Age-17 Follow-up of Home Visiting Intervention
MemphisY17
2 other identifiers
observational
1,880
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 27, 2008
CompletedFirst Posted
Study publicly available on registry
July 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedMay 4, 2022
April 1, 2022
7.4 years
May 27, 2008
April 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
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
Youth depression and anxiety
Measure of internalizing disorders based upon youth self-report.
at youth age 18
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
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 Outcomes (2)
Reduced maternal substance use disorders (SUDs) and depression.
at youth age 18
Improved child executive cognitive functioning, and rates of high school graduation.
at youth age 18
Other Outcomes (3)
Cumulative subsequent pregnancies - mothers
through youth age 18
Pregnancies - youth
through youth age 18
Relationship with Current Partner
at youth age 18
Study Arms (2)
Treatment 2: Transportation, Child Screening/Referral
The 514 families received: 1) free transportation for prenatal care; and 2) child developmental screening and referral services.
Treatment 4: Nurse Home Visiting through Age 2
The 228 families: 1) free transportation for prenatal care; 2) nurse home-visiting during pregnancy and through child's second birthday; and 3) child developmental screening and referral.
Interventions
Visits from nurses from mid-pregnancy to child age 2 years.
Eligibility Criteria
Very low-income African-Americans living in a major urban area. In this trial, 1,138 low-income pregnant women (98% unmarried, 67% \<19 years old, 92% African-American) were randomly assigned to experimental or comparison services; 742 were followed after delivery. The sample resided in extraordinarily stressful neighborhoods and endured extreme poverty. At registration, 85% of the sample had incomes below the federal poverty guidelines.
You may qualify if:
- Women who were enrolled in the New Mothers Study and their children as described in Study Population Description.
You may not qualify if:
- Women who were not enrolled in the New Mothers Study and their children as described in the Study Population Description.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Colorado, Denverlead
- University of Rochestercollaborator
- Emory Universitycollaborator
- University of Colorado, Bouldercollaborator
- RTI Internationalcollaborator
- National Institute on Drug Abuse (NIDA)collaborator
- Yale Universitycollaborator
Study Sites (1)
Memphis Study Office
Memphis, Tennessee, 38111, United States
Related Publications (11)
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.
PMID: 9272896BACKGROUNDKitzman 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.
PMID: 10789666BACKGROUNDOlds 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.
PMID: 15574614BACKGROUNDOlds 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.
PMID: 17908740BACKGROUNDOlds 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.
PMID: 20439792BACKGROUNDKitzman 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.
PMID: 20439791BACKGROUNDOlds 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.
PMID: 25003802BACKGROUNDConti G, Smith J, Anson E, Groth S, Knudtson M, Salvati A, Olds D. Early Home Visits and Health Outcomes in Low-Income Mothers and Offspring: 18-Year Follow-Up of a Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2351752. doi: 10.1001/jamanetworkopen.2023.51752.
PMID: 38236602DERIVEDKitzman H, Olds DL, Knudtson MD, Cole R, Anson E, Smith JA, Fishbein D, DiClemente R, Wingood G, Caliendo AM, Hopfer C, Miller T, Conti G. Prenatal and Infancy Nurse Home Visiting and 18-Year Outcomes of a Randomized Trial. Pediatrics. 2019 Dec;144(6):e20183876. doi: 10.1542/peds.2018-3876. Epub 2019 Nov 20.
PMID: 31748254DERIVEDOlds DL, Kitzman H, Anson E, Smith JA, Knudtson MD, Miller T, Cole R, Hopfer C, Conti G. Prenatal and Infancy Nurse Home Visiting Effects on Mothers: 18-Year Follow-up of a Randomized Trial. Pediatrics. 2019 Dec;144(6):e20183889. doi: 10.1542/peds.2018-3889. Epub 2019 Nov 20.
PMID: 31748253DERIVEDEnoch MA, Kitzman H, Smith JA, Anson E, Hodgkinson CA, Goldman D, Olds DL. A Prospective Cohort Study of Influences on Externalizing Behaviors Across Childhood: Results From a Nurse Home Visiting Randomized Controlled Trial. J Am Acad Child Adolesc Psychiatry. 2016 May;55(5):376-82. doi: 10.1016/j.jaac.2016.02.007. Epub 2016 Mar 2.
PMID: 27126851DERIVED
Related Links
Biospecimen
Spit samples will be taken.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David L Olds, PhD
University of Colorado, Denver
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 27, 2008
First Posted
July 2, 2008
Study Start
May 1, 2008
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
May 4, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- 2 years, beginning December 31st, 2023
- Access Criteria
- The data will be made available on publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal. Please contact Michael Knudtson, the study biostatistician, at michael.knudtson@cuanschutz.edu or 303-724-3199 for additional details.
Deidentified individual participant data (including data dictionaries) will be made available in addition to study protocols, the statistical analysis plan, and the informed consent form. The data will be made available on publication to researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal.