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Trial record 32 of 239 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Maternal Mental Health

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ClinicalTrials.gov Identifier: NCT03777046
Recruitment Status : Not yet recruiting
First Posted : December 17, 2018
Last Update Posted : December 17, 2018
Sponsor:
Information provided by (Responsible Party):
Michelle Lopez, Baylor College of Medicine

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.


Condition or disease Intervention/treatment Phase
Post Partum Depression Behavioral: Standard of Care (SOC) Behavioral: SOC with Psychology Therapy (CBT) Not Applicable

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1085 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ADDRESSING MATERNAL MENTAL HEALTH NEEDS DURING PEDIATRIC ACUTE CARE HOSPITALIZATIONS
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Screen fail subjects
Mothers that meet inclusion criteria for the study, but score less than 10 on the Edinburgh Postpartum Depression Scale (EPDS)
Active Comparator: PPD Control subjects
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.
Behavioral: Standard of Care (SOC)
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.

Experimental: PPD Intervention subjects
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.
Behavioral: SOC with Psychology Therapy (CBT)
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 Measures :
  1. Difference in PPD score [ Time Frame: at Month 1 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Based on the population being studied, only females with children that have given birth will be included.
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Mothers and their infant ≤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.
  2. English or Spanish speaking mother based on preferred language in Epic.
  3. Mother of 18 years old or greater.

Exclusion Criteria:

  1. Mother and infant 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777046


Contacts
Contact: Murali Gali 832-824-3301 Murali.Gali@bcm.edu

Locations
United States, Texas
Texas Children's Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Murali Gali    832-824-3301    Murali.Gali@bcm.edu   
Principal Investigator: Michelle Lopez, MD         
Sub-Investigator: Lucy Nutter, MD         
Sub-Investigator: Claire Bocchini, MD         
Sub-Investigator: Lisa Noll, PhD         
Sub-Investigator: Jean Raphael, MD, MPH         
Sub-Investigator: Alexis Wood, PhD         
Sub-Investigator: Christopher Greeley, MD         
Sub-Investigator: Bethanie Van Horne, DrPH         
Sponsors and Collaborators
Michelle Lopez
Investigators
Principal Investigator: Michelle Lopez, MD Texas Children's Hospital/Baylor College of Medicine

Responsible Party: Michelle Lopez, Principal Investigator, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT03777046     History of Changes
Other Study ID Numbers: H44040
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 17, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Michelle Lopez, Baylor College of Medicine:
PPD, Post Partum, Post Partum Depression

Additional relevant MeSH terms:
Depression
Depression, Postpartum
Behavioral Symptoms
Puerperal Disorders
Pregnancy Complications
Depressive Disorder
Mood Disorders
Mental Disorders