NCT00438516

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
627

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2000

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2000

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2003

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
Last Updated

January 15, 2008

Status Verified

December 1, 2007

First QC Date

February 21, 2007

Last Update Submit

January 9, 2008

Conditions

Child RearingAdolescent DevelopmentReproductive BehaviorRisk Reduction Behavior

Keywords

home visitspregnancywelfarechild developmentmortality

Outcome Measures

Primary Outcomes (12)

  • interval between birth of first and second children;

    When first child was 9

  • cumulative subsequent births per year following birth of the first child through the first child's 9th birthday;

    When first child was 9

  • duration of mother's relationship with current partner;

    When first child was 9

  • being partnered with, cohabiting with, or married to the child's biological father;

    When first child was 9

  • her sense of mastery;

    When first child was 9

  • duration of use of welfare (AFDC and TANF) and food stamps per year following birth of the first child;

    When first child was 9

  • the counts of maternal arrests and days jailed,

    When first child was 9

  • 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

  • children's grade point averages in reading, math, and behavior (conduct) from their school records

    At child age 9

  • children's achievement test scores

    At child age 9

  • teacher report of antisocial behavior

    At child age 9

  • maternal report of child disruptive behavior disorders and depressive and anxiety disorders

    At child age 9

Secondary Outcomes (9)

  • counts of subsequent miscarriages, abortions, and low-birth-weight newborns;

    When first child was 9

  • women's reported participation in the workforce;

    When first child was 9

  • their depression;

    When first child was 9

  • whether they had experienced physical violence from any of their partners since their first child was 6;

    When first child was 9

  • 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

  • +4 more secondary outcomes

Study Arms (2)

1

NO INTERVENTION

Control group

2

EXPERIMENTAL

Nurse home visitation

Behavioral: nurse home visitation

Interventions

nurse home visitationBEHAVIORAL

Nurse home visits from midway through pregnancy to child age 2

2

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester School of Nursing

Rochester, New York, 14642, United States

Location

Related Publications (4)

  • 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. doi: 10.1542/peds.2004-0962.

    PMID: 15574614BACKGROUND

  • 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. doi: 10.1001/jama.283.15.1983.

    PMID: 10789666BACKGROUND

  • 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: 9272896BACKGROUND

  • 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. doi: 10.1542/peds.2006-2111.

    PMID: 17908740RESULT

MeSH Terms

Conditions

Reproductive BehaviorRisk Reduction Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • David L Olds, PhD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 22, 2007

Study Start

June 1, 2000

Study Completion

March 1, 2003

Last Updated

January 15, 2008

Record last verified: 2007-12

Locations

US(1)