NCT00443638

Brief Summary

The Elmira follow-up study is designed to assess the extent to which prenatal and infancy home visitation by nurses affects the life-course development of 19-year-old youth whose mothers received those services during pregnancy and the first two years of the child's life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 1998

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

May 1, 1998

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2000

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

March 2, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2007

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

First QC Date

March 2, 2007

Last Update Submit

January 29, 2013

Conditions

Risk Reduction BehaviorReproductive Behavior

Outcome Measures

Primary Outcomes (6)

  • rates of pregnancy and out-of-wedlock child birth

    At age 19

  • educational achievement, including graduation from high school and participation in various types of post-high school education

    At age 19

  • participation in the work force, including enrollment in the armed services

    At age 19

  • use of welfare

    At age 19

  • use of substances (cigarettes, alcohol, and illegal drugs)

    At age 19

  • involvement with the criminal justice system (arrests, convictions, incarcerations, etc.)

    At age 19

Study Arms (3)

Control Group

NO INTERVENTION

Control Group

Home visitation through pregnancy

EXPERIMENTAL

Nurse home visitation through pregnancy

Behavioral: nurse home visitation

Home visitation through age 2

EXPERIMENTAL

Nurse home visitation through child age 2.

Behavioral: nurse home visitation

Interventions

nurse home visitationBEHAVIORAL

Nurse home visitation

Home visitation through age 2Home visitation through pregnancy

Eligibility Criteria

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

You may qualify if:

  • Pregnant women prior to the 25th week of gestation
  • no previous live births
  • one of the following sociodemographic risk characteristics:
  • young age (\< 19 years at registration);
  • unmarried
  • low socioeconomic status (Medicaid status or no private insurance)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIDS

Elmira, New York, 14901, United States

Location

Related Publications (12)

  • Izzo CV, Eckenrode JJ, Smith EG, Henderson CR, Cole R, Kitzman H, Olds DL. Reducing the impact of uncontrollable stressful life events through a program of nurse home visitation for new parents. Prev Sci. 2005 Dec;6(4):269-74. doi: 10.1007/s11121-005-0010-5.

    PMID: 16075193BACKGROUND

  • Eckenrode J, Zielinski D, Smith E, Marcynyszyn LA, Henderson CR Jr, Kitzman H, Cole R, Powers J, Olds DL. Child maltreatment and the early onset of problem behaviors: can a program of nurse home visitation break the link? Dev Psychopathol. 2001 Fall;13(4):873-90.

    PMID: 11771912BACKGROUND

  • Eckenrode J, Ganzel B, Henderson CR Jr, Smith E, Olds DL, Powers J, Cole R, Kitzman H, Sidora K. Preventing child abuse and neglect with a program of nurse home visitation: the limiting effects of domestic violence. JAMA. 2000 Sep 20;284(11):1385-91. doi: 10.1001/jama.284.11.1385.

    PMID: 10989400BACKGROUND

  • Olds DL, Eckenrode J, Henderson CR Jr, Kitzman H, Powers J, Cole R, Sidora K, Morris P, Pettitt LM, Luckey D. Long-term effects of home visitation on maternal life course and child abuse and neglect. Fifteen-year follow-up of a randomized trial. JAMA. 1997 Aug 27;278(8):637-43.

    PMID: 9272895BACKGROUND

  • Olds DL, Henderson CR Jr, Tatelbaum R. Intellectual impairment in children of women who smoke cigarettes during pregnancy. Pediatrics. 1994 Feb;93(2):221-7.

    PMID: 8121734BACKGROUND

  • Olds DL, Henderson CR Jr, Tatelbaum R. Prevention of intellectual impairment in children of women who smoke cigarettes during pregnancy. Pediatrics. 1994 Feb;93(2):228-33.

    PMID: 7510063BACKGROUND

  • Olds DL, Henderson CR Jr, Kitzman H. Does prenatal and infancy nurse home visitation have enduring effects on qualities of parental caregiving and child health at 25 to 50 months of life? Pediatrics. 1994 Jan;93(1):89-98.

    PMID: 8265329BACKGROUND

  • Olds DL, Henderson CR Jr, Phelps C, Kitzman H, Hanks C. Effect of prenatal and infancy nurse home visitation on government spending. Med Care. 1993 Feb;31(2):155-74. doi: 10.1097/00005650-199302000-00006.

    PMID: 8433578BACKGROUND

  • Olds DL, Henderson CR Jr, Tatelbaum R, Chamberlin R. Improving the life-course development of socially disadvantaged mothers: a randomized trial of nurse home visitation. Am J Public Health. 1988 Nov;78(11):1436-45. doi: 10.2105/ajph.78.11.1436.

    PMID: 3052116BACKGROUND

  • Olds DL, Henderson CR Jr, Chamberlin R, Tatelbaum R. Preventing child abuse and neglect: a randomized trial of nurse home visitation. Pediatrics. 1986 Jul;78(1):65-78.

    PMID: 2425334BACKGROUND

  • Lane C, Hogg E, Karwatowska LA, French L, Ranieri VF, Jesnick LGD, Roberts C, Scott S, Senior R, Skinner GC, Kennedy EMM. Personalised interventions for subgroups of children with conduct problems. Cochrane Database Syst Rev. 2023 Apr 28;4(4):CD012746. doi: 10.1002/14651858.CD012746.pub2.

    PMID: 37115724DERIVED

  • Eckenrode J, Campa M, Luckey DW, Henderson CR Jr, Cole R, Kitzman H, Anson E, Sidora-Arcoleo K, Powers J, Olds D. Long-term effects of prenatal and infancy nurse home visitation on the life course of youths: 19-year follow-up of a randomized trial. Arch Pediatr Adolesc Med. 2010 Jan;164(1):9-15. doi: 10.1001/archpediatrics.2009.240.

    PMID: 20048236DERIVED

MeSH Terms

Conditions

Risk Reduction BehaviorReproductive Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • David 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

March 2, 2007

First Posted

March 6, 2007

Study Start

May 1, 1998

Study Completion

April 1, 2000

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

US(1)