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临床试验/NCT03079752
NCT03079752已完成不适用

The Prenatal/Early Infancy Project: An Adolescent Follow-up

University of Colorado, Denver0 个研究点目标入组 629 人开始时间: 1994年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
629
主要终点
Timing of Subsequent Births - Mothers

研究概览

简要总结

The Nurse-Family Partnership, a program of prenatal and infancy home visiting by nurses, has been examined in a series of 3 randomized trials since 1977. It has received considerable attention in the scientific and public policy communities for its replicated effects on a variety of maternal and child health outcomes across these 3 trials, including prenatal health, childhood injuries, rates of subsequent pregnancies, inter-birth intervals, as well as its long-term effects on maternal life-course, criminal behavior, and 15-year-olds' criminal and antisocial behavior in the first trial of the program conducted in Elmira, New York.

详细描述

Although this program produced positive effects on maternal and child health from pregnancy through the child's fourth year of life, its long-term effects remain unexamined. The current study was conducted to determine the extent to which the beneficial effects of the program set in motion early in the life cycle altered the life-course trajectories of the mothers and the children's adaptive functioning through the first child's 15th birthday. This study examines the long-term effects of the program on two domains of maternal functioning: 1) maternal life course (subsequent children, use of welfare, employment, substance abuse, and encounters with the criminal justice system); and 2) perpetration of child abuse and neglect; and two domains of the children's behavior: 1) their functioning in schools, and 2) their criminal and antisocial behavior. The investigators hypothesized that the program effects in these domains of maternal and child functioning, as in earlier phases of the study, would be greater for families in which the mothers experienced a larger number of chronic stressors and had fewer resources to manage the challenges of living in poverty and being a parent.

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 not given access to the participants' original treatment assignments

入排标准

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

入选标准

  • Must be offspring of mothers who enrolled in Elmira randomized clinical trial of the Nurse-Family Partnership (known as the Prenatal Early Infancy Project) -

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

Timing of Subsequent Births - Mothers

时间窗: 15 years following birth of first child

Interval in days between birth date of first child and first subsequent child (self-reported)

Months Received Aid to Families with Dependent Children (AFDC) - Mothers

时间窗: 15-year interval following birth of first child

Number of months mother received AFDC (self-reported)

Number of Months Employed - Mothers

时间窗: 15-year interval following birth of first child

Number of months employed (self-reported)

Substance Abuse - Mothers

时间窗: 15-year period following birth of first child

Count of behavioral impairments due to use of substances (self-reported)

Arrests - Mothers

时间窗: 15-year interval following birth of first child

Count of arrests (self-reported)

Child Maltreatment Reports - Mothers

时间窗: 15-year interval following birth of first child

Count of substantiated reports of child abuse and neglect in which mother was perpetrator (review of records)

Running Away from Home - Children

时间窗: 15-year interval following birth of first child

Count of times ran away from home - self-report

Person in Need of Supervision (PIN) - Children

时间窗: 15-year period following their birth

Self report of ever having been adjudicated as a PIN

Arrests - Children

时间窗: 15-year period following birth

Count of Arrests - self-report

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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