Follow-up Evaluation of Home Nurse Visitation Program for Socially Disadvantaged Women and Their Children

June 8, 2021 updated by: University of Colorado, Denver

Age-27 Follow-up of Early Preventive Intervention

This study will evaluate the long-term effects of a prenatal and early childhood home nurse visitation program for socially disadvantaged women and their children.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Nearly half a million children are born each year to single, low-income mothers. Children born to socially disadvantaged mothers are more likely to experience chronic health problems, encounter child abuse and neglect, and receive insufficient health care. Home visitation by nurses during pregnancy and early childhood may prevent a wide range of health and developmental problems in children born to women who are either teenagers, unmarried, or of low economic status.

This study is associated with a home nurse visitation program that first began with 400 socially disadvantaged pregnant women between the years of 1977 and 1980 in an upstate New York semi-rural county. Participants in the original study were randomly assigned to participate in the home nurse visitation program or receive comparison services from pregnancy until the child's second birthday. Participants assigned to receive comparison services were provided with free transportation for prenatal and child care, as well as sensory and developmental screening for the child. Participants assigned to the home nurse visitation program were visited at home by a nurse 9 times during pregnancy and 23 times during the child's first 2 years of life. A follow-up study concluded that the home nurse visitation program reduced the number subsequent pregnancies, use of welfare, child abuse and neglect, and criminal behavior on the part of the socially disadvantaged mothers for up to 15 years after the birth of their first child.

This follow-up study will determine whether a home nurse visitation program has continued long-term effects on a child's health and development, 27 years later. Specifically, this study will evaluate whether the nurse-visited young adult offspring differ from the comparison group in their economic productivity; rates of child abuse and neglect; criminal behavior; mental health; abuse of substances; use of welfare, foster care, and healthcare in relation to government expenditures; and quality of their partnered relationships. Participants within the nurse-visited program group will be compared with each other to determine whether certain characteristics or factors, such as genetic vulnerabilities, environmental risks, or a history of child abuse, make someone less likely to benefit from a home nurse visitation program.

Study Type

Interventional

Enrollment (Anticipated)

345

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
        • Comprehensive Interdisciplinary Development Services (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

27 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Offspring of mothers who had participated in Elmira, N.Y. randomized clinical trial of prenatal and infant/toddler home visiting by nurses.
  • Participants needed to be at least 27 years of age.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Developmental Screening
Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age.
Behavioral: Developmental Screening
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Active Comparator: Screening plus Transportation
Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two).
Behavioral: Developmental Screening
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Behavioral: Screening plus Transportation
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
Active Comparator: Screening, Transport, Prenatal Visits
Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy.
Behavioral: Developmental Screening
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Behavioral: Screening plus Transportation
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
Behavioral: Screening, Transport, Prenatal Visits
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.
Experimental: Screen, Transport, Prenatal/Inf Visits
Participants received regular sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age; their mothers received free transportation for regular prenatal and well-child care (through child age two), plus nurse home visiting during pregnancy and through child age two.
Behavioral: Developmental Screening
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
Behavioral: Screening plus Transportation
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
Behavioral: Screening, Transport, Prenatal Visits
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.
Behavioral: Screen, Transport, Prenatal/Inf Visits
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy and 23 during the child's first two years of life.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Economic productivity (e.g., unemployment, employment in jobs with limited opportunities for career growth, use of welfare, rates of out-of-wedlock births)
Time Frame: Measured when child turns 27 years old
Measured when child turns 27 years old
Quality of partnered relationships (violence, commitment, and communication)
Time Frame: Measured when child turns 27 years old
Measured when child turns 27 years old
Rates of child abuse and neglect
Time Frame: Measured when child turns 27 years old
Measured when child turns 27 years old
Rates of criminal behavior, arrests, convictions, and imprisonment
Time Frame: Measured when child turns 27 years old
Measured when child turns 27 years old
Mental health and abuse of substances
Time Frame: Measured when child turns 27 years old
Measured when child turns 27 years old
Government expenditures and higher tax revenues
Time Frame: Measured when child turns 27 years old
Measured when child turns 27 years old

Collaborators and Investigators

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

Sponsor

University of Colorado, Denver

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: David L. Olds, PhD, University of Colorado, Denver
  • Study Director: John Eckenrode, PhD, Cornell University

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 (Actual)

September 1, 2004

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

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 (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 04-0002
  • DSIR 84-CTP (NIH)
  • R01MH070761 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share individual participant data once the primary reports on this phase of the trial are published. This includes baseline data on maternal characteristics at registration during pregnancy and outcome data on primary outcomes for offspring participants at the 27-year follow-up. Data will be made available through the University of Michigan Inter-University Consortium for Political and Social Research (ICPSR). We anticipate archiving the data from this study with ICPSR by March 2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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