<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/NCT03777046</url>
  </required_header>
  <id_info>
    <org_study_id>H44040</org_study_id>
    <nct_id>NCT03777046</nct_id>
  </id_info>
  <brief_title>Maternal Mental Health in the Hospital Setting</brief_title>
  <acronym>MMH</acronym>
  <official_title>Addressing Maternal Mental Health Needs During Pediatric Acute Care Hospitalizations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michelle Lopez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baylor College of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Perinatal (around the time of birth) mental health disorders are common difficulties of&#xD;
      pregnancy. Perinatal depression is made up of major and minor depressive events during&#xD;
      pregnancy and the first 12 months after delivery. It is estimated that 11%-19% of mothers&#xD;
      suffer from perinatal depression. However, rates may be significantly higher among some&#xD;
      subpopulations.&#xD;
&#xD;
      Left untreated, post partum depression (PPD) is linked with several significant negative&#xD;
      health impacts on the mother, her infant, and their families. PPD is linked with lower&#xD;
      quality maternal-child relationship, and this change in emotional attachment can lead to&#xD;
      physiologic changes and poorer cognitive outcomes in the infant.&#xD;
&#xD;
      The purpose of this study is to determine the maternal mental health effect of postpartum&#xD;
      depression screening and intervention during infants' short term hospitalizations. The study&#xD;
      is also aiming to define effects of PPD short term hospitalization interventions on maternal&#xD;
      PPD follow up and child health based on well child care (WCC), emergency department (ED)&#xD;
      visits, hospital readmissions, and parent's feelings on child's health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study participants will complete a survey about their general needs and access to resources&#xD;
      and a survey to screen for postpartum depression to determine if the participant will be&#xD;
      enrolled. Based on the answers provided, the study team may recommend that the participant&#xD;
      seek additional medical care, and may notify the participant's doctor, the child's doctor,&#xD;
      and hospital officials if the study team believes that the participant needs further medical&#xD;
      care for depression.&#xD;
&#xD;
      Half of the study participants will receive a social work consult and treatment with&#xD;
      psychology therapy in the hospital. The psychology therapy will be 2-3 fifty-minute therapy&#xD;
      sessions while the child is in the hospital. An outpatient psychiatry/psychology follow up&#xD;
      appointment will be offered if needed as per routine care.&#xD;
&#xD;
      Discharge Follow Up:&#xD;
&#xD;
      A discharge follow up questionnaire and survey will be completed on an electronic tablet&#xD;
      around the time of the baby's discharge home from the hospital or within 1 week of being at&#xD;
      home. The survey can be completed over the phone or it can be sent via email or text to&#xD;
      complete the survey online.&#xD;
&#xD;
      One Month Follow Up:&#xD;
&#xD;
      A one-time follow up questionnaire and survey will be completed 1 month after discharge from&#xD;
      the hospital. The survey can be completed in approximately 5 - 10 minutes over the phone or&#xD;
      it can be sent via email or text to complete the survey online.&#xD;
&#xD;
      The other half of the study participants will receive social work consult with information&#xD;
      about follow up options for PPD per current standard of care for mothers identified as having&#xD;
      postpartum depression in the hospital setting.&#xD;
&#xD;
      As part of this study a review of the child's medical record, including data collection, will&#xD;
      be performed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 24, 2019</start_date>
  <completion_date type="Actual">May 22, 2020</completion_date>
  <primary_completion_date type="Actual">March 13, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in PPD score</measure>
    <time_frame>at Month 1</time_frame>
    <description>PPD score will be measured using the Edinburgh Postnatal Depression Scale (EPDS). A score less than 8 suggests depression is not likely. A score of 9-11 suggests depression is possible. A score of 12-13 indicates fairly high possibility of depression. A score of 14 and higher suggest probable depression. Positive score of 1, 2 or 3 on question 10 suggests there is a suicidality risk.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">545</enrollment>
  <condition>Post Partum Depression</condition>
  <arm_group>
    <arm_group_label>Screen fail subjects</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Mothers and their babies that meet inclusion criteria for the study, but score less than 10 on the Edinburgh Postpartum Depression Scale (EPDS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PPD Control subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mothers and their babies that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PPD Intervention subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mothers and their babies that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Standard of Care (SOC)</intervention_name>
    <description>Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD.</description>
    <arm_group_label>PPD Control subjects</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>SOC with Psychology Therapy (CBT)</intervention_name>
    <description>Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital.</description>
    <arm_group_label>PPD Intervention subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age greater than or equal to 18 years old.&#xD;
&#xD;
          2. Mothers of infants ≤365 days of age admitted to the acute care floors at Texas&#xD;
             Children's Hospital Medical Center Campus and their infant based on date of birth in&#xD;
             Epic.&#xD;
&#xD;
          3. English or Spanish speaking mother.&#xD;
&#xD;
          4. Willing and able to provide informed consent.&#xD;
&#xD;
          5. Mothers with Edinburgh Postpartum Depression Scale (EPDS) score more than or equal to&#xD;
             10&#xD;
&#xD;
          6. Ability to complete study protocol.&#xD;
&#xD;
        NOTE: Inclusion item # 3 is as per their choice for bilingual mothers.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Mother and infant(s) reside outside 50-mile radius of Texas Children's Hospital&#xD;
             Medical Center Campus based on address on demographic form.&#xD;
&#xD;
          2. Mother is not the primary caregiver of infant(s) confirmed at time of informed&#xD;
             consent.&#xD;
&#xD;
          3. Enrollment in this study during previous hospitalization based on duplicate identified&#xD;
             in database.&#xD;
&#xD;
          4. Currently under care of psychiatrist or psychologist as reported in screening&#xD;
             questionnaire.&#xD;
&#xD;
        NOTE: Exclusion item #2 is self-reported by the mothers at the time of screening for&#xD;
        eligibility for the study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Based on the population being studied, only females with children that have given birth will be included.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michelle Lopez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Texas Children's Hospital/Baylor College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Texas Children's Hospital - Women's Pavilion</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Children's Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 13, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>February 11, 2023</last_update_submitted>
  <last_update_submitted_qc>February 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Baylor College of Medicine</investigator_affiliation>
    <investigator_full_name>Michelle Lopez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>PPD</keyword>
  <keyword>Post Partum</keyword>
  <keyword>Post Partum Depression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression, Postpartum</mesh_term>
    <mesh_term>Depression</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03777046
org study id: H44040
nct id: NCT03777046
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Perinatal (around the time of birth) mental health disorders are common difficulties of
      pregnancy. Perinatal depression is made up of major and minor depressive events during
      pregnancy and the first 12 months after delivery. It is estimated that 11%-19% of mothers
      suffer from perinatal depression. However, rates may be significantly higher among some
      subpopulations.

      Left untreated, post partum depression (PPD) is linked with several significant negative
      health impacts on the mother, her infant, and their families. PPD is linked with lower
      quality maternal-child relationship, and this change in emotional attachment can lead to
      physiologic changes and poorer cognitive outcomes in the infant.

      The purpose of this study is to determine the maternal mental health effect of postpartum
      depression screening and intervention during infants' short term hospitalizations. The study
      is also aiming to define effects of PPD short term hospitalization interventions on maternal
      PPD follow up and child health based on well child care (WCC), emergency department (ED)
      visits, hospital readmissions, and parent's feelings on child's health.
Study participants will complete a survey about their general needs and access to resources
      and a survey to screen for postpartum depression to determine if the participant will be
      enrolled. Based on the answers provided, the study team may recommend that the participant
      seek additional medical care, and may notify the participant's doctor, the child's doctor,
      and hospital officials if the study team believes that the participant needs further medical
      care for depression.

      Half of the study participants will receive a social work consult and treatment with
      psychology therapy in the hospital. The psychology therapy will be 2-3 fifty-minute therapy
      sessions while the child is in the hospital. An outpatient psychiatry/psychology follow up
      appointment will be offered if needed as per routine care.

      Discharge Follow Up:

      A discharge follow up questionnaire and survey will be completed on an electronic tablet
      around the time of the baby's discharge home from the hospital or within 1 week of being at
      home. The survey can be completed over the phone or it can be sent via email or text to
      complete the survey online.

      One Month Follow Up:

      A one-time follow up questionnaire and survey will be completed 1 month after discharge from
      the hospital. The survey can be completed in approximately 5 - 10 minutes over the phone or
      it can be sent via email or text to complete the survey online.

      The other half of the study participants will receive social work consult with information
      about follow up options for PPD per current standard of care for mothers identified as having
      postpartum depression in the hospital setting.

      As part of this study a review of the child's medical record, including data collection, will
      be performed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference in PPD score
time frame: at Month 1
description: PPD score will be measured using the Edinburgh Postnatal Depression Scale (EPDS). A score less than 8 suggests depression is not likely. A score of 9-11 suggests depression is possible. A score of 12-13 indicates fairly high possibility of depression. A score of 14 and higher suggest probable depression. Positive score of 1, 2 or 3 on question 10 suggests there is a suicidality risk.
arm group label: Screen fail subjects
arm group type: No Intervention
description: Mothers and their babies that meet inclusion criteria for the study, but score less than 10 on the Edinburgh Postpartum Depression Scale (EPDS)
arm group label: PPD Control subjects
arm group type: Active Comparator
description: Mothers and their babies that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD.
arm group label: PPD Intervention subjects
arm group type: Experimental
description: Mothers and their babies that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital.
intervention type: Behavioral
intervention name: Standard of Care (SOC)
description: Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD.
arm group label: PPD Control subjects
intervention type: Behavioral
intervention name: SOC with Psychology Therapy (CBT)
description: Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital.
arm group label: PPD Intervention subjects
criteria: 
gender: Female
gender based: Yes
gender description: Based on the population being studied, only females with children that have given birth will be included.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Michelle Lopez, MD
role: Principal Investigator
affiliation: Texas Children's Hospital/Baylor College of Medicine
facility: 
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Baylor College of Medicine
investigator full name: Michelle Lopez
investigator title: Principal Investigator
mesh term: Depression, Postpartum
mesh term: Depression
sharing ipd: No