<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/NCT03034083</url>
  </required_header>
  <id_info>
    <org_study_id>90FM0081</org_study_id>
    <nct_id>NCT03034083</nct_id>
  </id_info>
  <brief_title>An Evaluation of Healthy Marriage and Relationship Education Program: Elevate</brief_title>
  <official_title>Elevate: Taking Your Relationship to the Next Level</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Georgia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Health and Human Services</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Georgia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the healthy marriage and relationship&#xD;
      education program Elevate: Taking Your Relationship to the Next Level results in improved&#xD;
      couple, parenting, and co-parenting behaviors that lead to reduced child abuse/neglect&#xD;
      potential.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The descriptive study is based on the theory that couples can learn skills through&#xD;
      participating in the Elevate curriculum that will help them function better as a couple&#xD;
      resulting in improved relationship quality/stability, improved co-parenting skills, improved&#xD;
      financial management, and reduced financial stress. As a result of improved relationship&#xD;
      skills and better management of stress, couples will then provide more supportive, safe, and&#xD;
      stable family environments for children.&#xD;
&#xD;
      Individuals who are eligible (biological and foster parents of children 0-18) and agree to&#xD;
      participate in the study will complete surveys at three time points--before participating in&#xD;
      Elevate, 4-6 weeks after participating, and 8-10 months after participating in Elevate. The&#xD;
      surveys include items related to couple functioning behaviors, relationship&#xD;
      quality/stability, parenting/co-parenting skills, and financial management and distress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No subjects recruited&#xD;
  </why_stopped>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Elevate Pre-post program survey subscale measuring change in couple functioning and stability</measure>
    <time_frame>Time points 4-6 weeks prior to participation in Elevate, 4-6 week after participation, and 8-10 months after participation.</time_frame>
    <description>Study participant responses on Elevate pre-post survey subscale measuring change in couple functioning behaviors, including communication, conflict resolution, commitment, and supportive behaviors will be compared at three time points.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Elevate Pre-post survey subscale measuring change in parenting skills</measure>
    <time_frame>Time points 4-6 weeks prior to participation in Elevate, 4-6 week after participation, and 8-10 months after participation</time_frame>
    <description>Study participant responses on Elevate pre-post survey subscale measuring change in parenting skill level, including interactions with children, co-parenting approaches, and beliefs about appropriate parenting behaviors, will be compared at three time points.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Family Relations</condition>
  <arm_group>
    <arm_group_label>Couples Elevate Weekly Series</arm_group_label>
    <description>Participants in a couple relationship receive needs assessment and 8 hours of classes over a 4-week period in healthy couple functioning behaviors, relationship quality/stability, and parenting skills.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Foster Parents Elevate Weekend Intensive</arm_group_label>
    <description>Foster parent participants receive 8 hours of classes over a weekend in healthy couple functioning behaviors, relationship quality/stability, and parenting skills.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Elevate</intervention_name>
    <description>Study participants receive needs assessment and 8 hours of classes over a 4-week period in healthy couple functioning behaviors, relationship quality/stability, and parenting skills.</description>
    <arm_group_label>Couples Elevate Weekly Series</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population is biological and foster parents of children ages 0-18.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Biological parents of children 0-18 Parents must be in a committed couple relationship&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Incarceration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theodore Futris, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Georgia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Georgia</name>
      <address>
        <city>Athens</city>
        <state>Georgia</state>
        <zip>30602</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>June 13, 2018</last_update_submitted>
  <last_update_submitted_qc>June 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Georgia</investigator_affiliation>
    <investigator_full_name>Karen M. DeMeester</investigator_full_name>
    <investigator_title>Public Service Assistant</investigator_title>
  </responsible_party>
  <keyword>healthy marriage</keyword>
  <keyword>healthy relationships</keyword>
  <keyword>parenting</keyword>
  <keyword>healthy marriage and relationship education</keyword>
  <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/NCT03034083
org study id: 90FM0081
nct id: NCT03034083
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether the healthy marriage and relationship
      education program Elevate: Taking Your Relationship to the Next Level results in improved
      couple, parenting, and co-parenting behaviors that lead to reduced child abuse/neglect
      potential.
The descriptive study is based on the theory that couples can learn skills through
      participating in the Elevate curriculum that will help them function better as a couple
      resulting in improved relationship quality/stability, improved co-parenting skills, improved
      financial management, and reduced financial stress. As a result of improved relationship
      skills and better management of stress, couples will then provide more supportive, safe, and
      stable family environments for children.

      Individuals who are eligible (biological and foster parents of children 0-18) and agree to
      participate in the study will complete surveys at three time points--before participating in
      Elevate, 4-6 weeks after participating, and 8-10 months after participating in Elevate. The
      surveys include items related to couple functioning behaviors, relationship
      quality/stability, parenting/co-parenting skills, and financial management and distress.
observational model: Cohort
time perspective: Prospective
measure: Elevate Pre-post program survey subscale measuring change in couple functioning and stability
time frame: Time points 4-6 weeks prior to participation in Elevate, 4-6 week after participation, and 8-10 months after participation.
description: Study participant responses on Elevate pre-post survey subscale measuring change in couple functioning behaviors, including communication, conflict resolution, commitment, and supportive behaviors will be compared at three time points.
measure: Elevate Pre-post survey subscale measuring change in parenting skills
time frame: Time points 4-6 weeks prior to participation in Elevate, 4-6 week after participation, and 8-10 months after participation
description: Study participant responses on Elevate pre-post survey subscale measuring change in parenting skill level, including interactions with children, co-parenting approaches, and beliefs about appropriate parenting behaviors, will be compared at three time points.
arm group label: Couples Elevate Weekly Series
description: Participants in a couple relationship receive needs assessment and 8 hours of classes over a 4-week period in healthy couple functioning behaviors, relationship quality/stability, and parenting skills.
arm group label: Foster Parents Elevate Weekend Intensive
description: Foster parent participants receive 8 hours of classes over a weekend in healthy couple functioning behaviors, relationship quality/stability, and parenting skills.
intervention type: Behavioral
intervention name: Elevate
description: Study participants receive needs assessment and 8 hours of classes over a 4-week period in healthy couple functioning behaviors, relationship quality/stability, and parenting skills.
arm group label: Couples Elevate Weekly Series
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Theodore Futris, Ph.D.
role: Principal Investigator
affiliation: University of Georgia
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Georgia
investigator full name: Karen M. DeMeester
investigator title: Public Service Assistant
sharing ipd: No