Follow-up of Families in Early Preventive Intervention (MemphisYear9)

January 9, 2008 updated by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

627

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 1
Control group
Experimental: 2
Nurse home visitation
Behavioral: nurse home visitation
Nurse home visits from midway through pregnancy to child age 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
interval between birth of first and second children;
Time Frame: When first child was 9
When first child was 9
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
When first child was 9
duration of mother's relationship with current partner;
Time Frame: When first child was 9
When first child was 9
being partnered with, cohabiting with, or married to the child's biological father;
Time Frame: When first child was 9
When first child was 9
her sense of mastery;
Time Frame: When first child was 9
When first child was 9
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
When first child was 9
the counts of maternal arrests and days jailed,
Time Frame: When first child was 9
When first child was 9
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
When first child was 9
children's grade point averages in reading, math, and behavior (conduct) from their school records
Time Frame: At child age 9
At child age 9
children's achievement test scores
Time Frame: At child age 9
At child age 9
teacher report of antisocial behavior
Time Frame: At child age 9
At child age 9
maternal report of child disruptive behavior disorders and depressive and anxiety disorders
Time Frame: At child age 9
At child age 9

Secondary Outcome Measures

Outcome Measure
Time Frame
counts of subsequent miscarriages, abortions, and low-birth-weight newborns;
Time Frame: When first child was 9
When first child was 9
women's reported participation in the workforce;
Time Frame: When first child was 9
When first child was 9
their depression;
Time Frame: When first child was 9
When first child was 9
whether they had experienced physical violence from any of their partners since their first child was 6;
Time Frame: When first child was 9
When first child was 9
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
When first child was 9
number of times children were retained in grades 1-3
Time Frame: At child age 9
At child age 9
placement in special education
Time Frame: At child age 9
At child age 9
teachers' assessments of children's behavior
Time Frame: At child age 9
At child age 9
children's deaths
Time Frame: By child age 9
By child age 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Completion (Actual)

March 1, 2003

Study Registration Dates

First Submitted

February 21, 2007

First Submitted That Met QC Criteria

February 21, 2007

First Posted (Estimate)

February 22, 2007

Study Record Updates

Last Update Posted (Estimate)

January 15, 2008

Last Update Submitted That Met QC Criteria

January 9, 2008

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • R01HD043492 (U.S. NIH Grant/Contract)
  • 5R01MH061428-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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