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NCT Number: NCT03777046

Maternal Mental Health in the Hospital Setting

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.

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Key information

Conditions

Post Partum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Texas Children's Hospital, Houston, Texas, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Standard of Care (SOC)

Behavioral

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.

SOC with Psychology Therapy (CBT)

Behavioral

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 outcomes

  1. Difference in PPD score

    Time frame: at Month 1

    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.

Sponsors and collaborators

Lead sponsor

Michelle Lopez

Other

Registry information

Official study title

Addressing Maternal Mental Health Needs During Pediatric Acute Care Hospitalizations

Acronym: MMH

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 17, 2018
Registry last updated
Feb 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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