| February 20, 2007 |
| December 6, 2007 |
| September 2003 |
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- the number and spacing of subsequent pregnancies and births [ Time Frame: When first child is 12 ] [ Designated as safety issue: No ]
- the rates of marriage and cohabitation with the father of the child [ Time Frame: When first child is 12 ] [ Designated as safety issue: No ]
- mothers' employment, career growth, economic self-sufficiency, and welfare dependence [ Time Frame: When first child is 12 ] [ Designated as safety issue: No ]
- mothers' behavioral problems due to substance abuse [ Time Frame: When first child is 12 ] [ Designated as safety issue: No ]
- children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement [ Time Frame: At age 12 ] [ Designated as safety issue: No ]
- rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children [ Time Frame: At age 12 ] [ Designated as safety issue: No ]
- mothers' arrests for serious misdemeanors and felonies [ Time Frame: When first child is 12 ] [ Designated as safety issue: No ]
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- the number and spacing of subsequent pregnancies and births
- the rates of marriage and cohabitation with the father of the child
- mothers' employment, career growth, economic self-sufficiency, and welfare dependence
- mothers' behavioral problems due to substance abuse
- children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement
- rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children
- mothers' arrests for serious misdemeanors and felonies
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| Complete list of historical versions of study NCT00438165 on ClinicalTrials.gov Archive Site |
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| Age 12 Follow-up of Early Preventive Intervention (Memphis) |
| Age 12 Follow-up of Early Preventive Intervention |
To examine the impact of prenatal and infancy home visiting by nurses from child age 2 through 12. |
This study is a longitudinal follow-up of 679 low-income women (89% African American) and their firstborn and subsequent children who have participated in a randomized trial of prenatal and infancy home visiting by nurses in Memphis, Tennessee since 1988. The study was conducted when the first-born children completed sixth grade, at around their 12th birthday.
The current follow-up was designed to determine whether: a) nurse-visited women differ from comparison group women in their life-course outcomes (the number and spacing of subsequent pregnancies and births; the rates of marriage and cohabitation with the father of the child; their employment, career growth, economic self-sufficiency, and welfare dependence; and behavioral problems due to substance abuse; arrests for serious misdemeanors and felonies); b) children of nurse-visited women differ from comparison-children in their academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement; c) there are lower rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children born to nurse-visited women; d) nurse-visited families have fewer government expenditures and higher taxes paid; e) the effects of the program on child outcomes are concentrated on children born to women with low psychological resources; f) the effects of the program on maternal life course and government costs are concentrated on women with high psychological resources; g) the effects of the program on children are greater in schools and neighborhoods that contain greater risks for academic and behavioral problems; h) the effect of the program on children's disruptive behavior problems is explained by the combined effects of the program on maternal life-course, qualities of parental care-giving, and children's sequential processing skills, and aggressive and violent themes, reliance on adults, and story incoherence in their responses to the McArthur Story Stem Battery at earlier assessments. Data will be derived from maternal interviews and reviews of state administrative and school records. Results from this trial will provide policy makers with an estimate of likely long-term effects of this program when it is conducted in close to real-life conditions. |
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| Interventional |
| Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
- Child Rearing
- Reproductive Behavior
- Risk Reduction Behavior
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| Behavioral: home visitation |
- No Intervention: Control group
- Experimental: Nurse home visits
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- 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.
- 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.
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| Completed |
| 609 |
| December 2006 |
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Inclusion Criteria:
- Women <29 weeks gestation, with no previous live births, and with at least 2 socio-demographic risk characteristics (unmarried, <12 years of education, unemployed)
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| Female |
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| Yes |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
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| NCT00438165 |
| David Olds, Principal Investigator, University of Colorado |
| 1R01MH068790-01 |
| University of Colorado at Denver and Health Sciences Center |
| National Institute of Mental Health (NIMH) |
| Principal Investigator: |
David L Olds, PhD |
University of Colorado at Denver and Health Sciences Center |
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| University of Colorado at Denver and Health Sciences Center |
| December 2007 |