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临床试验/NCT01925664
NCT01925664已完成不适用

Doula Support for Young Mothers: A Randomized Trial

University of Chicago2 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2001年1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
248
试验地点
2
主要终点
Positive parenting behavior (Parent Child Observation Guide)

研究概览

简要总结

The goal of this study was to evaluate the impact of a doula home visiting intervention on young, low-income mothers' birth outcomes, breastfeeding, postpartum depressive symptoms, and parenting, and on their children's development.

详细描述

The goal of this study is to evaluate a doula home visiting model -- sometimes called the "community doula model." This model differs from typical hospital based doula interventions in several ways. Doulas are providers from the same community backgrounds as their clients. Services are not just provided during labor and delivery, but throughout the final trimester and during the first weeks after delivery. Prenatal and postpartum services are provided in the homes of the mothers. The model was developed specifically for working with low-income mothers and with young mothers.

A two-armed randomized controlled trial was conducted at the University of Chicago Hospitals. Participants were recruited through two out-patient obstetric clinics affiliated with the Hospitals. The clinics primarily served a low-income, African-American population, reflective of the families in the communities near to the hospital. The study was open to all young women receiving prenatal care at the clinics who met age and eligibility criteria. After providing informed consent and completing a baseline interview, participants were randomized into two groups. The experimental group, in addition to receiving regular clinical care, received weekly home visiting services from a doula and the support of a doula at the hospital during labor and delivery. Doulas worked with their clients until three months postpartum. The control group received standard clinical care and had access to social work case management.

Four paraprofessional doulas delivered the study intervention. Before providing study services, doulas had been trained to provide childbirth education, labor support, breastfeeding education, and parent-child interaction support.

Followup research assessments of the doula and control group mothers and infants were conducted during the first three days postpartum, at 4 months postpartum, at 12 months postpartum, and at 24 months postpartum. 80% of the sample was retained through the 24 month followup assessment. Follow up assessments involved interviews with the mothers, videotaping of mother-infant interaction, and behavioral assessment of the infants. Obstetric and newborn hospital medical charts were also reviewed.

The study evaluated outcomes that have been the focus of prior studies of hospital-only doula services: use of obstetrical intervention in labor and delivery (anesthesia, surgical delivery), mother labor efficacy, breastfeeding, and maternal depression. A major contribution of this study is to explore longer term outcomes not evaluated in prior studies of doula intervention, particularly parenting and child development outcomes. The study evaluated multiple dimensions of parenting including parenting behavior (sensitivity, stimulation), parenting efficacy, parenting attitudes, and parenting stress. Child development outcomes included cognitive development and early behavior problems.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 21 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • pregnant and less than 34 weeks gestation
  • planning to deliver at study hospital
  • between ages 14 and 21

排除标准

  • planning to move out of community after giving birth
  • planning to give up custody of infant
  • prior c-section delivery

结局指标

主要结局

Positive parenting behavior (Parent Child Observation Guide)

时间窗: 4 months postpartum

Videotaped interactions between mothers and infants coded by masked observers

Breastfeeding Initiation

时间窗: Three days postpartum

次要结局

  • Parenting Stress Index (PSI)(4-, 12-, and 24 months postpartum)
  • Breastfeeding duration(4- and 12 months postpartum)
  • Positive parenting behaviors (Parent Child Observation Guide)(12- and 24 months postpartum)
  • Center for Epidemiologic Studies Depression Scale (CES-D)(4-, 12-, and 24 months postpartum)
  • Timing of solid food introduction to infant(4- and 12 months postpartum)
  • Mullen Scales of Early Learning(24 months postpartum)
  • Use of labor anesthesia(Start of labor through childbirth)
  • Labour Agentry Scale(1 day postpartum)
  • Adult Adolescent Parenting Inventory (AAPI)(4 months postpartum)
  • Maternal Self-Efficacy Scale(4-, 12-, and 24 months postpartum)
  • The Brief Infant Toddler Social Emotional Assessment (BITSEA)(12- and 24 months postpartum)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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