Clinical trial NCT00438516: Follow-up of Families in Early Preventive Intervention
Official title: Follow-up of Families in Early Preventive Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Rearing
Adolescent Development
Reproductive Behavior
Risk Reduction Behavior
Keywords: home visits
pregnancy
welfare
child development
mortality
Lead sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Sponsor class: NIH
Collaborators: name: University of Colorado, Denver
First posted: 2007-02-22
Enrollment: 627
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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 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.

Primary outcomes:
measure: interval between birth of first and second children;
timeFrame: When first child was 9
measure: cumulative subsequent births per year following birth of the first child through the first child's 9th birthday;
timeFrame: When first child was 9
measure: duration of mother's relationship with current partner;
timeFrame: When first child was 9
measure: being partnered with, cohabiting with, or married to the child's biological father;
timeFrame: When first child was 9
measure: her sense of mastery;
timeFrame: When first child was 9
measure: duration of use of welfare (AFDC and TANF) and food stamps per year following birth of the first child;
timeFrame: When first child was 9
measure: the counts of maternal arrests and days jailed,
timeFrame: When first child was 9
measure: 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)
timeFrame: When first child was 9
measure: children's grade point averages in reading, math, and behavior (conduct) from their school records
timeFrame: At child age 9
measure: children's achievement test scores
timeFrame: At child age 9
measure: teacher report of antisocial behavior
timeFrame: At child age 9
measure: maternal report of child disruptive behavior disorders and depressive and anxiety disorders
timeFrame: At child age 9
Secondary outcomes:
measure: counts of subsequent miscarriages, abortions, and low-birth-weight newborns;
timeFrame: When first child was 9
measure: women's reported participation in the workforce;
timeFrame: When first child was 9
measure: their depression;
timeFrame: When first child was 9
measure: whether they had experienced physical violence from any of their partners since their first child was 6;
timeFrame: When first child was 9
measure: and the portion of time their current partners were employed while they were together following birth of the first child
timeFrame: When first child was 9
measure: number of times children were retained in grades 1-3
timeFrame: At child age 9
measure: placement in special education
timeFrame: At child age 9
measure: teachers' assessments of children's behavior
timeFrame: At child age 9
measure: children's deaths
timeFrame: By child age 9
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester School of Nursing
state: New York
Study officials:
affiliation: University of Colorado, Denver
name: David L Olds, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olds DL, Kitzman H, Cole R, Robinson J, Sidora K, Luckey DW, Henderson CR Jr, Hanks C, Bondy J, Holmberg J. Effects of nurse home-visiting on maternal life course and child development: age 6 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1550-9. doi: 10.1542/peds.2004-0962.
citation: Kitzman H, Olds DL, Sidora K, Henderson CR Jr, Hanks C, Cole R, Luckey DW, Bondy J, Cole K, Glazner J. Enduring effects of nurse home visitation on maternal life course: a 3-year follow-up of a randomized trial. JAMA. 2000 Apr 19;283(15):1983-9. doi: 10.1001/jama.283.15.1983.
citation: Kitzman H, Olds DL, Henderson CR Jr, Hanks C, Cole R, Tatelbaum R, McConnochie KM, Sidora K, Luckey DW, Shaver D, Engelhardt K, James D, Barnard K. Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. JAMA. 1997 Aug 27;278(8):644-52.
citation: Olds DL, Kitzman H, Hanks C, Cole R, Anson E, Sidora-Arcoleo K, Luckey DW, Henderson CR Jr, Holmberg J, Tutt RA, Stevenson AJ, Bondy J. Effects of nurse home visiting on maternal and child functioning: age-9 follow-up of a randomized trial. Pediatrics. 2007 Oct;120(4):e832-45. doi: 10.1542/peds.2006-2111.