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Completed

NCT Number: NCT03079752

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

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.

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Key information

Conditions

Behavior, Adaptive Behavior

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Developmental Screening

Behavioral

Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment of suspected problems at 12 and 24 months of age

Screening plus Transportation

Behavioral

Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment for suspected problems at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.

Screening, Transport, Prenatal Visits

Behavioral

Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment for suspected problems at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.

Screen, Transport, Prenatal/Inf Visits

Behavioral

Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment for suspected problems at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy and 23 during the child's first two years of life.

Primary outcomes

  1. Timing of Subsequent Births - Mothers

    Time frame: 15 years following birth of first child

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

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

    Time frame: 15-year interval following birth of first child

    Number of months mother received AFDC (self-reported)

  3. Number of Months Employed - Mothers

    Time frame: 15-year interval following birth of first child

    Number of months employed (self-reported)

  4. Substance Abuse - Mothers

    Time frame: 15-year period following birth of first child

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

  5. Arrests - Mothers

    Time frame: 15-year interval following birth of first child

    Count of arrests (self-reported)

  6. Child Maltreatment Reports - Mothers

    Time frame: 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)

  7. Running Away from Home - Children

    Time frame: 15-year interval following birth of first child

    Count of times ran away from home - self-report

  8. Person in Need of Supervision (PIN) - Children

    Time frame: 15-year period following their birth

    Self report of ever having been adjudicated as a PIN

  9. Arrests - Children

    Time frame: 15-year period following birth

    Count of Arrests - self-report

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Cornell University

Registry information

Important dates

Study start
1994
Primary completion
1996
Study completion
1998
First posted
Mar 14, 2017
Registry last updated
Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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