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

January 29, 2013 updated by: University of Colorado, Denver

Longitudinal Follow Up of Subjects Enrolled in Randomized Trials of Prenatal and Infancy Home Visitation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rates of pregnancy and out-of-wedlock child birth
Time Frame: At age 19
At age 19
educational achievement, including graduation from high school and participation in various types of post-high school education
Time Frame: At age 19
At age 19
participation in the work force, including enrollment in the armed services
Time Frame: At age 19
At age 19
use of welfare
Time Frame: At age 19
At age 19
use of substances (cigarettes, alcohol, and illegal drugs)
Time Frame: At age 19
At age 19
involvement with the criminal justice system (arrests, convictions, incarcerations, etc.)
Time Frame: At age 19
At age 19

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Smith-Richardson Foundation

Investigators

  • Principal Investigator: David Olds, PhD, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1998

Study Completion (Actual)

April 1, 2000

Study Registration Dates

First Submitted

March 2, 2007

First Submitted That Met QC Criteria

March 5, 2007

First Posted (Estimate)

March 6, 2007

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 98-0568

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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