goals for the implementation of sun safety practices, and guidance on the use of intervention materials to support implementation of sun safety practices in the school, 2) follow-up communications from coaches including email, telephone, and virtual meetings, 3) access to media and online resources to support implementation of sun safety practices, 4) mini-grants to support changes in school sun safety practices.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Attention Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>All participants in the attention control arm received three emails during the 20 month intervention period including (1) NASBE's Fit Healthy and Ready to Learn; A School Health Guide Part II: Policies to Promote Sun Safety and Prevent Skin Cancer, (2) CDC's Guidelines for Sun Safety to Prevent Skin Cancer, and (3) a link to the Surgeon General's 2014 Call to Action to Prevent Skin Cancer. This attention-control treatment will equalize schools on awareness of recommendations to implement school sun safety.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Translation of District Sun Safe Policies to Schools</intervention_name>
    <description>Translation of District Sun Safe Policies to Schools intervention was guided by Diffusion of Innovation Theory. Principals and other staff in intervention schools received 1) initial coaching meeting that guided principals through an evaluation of current sun safety practices, the selection of goals for the implementation of sun safety practices, and guidance on the use of intervention materials to support implementation of sun safety practices in the school, 2) follow-up communications from coaches including email, telephone, and virtual meetings, 3) access to media and online resources to support implementation of sun safety practices, 4) mini-grants to support changes in school sun safety practices. These components promoted implementation of the 10 policy components recommended by CDC.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Attention Control</intervention_name>
    <description>Schools in the control condition received three emails during the 20 month intervention period including (1) NASBE's Fit Healthy and Ready to Learn; A School Health Guide Part II: Policies to Promote Sun Safety and Prevent Skin Cancer, (2) CDC's Guidelines for Sun Safety to Prevent Skin Cancer, and (3) a link to the Surgeon General's 2014 Call to Action to Prevent Skin Cancer. This attention-control treatment will equalize schools on awareness of recommendations to implement school sun safety.</description>
    <arm_group_label>Attention Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  School districts in California with school Board Policy 5141.7 available online, and&#xD;
             with at least one elementary school.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Schools Districts that do not have school Board Policy 5141.7 online, or do not have&#xD;
             any elementary schools&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kim D Reynolds, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Claremont Graduate University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Claremont Graduate University</name>
      <address>
        <city>Claremont</city>
        <state>California</state>
        <zip>91711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>August 6, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>July 18, 2018</last_update_submitted>
  <last_update_submitted_qc>July 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Claremont Graduate University</investigator_affiliation>
    <investigator_full_name>Kim D. Reynolds</investigator_full_name>
    <investigator_title>Principal Investigator, Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Skin Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03243929
org study id: 5R01HD074416
nct id: NCT03243929
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the Translation of District Sun Safe Policies to Schools study was to test
      whether schools need assistance to facilitate the implementation of school district
      board-approved sun safety policies by individual elementary schools. The intervention is
      expected to produce a change in practices at the school level and to improve the sun safety
      behavior of children attending the intervention schools compared to control schools. A group
      of 40 school districts in Southern California that adopted board policy 5141.7 for sun safety
      provided 118 schools that were randomized to a intervention condition or to an attention
      control condition. The primary outcome is change in school-level sun safety practices based
      on 10 Centers for Disease Control and Prevention (CDC) categories for policy change (i.e.,
      sunscreen use, UV protective clothing, hats, student education, teacher education, provision
      of shade, scheduling to avoid peak UV exposure, parent outreach, resource allocation for sun
      safety, and an accountability system). This primary outcome was assessed by a survey of the
      principal and one teacher at each school (N=118 principals and 113 teachers at pretest).
      Parents (N=1770 at pretest) of children attending the schools completed a self-report measure
      assessing the secondary outcomes of change in individual-level sun safety behavior of their
      elementary school aged children and number of communications received from the school
      regarding sun safety. Assessment of principals, teachers and parents occurred at pretest,
      just prior to randomization, and at a posttest 20-months after the pretest. One Parent
      Teacher Association (PTA) representative per school was contacted to assess PTA involvement
      in intervention activities related to sun safety.

      The primary hypothesis was stated for the effectiveness of the intervention condition at
      increasing school-level sun safety practices consistent with the sun safety policies of the
      school districts and read, H1: At follow-up, a greater percentage of schools in the
      intervention condition will implement at least one component of the school district sun
      safety policy compared to schools randomized to the attention-control condition.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Measure of implementation of sun safety practices and policy at schools
time frame: 20 Months
description: Change in implementation of sun safety policy after intervention, through survey administration
measure: Students sun protection behavior
time frame: 20 Months
description: Change in sun safety behaviors after intervention, through survey administration
arm group label: Intervention
arm group type: Experimental
description: All participants in the Translation of District Sun Safe Policies to Schools arm received 1) initial coaching meeting that guided principals through an evaluation of current sun safety practices, the selection of goals for the implementation of sun safety practices, and guidance on the use of intervention materials to support implementation of sun safety practices in the school, 2) follow-up communications from coaches including email, telephone, and virtual meetings, 3) access to media and online resources to support implementation of sun safety practices, 4) mini-grants to support changes in school sun safety practices.
arm group label: Attention Control
arm group type: Other
description: All participants in the attention control arm received three emails during the 20 month intervention period including (1) NASBE's Fit Healthy and Ready to Learn; A School Health Guide Part II: Policies to Promote Sun Safety and Prevent Skin Cancer, (2) CDC's Guidelines for Sun Safety to Prevent Skin Cancer, and (3) a link to the Surgeon General's 2014 Call to Action to Prevent Skin Cancer. This attention-control treatment will equalize schools on awareness of recommendations to implement school sun safety.
intervention type: Behavioral
intervention name: Translation of District Sun Safe Policies to Schools
description: Translation of District Sun Safe Policies to Schools intervention was guided by Diffusion of Innovation Theory. Principals and other staff in intervention schools received 1) initial coaching meeting that guided principals through an evaluation of current sun safety practices, the selection of goals for the implementation of sun safety practices, and guidance on the use of intervention materials to support implementation of sun safety practices in the school, 2) follow-up communications from coaches including email, telephone, and virtual meetings, 3) access to media and online resources to support implementation of sun safety practices, 4) mini-grants to support changes in school sun safety practices. These components promoted implementation of the 10 policy components recommended by CDC.
arm group label: Intervention
intervention type: Behavioral
intervention name: Attention Control
description: Schools in the control condition received three emails during the 20 month intervention period including (1) NASBE's Fit Healthy and Ready to Learn; A School Health Guide Part II: Policies to Promote Sun Safety and Prevent Skin Cancer, (2) CDC's Guidelines for Sun Safety to Prevent Skin Cancer, and (3) a link to the Surgeon General's 2014 Call to Action to Prevent Skin Cancer. This attention-control treatment will equalize schools on awareness of recommendations to implement school sun safety.
arm group label: Attention Control
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kim D Reynolds, PhD
role: Principal Investigator
affiliation: Claremont Graduate University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Claremont Graduate University
investigator full name: Kim D. Reynolds
investigator title: Principal Investigator, Professor
mesh term: Skin Neoplasms
sharing ipd: No