跳至主要内容
临床试验/NCT03836430
NCT03836430已完成不适用

The Impact of a Newborn Behavioral Intervention on the Mental Health of Mothers With Late Pre-Term Infants

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 208 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
208
试验地点
2
主要终点
Maternal postpartum depression

研究概览

简要总结

Preterm birth is a serious public health issue, affecting 10% of all births in the US alone. Three quarters of these infants are born between 34 0/7 and 36 6⁄7 weeks' gestation or late-preterm (LP). Mothers of LP infants are at increased risk for postpartum stress, depression and mother-infant interaction problems posing significant risks for infant development. Our proposed project will advance the fields of maternal and child health by examining the impact of the Newborn Behavioral Observations Family Wellness (NBO-FW), a dyadic, two generational intervention targeting maternal wellbeing and early mother-infant relations in families of LP born infants. The NBO-FW is a 12week preventative intervention aimed at promoting maternal mental health and positive parenting. It is based on the highly successful NBO intervention developed by our team and applied across five continents, but with important new elements targeting maternal mental health and the needs of high-risk LP infants and their families. Participants will consist of 200 first-time mothers and their LP infants (100 intervention and 100 control dyads) born at Brigham and Women's Hospital (BWH), an urban teaching hospital of Harvard Medical School and the largest maternity care provider in Boston. Data will be collected at three time points: during the birth hospitalization, at a follow-up visit at 4-6 weeks corrected gestational age, and at a further visit 10-12 weeks after birth. Outcomes will include standardized measures of maternal stress, depression, parenting confidence, and observed mother-infant interaction. Information about infant health care practices and maternal/infant health will also be recorded. We hypothesize that, compared to mothers in the care as usual control group, first-time mothers of LP infants who receive the NBO-FW will demonstrate a) lower levels of stress and depression, b) greater parenting confidence, c) higher quality interactions with their infants (e.g., positive affect, sensitivity, responsiveness, emotional connection); and (d) engage in more optimal infant health care practices.

详细描述

Preterm birth is a serious public health issue, affecting 10% of births in the US alone. The vast majority of these infants are born between 32 and 37 weeks of gestation and are at increased risk of neurodevelopmental problems. The mothers of these infants are also at increased risk for postpartum stress, depression and mother-infant interaction problems which can further exacerbate child risks. Specific maternal and family challenges include mother-infant emotional disconnection, less sensitive maternal care behavior, and reduced engagement in healthy infant care practices such as breastfeeding.

To date, relatively little attention has been given to addressing the needs of preterm born (>32 and <37 weeks of gestation) infants and their families, with most research focusing on the very and extremely preterm born infant. As a result, there are few to no interventions that specifically: a) address the needs of the preterm infant and their caregivers; b) offer parent education; c) foster a close mother-infant relationship; and d) seek to provide support and empowerment of mothers. This stands in contrast to an extensive body of experimental and human infant research showing that early mother-infant contact is essential for both maternal wellbeing and offspring development, with disruptions to this early relationship having lifelong negative effects for the infant.

This research project meets this important gap, with the goal of advancing the fields of maternal and child health by examining the impact of a dyadic two-generation, Newborn Behavioral Observations-Family Wellness (NBO-FW) intervention on early maternal wellbeing and mother-infant relations in families of preterm born infants.

There is now good evidence to support the importance of early intervention as a preventative strategy to reduce the risks of longer term development problems in both typically developing and high-risk populations of mothers and infants. Intervening early with young children who are at risk for developmental delay has been shown to positively impact children's developmental outcomes across multiple functional domains, spanning health, language, cognitive and social-emotional development. In addition, families benefit from early intervention because it can increase their ability to understand and meet their child's needs, as well as mitigate stressors that may be adversely impacting maternal wellbeing, the mother-infant relationship and in turn, healthy child development.

Original Newborn Behavioral Observation Intervention The original NBO developed here in Boston by Kevin Nugent and colleagues is an interactive observational tool used by clinicians to strengthen the relationship between parents and infants from birth to age 3 months, or even longer in the case of the at-risk infant. As such, it is a flexible, short-term, family-centered early intervention strategy that is suitable for use and widely used in newborn units, the Neonatal Intensive Care Unit (NICU), obstetric, pediatric, and other primary care settings.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • First time mothers of singleton newborns born between 32 and 37 weeks of gestation
  • Mother fluent in either English or Spanish

排除标准

  • Maternal history of major psychosis or suicidality
  • Mother currently addicted to drugs or alcohol or being treated for drug addiction
  • Health condition limiting mother's ability to care for her infant
  • Primary diagnosis in infant is unrelated to prematurity
  • Infant not in legal and physical custody of the mother

结局指标

主要结局

Maternal postpartum depression

时间窗: The CESD-R will be administered at 4 months

Center for Epidemiological Studies Depression Scale-Revised (CESD-R). Scale is 0 - 36, where higher scores indicate higher levels of depressive symptoms.

Maternal parenting stress

时间窗: The PSI-SF will be administered at 4 months

Parenting Stress Index-Short Form 4th Edition (PSI-SF)

Parenting confidence

时间窗: The KPCS will be administered at 4 months

The Karitane Parenting Confidence Scale (KPCS). The scale ranges from 0-45, with higher scores indicating higher confidence in parenting skills and abilities.

Positive Parenting Quality

时间窗: The WECS will be administered at 4 months

Welch Emotional Connection Screen (WECS)

次要结局

  • Safe sleep practices(Infant care practices will be assessed at 4 months)
  • Breastfeeding(Infant care practices will be assessed at 4 months.)
  • Participation in well child visits(Attendance at well child visits will be assessed at 4 months)

研究者

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

Lise Carolyn Johnson

Pediatrician, Department of Pediatric Newborn Medicine

Brigham and Women's Hospital

研究点 (2)

Loading locations...

相似试验