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临床试验/NCT00443586
NCT00443586Unknown不适用

Age-27 Follow-up of Early Preventive Intervention

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 345 人开始时间: 2004年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
345
试验地点
1
主要终点
Economic productivity (e.g., unemployment, employment in jobs with limited opportunities for career growth, use of welfare, rates of out-of-wedlock births)

研究概览

简要总结

This study will evaluate the long-term effects of a prenatal and early childhood home nurse visitation program for socially disadvantaged women and their children.

详细描述

Nearly half a million children are born each year to single, low-income mothers. Children born to socially disadvantaged mothers are more likely to experience chronic health problems, encounter child abuse and neglect, and receive insufficient health care. Home visitation by nurses during pregnancy and early childhood may prevent a wide range of health and developmental problems in children born to women who are either teenagers, unmarried, or of low economic status.

This study is associated with a home nurse visitation program that first began with 400 socially disadvantaged pregnant women between the years of 1977 and 1980 in an upstate New York semi-rural county. Participants in the original study were randomly assigned to participate in the home nurse visitation program or receive comparison services from pregnancy until the child's second birthday. Participants assigned to receive comparison services were provided with free transportation for prenatal and child care, as well as sensory and developmental screening for the child. Participants assigned to the home nurse visitation program were visited at home by a nurse 9 times during pregnancy and 23 times during the child's first 2 years of life. A follow-up study concluded that the home nurse visitation program reduced the number subsequent pregnancies, use of welfare, child abuse and neglect, and criminal behavior on the part of the socially disadvantaged mothers for up to 15 years after the birth of their first child.

This follow-up study will determine whether a home nurse visitation program has continued long-term effects on a child's health and development, 27 years later. Specifically, this study will evaluate whether the nurse-visited young adult offspring differ from the comparison group in their economic productivity; rates of child abuse and neglect; criminal behavior; mental health; abuse of substances; use of welfare, foster care, and healthcare in relation to government expenditures; and quality of their partnered relationships. Participants within the nurse-visited program group will be compared with each other to determine whether certain characteristics or factors, such as genetic vulnerabilities, environmental risks, or a history of child abuse, make someone less likely to benefit from a home nurse visitation program.

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
Single (Outcomes Assessor)

盲法说明

Assessors were masked to original treatment assignments.

入排标准

年龄范围
27 Years 至 35 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Offspring of mothers who had participated in Elmira, N.Y. randomized clinical trial of prenatal and infant/toddler home visiting by nurses.
  • •Participants needed to be at least 27 years of age.

排除标准

  • 未提供

研究组 & 干预措施

Developmental Screening

Active Comparator

Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age.

干预措施: Developmental Screening (Behavioral)

Screening plus Transportation

Active Comparator

Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two).

干预措施: Developmental Screening (Behavioral)

Screening plus Transportation

Active Comparator

Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two).

干预措施: Screening plus Transportation (Behavioral)

Screening, Transport, Prenatal Visits

Active Comparator

Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy.

干预措施: Developmental Screening (Behavioral)

Screening, Transport, Prenatal Visits

Active Comparator

Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy.

干预措施: Screening plus Transportation (Behavioral)

Screening, Transport, Prenatal Visits

Active Comparator

Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy.

干预措施: Screening, Transport, Prenatal Visits (Behavioral)

Screen, Transport, Prenatal/Inf Visits

Experimental

Participants received regular sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy and through child age two.

干预措施: Developmental Screening (Behavioral)

Screen, Transport, Prenatal/Inf Visits

Experimental

Participants received regular sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy and through child age two.

干预措施: Screening plus Transportation (Behavioral)

Screen, Transport, Prenatal/Inf Visits

Experimental

Participants received regular sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy and through child age two.

干预措施: Screening, Transport, Prenatal Visits (Behavioral)

Screen, Transport, Prenatal/Inf Visits

Experimental

Participants received regular sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy and through child age two.

干预措施: Screen, Transport, Prenatal/Inf Visits (Behavioral)

结局指标

主要结局

Economic productivity (e.g., unemployment, employment in jobs with limited opportunities for career growth, use of welfare, rates of out-of-wedlock births)

时间窗: Measured when child turns 27 years old

Quality of partnered relationships (violence, commitment, and communication)

时间窗: Measured when child turns 27 years old

Rates of child abuse and neglect

时间窗: Measured when child turns 27 years old

Rates of criminal behavior, arrests, convictions, and imprisonment

时间窗: Measured when child turns 27 years old

Government expenditures and higher tax revenues

时间窗: Measured when child turns 27 years old

Mental health and abuse of substances

时间窗: Measured when child turns 27 years old

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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