Longitudinal Follow Up of Subjects Enrolled in Randomized Trial of Prenatal and Infancy Home Visitation (ElmiraY19)

This study has been completed.
Sponsor:
Collaborator:
Smith-Richardson Foundation
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00443638
First received: March 2, 2007
Last updated: January 29, 2013
Last verified: January 2013
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Longitudinal Follow Up of Subjects Enrolled in Randomized Trials of Prenatal and Infancy Home Visitation

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

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
No Intervention: Control Group
Control Group
Experimental: Home visitation through pregnancy
Nurse home visitation through pregnancy
Behavioral: nurse home visitation
Nurse home visitation
Experimental: Home visitation through age 2
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 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)
  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, Denver
Smith-Richardson Foundation
Investigators
Principal Investigator: David Olds, PhD University of Colorado, Denver
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00443638     History of Changes
Other Study ID Numbers: 98-0568
Study First Received: March 2, 2007
Last Updated: January 29, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on April 17, 2014