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临床试验/NCT03777046
NCT03777046已完成不适用

Addressing Maternal Mental Health Needs During Pediatric Acute Care Hospitalizations

Michelle Lopez4 个研究点 分布在 1 个国家目标入组 545 人开始时间: 2019年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
545
试验地点
4
主要终点
Difference in PPD score

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Difference in PPD score

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Michelle Lopez
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Michelle Lopez

Principal Investigator

Baylor College of Medicine

研究点 (4)

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