<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/NCT03790761</url>
  </required_header>
  <id_info>
    <org_study_id>5589</org_study_id>
    <nct_id>NCT03790761</nct_id>
  </id_info>
  <brief_title>Guam Healthy Relationships Education Program</brief_title>
  <acronym>GHREP</acronym>
  <official_title>Guam Healthy Relationships Education Program</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>WestCare Pacific Islands, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's Bureau - Administration for Children and Families</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>WestCare Pacific Islands, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</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 Guam Healthy Marriage Partnership (GHMP), a comprehensive culturally responsive program&#xD;
      that will foster healthy relationships and marriages on the island of Guam.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed Guam Healthy Relationships Education Program will improve the quality of life&#xD;
      for individuals/couples in Guam by using culturally responsive approaches to foster healthy&#xD;
      relationships and marriages using an Observational approach as there will be no comparison&#xD;
      group, only the control group. Project activities include a 6-month education program of&#xD;
      interactive curriculum-based groups and positive social/recreational activities to achieve&#xD;
      positive outcomes for individuals/couples, community awareness events, and community and&#xD;
      parenting skills training. The services offered is entrenched in cultures and traditions that&#xD;
      are meaningful to the people of Guam, and includes capacity building and community awareness&#xD;
      activities that will change community, family, and peer normative environments and attitudes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">March 31, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Relationship Satisfaction</measure>
    <time_frame>The pre-test is administered before starting the curriculum and the post-test is administered immediately following the conclusion of the curriculum.</time_frame>
    <description>The PREP 8.0 curriculum pre- and post-test will be administered to program participants to determine if there are any changes in relationship satisfaction.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Intimate Partner Violence</measure>
    <time_frame>The screening is administered before starting the curriculum and the screening is administered again immediately following the conclusion of the curriculum.</time_frame>
    <description>The HITS Screening Assessment will be administered to program participants to determine if there are any changes in intimate partner violence as a result of participating in the PREP 8.0 curriculum.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">556</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>PREP 8.0 Curriculum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All participants enrolled in the program will be given the PREP 8.0 curriculum - there will be no comparison group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>PREP 8.0 Curriculum</intervention_name>
    <description>The PREP 8.0 curriculum is an experiential curriculum designed to be implemented in a workshop or educational setting. Using techniques of cognitive-behavioral marital therapy and communication-oriented marital enhancement, PREP aims to help couples achieve high levels of relationship functioning and prevent marital problems. The PREP approach is based on research in the field of relational and marital health and success conducted at the University of Denver.</description>
    <arm_group_label>PREP 8.0 Curriculum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently in a long-term relationship, does not have to include marriage&#xD;
&#xD;
          -  Must be at least 18 years old&#xD;
&#xD;
          -  At least one of the partners need to be between the ages of 18-35 years old&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 18 years&#xD;
&#xD;
          -  Not in a long-term relationship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Melissa Rhea, Ed.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>WestCare Foundation, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>WestCare Pacific Islands Reflection Center</name>
      <address>
        <city>Hagatna</city>
        <zip>96910</zip>
        <country>Guam</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Guam</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Guam</keyword>
  <keyword>healthy relationships</keyword>
  <keyword>non-profit organization</keyword>
  <keyword>PREP 8.0 curriculum</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>WestCare is willing to work with other researchers in the field for the betterment of the quality of life of Guam's community. An individual participant data (IPD) will be determined based upon potential partner.</ipd_description>
  </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/NCT03790761
org study id: 5589
nct id: NCT03790761
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The Guam Healthy Marriage Partnership (GHMP), a comprehensive culturally responsive program
      that will foster healthy relationships and marriages on the island of Guam.
The proposed Guam Healthy Relationships Education Program will improve the quality of life
      for individuals/couples in Guam by using culturally responsive approaches to foster healthy
      relationships and marriages using an Observational approach as there will be no comparison
      group, only the control group. Project activities include a 6-month education program of
      interactive curriculum-based groups and positive social/recreational activities to achieve
      positive outcomes for individuals/couples, community awareness events, and community and
      parenting skills training. The services offered is entrenched in cultures and traditions that
      are meaningful to the people of Guam, and includes capacity building and community awareness
      activities that will change community, family, and peer normative environments and attitudes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in Relationship Satisfaction
time frame: The pre-test is administered before starting the curriculum and the post-test is administered immediately following the conclusion of the curriculum.
description: The PREP 8.0 curriculum pre- and post-test will be administered to program participants to determine if there are any changes in relationship satisfaction.
measure: Change in Intimate Partner Violence
time frame: The screening is administered before starting the curriculum and the screening is administered again immediately following the conclusion of the curriculum.
description: The HITS Screening Assessment will be administered to program participants to determine if there are any changes in intimate partner violence as a result of participating in the PREP 8.0 curriculum.
arm group label: PREP 8.0 Curriculum
arm group type: Experimental
description: All participants enrolled in the program will be given the PREP 8.0 curriculum - there will be no comparison group.
intervention type: Behavioral
intervention name: PREP 8.0 Curriculum
description: The PREP 8.0 curriculum is an experiential curriculum designed to be implemented in a workshop or educational setting. Using techniques of cognitive-behavioral marital therapy and communication-oriented marital enhancement, PREP aims to help couples achieve high levels of relationship functioning and prevent marital problems. The PREP approach is based on research in the field of relational and marital health and success conducted at the University of Denver.
arm group label: PREP 8.0 Curriculum
criteria: 
gender: All
minimum age: 18 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Melissa Rhea, Ed.D.
role: Principal Investigator
affiliation: WestCare Foundation, Inc.
facility: 
country: Guam
responsible party type: Sponsor
sharing ipd: Undecided
ipd description: WestCare is willing to work with other researchers in the field for the betterment of the quality of life of Guam's community. An individual participant data (IPD) will be determined based upon potential partner.