HIV Infections Clinical Trial
— MemphisY17Official title:
Age-17 Follow-up of Home Visiting Intervention
NCT number | NCT00708695 |
Other study ID # | 08-0616 |
Secondary ID | R01DA021624 |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 2008 |
Est. completion date | October 2015 |
Verified date | April 2022 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study is a longitudinal follow-up of 670 primarily African-American women and their 17-year-old firstborn children enrolled since 1990 in a highly significant randomized controlled trial (RCT) of prenatal and infancy home visiting by nurses. Nurses in this program are charged with improving pregnancy outcomes, child health and development, and maternal economic self-sufficiency. This follow-up examines whether earlier program effects on maternal and child functioning lead to less violent antisocial behavior, psychopathology, substance use and use-disorders, and risk for HIV; whether these effects are greater for those at both genetic and environmental risk; and whether program effects replicate those found with whites in an earlier trial.
Status | Completed |
Enrollment | 1880 |
Est. completion date | October 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 17 Years to 65 Years |
Eligibility | Inclusion Criteria: - Women who were enrolled in the New Mothers Study and their children as described in Study Population Description. Exclusion Criteria: - Women who were not enrolled in the New Mothers Study and their children as described in the Study Population Description. |
Country | Name | City | State |
---|---|---|---|
United States | Memphis Study Office | Memphis | Tennessee |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | Emory University, National Institute on Drug Abuse (NIDA), RTI International, University of Colorado, Boulder, University of Rochester, Yale University |
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
Kitzman HJ, Olds DL, Cole RE, Hanks CA, Anson EA, Arcoleo KJ, Luckey DW, Knudtson MD, Henderson CR Jr, Holmberg JR. Enduring effects of prenatal and infancy home visiting by nurses on children: follow-up of a randomized trial among children at age 12 years. Arch Pediatr Adolesc Med. 2010 May;164(5):412-8. doi: 10.1001/archpediatrics.2010.76. — 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. 2007 Oct;120(4):e832-45. — View Citation
Olds DL, Kitzman H, Knudtson MD, Anson E, Smith JA, Cole R. Effect of home visiting by nurses on maternal and child mortality: results of a 2-decade follow-up of a randomized clinical trial. JAMA Pediatr. 2014 Sep;168(9):800-6. doi: 10.1001/jamapediatrics.2014.472. — View Citation
Olds DL, Kitzman HJ, Cole RE, Hanks CA, Arcoleo KJ, Anson EA, Luckey DW, Knudtson MD, Henderson CR Jr, Bondy J, Stevenson AJ. Enduring effects of prenatal and infancy home visiting by nurses on maternal life course and government spending: follow-up of a randomized trial among children at age 12 years. Arch Pediatr Adolesc Med. 2010 May;164(5):419-24. doi: 10.1001/archpediatrics.2010.49. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cumulative subsequent pregnancies - mothers | Self-reported number of subsequent pregnancies, pregnancy outcomes, live births, low-birth weight newborns, and birth dates. Program effects on cumulative pregnancies and births hypothesized to be more pronounced among mothers with high psychological resources. | through youth age 18 | |
Other | Pregnancies - youth | Self-reported pregnancies and pregnancy outcomes. | through youth age 18 | |
Other | Relationship with Current Partner | Self-reported duration and quality of relationship, cohabitation, marriage, partner employment, and relationship to first-born child | at youth age 18 | |
Primary | Maternal life-course (reflected in reduced total public benefit expenditures for SNAP, AFDC/TANF, and Medicaid). | Public benefit expenditures estimated from review of state administrative records and maternal report of all children's birth dates. Program effects on public-benefit expenditures hypothesized to be especially pronounced for mothers with higher psychological resources. | through first child age 18 | |
Primary | Cognitive, language, and academic functioning among first-born children. | Direct tests of youth cognitive, language, and academic functioning. Program effects in this domain hypothesized to be most pronounced for children born to mothers with low psychological resources. | at youth age 18 | |
Primary | Youth depression and anxiety | Measure of internalizing disorders based upon youth self-report. | at youth age 18 | |
Primary | Youth gang membership, arrests, convictions, and self-reported antisocial behavior, especially for crimes involving interpersonal violence. | Self-reported involvement with criminal justice system and antisocial behavior. Program effects on arrests and convictions hypothesized to be greater for females. | at youth age 18 | |
Primary | Youth risk for HIV infection, pregnancies, births, use of substances, and SUDs. | Outcomes based upon self-report and urine assays for STI's and substance use. | at youth age 18. | |
Secondary | Reduced maternal substance use disorders (SUDs) and depression. | Based upon maternal self-report of SUDs and depression. | at youth age 18 | |
Secondary | Improved child executive cognitive functioning, and rates of high school graduation. | Based upon direct tests of risky decision making, impulsivity, facial recognition, verbal working memory) and records of high school graduation. Program effects in this domain hypothesized to be more pronounced for children born to mothers with low psychological resources. | at youth age 18 |
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