Trial record 9 of 17 for:    reading | NICHD

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

This study has been completed.
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00438516
First received: February 21, 2007
Last updated: January 9, 2008
Last verified: December 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Follow-up of Families in Early Preventive Intervention

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • duration of mother's relationship with current partner; [ Time Frame: When first child was 9 ] [ Designated as safety issue: No ]
  • being partnered with, cohabiting with, or married to the child's biological father; [ Time Frame: When first child was 9 ] [ Designated as safety issue: No ]
  • her sense of mastery; [ Time Frame: When first child was 9 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • the counts of maternal arrests and days jailed, [ Time Frame: When first child was 9 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • children's grade point averages in reading, math, and behavior (conduct) from their school records [ Time Frame: At child age 9 ] [ Designated as safety issue: No ]
  • children's achievement test scores [ Time Frame: At child age 9 ] [ Designated as safety issue: No ]
  • teacher report of antisocial behavior [ Time Frame: At child age 9 ] [ Designated as safety issue: No ]
  • maternal report of child disruptive behavior disorders and depressive and anxiety disorders [ Time Frame: At child age 9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • counts of subsequent miscarriages, abortions, and low-birth-weight newborns; [ Time Frame: When first child was 9 ] [ Designated as safety issue: Yes ]
  • women's reported participation in the workforce; [ Time Frame: When first child was 9 ] [ Designated as safety issue: No ]
  • their depression; [ Time Frame: When first child was 9 ] [ Designated as safety issue: No ]
  • whether they had experienced physical violence from any of their partners since their first child was 6; [ Time Frame: When first child was 9 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • number of times children were retained in grades 1-3 [ Time Frame: At child age 9 ] [ Designated as safety issue: No ]
  • placement in special education [ Time Frame: At child age 9 ] [ Designated as safety issue: No ]
  • teachers' assessments of children's behavior [ Time Frame: At child age 9 ] [ Designated as safety issue: No ]
  • children's deaths [ Time Frame: By child age 9 ] [ Designated as safety issue: No ]

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

Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00438516

Locations
United States, New York
University of Rochester School of Nursing
Rochester, New York, United States, 14642
Sponsors and Collaborators
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: RO1HD043492, 5R01MH061428-02
Study First Received: February 21, 2007
Last Updated: January 9, 2008
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on October 19, 2014