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Maternal Mental Health in the Hospital Setting (MMH)

Primary Purpose

Post Partum Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard of Care (SOC)
SOC with Psychology Therapy (CBT)
Sponsored by
Michelle Lopez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Partum Depression focused on measuring PPD, Post Partum, Post Partum Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age greater than or equal to 18 years old.
  2. Mothers of infants ≤365 days of age admitted to the acute care floors at Texas Children's Hospital Medical Center Campus and their infant based on date of birth in Epic.
  3. English or Spanish speaking mother.
  4. Willing and able to provide informed consent.
  5. Mothers with Edinburgh Postpartum Depression Scale (EPDS) score more than or equal to 10
  6. Ability to complete study protocol.

NOTE: Inclusion item # 3 is as per their choice for bilingual mothers.

Exclusion Criteria:

  1. Mother and infant(s) reside outside 50-mile radius of Texas Children's Hospital Medical Center Campus based on address on demographic form.
  2. Mother is not the primary caregiver of infant(s) confirmed at time of informed consent.
  3. Enrollment in this study during previous hospitalization based on duplicate identified in database.
  4. Currently under care of psychiatrist or psychologist as reported in screening questionnaire.

NOTE: Exclusion item #2 is self-reported by the mothers at the time of screening for eligibility for the study.

Sites / Locations

  • Texas Children's Hospital - Women's Pavilion
  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Active Comparator

Experimental

Arm Label

Screen fail subjects

PPD Control subjects

PPD Intervention subjects

Arm Description

Mothers and their babies that meet inclusion criteria for the study, but score less than 10 on the Edinburgh Postpartum Depression Scale (EPDS)

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.

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.

Outcomes

Primary Outcome Measures

Difference in PPD score
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.

Secondary Outcome Measures

Full Information

First Posted
December 13, 2018
Last Updated
February 11, 2023
Sponsor
Michelle Lopez
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1. Study Identification

Unique Protocol Identification Number
NCT03777046
Brief Title
Maternal Mental Health in the Hospital Setting
Acronym
MMH
Official Title
Addressing Maternal Mental Health Needs During Pediatric Acute Care Hospitalizations
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 24, 2019 (Actual)
Primary Completion Date
March 13, 2020 (Actual)
Study Completion Date
May 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michelle Lopez

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum Depression
Keywords
PPD, Post Partum, Post Partum Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
545 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Screen fail subjects
Arm Type
No Intervention
Arm 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 Title
PPD Control subjects
Arm Type
Active Comparator
Arm 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 Title
PPD Intervention subjects
Arm Type
Experimental
Arm 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(s)
Standard of Care (SOC)
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
SOC with Psychology Therapy (CBT)
Intervention 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.
Primary Outcome Measure Information:
Title
Difference in PPD score
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.
Time Frame
at Month 1

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Based on the population being studied, only females with children that have given birth will be included.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age greater than or equal to 18 years old. Mothers of infants ≤365 days of age admitted to the acute care floors at Texas Children's Hospital Medical Center Campus and their infant based on date of birth in Epic. English or Spanish speaking mother. Willing and able to provide informed consent. Mothers with Edinburgh Postpartum Depression Scale (EPDS) score more than or equal to 10 Ability to complete study protocol. NOTE: Inclusion item # 3 is as per their choice for bilingual mothers. Exclusion Criteria: Mother and infant(s) reside outside 50-mile radius of Texas Children's Hospital Medical Center Campus based on address on demographic form. Mother is not the primary caregiver of infant(s) confirmed at time of informed consent. Enrollment in this study during previous hospitalization based on duplicate identified in database. Currently under care of psychiatrist or psychologist as reported in screening questionnaire. NOTE: Exclusion item #2 is self-reported by the mothers at the time of screening for eligibility for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Lopez, MD
Organizational Affiliation
Texas Children's Hospital/Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital - Women's Pavilion
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Maternal Mental Health in the Hospital Setting

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