<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/NCT02979444</url>
  </required_header>
  <id_info>
    <org_study_id>STU00203761</org_study_id>
    <nct_id>NCT02979444</nct_id>
  </id_info>
  <brief_title>Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression</brief_title>
  <official_title>Comparing the Effectiveness of Clinicians and Paraprofessionals to Reduce Disparities in Perinatal Depression</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwestern University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There is considerable evidence that most perinatal women at risk for postpartum depression do&#xD;
      not engage in mental health services, even when referred by home visiting (HV) programs,&#xD;
      primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be&#xD;
      delivered via alternative settings-e.g., HV programs-are essential to prevent the onset of&#xD;
      major depression and worsening of depressive symptoms among perinatal women. This Patient&#xD;
      Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the&#xD;
      Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is&#xD;
      more efficacious than usual care (i.e., home visiting without the MB enhancement). It will&#xD;
      also examine if MB, when led by paraprofessional home visitors, is not inferior to MB&#xD;
      delivered by mental health professionals. The results of this study will inform&#xD;
      decision-making by HV programs regarding provision of MB to perinatal women at risk for&#xD;
      developing major depression.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study Aims:&#xD;
&#xD;
      Aim #1 is to conduct a superiority trial that compares the efficacy of MB delivered by&#xD;
      paraprofessional home visitors versus usual care (i.e., home visiting without MB) on&#xD;
      patient-reported outcomes, including depressive symptoms, quality of life, parenting&#xD;
      practices, engagement in pleasant activities, and relationship with one's partner.&#xD;
&#xD;
      Aim #2 is to conduct a non-inferiority trial that compares the effectiveness of MB delivered&#xD;
      by (a) mental health clinicians versus (b) paraprofessional home visitors.&#xD;
&#xD;
      Aim #3 is to evaluate whether effectiveness of the two versions of MB (clinician led vs.&#xD;
      paraprofessional home visitor led) varies according to patient characteristics (e.g., race,&#xD;
      ethnicity, first-time mother, and/or geographic type of home visiting (HV) program (i.e.,&#xD;
      urban vs. rural).&#xD;
&#xD;
      Aim #4 is to examine the feasibility and acceptability of MB delivered by paraprofessional&#xD;
      home visitors and mental health clinicians.&#xD;
&#xD;
      Postpartum depression is a serious mental health disorder that poses significant health and&#xD;
      mental health risks for mothers and their infants. Research suggests that prevalence rates of&#xD;
      postpartum depression are higher among low-income women than among middle-or high-income&#xD;
      women. There is also consistent evidence that low-income women are less likely to receive&#xD;
      mental health services in the perinatal (i.e., pregnancy until child's first birthday) period&#xD;
      than their more affluent counterparts due to a variety of factors including stigma related to&#xD;
      mental health service use and lack of access to community-based mental health providers.&#xD;
      Postpartum depression is a particularly serious problem for low-income women, as it has the&#xD;
      potential to create two generations of suffering, for both mother and child. It is estimated&#xD;
      that over 10% of low-income infants have a mother who has major depression and more than 50%&#xD;
      have a mother with some depressive symptoms. Postpartum depression has negative consequences&#xD;
      for maternal parenting practices. Compared with women not suffering from postpartum&#xD;
      depression, depressed women tend to be less positive, less spontaneous, and less responsive&#xD;
      with their infants. Postpartum depression has been linked to developmental delays among&#xD;
      infants of depressed mothers, including social interaction difficulties, attachment&#xD;
      insecurity, and cognitive impairments.&#xD;
&#xD;
      Home visiting (HV) programs that provide services to perinatal women are one of the largest&#xD;
      avenues through which perinatal women come to the attention of service providers, making HV a&#xD;
      unique and viable setting for delivering mental health services. Although professional HV&#xD;
      models exist (e.g., Nurse-Family Partnership), most HV programs in the United States use&#xD;
      paraprofessionals. Previously, study investigators have established the efficacy of a&#xD;
      group-based intervention -the Mothers and Babies (MB) Course-in preventing the onset of&#xD;
      postpartum depression and reducing depressive symptoms when led by mental health&#xD;
      professionals. However, to date there are no interventions led by non-health or non-mental&#xD;
      health professionals that have demonstrated efficacy in preventing the onset and worsening of&#xD;
      postpartum depression among low-income women. This project attempts to fill this notable gap.&#xD;
&#xD;
      The investigators will conduct a cluster randomized trial in which HV clients receive either&#xD;
      a) MB delivered by mental health professionals, b) MB delivered by paraprofessional home&#xD;
      visitors, or c) usual home visiting services. This study design will allow the investigators&#xD;
      to conduct a superiority trial that compares the efficacy of MB delivered by paraprofessional&#xD;
      home visitors versus usual care. A superiority trial will allow the investigators to generate&#xD;
      efficacy data on MB delivered by paraprofessional home visitors. The study design will also&#xD;
      allow the investigators to conduct a non-inferiority trial that compares the effectiveness of&#xD;
      MB delivered by mental health professionals versus paraprofessional home visitors. Should the&#xD;
      investigators find that paraprofessional home visitors are not inferior to mental health&#xD;
      professionals in delivering the intervention, HV programs throughout the United States will&#xD;
      be able to implement the MB Course with paraprofessional home visitors-an approach that is&#xD;
      considerably more efficient and cost-effective than employing mental health professionals.&#xD;
&#xD;
      This study was born out of community stakeholders' need and desire for a low-cost&#xD;
      intervention that could prevent the onset and worsening of depression among low-income women&#xD;
      enrolled in HV programs. Maternal depression is an enormous challenge facing HV programs.&#xD;
      However, there is consistent evidence that low-income women exhibiting depressive&#xD;
      symptoms-including women enrolled in HV programs-do not access mental health treatment in the&#xD;
      community. Lack of available mental health professionals, stigma in seeking mental health&#xD;
      services, and logistical challenges (e.g., childcare, transportation) are a few of the&#xD;
      barriers faced by perinatal women seeking mental health services. For those clients who do&#xD;
      access services, most perinatal women are likely to receive pharmacological treatments,&#xD;
      despite the fact that the vast majority of perinatal women prefer non-pharmacologic&#xD;
      interventions.&#xD;
&#xD;
      HV programs are ideal settings for delivering mental health care to perinatal women because&#xD;
      their mission is not stigmatizing and HV programs tend to be trusted entities in the&#xD;
      communities they serve. However, there is not yet an evidence-based intervention that can be&#xD;
      delivered by paraprofessionals (such as home visitors), thereby limiting HV programs'&#xD;
      capacity to meet the needs of their clients needing mental health services.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2016</start_date>
  <completion_date type="Actual">August 13, 2020</completion_date>
  <primary_completion_date type="Actual">August 5, 2019</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>Factorial Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum</measure>
    <time_frame>Baseline and 12 and 24-week postpartum follow-up</time_frame>
    <description>Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16). The QIDS-SR16 was used to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual symptom criteria. Total scores range from 0-27; higher scores indicate greater symptomatology. The investigators anticipate a clinically meaningfully difference to be on the order of five points (as this is the difference in score on each severity level of depression) (Trivedi et al., 2004). For our non-inferiority analyses comparing MB led by home visitors vs. MB led by mental health clinicians, we will have &gt;85% power to detect a difference difference in mean QIDS-16 scores of two points between the two active intervention arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum</measure>
    <time_frame>Baseline and 12 and 24-week postpartum follow-ups</time_frame>
    <description>Behavioral Activation will be measured using the Behavioral Activation Depression Scale (BADS). The BADS assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategies. It examines changes in the following areas: activation, avoidance/ rumination, work/school impairment, and social impairment. The BADS consists of 25 items, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). The range of the scale is 0-64. For the total scale, higher scores represent increased activation. The BADS has demonstrated strong internal consistency, construct validity, and predictive validity (Kanter et al, 2007; Kanter et al., 2009).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Change in the Negative Mood Regulation Scale</measure>
    <time_frame>Baseline and 12 and 24-week postpartum follow-ups</time_frame>
    <description>Mood regulation will be measured using the 30-item Negative Mood Regulation Scale (NMRS) (Catanzaro &amp; Means, 1990). For each question, respondents use a 5-point scale to indicate what they believe they can do when they are disappointed or experiencing a negative mood. For our analyses, these items were averaged to create a mean NMRS score (range 1-5). Higher scores indicate a greater ability to regulate one's mood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum</measure>
    <time_frame>Baseline and 12 and 24-week follow-ups</time_frame>
    <description>Social support will be measured using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne &amp; Stewart, 1991). This brief self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction. The range is 1-5 with greater scores indicating more perceived social support.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum</measure>
    <time_frame>Baseline and 12 and 24-week follow-ups</time_frame>
    <description>Decentering will be measured using the Experiences Questionnaire (EQ) (Fresco et al., 2007). The EQ is a 20 item self-report scale designed to measure decentering and rumination, which has demonstrated strong internal consistency in a number of studies examining effects of interventions that incorporate cognitive restructuring techniques. Response choices are on a 1-5 scale. For the purposes of our analyses, we created a mean EQ score (range 1-5), with higher scores indicating more decentering/rumination.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">874</enrollment>
  <condition>Perinatal Depression</condition>
  <condition>PostPartum Depression</condition>
  <arm_group>
    <arm_group_label>Mothers and Babies Groups Home-Visitor</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mothers and Babies Groups Clinician</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mothers and Babies Groups</intervention_name>
    <description>The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
    <arm_group_label>Mothers and Babies Groups Clinician</arm_group_label>
    <arm_group_label>Mothers and Babies Groups Home-Visitor</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The investigators will enroll only pregnant women in this study, given that the&#xD;
             Mothers and Babies Course is delivered prenatally as a postpartum depression&#xD;
             prevention intervention. The investigators will offer participation to prenatal home&#xD;
             visiting clients, ages 16 and older, knowing the client base for home visiting&#xD;
             programs includes pregnant teens.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women with high-risk medical and pregnancy conditions will be excluded since this may&#xD;
             preclude women from regularly attending intervention sessions. The investigators will&#xD;
             not exclude women based on race/ethnicity or based on demographic characteristics&#xD;
             other than the ability to speak English or Spanish.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Darius Tandon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Abrams LS, Dornig K, Curran L. Barriers to service use for postpartum depression symptoms among low-income ethnic minority mothers in the United States. Qual Health Res. 2009 Apr;19(4):535-51. doi: 10.1177/1049732309332794.</citation>
    <PMID>19299758</PMID>
  </reference>
  <reference>
    <citation>Catanzaro SJ, Mearns J. Measuring generalized expectancies for negative mood regulation: initial scale development and implications. J Pers Assess. 1990 Summer;54(3-4):546-63. doi: 10.1080/00223891.1990.9674019.</citation>
    <PMID>2348341</PMID>
  </reference>
  <reference>
    <citation>Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.</citation>
    <PMID>3651732</PMID>
  </reference>
  <reference>
    <citation>Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD, Williams JM. Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering. Behav Ther. 2007 Sep;38(3):234-46. doi: 10.1016/j.beth.2006.08.003. Epub 2007 Apr 24.</citation>
    <PMID>17697849</PMID>
  </reference>
  <reference>
    <citation>Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available.</citation>
    <PMID>15760246</PMID>
  </reference>
  <reference>
    <citation>Grace SL, Evindar A, Stewart DE. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Womens Ment Health. 2003 Nov;6(4):263-74. doi: 10.1007/s00737-003-0024-6.</citation>
    <PMID>14628179</PMID>
  </reference>
  <reference>
    <citation>Huybrechts KF, Palmsten K, Mogun H, Kowal M, Avorn J, Setoguchi-Iwata S, Hernandez-Diaz S. National trends in antidepressant medication treatment among publicly insured pregnant women. Gen Hosp Psychiatry. 2013 May-Jun;35(3):265-71. doi: 10.1016/j.genhosppsych.2012.12.010. Epub 2013 Jan 30.</citation>
    <PMID>23374897</PMID>
  </reference>
  <reference>
    <citation>Leis JA, Mendelson T, Perry DF, Tandon SD. Perceptions of mental health services among low-income, perinatal African-American women. Womens Health Issues. 2011 Jul-Aug;21(4):314-9. doi: 10.1016/j.whi.2011.03.005.</citation>
    <PMID>21712144</PMID>
  </reference>
  <reference>
    <citation>Meijer JL, Beijers C, van Pampus MG, Verbeek T, Stolk RP, Milgrom J, Bockting CL, Burger H. Predictive accuracy of Edinburgh postnatal depression scale assessment during pregnancy for the risk of developing postpartum depressive symptoms: a prospective cohort study. BJOG. 2014 Dec;121(13):1604-10. doi: 10.1111/1471-0528.12759. Epub 2014 Apr 7.</citation>
    <PMID>24703235</PMID>
  </reference>
  <reference>
    <citation>Rich-Edwards JW, Kleinman K, Abrams A, Harlow BL, McLaughlin TJ, Joffe H, Gillman MW. Sociodemographic predictors of antenatal and postpartum depressive symptoms among women in a medical group practice. J Epidemiol Community Health. 2006 Mar;60(3):221-7. doi: 10.1136/jech.2005.039370.</citation>
    <PMID>16476752</PMID>
  </reference>
  <reference>
    <citation>Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.</citation>
    <PMID>2035047</PMID>
  </reference>
  <reference>
    <citation>Sohr-Preston SL, Scaramella LV. Implications of timing of maternal depressive symptoms for early cognitive and language development. Clin Child Fam Psychol Rev. 2006 Mar;9(1):65-83. doi: 10.1007/s10567-006-0004-2.</citation>
    <PMID>16817009</PMID>
  </reference>
  <reference>
    <citation>Trivedi MH, Rush AJ, Ibrahim HM, Carmody TJ, Biggs MM, Suppes T, Crismon ML, Shores-Wilson K, Toprac MG, Dennehy EB, Witte B, Kashner TM. The Inventory of Depressive Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation. Psychol Med. 2004 Jan;34(1):73-82. doi: 10.1017/s0033291703001107.</citation>
    <PMID>14971628</PMID>
  </reference>
  <reference>
    <citation>van Doesum KTM, Hosman CMH, Riksen-Walraven JM, Hoefnagels C. Correlates of depressed mothers' sensitivity toward their infants: the role of maternal, child, and contextual characteristics. J Am Acad Child Adolesc Psychiatry. 2007 Jun;46(6):747-756. doi: 10.1097/CHI.0b013e318040b272.</citation>
    <PMID>17513987</PMID>
  </reference>
  <reference>
    <citation>Zittel-Palamara K, Rockmaker JR, Schwabel KM, Weinstein WL, Thompson SJ. Desired assistance versus care received for postpartum depression: access to care differences by race. Arch Womens Ment Health. 2008 Jun;11(2):81-92. doi: 10.1007/s00737-008-0001-1. Epub 2008 May 8.</citation>
    <PMID>18463943</PMID>
  </reference>
  <reference>
    <citation>Kanter, J.W., Mulick, P.S., Busch, A.M., Berlin, K.S., &amp; Martell, C.R. (2007). The Behavioral Activation for Depression Scale (BADS): Psychometric properties and factor structure. Journal of Psychopathology and Behavioral Assessment, 29, 191-202.</citation>
  </reference>
  <reference>
    <citation>Kanter, J.W., Rusch, L.C., Busch, A.M., &amp; Sedivy, S.K. (2009). Validation of the behavioral activation for depression scale (BADS) in a community sample with elevated depressive symptoms. Journal of Psychopathology and Behavioral Assessment, 31, 36-42.</citation>
  </reference>
  <reference>
    <citation>Teri L, Lewinsohn P. Modification of the Pleasant and Unpleasant Events Schedules for use with the elderly. J Consult Clin Psychol. 1982 Jun;50(3):444-5. doi: 10.1037//0022-006x.50.3.444. No abstract available.</citation>
    <PMID>7096747</PMID>
  </reference>
  <reference>
    <citation>O'Hara, M., &amp; Swain, A. (1996). Rates and risk of postpartum depression: A meta-analysis. International Review of Psychiatry, 8, 37-54.</citation>
  </reference>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <results_first_submitted>November 26, 2019</results_first_submitted>
  <results_first_submitted_qc>April 10, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 13, 2020</results_first_posted>
  <last_update_submitted>September 13, 2020</last_update_submitted>
  <last_update_submitted_qc>September 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Darius Tandon</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Asphyxia Neonatorum</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT02979444/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 6, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT02979444/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>All enrolled participants were randomized to one of the three study arms</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mothers and Babies Groups Home-Visitor</title>
          <description>Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components: Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
        </group>
        <group group_id="P2">
          <title>Mothers and Babies Groups Clinician</title>
          <description>Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components: Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
        </group>
        <group group_id="P3">
          <title>Control</title>
          <description>Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum. These women will receive usual home visiting services.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="405"/>
                <participants group_id="P2" count="310"/>
                <participants group_id="P3" count="159"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="382"/>
                <participants group_id="P2" count="293"/>
                <participants group_id="P3" count="149"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mothers and Babies Groups Home-Visitor</title>
          <description>Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
        </group>
        <group group_id="B2">
          <title>Mothers and Babies Groups Clinician</title>
          <description>Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
        </group>
        <group group_id="B3">
          <title>Control</title>
          <description>Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.</description>
        </group>
        <group group_id="B4">
          <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="405"/>
            <count group_id="B2" value="310"/>
            <count group_id="B3" value="159"/>
            <count group_id="B4" value="874"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.42" spread="5.82"/>
                    <measurement group_id="B2" value="25.80" spread="6.01"/>
                    <measurement group_id="B3" value="25.81" spread="5.39"/>
                    <measurement group_id="B4" value="26.09" spread="5.81"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="405"/>
                    <measurement group_id="B2" value="310"/>
                    <measurement group_id="B3" value="159"/>
                    <measurement group_id="B4" value="874"/>
                  </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 group_id="B4" 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>
              <category_list>
                <category>
                  <title>Black/African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="229"/>
                    <measurement group_id="B2" value="129"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="382"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="82"/>
                    <measurement group_id="B3" value="99"/>
                    <measurement group_id="B4" value="257"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic/Latina</title>
                  <measurement_list>
                    <measurement group_id="B1" value="63"/>
                    <measurement group_id="B2" value="79"/>
                    <measurement group_id="B3" value="24"/>
                    <measurement group_id="B4" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Biracial</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="6"/>
                    <measurement group_id="B4" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="21"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="405"/>
                    <measurement group_id="B2" value="310"/>
                    <measurement group_id="B3" value="159"/>
                    <measurement group_id="B4" value="874"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum</title>
        <description>Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16). The QIDS-SR16 was used to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual symptom criteria. Total scores range from 0-27; higher scores indicate greater symptomatology. The investigators anticipate a clinically meaningfully difference to be on the order of five points (as this is the difference in score on each severity level of depression) (Trivedi et al., 2004). For our non-inferiority analyses comparing MB led by home visitors vs. MB led by mental health clinicians, we will have &gt;85% power to detect a difference difference in mean QIDS-16 scores of two points between the two active intervention arms.</description>
        <time_frame>Baseline and 12 and 24-week postpartum follow-up</time_frame>
        <population>These numbers reflect the number of study participants with complete data at our 24-week postpartum assessment.</population>
        <group_list>
          <group group_id="O1">
            <title>Mothers and Babies Groups Home-Visitor</title>
            <description>Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
          </group>
          <group group_id="O2">
            <title>Mothers and Babies Groups Clinician</title>
            <description>Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum</title>
          <description>Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16). The QIDS-SR16 was used to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual symptom criteria. Total scores range from 0-27; higher scores indicate greater symptomatology. The investigators anticipate a clinically meaningfully difference to be on the order of five points (as this is the difference in score on each severity level of depression) (Trivedi et al., 2004). For our non-inferiority analyses comparing MB led by home visitors vs. MB led by mental health clinicians, we will have &gt;85% power to detect a difference difference in mean QIDS-16 scores of two points between the two active intervention arms.</description>
          <population>These numbers reflect the number of study participants with complete data at our 24-week postpartum assessment.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="365"/>
                <count group_id="O2" value="272"/>
                <count group_id="O3" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-Week Postpartum Time Point</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.9" spread="4.5"/>
                    <measurement group_id="O2" value="5.3" spread="4.5"/>
                    <measurement group_id="O3" value="5.8" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12- Week Postpartum Time Point</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4" spread="4.5"/>
                    <measurement group_id="O2" value="5.5" spread="4.5"/>
                    <measurement group_id="O3" value="5.9" spread="4.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="4.3"/>
                    <measurement group_id="O2" value="7.8" spread="4.3"/>
                    <measurement group_id="O3" value="6.7" spread="3.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum</title>
        <description>Behavioral Activation will be measured using the Behavioral Activation Depression Scale (BADS). The BADS assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategies. It examines changes in the following areas: activation, avoidance/ rumination, work/school impairment, and social impairment. The BADS consists of 25 items, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). The range of the scale is 0-64. For the total scale, higher scores represent increased activation. The BADS has demonstrated strong internal consistency, construct validity, and predictive validity (Kanter et al, 2007; Kanter et al., 2009).</description>
        <time_frame>Baseline and 12 and 24-week postpartum follow-ups</time_frame>
        <population>Overall number of participants analyzed at 24-weeks postpartum</population>
        <group_list>
          <group group_id="O1">
            <title>Mothers and Babies Groups Home-Visitor</title>
            <description>Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
          </group>
          <group group_id="O2">
            <title>Mothers and Babies Groups Clinician</title>
            <description>Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum</title>
          <description>Behavioral Activation will be measured using the Behavioral Activation Depression Scale (BADS). The BADS assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategies. It examines changes in the following areas: activation, avoidance/ rumination, work/school impairment, and social impairment. The BADS consists of 25 items, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). The range of the scale is 0-64. For the total scale, higher scores represent increased activation. The BADS has demonstrated strong internal consistency, construct validity, and predictive validity (Kanter et al, 2007; Kanter et al., 2009).</description>
          <population>Overall number of participants analyzed at 24-weeks postpartum</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="365"/>
                <count group_id="O2" value="272"/>
                <count group_id="O3" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-Week Postpartum Time Point</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.1"/>
                    <measurement group_id="O2" value="3.8" spread="1.1"/>
                    <measurement group_id="O3" value="4.0" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12- Week Postpartum Time Point</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.1"/>
                    <measurement group_id="O2" value="3.8" spread="1.1"/>
                    <measurement group_id="O3" value="4.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.1"/>
                    <measurement group_id="O2" value="3.8" spread="1.1"/>
                    <measurement group_id="O3" value="4.1" spread="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change in the Negative Mood Regulation Scale</title>
        <description>Mood regulation will be measured using the 30-item Negative Mood Regulation Scale (NMRS) (Catanzaro &amp; Means, 1990). For each question, respondents use a 5-point scale to indicate what they believe they can do when they are disappointed or experiencing a negative mood. For our analyses, these items were averaged to create a mean NMRS score (range 1-5). Higher scores indicate a greater ability to regulate one's mood.</description>
        <time_frame>Baseline and 12 and 24-week postpartum follow-ups</time_frame>
        <population>Participants analyzed at 24-weeks postpartum</population>
        <group_list>
          <group group_id="O1">
            <title>Mothers and Babies Groups Home-Visitor</title>
            <description>Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
          </group>
          <group group_id="O2">
            <title>Mothers and Babies Groups Clinician</title>
            <description>Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change in the Negative Mood Regulation Scale</title>
          <description>Mood regulation will be measured using the 30-item Negative Mood Regulation Scale (NMRS) (Catanzaro &amp; Means, 1990). For each question, respondents use a 5-point scale to indicate what they believe they can do when they are disappointed or experiencing a negative mood. For our analyses, these items were averaged to create a mean NMRS score (range 1-5). Higher scores indicate a greater ability to regulate one's mood.</description>
          <population>Participants analyzed at 24-weeks postpartum</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="365"/>
                <count group_id="O2" value="272"/>
                <count group_id="O3" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-Week Postpartum Time Point</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="0.6"/>
                    <measurement group_id="O2" value="3.8" spread="0.6"/>
                    <measurement group_id="O3" value="3.8" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12- Week Postpartum Time Point</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="0.6"/>
                    <measurement group_id="O2" value="3.8" spread="0.6"/>
                    <measurement group_id="O3" value="3.9" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="0.6"/>
                    <measurement group_id="O2" value="3.7" spread="0.6"/>
                    <measurement group_id="O3" value="3.9" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum</title>
        <description>Social support will be measured using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne &amp; Stewart, 1991). This brief self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction. The range is 1-5 with greater scores indicating more perceived social support.</description>
        <time_frame>Baseline and 12 and 24-week follow-ups</time_frame>
        <population>Participants analyzed at the 24-week postpartum time point</population>
        <group_list>
          <group group_id="O1">
            <title>Mothers and Babies Groups Home-Visitor</title>
            <description>Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
          </group>
          <group group_id="O2">
            <title>Mothers and Babies Groups Clinician</title>
            <description>Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum</title>
          <description>Social support will be measured using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne &amp; Stewart, 1991). This brief self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction. The range is 1-5 with greater scores indicating more perceived social support.</description>
          <population>Participants analyzed at the 24-week postpartum time point</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="365"/>
                <count group_id="O2" value="272"/>
                <count group_id="O3" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-Week Postpartum Time Point</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="1.2"/>
                    <measurement group_id="O2" value="3.8" spread="1.1"/>
                    <measurement group_id="O3" value="4.1" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12- Week Postpartum Time Point</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.8" spread="1.1"/>
                    <measurement group_id="O2" value="3.9" spread="1.2"/>
                    <measurement group_id="O3" value="4.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="1.2"/>
                    <measurement group_id="O2" value="3.7" spread="1.2"/>
                    <measurement group_id="O3" value="4.2" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum</title>
        <description>Decentering will be measured using the Experiences Questionnaire (EQ) (Fresco et al., 2007). The EQ is a 20 item self-report scale designed to measure decentering and rumination, which has demonstrated strong internal consistency in a number of studies examining effects of interventions that incorporate cognitive restructuring techniques. Response choices are on a 1-5 scale. For the purposes of our analyses, we created a mean EQ score (range 1-5), with higher scores indicating more decentering/rumination.</description>
        <time_frame>Baseline and 12 and 24-week follow-ups</time_frame>
        <population>Participants analyzed at 24-weeks postpartum</population>
        <group_list>
          <group group_id="O1">
            <title>Mothers and Babies Groups Home-Visitor</title>
            <description>Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
          </group>
          <group group_id="O2">
            <title>Mothers and Babies Groups Clinician</title>
            <description>Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
          </group>
          <group group_id="O3">
            <title>Control</title>
            <description>Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.</description>
          </group>
        </group_list>
        <measure>
          <title>The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum</title>
          <description>Decentering will be measured using the Experiences Questionnaire (EQ) (Fresco et al., 2007). The EQ is a 20 item self-report scale designed to measure decentering and rumination, which has demonstrated strong internal consistency in a number of studies examining effects of interventions that incorporate cognitive restructuring techniques. Response choices are on a 1-5 scale. For the purposes of our analyses, we created a mean EQ score (range 1-5), with higher scores indicating more decentering/rumination.</description>
          <population>Participants analyzed at 24-weeks postpartum</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="365"/>
                <count group_id="O2" value="272"/>
                <count group_id="O3" value="146"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>24-Week Postpartum Time Point</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.8"/>
                    <measurement group_id="O2" value="3.5" spread="0.7"/>
                    <measurement group_id="O3" value="3.5" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12- Week Postpartum Time Point</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.7"/>
                    <measurement group_id="O2" value="3.4" spread="0.8"/>
                    <measurement group_id="O3" value="3.5" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="0.7"/>
                    <measurement group_id="O2" value="3.4" spread="0.7"/>
                    <measurement group_id="O3" value="3.5" spread="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Between baseline assessment through our 24-week postpartum follow-up. This varied across study participants, but generally was approximately 12 months.</time_frame>
      <desc>We used the clinicaltrials.gov definition of an adverse event. All-Cause Mortality and Serious Adverse Events were not monitored/assessed.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mothers and Babies Groups Home-Visitor</title>
          <description>Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
        </group>
        <group group_id="E2">
          <title>Mothers and Babies Groups Clinician</title>
          <description>Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.&#xD;
Mothers and Babies Groups: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a &quot;toolkit&quot; of approaches they can use to improve their mood.</description>
        </group>
        <group group_id="E3">
          <title>Control</title>
          <description>Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.</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="405"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="159"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="405"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="159"/>
              </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="405"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="310"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="159"/>
              </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>Our overall sample's baseline depressive symptom score falls in the mild symptom range of the QIDS. There may have been a potential flooring effect in which there was less room to demonstrate improvement in symptom reduction.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Darius Tandon, PhD</name_or_title>
      <organization>Northwestern University Feinberg School of Medicine</organization>
      <phone>410-852-0399</phone>
      <email>dtandon@northwestern.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/NCT02979444
org study id: STU00203761
nct id: NCT02979444
lead sponsor: 
has dmc: No
There is considerable evidence that most perinatal women at risk for postpartum depression do
      not engage in mental health services, even when referred by home visiting (HV) programs,
      primary care physicians, obstetricians, or gynecologists. Thus, interventions that can be
      delivered via alternative settings-e.g., HV programs-are essential to prevent the onset of
      major depression and worsening of depressive symptoms among perinatal women. This Patient
      Centered Outcomes Research Institute (PCORI) funded project aims to evaluate whether the
      Mothers and Babies (MB) group intervention, when led by paraprofessional home visitors, is
      more efficacious than usual care (i.e., home visiting without the MB enhancement). It will
      also examine if MB, when led by paraprofessional home visitors, is not inferior to MB
      delivered by mental health professionals. The results of this study will inform
      decision-making by HV programs regarding provision of MB to perinatal women at risk for
      developing major depression.
Study Aims:

      Aim #1 is to conduct a superiority trial that compares the efficacy of MB delivered by
      paraprofessional home visitors versus usual care (i.e., home visiting without MB) on
      patient-reported outcomes, including depressive symptoms, quality of life, parenting
      practices, engagement in pleasant activities, and relationship with one's partner.

      Aim #2 is to conduct a non-inferiority trial that compares the effectiveness of MB delivered
      by (a) mental health clinicians versus (b) paraprofessional home visitors.

      Aim #3 is to evaluate whether effectiveness of the two versions of MB (clinician led vs.
      paraprofessional home visitor led) varies according to patient characteristics (e.g., race,
      ethnicity, first-time mother, and/or geographic type of home visiting (HV) program (i.e.,
      urban vs. rural).

      Aim #4 is to examine the feasibility and acceptability of MB delivered by paraprofessional
      home visitors and mental health clinicians.

      Postpartum depression is a serious mental health disorder that poses significant health and
      mental health risks for mothers and their infants. Research suggests that prevalence rates of
      postpartum depression are higher among low-income women than among middle-or high-income
      women. There is also consistent evidence that low-income women are less likely to receive
      mental health services in the perinatal (i.e., pregnancy until child's first birthday) period
      than their more affluent counterparts due to a variety of factors including stigma related to
      mental health service use and lack of access to community-based mental health providers.
      Postpartum depression is a particularly serious problem for low-income women, as it has the
      potential to create two generations of suffering, for both mother and child. It is estimated
      that over 10% of low-income infants have a mother who has major depression and more than 50%
      have a mother with some depressive symptoms. Postpartum depression has negative consequences
      for maternal parenting practices. Compared with women not suffering from postpartum
      depression, depressed women tend to be less positive, less spontaneous, and less responsive
      with their infants. Postpartum depression has been linked to developmental delays among
      infants of depressed mothers, including social interaction difficulties, attachment
      insecurity, and cognitive impairments.

      Home visiting (HV) programs that provide services to perinatal women are one of the largest
      avenues through which perinatal women come to the attention of service providers, making HV a
      unique and viable setting for delivering mental health services. Although professional HV
      models exist (e.g., Nurse-Family Partnership), most HV programs in the United States use
      paraprofessionals. Previously, study investigators have established the efficacy of a
      group-based intervention -the Mothers and Babies (MB) Course-in preventing the onset of
      postpartum depression and reducing depressive symptoms when led by mental health
      professionals. However, to date there are no interventions led by non-health or non-mental
      health professionals that have demonstrated efficacy in preventing the onset and worsening of
      postpartum depression among low-income women. This project attempts to fill this notable gap.

      The investigators will conduct a cluster randomized trial in which HV clients receive either
      a) MB delivered by mental health professionals, b) MB delivered by paraprofessional home
      visitors, or c) usual home visiting services. This study design will allow the investigators
      to conduct a superiority trial that compares the efficacy of MB delivered by paraprofessional
      home visitors versus usual care. A superiority trial will allow the investigators to generate
      efficacy data on MB delivered by paraprofessional home visitors. The study design will also
      allow the investigators to conduct a non-inferiority trial that compares the effectiveness of
      MB delivered by mental health professionals versus paraprofessional home visitors. Should the
      investigators find that paraprofessional home visitors are not inferior to mental health
      professionals in delivering the intervention, HV programs throughout the United States will
      be able to implement the MB Course with paraprofessional home visitors-an approach that is
      considerably more efficient and cost-effective than employing mental health professionals.

      This study was born out of community stakeholders' need and desire for a low-cost
      intervention that could prevent the onset and worsening of depression among low-income women
      enrolled in HV programs. Maternal depression is an enormous challenge facing HV programs.
      However, there is consistent evidence that low-income women exhibiting depressive
      symptoms-including women enrolled in HV programs-do not access mental health treatment in the
      community. Lack of available mental health professionals, stigma in seeking mental health
      services, and logistical challenges (e.g., childcare, transportation) are a few of the
      barriers faced by perinatal women seeking mental health services. For those clients who do
      access services, most perinatal women are likely to receive pharmacological treatments,
      despite the fact that the vast majority of perinatal women prefer non-pharmacologic
      interventions.

      HV programs are ideal settings for delivering mental health care to perinatal women because
      their mission is not stigmatizing and HV programs tend to be trusted entities in the
      communities they serve. However, there is not yet an evidence-based intervention that can be
      delivered by paraprofessionals (such as home visitors), thereby limiting HV programs'
      capacity to meet the needs of their clients needing mental health services.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: The Change in QIDS-16 Scores From Baseline to 24 Weeks Postpartum
time frame: Baseline and 12 and 24-week postpartum follow-up
description: Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR16). The QIDS-SR16 was used to assess severity of depressive symptoms consistent with Diagnostic and Statistical Manual symptom criteria. Total scores range from 0-27; higher scores indicate greater symptomatology. The investigators anticipate a clinically meaningfully difference to be on the order of five points (as this is the difference in score on each severity level of depression) (Trivedi et al., 2004). For our non-inferiority analyses comparing MB led by home visitors vs. MB led by mental health clinicians, we will have >85% power to detect a difference difference in mean QIDS-16 scores of two points between the two active intervention arms.
measure: The Change in the Behavioral Activation Scale From Baseline to 24-weeks Postpartum
time frame: Baseline and 12 and 24-week postpartum follow-ups
description: Behavioral Activation will be measured using the Behavioral Activation Depression Scale (BADS). The BADS assesses behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation strategies. It examines changes in the following areas: activation, avoidance/ rumination, work/school impairment, and social impairment. The BADS consists of 25 items, each rated on a seven point scale ranging from 0 (not at all) to 6 (completely). The range of the scale is 0-64. For the total scale, higher scores represent increased activation. The BADS has demonstrated strong internal consistency, construct validity, and predictive validity (Kanter et al, 2007; Kanter et al., 2009).
measure: The Change in the Negative Mood Regulation Scale
time frame: Baseline and 12 and 24-week postpartum follow-ups
description: Mood regulation will be measured using the 30-item Negative Mood Regulation Scale (NMRS) (Catanzaro & Means, 1990). For each question, respondents use a 5-point scale to indicate what they believe they can do when they are disappointed or experiencing a negative mood. For our analyses, these items were averaged to create a mean NMRS score (range 1-5). Higher scores indicate a greater ability to regulate one's mood.
measure: The Change in the MOS Social Support Survey From Baseline to 24-Weeks Postpartum
time frame: Baseline and 12 and 24-week follow-ups
description: Social support will be measured using the 19-item Medical Outcomes Study Social Support Survey (MOS-SSS) (Sherbourne & Stewart, 1991). This brief self-administered survey includes an overall functional social support index, as well as four functional support subscales: affectionate, emotional/informational, tangible, and positive social interaction. The range is 1-5 with greater scores indicating more perceived social support.
measure: The Change in the Experiences Questionnaire From Baseline to 24-Weeks Postpartum
time frame: Baseline and 12 and 24-week follow-ups
description: Decentering will be measured using the Experiences Questionnaire (EQ) (Fresco et al., 2007). The EQ is a 20 item self-report scale designed to measure decentering and rumination, which has demonstrated strong internal consistency in a number of studies examining effects of interventions that incorporate cognitive restructuring techniques. Response choices are on a 1-5 scale. For the purposes of our analyses, we created a mean EQ score (range 1-5), with higher scores indicating more decentering/rumination.
arm group label: Mothers and Babies Groups Home-Visitor
arm group type: Experimental
description: Women who participate in the home-visitor led arm will receive the intervention from a paraprofessional home-visitor and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.
arm group label: Mothers and Babies Groups Clinician
arm group type: Experimental
description: Women who participate in the mental health consultant led arm will receive the intervention from a mental health consultant and complete assessments at baseline, post-intervention, and 12 and 24 weeks postpartum.
arm group label: Control
arm group type: No Intervention
description: Women who participate in the control arm will not receive the intervention but will complete assessments at baseline, 8 weeks post-baseline, and 12 and 24 weeks postpartum.
intervention type: Behavioral
intervention name: Mothers and Babies Groups
description: The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a "toolkit" of approaches they can use to improve their mood.
arm group label: Mothers and Babies Groups Clinician
arm group label: Mothers and Babies Groups Home-Visitor
criteria: 
gender: Female
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Darius Tandon, PhD
role: Principal Investigator
affiliation: Northwestern University
facility: 
country: United States
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PMID: 19299758
citation: Catanzaro SJ, Mearns J. Measuring generalized expectancies for negative mood regulation: initial scale development and implications. J Pers Assess. 1990 Summer;54(3-4):546-63. doi: 10.1080/00223891.1990.9674019.
PMID: 2348341
citation: Cox JL, Holden JM, Sagovsky R. Detection of postnatal depression. Development of the 10-item Edinburgh Postnatal Depression Scale. Br J Psychiatry. 1987 Jun;150:782-6. doi: 10.1192/bjp.150.6.782.
PMID: 3651732
citation: Fresco DM, Moore MT, van Dulmen MH, Segal ZV, Ma SH, Teasdale JD, Williams JM. Initial psychometric properties of the experiences questionnaire: validation of a self-report measure of decentering. Behav Ther. 2007 Sep;38(3):234-46. doi: 10.1016/j.beth.2006.08.003. Epub 2007 Apr 24.
PMID: 17697849
citation: Gaynes BN, Gavin N, Meltzer-Brody S, Lohr KN, Swinson T, Gartlehner G, Brody S, Miller WC. Perinatal depression: prevalence, screening accuracy, and screening outcomes. Evid Rep Technol Assess (Summ). 2005 Feb;(119):1-8. doi: 10.1037/e439372005-001. No abstract available.
PMID: 15760246
citation: Grace SL, Evindar A, Stewart DE. The effect of postpartum depression on child cognitive development and behavior: a review and critical analysis of the literature. Arch Womens Ment Health. 2003 Nov;6(4):263-74. doi: 10.1007/s00737-003-0024-6.
PMID: 14628179
citation: Huybrechts KF, Palmsten K, Mogun H, Kowal M, Avorn J, Setoguchi-Iwata S, Hernandez-Diaz S. National trends in antidepressant medication treatment among publicly insured pregnant women. Gen Hosp Psychiatry. 2013 May-Jun;35(3):265-71. doi: 10.1016/j.genhosppsych.2012.12.010. Epub 2013 Jan 30.
PMID: 23374897
citation: Leis JA, Mendelson T, Perry DF, Tandon SD. Perceptions of mental health services among low-income, perinatal African-American women. Womens Health Issues. 2011 Jul-Aug;21(4):314-9. doi: 10.1016/j.whi.2011.03.005.
PMID: 21712144
citation: Meijer JL, Beijers C, van Pampus MG, Verbeek T, Stolk RP, Milgrom J, Bockting CL, Burger H. Predictive accuracy of Edinburgh postnatal depression scale assessment during pregnancy for the risk of developing postpartum depressive symptoms: a prospective cohort study. BJOG. 2014 Dec;121(13):1604-10. doi: 10.1111/1471-0528.12759. Epub 2014 Apr 7.
PMID: 24703235
citation: Rich-Edwards JW, Kleinman K, Abrams A, Harlow BL, McLaughlin TJ, Joffe H, Gillman MW. Sociodemographic predictors of antenatal and postpartum depressive symptoms among women in a medical group practice. J Epidemiol Community Health. 2006 Mar;60(3):221-7. doi: 10.1136/jech.2005.039370.
PMID: 16476752
citation: Sherbourne CD, Stewart AL. The MOS social support survey. Soc Sci Med. 1991;32(6):705-14. doi: 10.1016/0277-9536(91)90150-b.
PMID: 2035047
citation: Sohr-Preston SL, Scaramella LV. Implications of timing of maternal depressive symptoms for early cognitive and language development. Clin Child Fam Psychol Rev. 2006 Mar;9(1):65-83. doi: 10.1007/s10567-006-0004-2.
PMID: 16817009
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PMID: 14971628
citation: van Doesum KTM, Hosman CMH, Riksen-Walraven JM, Hoefnagels C. Correlates of depressed mothers' sensitivity toward their infants: the role of maternal, child, and contextual characteristics. J Am Acad Child Adolesc Psychiatry. 2007 Jun;46(6):747-756. doi: 10.1097/CHI.0b013e318040b272.
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citation: Zittel-Palamara K, Rockmaker JR, Schwabel KM, Weinstein WL, Thompson SJ. Desired assistance versus care received for postpartum depression: access to care differences by race. Arch Womens Ment Health. 2008 Jun;11(2):81-92. doi: 10.1007/s00737-008-0001-1. Epub 2008 May 8.
PMID: 18463943
citation: Kanter, J.W., Mulick, P.S., Busch, A.M., Berlin, K.S., & Martell, C.R. (2007). The Behavioral Activation for Depression Scale (BADS): Psychometric properties and factor structure. Journal of Psychopathology and Behavioral Assessment, 29, 191-202.
citation: Kanter, J.W., Rusch, L.C., Busch, A.M., & Sedivy, S.K. (2009). Validation of the behavioral activation for depression scale (BADS) in a community sample with elevated depressive symptoms. Journal of Psychopathology and Behavioral Assessment, 31, 36-42.
citation: Teri L, Lewinsohn P. Modification of the Pleasant and Unpleasant Events Schedules for use with the elderly. J Consult Clin Psychol. 1982 Jun;50(3):444-5. doi: 10.1037//0022-006x.50.3.444. No abstract available.
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responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Darius Tandon
investigator title: Associate Professor
mesh term: Depression, Postpartum
mesh term: Asphyxia Neonatorum
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Our overall sample's baseline depressive symptom score falls in the mild symptom range of the QIDS. There may have been a potential flooring effect in which there was less room to demonstrate improvement in symptom reduction.
point of contact: 