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临床试验/NCT00708695
NCT00708695已完成不适用

Age-17 Follow-up of Home Visiting Intervention

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 1,880 人开始时间: 2008年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,880
试验地点
1
主要终点
Cognitive, language, and academic functioning among first-born children.

研究概览

简要总结

This study is a longitudinal follow-up of 670 primarily African-American women and their 17-year-old firstborn children enrolled since 1990 in a highly significant randomized controlled trial (RCT) of prenatal and infancy home visiting by nurses. Nurses in this program are charged with improving pregnancy outcomes, child health and development, and maternal economic self-sufficiency. This follow-up examines whether earlier program effects on maternal and child functioning lead to less violent antisocial behavior, psychopathology, substance use and use-disorders, and risk for HIV; whether these effects are greater for those at both genetic and environmental risk; and whether program effects replicate those found with whites in an earlier trial.

详细描述

This study is a longitudinal follow-up of 670 primarily African-American women and their 18-year-old firstborn children enrolled since 1990 in a randomized controlled trial (RCT) of prenatal and infancy home visiting by nurses. Nurses in this program are charged with improving pregnancy outcomes, child health and development, and maternal economic self-sufficiency.1 This follow-up examines whether earlier program effects on maternal and child functioning 2-7 lead to less violent antisocial behavior, psychopathology, substance use and use-disorders, and risk for HIV; whether these effects are greater for those who carry genetic susceptibility to the environment and are at environmental risk; and whether program effects replicate those found with whites in an earlier trial.8-10 Results from earlier phases of follow-up from this trial found that the Memphis program affected women's prenatal health, fertility, partner relations, and use of welfare; children's injuries, cognition, language, achievement, conduct, depression/anxiety, and use of substances through child age 12.2-7 Program effects on maternal life-course were concentrated among mothers with higher psychological resources (better intellectual functioning, mental health, and sense of mastery), probably because higher-resource mothers could envision their success in the world of work, leading to better pregnancy planning and employment. Program effects on children were greater for those born to mothers with low psychological resources, because without help, low-resource mothers are especially challenged in the care of their children and their children function less well. Given the damaging effects of early stressors on developing neural circuitry, and given that many early neural developmental insults do not become fully evident until synaptic pruning is complete in late adolescence and early adulthood, there was reason to expect this early intervention would have enduring effects at youth age 18.

Hypotheses for Primary Grant

We specified hypotheses based upon the pattern of results found through child age 12, and separated them into primary and secondary hypotheses. Following the original formulation of hypotheses, we edited them to take into account results from the earlier Elmira trial10 that were analyzed following the submission of the proposal for the current phase of follow-up in Memphis. We had originally hypothesized that program effects would be more pronounced for mothers and children living in the most disadvantaged neighborhoods in Memphis, but realized as these data were being gathered that virtually all of the participants in the Memphis trial lived in neighborhoods that were so disadvantaged that there was little meaningful variation among neighborhoods, and therefore removed this aspect of our hypotheses. We also found that it was impossible to consistently gather information from children's school records on outcomes like conduct grades from hundreds of schools, so substituted high school graduation as a secondary outcome. These refined hypotheses were specified prior to the completion of data gathering and any analysis of treatment-control differences. We specify the original hypotheses and then indicate the revised hypotheses for maternal and child outcomes. Compared to control-group counterparts:

Original Maternal Outcomes Hypotheses

  1. (Primary) The program will continue to improve maternal life-course (fewer short inter-birth intervals, less use of welfare, more stable partner relations), especially for mothers with higher psychological resources.
  2. (Secondary) The program will reduce maternal substance use disorders (SUDs) and depression, effects that will be more pronounced for a) mothers with low psychological resources, and b) those living in the most disadvantaged neighborhoods at registration.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
17 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Women who were enrolled in the New Mothers Study and their children as described in Study Population Description.

排除标准

  • Women who were not enrolled in the New Mothers Study and their children as described in the Study Population Description.

结局指标

主要结局

Cognitive, language, and academic functioning among first-born children.

时间窗: at youth age 18

Direct tests of youth cognitive, language, and academic functioning. Program effects in this domain hypothesized to be most pronounced for children born to mothers with low psychological resources.

Youth gang membership, arrests, convictions, and self-reported antisocial behavior, especially for crimes involving interpersonal violence.

时间窗: at youth age 18

Self-reported involvement with criminal justice system and antisocial behavior. Program effects on arrests and convictions hypothesized to be greater for females.

Youth risk for HIV infection, pregnancies, births, use of substances, and SUDs.

时间窗: at youth age 18.

Outcomes based upon self-report and urine assays for STI's and substance use.

Maternal life-course (reflected in reduced total public benefit expenditures for SNAP, AFDC/TANF, and Medicaid).

时间窗: through first child age 18

Public benefit expenditures estimated from review of state administrative records and maternal report of all children's birth dates. Program effects on public-benefit expenditures hypothesized to be especially pronounced for mothers with higher psychological resources.

Youth depression and anxiety

时间窗: at youth age 18

Measure of internalizing disorders based upon youth self-report.

次要结局

  • Improved child executive cognitive functioning, and rates of high school graduation.(at youth age 18)
  • Reduced maternal substance use disorders (SUDs) and depression.(at youth age 18)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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