Illinois Maternal, Infant, and Early Childhood Home Visiting (MIECHV): Doula Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 312
- 主要终点
- National Institute of Child Health and Human Development (NICHD) mother-child interaction measures
研究概览
简要总结
The purpose of this randomized controlled trial is to examine whether evidence-based home visiting programs enhanced by doula services have effects on positive parenting practices, breastfeeding, and child and maternal health outcomes.
详细描述
The goal of this study is to evaluate the impact of doula enhanced evidence-based home visiting programs for young mothers in Illinois. Mothers in the intervention group receive home visits from doulas during pregnancy and in the first few weeks postpartum, and doulas provide mothers with support at the hospital during labor, delivery, and with early breastfeeding. Additionally, mothers in the intervention group receive prenatal and long-term postpartum home visitation services through an evidence-based home visiting program, such as Parents as Teachers and Healthy Families Illinois. Mothers in the comparison group receive a less intensive case management service.
Four existing doula home visiting programs located in economically distressed communities in Illinois were selected for participation in the study. At each site, young pregnant women are recruited for participation in the study, provide informed consent, and complete a baseline interview in their homes during mid-pregnancy. At completion of the baseline interview, mothers are randomly assigned to either the doula home visiting intervention group or the case management comparison group.
At 37 weeks of pregnancy, and at 3 weeks-, 3 months-, 13 months-, and 30 months, and 4 years postpartum, mothers are interviewed in their homes on topics including pregnancy, parenting, health, mental health, feeding practices, employment/education, and relationships. Additionally, at all postpartum visits, mothers are videorecorded interacting with their infants. At the 13 month, 30 month, and 4 year followup sessions, children of the study participants are administered developmental and behavioral assessments.
Based on prior studies of doula services and the goals of doula enhanced home visiting programs, a variety of outcomes are assessed at followup time points. These outcomes include prenatal medical care, prenatal bonding with infant, feelings of efficacy during labor, anesthesia use during labor, breastfeeding, positive parenting behaviors, parenting attitudes and stress, infant health, maternal health, maternal depressive symptoms, and child behavior and development.
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 24 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •pregnant and between 12 and 34 weeks gestation
- •live within the catchment area of a program site
- •between ages of 14-24
- •English or Spanish speaking
排除标准
- •ward of the Department of Children and Family Services (DCFS)
- •under supervision of juvenile justice system
- •planning to give up custody of infant
- •pregnancy result of sexual assault
结局指标
主要结局
National Institute of Child Health and Human Development (NICHD) mother-child interaction measures
时间窗: 3 weeks postpartum
Videotaped interactions between mothers and infants coded by masked observers for maternal sensitivity, intrusiveness, detachment, stimulation of cognitive development, positive and negative regard for the child, and flatness of affect.
Breastfeeding initiation
时间窗: 3 weeks postpartum
次要结局
- Breastfeeding duration(3 week, 3 month, and 13 months postpartum)
- Center for Epidemiologic Studies Depression Scale (CES-D)(37 weeks pregnancy, and 3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum)
- Adult Adolescent Parenting Inventory (AAPI)(3 months, 13 months, 30 months, and 4 years postpartum)
- Mullen Scales of Early Learning - Visual Reception(13 months and 30 months postpartum)
- Subsequent pregnancy(3 month,13 months, 30 months, and 4 years postpartum)
- Woodcock-Johnson III Tests of Achievement(4 years postpartum)
- Parenting Stress Inventory (PSI)(3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum)
- Timing of solid food introduction(3 weeks, 3 months, and 13 months postpartum)
- Knowledge of Infant Development Inventory (KIDI)(3 months,13 months, and 30 months postpartum)
- Infant Toddler Social and Emotional Assessment (ITSEA)(13 months and 30 months postpartum)
- Labour Agentry Scale(3 weeks postpartum)
- Use of labor analgesia(3 weeks postpartum)
- Maternal Postnatal Attachment Scale (MPAS)(3 weeks postpartum)
- Infant/child hospitalizations(3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum)
- Parent-Child Conflict Tactics Scales (CTS PC)(13 months, 30 months, and 4 years postpartum)
- Maternal Antenatal Attachment Scale (MAAS)(37 weeks of pregnancy)
- Infant/child ER visits(3 weeks, 3 months, 13 months, 30 months, and 4 years postpartum)
- Infant/child immunizations(13 months, 30 months, and 4 years postpartum)
- Preschool Language Scales-5 (PLS-5)(13 months postpartum)
- National Institute of Child Health and Human Development (NICHD) mother-child interaction measures.(3 months, 13 months, and 30 months postpartum)