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Completed

NCT Number: NCT00438516

Follow-up of Families in Early Preventive Intervention

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester School of Nursing

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Treatment and study plan

nurse home visitation

Behavioral

Nurse home visits from midway through pregnancy to child age 2

Primary outcomes

  1. interval between birth of first and second children;

    Time frame: When first child was 9

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

    Time frame: When first child was 9

  3. duration of mother's relationship with current partner;

    Time frame: When first child was 9

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

    Time frame: When first child was 9

  5. her sense of mastery;

    Time frame: When first child was 9

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

    Time frame: When first child was 9

  7. the counts of maternal arrests and days jailed,

    Time frame: When first child was 9

  8. 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)

    Time frame: When first child was 9

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

    Time frame: At child age 9

  10. children's achievement test scores

    Time frame: At child age 9

  11. teacher report of antisocial behavior

    Time frame: At child age 9

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

    Time frame: At child age 9

Secondary outcomes

  1. counts of subsequent miscarriages, abortions, and low-birth-weight newborns;

    Time frame: When first child was 9

  2. women's reported participation in the workforce;

    Time frame: When first child was 9

  3. their depression;

    Time frame: When first child was 9

  4. whether they had experienced physical violence from any of their partners since their first child was 6;

    Time frame: When first child was 9

  5. and the portion of time their current partners were employed while they were together following birth of the first child

    Time frame: When first child was 9

  6. number of times children were retained in grades 1-3

    Time frame: At child age 9

  7. placement in special education

    Time frame: At child age 9

  8. teachers' assessments of children's behavior

    Time frame: At child age 9

  9. children's deaths

    Time frame: By child age 9

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Collaborators

  • University of Colorado, Denver

Registry information

Acronym: MemphisYear9

Important dates

Study start
2000
Study completion
2003
First posted
Feb 22, 2007
Registry last updated
Jan 15, 2008

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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