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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 27, 2014