Adolescent Development Clinical Trial
— MemphisYear9Official title:
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.
Status | Completed |
Enrollment | 627 |
Est. completion date | March 2003 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Rochester School of Nursing | Rochester | New York |
Lead Sponsor | Collaborator |
---|---|
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | University of Colorado, Denver |
United States,
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. — View 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. — View 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. — View 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. 20 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | interval between birth of first and second children; | When first child was 9 | No | |
Primary | cumulative subsequent births per year following birth of the first child through the first child's 9th birthday; | When first child was 9 | No | |
Primary | duration of mother's relationship with current partner; | When first child was 9 | No | |
Primary | being partnered with, cohabiting with, or married to the child's biological father; | When first child was 9 | No | |
Primary | her sense of mastery; | When first child was 9 | No | |
Primary | duration of use of welfare (AFDC and TANF) and food stamps per year following birth of the first child; | When first child was 9 | No | |
Primary | the counts of maternal arrests and days jailed, | When first child was 9 | No | |
Primary | 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) | When first child was 9 | No | |
Primary | children's grade point averages in reading, math, and behavior (conduct) from their school records | At child age 9 | No | |
Primary | children's achievement test scores | At child age 9 | No | |
Primary | teacher report of antisocial behavior | At child age 9 | No | |
Primary | maternal report of child disruptive behavior disorders and depressive and anxiety disorders | At child age 9 | No | |
Secondary | counts of subsequent miscarriages, abortions, and low-birth-weight newborns; | When first child was 9 | Yes | |
Secondary | women's reported participation in the workforce; | When first child was 9 | No | |
Secondary | their depression; | When first child was 9 | No | |
Secondary | whether they had experienced physical violence from any of their partners since their first child was 6; | When first child was 9 | Yes | |
Secondary | and the portion of time their current partners were employed while they were together following birth of the first child | When first child was 9 | No | |
Secondary | number of times children were retained in grades 1-3 | At child age 9 | No | |
Secondary | placement in special education | At child age 9 | No | |
Secondary | teachers' assessments of children's behavior | At child age 9 | No | |
Secondary | children's deaths | By child age 9 | No |
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