跳至主要内容
临床试验/NCT00056680
NCT00056680已完成不适用

Adult Attachment and Intervention Efficacy With Preterms

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)10 个研究点 分布在 1 个国家目标入组 173 人开始时间: 2001年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
173
试验地点
10
主要终点
Anthropometrics (weight, height, head circumference), Bayley Scales of Infant Development, infant behavioral problems and behavioral competencies, maternal sensitivity, infant-parent attachment

研究概览

简要总结

This study evaluated the efficacy of a comprehensive, three-part program for parents of premature infants. This program was designed to improve development in preterm children and includes an educational video, tests to evaluate the child's strengths and abilities, and instruction in infant massage.

详细描述

Premature birth is a major cause of developmental delay, and cost-effective, replicable methods to promote development in preterm children are needed. Despite the success of first generation interventions, little is understood about why early intervention does not affect all parents and preterms to the same degree.

This study assessed the efficacy of a three-component intervention (psychoeducational video, serial administrations of the Brazelton Neonatal Behavioral Assessment Scale, and parent-administered infant massage) that targets preterm infants and their mothers and fathers. Outcome measures included infant physical, intellectual, and socioemotional development; parental sensitivity; and infant-parent attachment. The project also assessed the role of parental state of mind regarding attachment and parental commitment to the intervention.

Participants in this study were urban African American mothers and fathers of preterm, low birthweight infants admitted to the neonatal intensive care unit. Fathers were eligible for the study if nominated by the child's mother. Participants were randomly assigned to an intervention group or a control group. Both groups were comparable with respect to race, maternal pregnancy history, education, income, presence/absence of partner, infant gestational age, infant small-for-date status, and infant gender.

The intervention group viewed a videotape about preterm infant abilities. Over the course of the study, the intervention group administered infant massage and completed multiple administrations of the Brazelton Neonatal Behavioral Assessment Scale with increasing parental involvement.

The intervention began when infants were 32 to 36 weeks post-conceptual age (PCA) and ended when infants are 52 to 56 weeks PCA. The efficacy of the intervention and the moderating roles of adult attachment and parental commitment to the intervention were evaluated in terms of infant physical, mental, motor, and social development, and parental adjustment and sensitivity to the infant during the first 2 years.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single

入排标准

年龄范围
32 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born < 37 weeks gestational age
  • Mothers 18 years of age or older
  • African American

排除标准

  • Infants with chromosomal abnormalities or other genetic syndromes
  • Mothers with positive postpartum toxicology screens
  • Infants destined for foster care
  • Note: age limits for infants refer to post-conceptual age (not actual age)

结局指标

主要结局

Anthropometrics (weight, height, head circumference), Bayley Scales of Infant Development, infant behavioral problems and behavioral competencies, maternal sensitivity, infant-parent attachment

时间窗: collected at 4, 12, and 24 months of infant age

次要结局

  • Maternal self-efficacy, parenting stress, perceptions of infant temperament(Collected at 4, 12, and 24 months of infant age)

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (10)

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