<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/NCT03029221</url>
  </required_header>
  <id_info>
    <org_study_id>90FM0104-01-01</org_study_id>
    <nct_id>NCT03029221</nct_id>
  </id_info>
  <brief_title>Local Evaluation of Real Relationships</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Aid Society in Clearfield County</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>By The Numbers Data Analysis &amp; Statistical Solutions</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Children's Aid Society in Clearfield County</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project evaluates Real Relationships, a program provided by the Children's Aid Society&#xD;
      (CAS) in Clearfield County, and funded through the DHHS Healthy Marriage (and Responsible&#xD;
      Fatherhood) program. Research questions focus on recruitment and retention of participants,&#xD;
      and short- and long-term participant outcomes associated with different formats for offering&#xD;
      the program.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Only adult participants living in the community are included in the local evaluation. Three&#xD;
      research questions are examined in detail by the local evaluation. First, what recruitment&#xD;
      strategies are most effective in the rural service area of Real Relationships? The answers to&#xD;
      this research question will increase the CAS's and the funder's understanding of recruitment&#xD;
      in rural areas. Secondly, what are barriers to Real Relationships class/workshop attendance&#xD;
      for adults who enrolled but did not participate in any workshops? Again, answers to this&#xD;
      research question will increase CAS's and the funder's understanding of barriers to retention&#xD;
      (from the point of entry into the program to when participation begins), particularly in&#xD;
      rural areas. A better understanding of barriers at this point of the enrollment process can&#xD;
      be used to develop programming that helps to avoid these barriers, and the development of&#xD;
      programming aimed at reaching populations that have been missed due to specific barriers.&#xD;
      Third, how do short- and long-term outcomes for participants who complete their Real&#xD;
      Relationships class/workshop differ by the format of the class/workshop format (i.e., weekend&#xD;
      workshop, multi-week classes)? The answers to this research question will increase CAS's and&#xD;
      the funder's understanding of programming in this field by adding to the knowledge base&#xD;
      regarding the most effective formats for achieving the outcomes relevant to the goals of Real&#xD;
      Relationships. Results will also speak to the importance of other activities, such as case&#xD;
      management and parenting classes, for achieving desired outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2016</start_date>
  <completion_date type="Actual">September 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 2020</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>Change from Baseline in Work on Serious Disagreement at Post-Survey</measure>
    <time_frame>Pre-Survey and Post-Survey, which would range from 30 days to 10 weeks</time_frame>
    <description>nFORM Question on Pre/Post Survey, &amp; Follow-up Survey: when have serious disagreement with spouse, worked on it together to find a resolution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Post-Survey in Work on Serious Disagreement at Follow-up Survey</measure>
    <time_frame>Post-Survey and Follow-up Survey, up to 4 months</time_frame>
    <description>nFORM Question on Pre/Post Survey, &amp; Follow-up Survey: when have serious disagreement with spouse, worked on it together to find a resolution</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Spending Time with Child at Post-Survey</measure>
    <time_frame>Pre-Survey and Post-Survey, which would range from 30 days to 10 weeks</time_frame>
    <description>nFORM Question on Pre/Post Survey, &amp; Follow-up Survey: frequency of spending time with a child doing things that he/she likes to do</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Post-Survey in Spending Time with Child at Follow-up</measure>
    <time_frame>Post-Survey and Follow-up Survey, up to 4 months</time_frame>
    <description>nFORM Question on Pre/Post Survey, &amp; Follow-up Survey: frequency of spending time with a child doing things that he/she likes to do</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline in Use of Written Budget at Post-Survey</measure>
    <time_frame>Pre-Survey and Post-Survey, which would range from 30 days to 10 weeks</time_frame>
    <description>nFORM Question on Pre/Post Survey, &amp; Follow-up Survey: use a written budget to plan spending</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Post-Survey in Use of Written Budget at Follow-up Survey</measure>
    <time_frame>Post-Survey and Follow-up Survey, up to 4 months</time_frame>
    <description>nFORM Question on Pre/Post Survey, &amp; Follow-up Survey: use a written budget to plan spending</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">1119</enrollment>
  <condition>Family Relationships</condition>
  <condition>Parent-Child Relationships</condition>
  <arm_group>
    <arm_group_label>Marriage &amp; Relationship Ed Skills-Couples</arm_group_label>
    <description>This group will receive the PREP 8.0 curriculum developed by PREP. In Years 2-5, 4 7-week class series will be held each year in Clearfield and Centre Counties (PA); 32 adults will be served each year. In Year 1, 8 adults will be served. Couples will receive 11 hours of curriculum instruction. This group will also receive two 30-minute presentations on available financial management, and job and career advancement services through two partnering organizations (CareerLink and Central PA Community Action, Inc.). Participants will also have access to optional parenting skills training provided by CAS (i.e., Triple P - Positive parenting Program). Referrals to community agencies based on individual/family needs will be provided by participant's case managers, as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Marriage &amp; Relationship Ed Skills-Individuals</arm_group_label>
    <description>This group will receive the Within My Reach curriculum developed by PREP. In Years 2-5, 4 9-week class series will be held each year in Clearfield and Centre Counties (PA); 32 adults will be served each year. In Year 1, 8 adults will be served. Participants will receive 15 hours of curriculum instruction. This group will also receive two 30-minute presentations on available financial management, and job and career advancement services through two partnering organizations (CareerLink and Central PA Community Action, Inc.). Participants will also have access to optional parenting skills training provided by CAS (i.e., Triple P - Positive parenting Program). Referrals to community agencies based on individual/family needs will be provided by participant's case managers, as needed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pre-Marital Ed and Marriage Skills</arm_group_label>
    <description>This group will receive healthy marriage and relationship education to pre-marital couples using Within Our Reach 8 Hours curriculum developed by PREP. In Years 2-5, 9 10-hour weekend workshops will be held each year in nine central PA counties; 72 adults will be served each year. In Year 1, 24 adults will be served.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Marriage Enhancement and Marriage Skills</arm_group_label>
    <description>This group will receive healthy marriage and relationship education to married couples using Within Our Reach 8 Hours curriculum developed by PREP. In Years 2-5, 9 12-hour weekend workshops will be held each year in nine central PA counties; 174 adults will be served each year. In Year 1, 60 adults will be served.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PREP 8.0 curriculum developed by PREP</intervention_name>
    <description>healthy marriage and relationship education</description>
    <arm_group_label>Marriage &amp; Relationship Ed Skills-Couples</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Within My Reach curriculum developed by PREP</intervention_name>
    <description>healthy marriage and relationship education</description>
    <arm_group_label>Marriage &amp; Relationship Ed Skills-Individuals</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Within Our Reach 8 Hours curriculum</intervention_name>
    <description>healthy marriage and relationship education</description>
    <arm_group_label>Marriage Enhancement and Marriage Skills</arm_group_label>
    <arm_group_label>Pre-Marital Ed and Marriage Skills</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults who participate in Children's Aid Society's Real Relationships program who live in&#xD;
        the coimmunity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  living in the community&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  living in an institution&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bonnie Floro</last_name>
    <role>Study Director</role>
    <affiliation>Children's Aid Society in Clearfield County</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Children's Aid Society in Clearfield County</name>
      <address>
        <city>Clearfield</city>
        <state>Pennsylvania</state>
        <zip>16830</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>July 26, 2021</last_update_submitted>
  <last_update_submitted_qc>July 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03029221
org study id: 90FM0104-01-01
nct id: NCT03029221
lead sponsor: 
collaborator: 
has dmc: No
This project evaluates Real Relationships, a program provided by the Children's Aid Society
      (CAS) in Clearfield County, and funded through the DHHS Healthy Marriage (and Responsible
      Fatherhood) program. Research questions focus on recruitment and retention of participants,
      and short- and long-term participant outcomes associated with different formats for offering
      the program.
Only adult participants living in the community are included in the local evaluation. Three
      research questions are examined in detail by the local evaluation. First, what recruitment
      strategies are most effective in the rural service area of Real Relationships? The answers to
      this research question will increase the CAS's and the funder's understanding of recruitment
      in rural areas. Secondly, what are barriers to Real Relationships class/workshop attendance
      for adults who enrolled but did not participate in any workshops? Again, answers to this
      research question will increase CAS's and the funder's understanding of barriers to retention
      (from the point of entry into the program to when participation begins), particularly in
      rural areas. A better understanding of barriers at this point of the enrollment process can
      be used to develop programming that helps to avoid these barriers, and the development of
      programming aimed at reaching populations that have been missed due to specific barriers.
      Third, how do short- and long-term outcomes for participants who complete their Real
      Relationships class/workshop differ by the format of the class/workshop format (i.e., weekend
      workshop, multi-week classes)? The answers to this research question will increase CAS's and
      the funder's understanding of programming in this field by adding to the knowledge base
      regarding the most effective formats for achieving the outcomes relevant to the goals of Real
      Relationships. Results will also speak to the importance of other activities, such as case
      management and parenting classes, for achieving desired outcomes.
observational model: Cohort
time perspective: Prospective
measure: Change from Baseline in Work on Serious Disagreement at Post-Survey
time frame: Pre-Survey and Post-Survey, which would range from 30 days to 10 weeks
description: nFORM Question on Pre/Post Survey, & Follow-up Survey: when have serious disagreement with spouse, worked on it together to find a resolution
measure: Change from Post-Survey in Work on Serious Disagreement at Follow-up Survey
time frame: Post-Survey and Follow-up Survey, up to 4 months
description: nFORM Question on Pre/Post Survey, & Follow-up Survey: when have serious disagreement with spouse, worked on it together to find a resolution
measure: Change from Baseline in Spending Time with Child at Post-Survey
time frame: Pre-Survey and Post-Survey, which would range from 30 days to 10 weeks
description: nFORM Question on Pre/Post Survey, & Follow-up Survey: frequency of spending time with a child doing things that he/she likes to do
measure: Change from Post-Survey in Spending Time with Child at Follow-up
time frame: Post-Survey and Follow-up Survey, up to 4 months
description: nFORM Question on Pre/Post Survey, & Follow-up Survey: frequency of spending time with a child doing things that he/she likes to do
measure: Change from Baseline in Use of Written Budget at Post-Survey
time frame: Pre-Survey and Post-Survey, which would range from 30 days to 10 weeks
description: nFORM Question on Pre/Post Survey, & Follow-up Survey: use a written budget to plan spending
measure: Change from Post-Survey in Use of Written Budget at Follow-up Survey
time frame: Post-Survey and Follow-up Survey, up to 4 months
description: nFORM Question on Pre/Post Survey, & Follow-up Survey: use a written budget to plan spending
arm group label: Marriage & Relationship Ed Skills-Couples
description: This group will receive the PREP 8.0 curriculum developed by PREP. In Years 2-5, 4 7-week class series will be held each year in Clearfield and Centre Counties (PA); 32 adults will be served each year. In Year 1, 8 adults will be served. Couples will receive 11 hours of curriculum instruction. This group will also receive two 30-minute presentations on available financial management, and job and career advancement services through two partnering organizations (CareerLink and Central PA Community Action, Inc.). Participants will also have access to optional parenting skills training provided by CAS (i.e., Triple P - Positive parenting Program). Referrals to community agencies based on individual/family needs will be provided by participant's case managers, as needed.
arm group label: Marriage & Relationship Ed Skills-Individuals
description: This group will receive the Within My Reach curriculum developed by PREP. In Years 2-5, 4 9-week class series will be held each year in Clearfield and Centre Counties (PA); 32 adults will be served each year. In Year 1, 8 adults will be served. Participants will receive 15 hours of curriculum instruction. This group will also receive two 30-minute presentations on available financial management, and job and career advancement services through two partnering organizations (CareerLink and Central PA Community Action, Inc.). Participants will also have access to optional parenting skills training provided by CAS (i.e., Triple P - Positive parenting Program). Referrals to community agencies based on individual/family needs will be provided by participant's case managers, as needed.
arm group label: Pre-Marital Ed and Marriage Skills
description: This group will receive healthy marriage and relationship education to pre-marital couples using Within Our Reach 8 Hours curriculum developed by PREP. In Years 2-5, 9 10-hour weekend workshops will be held each year in nine central PA counties; 72 adults will be served each year. In Year 1, 24 adults will be served.
arm group label: Marriage Enhancement and Marriage Skills
description: This group will receive healthy marriage and relationship education to married couples using Within Our Reach 8 Hours curriculum developed by PREP. In Years 2-5, 9 12-hour weekend workshops will be held each year in nine central PA counties; 174 adults will be served each year. In Year 1, 60 adults will be served.
intervention type: Other
intervention name: PREP 8.0 curriculum developed by PREP
description: healthy marriage and relationship education
arm group label: Marriage & Relationship Ed Skills-Couples
intervention type: Other
intervention name: Within My Reach curriculum developed by PREP
description: healthy marriage and relationship education
arm group label: Marriage & Relationship Ed Skills-Individuals
intervention type: Other
intervention name: Within Our Reach 8 Hours curriculum
description: healthy marriage and relationship education
arm group label: Marriage Enhancement and Marriage Skills
arm group label: Pre-Marital Ed and Marriage Skills
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bonnie Floro
role: Study Director
affiliation: Children's Aid Society in Clearfield County
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No