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临床试验/NCT02379130
NCT02379130终止不适用

FNI Between Mothers and Preschool Age Children

Columbia University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2015年2月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
36
试验地点
2
主要终点
Child Behavior Checklist (CBCL) Scale

研究概览

简要总结

The purpose of this study is to determine the effects of Family Nurture Intervention in preschool aged children between 2.5 and 4.5 years of age who were born prematurely and exhibit developmental deficits. The new approach is based on improving aspects of maternal nurturing behaviors as well as mother-child co-regulation, which are important to early development. Since young children with developmental deficits are often easily upset, mothers will be taught how to co-regulate with their child through comfort and calming interactions during 11 clinic visits. Assessments in the follow-up clinic will test the immediate and long-term effects of this new approach to the nurture of children who were born early and demonstrate developmental problems and behavioral problems.

详细描述

Mother-infant interactions are the foundation for the organization of the infant's neurobiological, sensory, perceptual, emotional, physical, and relational systems (Hofer, 1987). For the developing infant, one of the most critical sources of regulatory input is through contact with the mother and her nurturing behavior. The infant's responses to the mother provide feedback that shapes her behavior as well. There are many co-regulatory processes embedded in these synchronous and reciprocal interactions which cross neurophysiological and neurobehavioral domains (Als, 1999). A necessary but detrimental separation between mother and infant is created at a critical period when mother-infant co-regulation should be developing. Regardless of NICU or well-baby nursery care, the physiological challenges associated with being born too soon, along with disturbances in normal mother-infant interactions are key factors underlying the risks of early and late preterm infants for a broad range of early and midlife disorders (DeBoer, et al., 1984 if this does not include late preterm, find another reference). This study compares common early interventions such as occupational, physical, and speech therapy with a Family Nurture Intervention (FNI), instituted at age 3 to 4 for preschool aged children with developmental delays. This is a developmental time point at which delays including deficits in emotion regulation, language, cognition, and attention are identifiable. The investigators hypothesize that the Family Nurture Intervention will alter a wide range of physiological regulatory capacities and will result in improved indices of mother psychological and child neurobehavioral outcomes.

研究设计

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

入排标准

年龄范围
30 Months 至 40 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infant is a singleton (matched between groups)
  • Mother is 18 years of age or older
  • Mother has at least one supporting person in the home (e.g. significant other, mother, father, sibling, aunt, grandmother, step-parent)
  • Child demonstrates developmental deficit (language, cognition, motor, emotion)

排除标准

  • The child has severe congenital anomalies including chromosomal anomalies
  • The child has severe motor or physical disability
  • Mother currently presents with psychosis or is currently taking antipsychotic medication
  • Status of enrolled subject changes and subject no longer falls in inclusion criteria
  • Mother and/or infant has a medical condition that precludes intervention components
  • Mother and/or infant has a contagion that endangers other participants in the study

结局指标

主要结局

Child Behavior Checklist (CBCL) Scale

时间窗: Baseline, 5 weeks, 6 months, 12 months

The Child Behavior Checklist (CBCL) is a device by which parents rate a child's problem behaviors and competencies. The CBCL can also be used to measure a child's change in behavior over time or following a treatment. The CBCL consists of 100 items.

次要结局

  • Salivary Cortisol Level(Up to 3 years)
  • Maternal Self Efficacy Scale(Up to 3 years)
  • Norbeck Social Support Questionnaire (NSSQ) Score(Up to 3 years)
  • Oxytocin (OT) Level(Up to 3 years)
  • Center for Epidemiologic Studies Depression (CES-D) Score(Up to 3 years)
  • Sleep Habits Questionnaire (SHQ) Score(Up to 3 years)
  • Mom's Support Circle Scale(Up to 3 years)
  • Strengths and Difficulties Questionnaire (SDQ) Score(Up to 3 years)
  • State-Trait Anxiety Inventory (STAI) Scale(Up to 3 years)
  • Parenting Stress Index (PSI) Scale(Up to 3 years)
  • Variance in Vagal Tone (High Frequency Heart Period Variability)(Up to 3 years)

研究者

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

Martha G. Welch, MD

Associate Professor of Psychiatry in Pediatrics and Pathology and Cell Biology

Columbia University

研究点 (2)

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