<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/NCT03021226</url>
  </required_header>
  <id_info>
    <org_study_id>90FK087-01-01</org_study_id>
    <nct_id>NCT03021226</nct_id>
  </id_info>
  <brief_title>Evaluation of the Brothers United Fatherhood Program</brief_title>
  <official_title>An Impact Evaluation of the Brothers United Fatherhood Program, a Community-Based Responsible Fatherhood Initiative</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Economic Opportunity Planning Association dba Pathway, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Economic Opportunity Planning Association dba Pathway, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The Brothers United Fatherhood Program (BUFP) will be conducting an evaluation that builds on&#xD;
      literature and existing research from the healthy marriage/responsible fatherhood initiatives&#xD;
      developed by ACF over the last 10 years, in particular the Supporting Healthy Marriage&#xD;
      Program initiative that established a randomized clinical trial. The Brothers United&#xD;
      Fatherhood Program will provide important data to expand the area of fatherhood development&#xD;
      with the target population. This program is funded through an initiative of the&#xD;
      Administration for Children and Families, Office of Family Assistance (OFA).&#xD;
&#xD;
      The study is intended to measure if the identified interventions improve the well-being and&#xD;
      relationship between targeted participants and their families. The study intends to focus on&#xD;
      the following outcomes:&#xD;
&#xD;
        -  Demonstrate increased intake &amp; knowledge of systems that help fathers&#xD;
&#xD;
        -  Improvement in knowledge of employment &amp; learn new opportunities for economic mobility&#xD;
&#xD;
        -  Improvement communication &amp; empathy skills towards partner&#xD;
&#xD;
        -  Increase in understanding of healthy marriage &amp; its value to fathers&#xD;
&#xD;
        -  Demonstrate an understanding of financial planning&#xD;
&#xD;
        -  Demonstrate improved conflict resolution, behavior patterns, including those leading to&#xD;
           domestic violence&#xD;
&#xD;
        -  Increase in reports of improved adult &amp; child relationships&#xD;
&#xD;
        -  Demonstrate an increase job readiness skills such as employment preparedness &amp; career&#xD;
           direction&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Do those who participate in the program result in more positive self-reported attitudes and&#xD;
      behaviors than the control group relative to the following:&#xD;
&#xD;
        1. Improved healthy relationship and marriage skills.&#xD;
&#xD;
        2. Improved co-parenting skills&#xD;
&#xD;
        3. Increased frequency of father/child engagement&#xD;
&#xD;
        4. Increased financial responsibility of fathers&#xD;
&#xD;
        5. Progress toward a greater economic stability, including skill attainment and employment.&#xD;
&#xD;
        6. Reduce recidivism?&#xD;
&#xD;
      This reflects intention-to-treat (ITT) analysis where all participants who are enrolled and&#xD;
      randomly assigned to treatment are included in the analysis regardless of their adherence&#xD;
      with the entry criteria, regardless of subsequent withdrawal from treatment or deviation from&#xD;
      the protocol. This will preserve the pragmatic balance generated by the original random&#xD;
      treatment allocation.&#xD;
&#xD;
      Also, &quot;per protocol analysis&quot; will be conducted to evaluate if full project participation&#xD;
      results in more positive self-reported attitudes and behaviors than the control group&#xD;
      participants.&#xD;
&#xD;
      What personal characteristics and other external factors are related to achieving successful&#xD;
      outcomes in the program?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2016</start_date>
  <completion_date type="Actual">April 27, 2020</completion_date>
  <primary_completion_date type="Actual">April 27, 2020</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Fatherhood Development measured with a Questionnaire</measure>
    <time_frame>At program enrollment-during registration, immediately after completing intervention, and at 1 year follow up.</time_frame>
    <description>Fatherhood Development - Questionnaire developed for intervention to measure change from before intervention to immediately after intervention, and at 1 year after completion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Relationship Enhancement measured with a Questionnaire</measure>
    <time_frame>At program enrollment-during registration, immediately after completing intervention, and at 1 year follow up.</time_frame>
    <description>Relationship Enhancement - Questionnaire developed for intervention to measure change from before intervention to immediately after intervention, and at 1 year after completion.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Financial Literacy/Work Skills measured with a Questionnaire</measure>
    <time_frame>At program enrollment-during registration, immediately after completing intervention, and at 1 year follow up.</time_frame>
    <description>Financial Literacy/Work Skills - Questionnaire developed for intervention to measure change from before intervention to immediately after intervention, and at 1 year after completion.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">319</enrollment>
  <condition>Health Behavior</condition>
  <arm_group>
    <arm_group_label>Group I: Adults</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Group I will be adults ages 20 to 24 years of age, 50 hours of instruction provided over a six-week period, and address three major topic areas: Fatherhood Development, Relationship Enhancement, and Financial Literacy/Work.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group II: No Intervention: Adults</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in Group II will be adults ages 20 to 24 years of age who do not receive any hours of intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fatherhood Development</intervention_name>
    <description>Fatherhood Development is a curriculum based program provided by a facilitator through a skill-based education intervention.</description>
    <arm_group_label>Group I: Adults</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Relationship Enhancement</intervention_name>
    <description>Relationship Enhancement is a curriculum based program provided by a facilitator through a skill-based education intervention.</description>
    <arm_group_label>Group I: Adults</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Financial Literacy</intervention_name>
    <description>Relationship Enhancement is a curriculum based program provided by a facilitator through skill-based education intervention.</description>
    <arm_group_label>Group I: Adults</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must be parents between the ages of 20 to 24.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants cannot be younger than 20 years of age.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>24 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael Young, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Center for Evidence-Based Programming</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pathway, Inc.</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43604</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>April 27, 2020</last_update_submitted>
  <last_update_submitted_qc>April 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Economic Opportunity Planning Association dba Pathway, Inc.</investigator_affiliation>
    <investigator_full_name>Michael Young, Ph.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Health Behavior</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/NCT03021226
org study id: 90FK087-01-01
nct id: NCT03021226
lead sponsor: 
has dmc: No
The Brothers United Fatherhood Program (BUFP) will be conducting an evaluation that builds on
      literature and existing research from the healthy marriage/responsible fatherhood initiatives
      developed by ACF over the last 10 years, in particular the Supporting Healthy Marriage
      Program initiative that established a randomized clinical trial. The Brothers United
      Fatherhood Program will provide important data to expand the area of fatherhood development
      with the target population. This program is funded through an initiative of the
      Administration for Children and Families, Office of Family Assistance (OFA).

      The study is intended to measure if the identified interventions improve the well-being and
      relationship between targeted participants and their families. The study intends to focus on
      the following outcomes:

        -  Demonstrate increased intake & knowledge of systems that help fathers

        -  Improvement in knowledge of employment & learn new opportunities for economic mobility

        -  Improvement communication & empathy skills towards partner

        -  Increase in understanding of healthy marriage & its value to fathers

        -  Demonstrate an understanding of financial planning

        -  Demonstrate improved conflict resolution, behavior patterns, including those leading to
           domestic violence

        -  Increase in reports of improved adult & child relationships

        -  Demonstrate an increase job readiness skills such as employment preparedness & career
           direction
Do those who participate in the program result in more positive self-reported attitudes and
      behaviors than the control group relative to the following:

        1. Improved healthy relationship and marriage skills.

        2. Improved co-parenting skills

        3. Increased frequency of father/child engagement

        4. Increased financial responsibility of fathers

        5. Progress toward a greater economic stability, including skill attainment and employment.

        6. Reduce recidivism?

      This reflects intention-to-treat (ITT) analysis where all participants who are enrolled and
      randomly assigned to treatment are included in the analysis regardless of their adherence
      with the entry criteria, regardless of subsequent withdrawal from treatment or deviation from
      the protocol. This will preserve the pragmatic balance generated by the original random
      treatment allocation.

      Also, "per protocol analysis" will be conducted to evaluate if full project participation
      results in more positive self-reported attitudes and behaviors than the control group
      participants.

      What personal characteristics and other external factors are related to achieving successful
      outcomes in the program?
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Fatherhood Development measured with a Questionnaire
time frame: At program enrollment-during registration, immediately after completing intervention, and at 1 year follow up.
description: Fatherhood Development - Questionnaire developed for intervention to measure change from before intervention to immediately after intervention, and at 1 year after completion.
measure: Relationship Enhancement measured with a Questionnaire
time frame: At program enrollment-during registration, immediately after completing intervention, and at 1 year follow up.
description: Relationship Enhancement - Questionnaire developed for intervention to measure change from before intervention to immediately after intervention, and at 1 year after completion.
measure: Financial Literacy/Work Skills measured with a Questionnaire
time frame: At program enrollment-during registration, immediately after completing intervention, and at 1 year follow up.
description: Financial Literacy/Work Skills - Questionnaire developed for intervention to measure change from before intervention to immediately after intervention, and at 1 year after completion.
arm group label: Group I: Adults
arm group type: Experimental
description: Participants in Group I will be adults ages 20 to 24 years of age, 50 hours of instruction provided over a six-week period, and address three major topic areas: Fatherhood Development, Relationship Enhancement, and Financial Literacy/Work.
arm group label: Group II: No Intervention: Adults
arm group type: No Intervention
description: Participants in Group II will be adults ages 20 to 24 years of age who do not receive any hours of intervention.
intervention type: Behavioral
intervention name: Fatherhood Development
description: Fatherhood Development is a curriculum based program provided by a facilitator through a skill-based education intervention.
arm group label: Group I: Adults
intervention type: Behavioral
intervention name: Relationship Enhancement
description: Relationship Enhancement is a curriculum based program provided by a facilitator through a skill-based education intervention.
arm group label: Group I: Adults
intervention type: Behavioral
intervention name: Financial Literacy
description: Relationship Enhancement is a curriculum based program provided by a facilitator through skill-based education intervention.
arm group label: Group I: Adults
criteria: 
gender: All
minimum age: 20 Years
maximum age: 24 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Michael Young, PHD
role: Principal Investigator
affiliation: Center for Evidence-Based Programming
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Economic Opportunity Planning Association dba Pathway, Inc.
investigator full name: Michael Young, Ph.D.
investigator title: Principal Investigator
sharing ipd: No