We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438516
First Posted: February 22, 2007
Last Update Posted: January 15, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
University of Colorado, Denver
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  Purpose
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.

Condition Intervention
Child Rearing Adolescent Development Reproductive Behavior Risk Reduction Behavior Behavioral: nurse home visitation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Follow-up of Families in Early Preventive Intervention

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • interval between birth of first and second children; [ Time Frame: 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 ]
  • duration of mother's relationship with current partner; [ Time Frame: 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 ]
  • her sense of mastery; [ Time Frame: 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 ]
  • the counts of maternal arrests and days jailed, [ Time Frame: 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 ]
  • children's grade point averages in reading, math, and behavior (conduct) from their school records [ Time Frame: At child age 9 ]
  • children's achievement test scores [ Time Frame: At child age 9 ]
  • teacher report of antisocial behavior [ Time Frame: At child age 9 ]
  • maternal report of child disruptive behavior disorders and depressive and anxiety disorders [ Time Frame: At child age 9 ]

Secondary Outcome Measures:
  • counts of subsequent miscarriages, abortions, and low-birth-weight newborns; [ Time Frame: When first child was 9 ]
  • women's reported participation in the workforce; [ Time Frame: When first child was 9 ]
  • their depression; [ Time Frame: 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 ]
  • 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 ]
  • number of times children were retained in grades 1-3 [ Time Frame: At child age 9 ]
  • placement in special education [ Time Frame: At child age 9 ]
  • teachers' assessments of children's behavior [ Time Frame: At child age 9 ]
  • children's deaths [ Time Frame: By child age 9 ]

Enrollment: 627
Study Start Date: June 2000
Study Completion Date: March 2003
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00438516


Locations
United States, New York
University of Rochester School of Nursing
Rochester, New York, United States, 14642
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Colorado, Denver
Investigators
Principal Investigator: David L Olds, PhD University of Colorado, Denver
  More Information

Publications:
Responsible Party: David Olds, Principal Investigator, University of Colorado Denver
ClinicalTrials.gov Identifier: NCT00438516     History of Changes
Other Study ID Numbers: R01HD043492 ( U.S. NIH Grant/Contract )
5R01MH061428-02 ( U.S. NIH Grant/Contract )
First Submitted: February 21, 2007
First Posted: February 22, 2007
Last Update Posted: January 15, 2008
Last Verified: December 2007

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
home visits
pregnancy
welfare
child development
mortality