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

Sponsor

University of Colorado, Denver (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00443586

Collaborator

National Institute of Mental Health (NIMH) (NIH)

345

Enrollment

Location

Arms

207

Anticipated Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Risk Reduction Behavior	Behavioral: Developmental Screening Behavioral: Screening plus Transportation Behavioral: Screening, Transport, Prenatal Visits Behavioral: Screen, Transport, Prenatal/Inf Visits	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

345 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Assessors were masked to original treatment assignments.

Primary Purpose:

Prevention

Official Title:

Age-27 Follow-up of Early Preventive Intervention

Actual Study Start Date :

Sep 1, 2004

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

27 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Comprehensive Interdisciplinary Development Services (CIDS)	Elmira	New York	United States	14901

Sponsors and Collaborators

University of Colorado, Denver
National Institute of Mental Health (NIMH)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University of Colorado, Denver

ClinicalTrials.gov Identifier:

NCT00443586

Other Study ID Numbers:

04-0002
R01MH070761
DSIR 84-CTP

First Posted:

Mar 6, 2007

Last Update Posted:

Jun 10, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Colorado, Denver

Study Results

No Results Posted as of Jun 10, 2021