| February 21, 2007 |
| January 9, 2008 |
| June 2000 |
| |
- 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 ]
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- interval between birth of first and second children;
- cumulative subsequent births per year following birth of the first child through the first child’s 9th birthday;
- duration of mother's relationship with current partner;
- being partnered with, cohabiting with, or married to the child’s biological father;
- her sense of mastery;
- duration of use of welfare (AFDC and TANF) and food stamps per year following birth of the first child;
- the counts of maternal arrests and days jailed,
- 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)
- children’s grade point averages in reading, math, and behavior (conduct) from their school records
- children’s achievement test scores
- teacher report of antisocial behavior
- maternal report of child disruptive behavior disorders and depressive and anxiety disorders
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| Complete list of historical versions of study NCT00438516 on ClinicalTrials.gov Archive Site |
- 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 ]
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- counts of subsequent miscarriages, abortions, and low-birth-weight newborns;
- women’s reported participation in the workforce;
- their depression;
- whether they had experienced physical violence from any of their partners since their first child was 6;
- and the portion of time their current partners were employed while they were together following birth of the first child
- number of times children were retained in grades 1–3
- placement in special education
- teachers’ assessments of children’s behavior
- children’s deaths
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| |
| Follow-up of Families in Early Preventive Intervention |
| 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. |
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. |
| |
| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
- Child Rearing
- Adolescent Development
- Reproductive Behavior
- Risk Reduction Behavior
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| Behavioral: nurse home visitation |
- No Intervention: Control group
- Experimental: Nurse home visitation
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- 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.
- 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.
- 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.
- 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.
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| |
| Completed |
| 627 |
| March 2003 |
|
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.
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| Female |
|
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00438516 |
| David Olds, Principal Investigator, University of Colorado Denver |
| RO1HD043492, 5R01MH061428-02 |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| University of Colorado at Denver and Health Sciences Center |
| Principal Investigator: |
David L Olds, PhD |
University of Colorado at Denver and Health Sciences Center |
|
|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
| December 2007 |