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临床试验/NCT01214967
NCT01214967已完成不适用

Empowering Low Income Mothers With Preterm Infants: a Randomized Controlled Trial

Boston Medical Center4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
4
主要终点
Maternal Depressive Symptoms

研究概览

简要总结

Premature infants are born at substantial risk for poor health and developmental outcomes, which commonly include hearing and vision problems, developmental delays, and poor school performance. Premature infants of low-income families face additional social risks known to worsen these outcomes. The Institute of Medicine recognized this important public health problem in its 2006 report, Preterm Birth, which argued for the need to improve the quality of follow-up care for preterm infants discharged from the neonatal intensive care unit (NICU). The underpinning of this proposal is that maternal depression - common among families of premature infants - interferes with adherence to follow-up services, and (both through this mechanism and directly) adversely impacts child health and development. Conversely, alleviating depressive symptoms among these women represents a promising strategy to improve adherence to NICU follow-up services and to improve the outcomes of this vulnerable population.

This project aims to mitigate the adverse effects of maternal depression in this specific high-risk population by testing a theory-based, parent-directed empowerment strategy, called Problem Solving Education (PSE). In the past, similar strategies have been proven effective for improving the mood and functioning of depressed adults, and for improving adherence to medical treatment. However, they have never been tested in the setting of a parent-child relationship or among families of premature infants.

This project involves a clinical trial of PSE among 50 low-income mothers at risk for depression, who have premature infants in two Boston NICUs: Boston Medical Center and Tufts Medical Center. The investigators aim to determine the impact of PSE on maternal depressive symptoms and functioning, and adherence to child health supervision and immunization schedules, vision screening, and early intervention evaluation for babies with suspected developmental delays.

Approximately 100,000 children are born prematurely to low-income families each year. Parent-directed PSE aims to improve outcomes for these children through the prevention and/or attenuation of maternal depressive symptoms, as well as through family activation and promotion of adherence to follow-up care. If successful, PSE could also provide the cornerstone of a more generalizable empowerment strategy for families of children with chronic medical conditions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Baby is ≤ 33 weeks gestational age and is expected to survive.
  • Baby qualifies to receive WIC
  • Mother is comfortable in English or Spanish.

排除标准

  • Mother has psychosis
  • Mother endorses suicidal ideation
  • Custody of baby is uncertain
  • Mother is cognitively limited, per judgment of NICU attending physician
  • Baby is critically ill, per judgment of NICU attending physician

结局指标

主要结局

Maternal Depressive Symptoms

时间窗: 6 months

次要结局

  • Health Care Supervision Schedule for Children(6 months)
  • Immunization Schedule for Children(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Silverstein

BMC Attending Physician

Boston Medical Center

研究点 (4)

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