<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/NCT01665872</url>
  </required_header>
  <id_info>
    <org_study_id>1010007484</org_study_id>
    <secondary_id>5CCEWH1110210501</secondary_id>
    <nct_id>NCT01665872</nct_id>
  </id_info>
  <brief_title>New Haven MOMS Partnership</brief_title>
  <official_title>New Haven Mental Health Outreach for MotherS (MOMS) Partnership</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</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>
    <collaborator>
      <agency>Office of Research on Women's Health (ORWH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Yale University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase II of the MOMS Partnership aims to:&#xD;
&#xD;
        1. conduct a needs assessment of the mental health of mothers residing in New Haven, CT;&#xD;
&#xD;
        2. provide on-site group intervention services (randomized by housing community) to improve&#xD;
           signs/symptoms of depression/stress/trauma among mothers living onsite.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this project is to expand and enhance the New Haven Mental health Outreach for&#xD;
      Mothers (MOMs) Coalition beyond pregnancy and depression to include a broader definition of&#xD;
      mental illness (depressive, anxiety, and substance use disorders), and a larger target&#xD;
      population (low-income, racially and ethnically diverse, pregnant and parenting women) in the&#xD;
      City of New Haven. Through this expansion, the Coalition will bring together the community of&#xD;
      women, their families and advocates, healthcare providers, policy and agency leaders, and&#xD;
      academics, to inform the development and conduct of public health approaches around the&#xD;
      mental health of low-income, racially and ethnically diverse, pregnant and parenting women.&#xD;
      The specific goals of this Phase I proposal are:&#xD;
&#xD;
        1. To conduct a community-led needs assessment on the mental health of low-income,&#xD;
           ethnically and racially diverse pregnant and parenting women in the City of New Haven.&#xD;
&#xD;
        2. To provide randomized intervention services to improve signs/symptoms of&#xD;
           depression/stress/trauma among mothers living in public housing in New Haven, CT&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2012</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Total Outpatient Mental Health or Substance Abuse Visits</measure>
    <time_frame>1 year</time_frame>
    <description>Self-report questionnaire which measure attitudes toward seeking mental health treatment. This is defined by looking at total number of outpatient mental health or substance abuse treatment visits in the past year.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Depressive and Anxiety Symptoms (CES-D)</measure>
    <time_frame>approximately 1 year</time_frame>
    <description>The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening test for depression and depressive disorder. The total score is a sum which ranges from 0-60. Higher scores indicate the presence of more symptomatology.&#xD;
Radloff, L.S. (1977) 'The CES-D scale: A self report depression scale for research in the general population'. Applied Psychological Measurement 1: 385-401.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parenting Stress</measure>
    <time_frame>1 year</time_frame>
    <description>Parenting Stress Index Short Form by Richard R. Abidin (total score (36 questions) and 3 subscales (12 questions each) was used to describe parenting stress. Scores were created by summing the responses and then translated to percentiles for normative data (provided by the publisher). The total score represents an overall level of experienced parenting stress. A score 90 or above indicates experiencing clinically significant levels of stress. The subscale Parental Distress measures distress that the parent is experiencing related to parenting. High scores indicate more distress. The Parent-Child Dysfunctional Interaction subscale measures the parent's perception regarding a child meeting expectations and reinforcing interactions with the child. High scores indicate a parent-child bond that is threatened or not adequately established. The Difficult Child subscale looks at behavioral characteristics of children. Higher scores indicating difficulty managing the child's behavior.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Gainful Employment</measure>
    <time_frame>1 year</time_frame>
    <description>Measure of subject's ability to obtain gainful employment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implementation Cost</measure>
    <time_frame>1 series</time_frame>
    <description>The implementation cost of providing a 8 session Stress Management (SM) Series (with 1 active series at a time) for both Standard of care with only a clinician, and also for a clinician and CMHA. The implementation costs include startup costs and on-going costs. On-going costs include staff salary, travel time, cell phones, space, and materials).</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Depression</condition>
  <condition>Stress</condition>
  <arm_group>
    <arm_group_label>Cognitive-Behavioral Group Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention co-facilitated by mental health clinician and a Community Mental Health Ambassador (peer).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care - Cognitive-Behavioral Group Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention administered by mental health clinician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-Behavioral Group Therapy</intervention_name>
    <description>CBT Group</description>
    <arm_group_label>Cognitive-Behavioral Group Therapy</arm_group_label>
    <arm_group_label>Standard of care - Cognitive-Behavioral Group Therapy</arm_group_label>
    <other_name>CBT Group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  CES-D score &gt;=16&#xD;
&#xD;
          -  Child under the age of 18 (participant must be a mother)&#xD;
&#xD;
          -  Resident of public housing authority complex in New Haven, CT or an affiliated Section&#xD;
             8 recipient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Positive for psychosis&#xD;
&#xD;
          -  Active suicidal ideation&#xD;
&#xD;
          -  Non-English or Spanish speakers&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Unwilling to accept randomization&#xD;
&#xD;
          -  Moving within the intervention &amp; follow-up period&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megan V Smith, MPH, DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yale School of Medicine</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <results_first_submitted>February 15, 2019</results_first_submitted>
  <results_first_submitted_qc>February 6, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 10, 2020</results_first_posted>
  <last_update_submitted>February 6, 2020</last_update_submitted>
  <last_update_submitted_qc>February 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mothers</keyword>
  <keyword>Depression</keyword>
  <keyword>Stress</keyword>
  <keyword>Trauma</keyword>
  <keyword>Public Housing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were screened throughout the community with a needs assessment during the time frame 05/21/2012 through 06/02/2016.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Cognitive-Behavioral Group Therapy</title>
          <description>8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention co-facilitated by mental health clinician and a Community Mental Health Ambassador (peer).&#xD;
Cognitive-Behavioral Group Therapy: CBT Group</description>
        </group>
        <group group_id="P2">
          <title>Standard of Care - Cognitive-Behavioral Group Therapy</title>
          <description>8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention administered by mental health clinician.&#xD;
Cognitive-Behavioral Group Therapy: CBT Group</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Screening</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="172"/>
                <participants group_id="P2" count="172"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Treatment</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="87"/>
                <participants group_id="P2" count="67"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="17"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>6 Month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="66"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>12 Month Follow-up</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="58"/>
                <participants group_id="P2" count="47"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Cognitive-Behavioral Group Therapy</title>
          <description>Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador</description>
        </group>
        <group group_id="B2">
          <title>Standard of Care - Cognitive-Behavioral Group Therapy</title>
          <description>Stress Management Class delivered in public housing sites by only a clinician</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="87"/>
            <count group_id="B2" value="67"/>
            <count group_id="B3" value="154"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="154"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="38.1" spread="11.0"/>
                    <measurement group_id="B2" value="39.2" spread="11.2"/>
                    <measurement group_id="B3" value="38.6" spread="11.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="154"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race / Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>White, Non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black, Non-Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="68"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="120"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White, Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black, Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="87"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>CES-D total score</title>
          <description>The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening test for depression and depressive disorder. The total score is a sum which ranges from 0-60. Higher scores indicate the presence of more symptomatology.&#xD;
Radloff, L.S. (1977) 'The CES-D scale: A self report depression scale for research in the general population'. Applied Psychological Measurement 1: 385-401.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28.2" spread="9.3"/>
                    <measurement group_id="B2" value="30.4" spread="9.8"/>
                    <measurement group_id="B3" value="29.2" spread="9.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Total outpatient mental health or substance abuse visits</title>
          <population>We did not have a response from 3 participants in the Cognitive-Behavioral Group Therapy group</population>
          <units>visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="84"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="151"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4.5" spread="16.3"/>
                    <measurement group_id="B2" value="2.1" spread="10.0"/>
                    <measurement group_id="B3" value="3.4" spread="13.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parenting Stress Index Short Form: Parental Distress Percentile</title>
          <description>Parental Distress is a subscale of Parenting Stress Index Short Form by Richard R. Abidin. This subscale contains 12 questions. The score is the sum of all 12 questions that is then translated to percentiles for normative data (provided by the publisher). This subscale measures distress that the parent is experiencing in their role as a parent as a result of factors related to parenting. High scores indicate more distress.&#xD;
Percentiles range from 0-100.</description>
          <population>This measure was only collected on participants whose youngest child was 7 years or younger.</population>
          <units>percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="47"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="82.4" spread="21.2"/>
                    <measurement group_id="B2" value="73.9" spread="28.5"/>
                    <measurement group_id="B3" value="78.9" spread="24.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parenting Stress Index: Parent-Child Dysfunctional Interaction Percentile</title>
          <description>Parent-Child Dysfunctional Interaction is a subscale (12 questions) of Parenting Stress Index Short Form by Richard R. Abidin. The score is the sum of all 12 questions. This score is then translated to percentiles for normative data (provided by the publisher). The Parent-Child Dysfunctional Interaction subscale measures the parent's perception that a child does or does not meet their expectations and if interactions with the child are reinforcing to the parent. High scores indicate a parent-child bond that is threatened or not adequately established. Percentiles range from 0-100.</description>
          <population>This measure was only collected on participants whose youngest child was 7 years or younger.</population>
          <units>percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="47"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.4" spread="30.0"/>
                    <measurement group_id="B2" value="59.6" spread="33.3"/>
                    <measurement group_id="B3" value="60.7" spread="31.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parenting Stress Index: Difficult Child Percentile</title>
          <description>The Difficult Child is a subscale of Parenting Stress Index Short Form by Richard R. Abidin that is created from 12 questions. The score is the sum of all 12 questions. This score is then translated to percentiles for normative data (provided by the publisher). The Difficult Child subscale looks at behavioral characteristics of children (temperament but also patterns of behavior) that make the child easy or difficult to manage. Higher scores generally indicate the parent is experiencing difficulty managing the child's behavior.&#xD;
Percentiles range from 0-100.</description>
          <population>This measure was only collected on participants whose youngest child was 7 years or younger.</population>
          <units>percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="47"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.0" spread="33.6"/>
                    <measurement group_id="B2" value="58.9" spread="31.4"/>
                    <measurement group_id="B3" value="60.7" spread="32.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parenting Stress Index Short Form: Total Score Percentile</title>
          <description>Parenting Stress Index Short Form by Richard R. Abidin, contains a total score which is the sum of all 36 questions. The score is then translated to percentiles for normative data (provided by the publisher). The total score is intended to represent an overall level of parenting stress that the individual is experiencing. A score at or above 90 indicates experiencing clinically significant levels of stress.&#xD;
Percentiles range from 0-100.</description>
          <population>This measure was only collected on participants whose youngest child was 7 years or younger.</population>
          <units>percentile</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="47"/>
                    <count group_id="B2" value="34"/>
                    <count group_id="B3" value="81"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="75.8" spread="27.6"/>
                    <measurement group_id="B2" value="71.4" spread="29.2"/>
                    <measurement group_id="B3" value="74.0" spread="28.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gainful Employment</title>
          <description>Do you work 15 hours or more per week for pay?</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="87"/>
                    <count group_id="B2" value="67"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Yes</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No</title>
                  <measurement_list>
                    <measurement group_id="B1" value="71"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Total Outpatient Mental Health or Substance Abuse Visits</title>
        <description>Self-report questionnaire which measure attitudes toward seeking mental health treatment. This is defined by looking at total number of outpatient mental health or substance abuse treatment visits in the past year.</description>
        <time_frame>1 year</time_frame>
        <population>Participants who attended the 12 month follow-up assessment and completed the questions regarding mental health and substance abuse visits.</population>
        <group_list>
          <group group_id="O1">
            <title>Cognitive-Behavioral Group Therapy</title>
            <description>Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care - Cognitive-Behavioral Group Therapy</title>
            <description>Stress Management Class delivered in public housing sites by only a clinician</description>
          </group>
        </group_list>
        <measure>
          <title>Total Outpatient Mental Health or Substance Abuse Visits</title>
          <description>Self-report questionnaire which measure attitudes toward seeking mental health treatment. This is defined by looking at total number of outpatient mental health or substance abuse treatment visits in the past year.</description>
          <population>Participants who attended the 12 month follow-up assessment and completed the questions regarding mental health and substance abuse visits.</population>
          <units>visits</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="68"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.03" spread="2.95"/>
                    <measurement group_id="O2" value="1.21" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.</non_inferiority_desc>
            <p_value>0.172</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Depressive and Anxiety Symptoms (CES-D)</title>
        <description>The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening test for depression and depressive disorder. The total score is a sum which ranges from 0-60. Higher scores indicate the presence of more symptomatology.&#xD;
Radloff, L.S. (1977) 'The CES-D scale: A self report depression scale for research in the general population'. Applied Psychological Measurement 1: 385-401.</description>
        <time_frame>approximately 1 year</time_frame>
        <population>Participants who attended the 12 month follow-up assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cognitive-Behavioral Group Therapy</title>
            <description>Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care - Cognitive-Behavioral Group Therapy</title>
            <description>Stress Management Class delivered in public housing sites by only a clinician</description>
          </group>
        </group_list>
        <measure>
          <title>Depressive and Anxiety Symptoms (CES-D)</title>
          <description>The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening test for depression and depressive disorder. The total score is a sum which ranges from 0-60. Higher scores indicate the presence of more symptomatology.&#xD;
Radloff, L.S. (1977) 'The CES-D scale: A self report depression scale for research in the general population'. Applied Psychological Measurement 1: 385-401.</description>
          <population>Participants who attended the 12 month follow-up assessment.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" lower_limit="9" upper_limit="21"/>
                    <measurement group_id="O2" value="15" lower_limit="9" upper_limit="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Are CES-D scores at 12 months different between groups?</groups_desc>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.</non_inferiority_desc>
            <p_value>0.5337</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Parenting Stress</title>
        <description>Parenting Stress Index Short Form by Richard R. Abidin (total score (36 questions) and 3 subscales (12 questions each) was used to describe parenting stress. Scores were created by summing the responses and then translated to percentiles for normative data (provided by the publisher). The total score represents an overall level of experienced parenting stress. A score 90 or above indicates experiencing clinically significant levels of stress. The subscale Parental Distress measures distress that the parent is experiencing related to parenting. High scores indicate more distress. The Parent-Child Dysfunctional Interaction subscale measures the parent's perception regarding a child meeting expectations and reinforcing interactions with the child. High scores indicate a parent-child bond that is threatened or not adequately established. The Difficult Child subscale looks at behavioral characteristics of children. Higher scores indicating difficulty managing the child's behavior.</description>
        <time_frame>1 year</time_frame>
        <population>This questionnaire was only administered to participants who had a child 8 years or older. Results are from participants who attended the 12 month follow-up assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cognitive-Behavioral Group Therapy</title>
            <description>Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care - Cognitive-Behavioral Group Therapy</title>
            <description>Stress Management Class delivered in public housing sites by only a clinician</description>
          </group>
        </group_list>
        <measure>
          <title>Parenting Stress</title>
          <description>Parenting Stress Index Short Form by Richard R. Abidin (total score (36 questions) and 3 subscales (12 questions each) was used to describe parenting stress. Scores were created by summing the responses and then translated to percentiles for normative data (provided by the publisher). The total score represents an overall level of experienced parenting stress. A score 90 or above indicates experiencing clinically significant levels of stress. The subscale Parental Distress measures distress that the parent is experiencing related to parenting. High scores indicate more distress. The Parent-Child Dysfunctional Interaction subscale measures the parent's perception regarding a child meeting expectations and reinforcing interactions with the child. High scores indicate a parent-child bond that is threatened or not adequately established. The Difficult Child subscale looks at behavioral characteristics of children. Higher scores indicating difficulty managing the child's behavior.</description>
          <population>This questionnaire was only administered to participants who had a child 8 years or older. Results are from participants who attended the 12 month follow-up assessment.</population>
          <units>percentile</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="28"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Parental Distress</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65" lower_limit="32.5" upper_limit="90"/>
                    <measurement group_id="O2" value="50" lower_limit="1" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Parent-Child Dysfunctional Interaction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.5" lower_limit="7.5" upper_limit="85"/>
                    <measurement group_id="O2" value="20" lower_limit="5" upper_limit="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Difficult Child</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="57.5" lower_limit="15" upper_limit="80"/>
                    <measurement group_id="O2" value="10" lower_limit="1" upper_limit="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65" lower_limit="25" upper_limit="85"/>
                    <measurement group_id="O2" value="15" lower_limit="5" upper_limit="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.</non_inferiority_desc>
            <p_value>0.0920</p_value>
            <p_value_desc>This test looks at a difference in Parental Distress at the 12 month follow-up between groups.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.</non_inferiority_desc>
            <p_value>0.3352</p_value>
            <p_value_desc>This test looks at a difference in Parent-Child Dysfunctional Interaction at the 12 month follow-up between groups.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.</non_inferiority_desc>
            <p_value>0.0404</p_value>
            <p_value_desc>This test looks at a difference in Difficult Child at the 12 month follow-up between groups.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>A Wilcoxon-Mann-Whitney test was used to test for equivalence. A p-value of 0.05 was used to determine if the difference falls out of the equivalence limits.</non_inferiority_desc>
            <p_value>0.0915</p_value>
            <p_value_desc>This test looks at a difference in PSI total score (percentile) at the 12 month follow-up between groups.</p_value_desc>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Gainful Employment</title>
        <description>Measure of subject's ability to obtain gainful employment</description>
        <time_frame>1 year</time_frame>
        <population>Participants who attended 12 month follow-up assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Cognitive-Behavioral Group Therapy</title>
            <description>Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care - Cognitive-Behavioral Group Therapy</title>
            <description>Stress Management Class delivered in public housing sites by only a clinician</description>
          </group>
        </group_list>
        <measure>
          <title>Gainful Employment</title>
          <description>Measure of subject's ability to obtain gainful employment</description>
          <population>Participants who attended 12 month follow-up assessment.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="58"/>
                <count group_id="O2" value="47"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Work 15 hours or more for pay</title>
                  <measurement_list>
                    <measurement group_id="O1" value="19"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Does not work 15 hours or more for pay</title>
                  <measurement_list>
                    <measurement group_id="O1" value="39"/>
                    <measurement group_id="O2" value="36"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Equivalence</non_inferiority_type>
            <non_inferiority_desc>Chi-square was used with a p-value of 0.05 to determine if the difference was statistically greater than 0.</non_inferiority_desc>
            <p_value>0.2914</p_value>
            <method>Chi-squared</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Implementation Cost</title>
        <description>The implementation cost of providing a 8 session Stress Management (SM) Series (with 1 active series at a time) for both Standard of care with only a clinician, and also for a clinician and CMHA. The implementation costs include startup costs and on-going costs. On-going costs include staff salary, travel time, cell phones, space, and materials).</description>
        <time_frame>1 series</time_frame>
        <population>Since we are looking at implementation cost this measure isn't participant based, but calculated on what it would cost to run one series.</population>
        <group_list>
          <group group_id="O1">
            <title>Cognitive-Behavioral Group Therapy</title>
            <description>Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador</description>
          </group>
          <group group_id="O2">
            <title>Standard of Care - Cognitive-Behavioral Group Therapy</title>
            <description>Stress Management Class delivered in public housing sites by only a clinician</description>
          </group>
        </group_list>
        <measure>
          <title>Implementation Cost</title>
          <description>The implementation cost of providing a 8 session Stress Management (SM) Series (with 1 active series at a time) for both Standard of care with only a clinician, and also for a clinician and CMHA. The implementation costs include startup costs and on-going costs. On-going costs include staff salary, travel time, cell phones, space, and materials).</description>
          <population>Since we are looking at implementation cost this measure isn't participant based, but calculated on what it would cost to run one series.</population>
          <units>American Dollars</units>
          <param>Number</param>
          <units_analyzed>1 SM series</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="NA"/>
                <count group_id="O2" value="NA"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>1 SM series</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1"/>
                <count group_id="O2" value="1"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11350"/>
                    <measurement group_id="O2" value="10471"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data was monitored for all enrolled participants beginning at enrollment. This continued through engagement in the intervention and all follow-up (1 year post intervention).</time_frame>
      <desc>The definition does not differ.&#xD;
Methods for reporting adverse events: any serious, unanticipated and related adverse events or unanticipated problems involving risks to subjects or others will be reported in writing within 48 hours to the HIC and any appropriate funding and regulatory agencies. Fellow investigators and study personnel will be informed through regular study meetings and study sponsors will be informed within 5 days of the event becoming known to the principal investigator.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cognitive-Behavioral Group Therapy</title>
          <description>Stress Management Class delivered in public housing sites by both a clinician and Community Mental Health Ambassador</description>
        </group>
        <group group_id="E2">
          <title>Standard of Care - Cognitive-Behavioral Group Therapy</title>
          <description>Stress Management Class delivered in public housing sites by only a clinician</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="87"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="67"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Limitations include subjects self-selected to participate and uncertainty in the representativeness of our sample to all residents of public housing. The ICER could not be calculated due to similarity in CES-D scores in both groups.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Megan Smith</name_or_title>
      <organization>Yale University</organization>
      <phone>2037648655</phone>
      <email>megan.smith@yale.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01665872
org study id: 1010007484
secondary id: 5CCEWH1110210501
nct id: NCT01665872
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Phase II of the MOMS Partnership aims to:

        1. conduct a needs assessment of the mental health of mothers residing in New Haven, CT;

        2. provide on-site group intervention services (randomized by housing community) to improve
           signs/symptoms of depression/stress/trauma among mothers living onsite.
The purpose of this project is to expand and enhance the New Haven Mental health Outreach for
      Mothers (MOMs) Coalition beyond pregnancy and depression to include a broader definition of
      mental illness (depressive, anxiety, and substance use disorders), and a larger target
      population (low-income, racially and ethnically diverse, pregnant and parenting women) in the
      City of New Haven. Through this expansion, the Coalition will bring together the community of
      women, their families and advocates, healthcare providers, policy and agency leaders, and
      academics, to inform the development and conduct of public health approaches around the
      mental health of low-income, racially and ethnically diverse, pregnant and parenting women.
      The specific goals of this Phase I proposal are:

        1. To conduct a community-led needs assessment on the mental health of low-income,
           ethnically and racially diverse pregnant and parenting women in the City of New Haven.

        2. To provide randomized intervention services to improve signs/symptoms of
           depression/stress/trauma among mothers living in public housing in New Haven, CT
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Total Outpatient Mental Health or Substance Abuse Visits
time frame: 1 year
description: Self-report questionnaire which measure attitudes toward seeking mental health treatment. This is defined by looking at total number of outpatient mental health or substance abuse treatment visits in the past year.
measure: Depressive and Anxiety Symptoms (CES-D)
time frame: approximately 1 year
description: The Center for Epidemiologic Studies Depression Scale (CES-D) is a screening test for depression and depressive disorder. The total score is a sum which ranges from 0-60. Higher scores indicate the presence of more symptomatology.
Radloff, L.S. (1977) 'The CES-D scale: A self report depression scale for research in the general population'. Applied Psychological Measurement 1: 385-401.
measure: Parenting Stress
time frame: 1 year
description: Parenting Stress Index Short Form by Richard R. Abidin (total score (36 questions) and 3 subscales (12 questions each) was used to describe parenting stress. Scores were created by summing the responses and then translated to percentiles for normative data (provided by the publisher). The total score represents an overall level of experienced parenting stress. A score 90 or above indicates experiencing clinically significant levels of stress. The subscale Parental Distress measures distress that the parent is experiencing related to parenting. High scores indicate more distress. The Parent-Child Dysfunctional Interaction subscale measures the parent's perception regarding a child meeting expectations and reinforcing interactions with the child. High scores indicate a parent-child bond that is threatened or not adequately established. The Difficult Child subscale looks at behavioral characteristics of children. Higher scores indicating difficulty managing the child's behavior.
measure: Gainful Employment
time frame: 1 year
description: Measure of subject's ability to obtain gainful employment
measure: Implementation Cost
time frame: 1 series
description: The implementation cost of providing a 8 session Stress Management (SM) Series (with 1 active series at a time) for both Standard of care with only a clinician, and also for a clinician and CMHA. The implementation costs include startup costs and on-going costs. On-going costs include staff salary, travel time, cell phones, space, and materials).
arm group label: Cognitive-Behavioral Group Therapy
arm group type: Experimental
description: 8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention co-facilitated by mental health clinician and a Community Mental Health Ambassador (peer).
arm group label: Standard of care - Cognitive-Behavioral Group Therapy
arm group type: Active Comparator
description: 8-session Cognitive-Behavioral intervention based on Munoz et al's Mother Baby Manual, modified to meet the needs of mothers of children of all ages residing in public housing in New Haven, CT. Intervention administered by mental health clinician.
intervention type: Behavioral
intervention name: Cognitive-Behavioral Group Therapy
description: CBT Group
arm group label: Cognitive-Behavioral Group Therapy
arm group label: Standard of care - Cognitive-Behavioral Group Therapy
other name: CBT Group
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Megan V Smith, MPH, DrPH
role: Principal Investigator
affiliation: Yale School of Medicine
facility: 
country: United States
responsible party type: Sponsor
mesh term: Depression
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Limitations include subjects self-selected to participate and uncertainty in the representativeness of our sample to all residents of public housing. The ICER could not be calculated due to similarity in CES-D scores in both groups.
point of contact: 