Overview

This trial is active, not recruiting.

Condition risk reduction behavior
Treatments nurse home visitation, comparison services
Sponsor University of Colorado, Denver
Collaborator National Institute of Mental Health (NIMH)
Start date September 2004
End date December 2016
Trial size 345 participants
Trial identifier NCT00443586, 04-0002, DSIR 84-CTP, R01MH070761

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Participants who have received nurse home visitation
nurse home visitation
Nurse-visited young adult participants were visited at home by a nurse 9 times during their mother's pregnancy and 23 times during the first 2 years of their life.
(Active Comparator)
Participants who have received comparison services
comparison services
Control group 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.

Primary Outcomes

Measure
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
Quality of partnered relationships (violence, commitment, and communication)
time frame: Measured when child turns 27 years old
Rates of child abuse and neglect
time frame: Measured when child turns 27 years old
Rates of criminal behavior, arrests, convictions, and imprisonment
time frame: Measured when child turns 27 years old
Mental health and abuse of substances
time frame: Measured when child turns 27 years old
Government expenditures and higher tax revenues
time frame: Measured when child turns 27 years old

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Any woman in Elmira, NY in 1977 who was pregnant with her first child

Additional Information

Official title Age-27 Follow-up of Early Preventive Intervention
Principal investigator David L. Olds, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.