跳至主要内容
临床试验/NCT00438516
NCT00438516已完成不适用

Follow-up of Families in Early Preventive Intervention

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 个研究点 分布在 1 个国家目标入组 627 人开始时间: 2000年6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
627
试验地点
2
主要终点
interval between birth of first and second children;

研究概览

简要总结

This project supports the post-third-grade assessment of 693 children and their families who were enrolled in a randomized trial of a program of prenatal and infancy home visitation by nurses that was epidemiologically and theoretically grounded. The project will determine whether the beneficial effects of the program on maternal, child, and family functioning extend through the early elementary school years, giving particular attention to maternal life-course and children's emerging antisocial behavior. Assessments of the children will be based on both mother and teacher reports. Teachers are independent, natural raters of the children's adaptation to an important social context. There are numerous reasons to expect that, from a developmental perspective, the effects of the program will increase as children experience the increased academic demands associated with entry into third grade. In addressing these questions, the current study will determine the extent to which this program of prenatal and infancy home visitation by nurses can produce enduring effects on maternal and child functioning (giving particular attention to the prevention of early-onset disruptive behavior disorders) in urban African Americans that are consistent with those achieved with whites in a central New York state county in a separate trial of this program conducted over the past 20 years.

详细描述

This project supports the post-third-grade assessment of 693 children and their families who were enrolled in a randomized trial of a program of prenatal and infancy home visitation by nurses that was epidemiologically and theoretically grounded. The sample enrolled was composed of low-income women who had no previous live births and who were largely African American (92%), unmarried (98%), and adolescent (67%) at the time of registration during pregnancy. In earlier phases of assessment, the program was found to improve the quality of care patients provided to their children, to reduce children's health-care encounters in which injuries were detected, to increase children's sequential processing skills as measured by the KABC, to reduce the number of dysregulated aggressive and violent themes expressed in their response to the MacArthur Story Stem Battery, and so to improve maternal life-course as reflected in fewer subsequent pregnancies, reduced use of welfare, and increases in the marriage and cohabitation with the biological father of the child. Many of the benefits in the area of parental care-giving and child functioning were concentrated in those children and their mothers who had few psychological resources (where psychological resources was defined as the absence of mental disorder symptoms, adequate intellectual functioning, and belief in their control over their life circumstances).

The project will determine whether the beneficial effects of the program on maternal, child, and family functioning extend through the early elementary school years, giving particular attention to maternal life-course and children's emerging antisocial behavior. Assessments of the children will be based on both mother and teacher reports. Teachers are independent, natural raters of the children's adaptation to an important social context. There are numerous reasons to expect that, from a developmental perspective, the effects of the program will increase as children experience the increased academic demands associated with entry into third grade. In addressing these questions, the current study will determine the extent to which this program of prenatal and infancy home visitation by nurses can produce enduring effects on maternal and child functioning (giving particular attention to the prevention of early-onset disruptive behavior disorders) in urban African Americans that are consistent with those achieved with whites in a central New York state county in a separate trial of this program conducted over the past 20 years.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women <29 weeks of gestation were recruited if they had no previous live births, no specific chronic illnesses thought to contribute to fetal growth retardation or pre-term delivery, and at least 2 of the following socio-demographic risk conditions:
  • Unmarried,
  • <12 years of education, and
  • Unemployed.

排除标准

  • 未提供

结局指标

主要结局

interval between birth of first and second children;

时间窗: When first child was 9

cumulative subsequent births per year following birth of the first child through the first child's 9th birthday;

时间窗: When first child was 9

duration of mother's relationship with current partner;

时间窗: When first child was 9

being partnered with, cohabiting with, or married to the child's biological father;

时间窗: When first child was 9

her sense of mastery;

时间窗: When first child was 9

duration of use of welfare (AFDC and TANF) and food stamps per year following birth of the first child;

时间窗: When first child was 9

the counts of maternal arrests and days jailed,

时间窗: When first child was 9

the count of substances used (3 or more drinks of alcohol 3 or more times per month in the last year, use of marijuana, and use of cocaine since last interview at child age 6)

时间窗: When first child was 9

children's grade point averages in reading, math, and behavior (conduct) from their school records

时间窗: At child age 9

children's achievement test scores

时间窗: At child age 9

teacher report of antisocial behavior

时间窗: At child age 9

maternal report of child disruptive behavior disorders and depressive and anxiety disorders

时间窗: At child age 9

次要结局

  • counts of subsequent miscarriages, abortions, and low-birth-weight newborns;(When first child was 9)
  • women's reported participation in the workforce;(When first child was 9)
  • their depression;(When first child was 9)
  • whether they had experienced physical violence from any of their partners since their first child was 6;(When first child was 9)
  • and the portion of time their current partners were employed while they were together following birth of the first child(When first child was 9)
  • number of times children were retained in grades 1-3(At child age 9)
  • placement in special education(At child age 9)
  • teachers' assessments of children's behavior(At child age 9)
  • children's deaths(By child age 9)

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 (2)

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