NCT00438165

Brief Summary

To examine the impact of prenatal and infancy home visiting by nurses from child age 2 through 12.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
609

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2003

Longer than P75 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

September 1, 2003

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2007

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

8.7 years

First QC Date

February 20, 2007

Last Update Submit

February 18, 2016

Conditions

Child RearingReproductive BehaviorRisk Reduction Behavior

Keywords

nursehome visitspregnancywelfarechild development

Outcome Measures

Primary Outcomes (7)

  • the number and spacing of subsequent pregnancies and births

    When first child is 12

  • the rates of marriage and cohabitation with the father of the child

    When first child is 12

  • mothers' employment, career growth, economic self-sufficiency, and welfare dependence

    When first child is 12

  • mothers' behavioral problems due to substance abuse

    When first child is 12

  • children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement

    At age 12

  • rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children

    At age 12

  • mothers' arrests for serious misdemeanors and felonies

    When first child is 12

Study Arms (2)

1

NO INTERVENTION

Control group

2

EXPERIMENTAL

Nurse home visits

Behavioral: home visitation

Interventions

home visitationBEHAVIORAL

Home visitation by nurses from midway through pregnancy until child age 12

2

Eligibility Criteria

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

You may qualify if:

  • Women \<29 weeks gestation
  • No previous live births
  • At least 2 socio-demographic risk characteristics; e.g. unmarried, \<12 years of education, 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 (6)

  • 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: 17908740BACKGROUND

  • 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.

    PMID: 20439792DERIVED

  • 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.

    PMID: 20439791DERIVED

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
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2007

First Posted

February 22, 2007

Study Start

September 1, 2003

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

US(1)