Longitudinal Follow Up of Subjects Enrolled in Randomized Trial of Prenatal and Infancy Home Visitation - Full Text View

Sponsors and Collaborators:	University of Colorado at Denver and Health Sciences Center Smith-Richardson Foundation
Information provided by:	University of Colorado at Denver and Health Sciences Center
ClinicalTrials.gov Identifier:	NCT00443638

Purpose

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.

Condition	Intervention
Risk Reduction Behavior Reproductive Behavior	Behavioral: nurse home visitation

MedlinePlus related topics: Prenatal Care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Longitudinal Follow Up of Subjects Enrolled in Randomized Trials of Prenatal and Infancy Home Visitation

Further study details as provided by University of Colorado at Denver and Health Sciences Center:

Primary Outcome Measures:

rates of pregnancy and out-of-wedlock child birth [ Time Frame: At age 19 ] [ Designated as safety issue: No ]
educational achievement, including graduation from high school and participation in various types of post-high school education [ Time Frame: At age 19 ] [ Designated as safety issue: No ]
participation in the work force, including enrollment in the armed services [ Time Frame: At age 19 ] [ Designated as safety issue: No ]
use of welfare [ Time Frame: At age 19 ] [ Designated as safety issue: No ]
use of substances (cigarettes, alcohol, and illegal drugs) [ Time Frame: At age 19 ] [ Designated as safety issue: No ]
involvement with the criminal justice system (arrests, convictions, incarcerations, etc.) [ Time Frame: At age 19 ] [ Designated as safety issue: No ]

Enrollment:	320
Study Start Date:	May 1998
Study Completion Date:	April 2000

Arms	Assigned Interventions
1: No Intervention Control Group
2: Experimental Nurse home visitation through pregnancy	Behavioral: nurse home visitation Nurse home visitation
3: Experimental Nurse home visitation through child age 2.	Behavioral: nurse home visitation Nurse home visitation

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Pregnant women were actively recruited for the study if they had no previous live births, could register in the study prior to the 25th week of gestation, and had at least one of the following sociodemographic risk characteristics:
- young age (< 19 years at registration);
- unmarried; or
- low socioeconomic status (Medicaid status or no private insurance).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00443638

Locations

United States, New York
CIDS
Elmira, New York, United States, 14901

Sponsors and Collaborators

University of Colorado at Denver and Health Sciences Center

Smith-Richardson Foundation

Investigators

Principal Investigator:

David Olds, PhD

University of Colorado at Denver and Health Sciences Center

More Information

Publications:

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.

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.

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.

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.

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. Erratum in: Pediatrics 1994 Jun;93(6 Pt 1):973.

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. Erratum in: Pediatrics 1994 Jun;93(6 Pt 1):973.

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.

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.

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.

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.

Responsible Party:	University of Colorado Denver ( David Olds, Principal Investigator )
Study ID Numbers:	9801-099
Study First Received:	March 2, 2007
Last Updated:	December 6, 2007
ClinicalTrials.gov Identifier:	NCT00443638
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on January 16, 2009