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

University of Colorado Denver (CU Denver) logo

University of Colorado Denver (CU Denver)

Status

Unknown

Conditions

Risk Reduction Behavior

Treatments

Behavioral: Screen, Transport, Prenatal/Inf Visits
Behavioral: Screening plus Transportation
Behavioral: Screening, Transport, Prenatal Visits
Behavioral: Developmental Screening

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00443586
DSIR 84-CTP
R01MH070761 (U.S. NIH Grant/Contract)
04-0002

Details and patient eligibility

About

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.

Full 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.

Enrollment

345 estimated patients

Sex

All

Ages

27 to 35 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

345 participants in 4 patient groups

Developmental Screening
Active Comparator group
Description:
Participants received sensory and developmental screening and referral for further evaluation and treatment of suspected problems at 12 and 24 months of age.
Treatment:
Behavioral: Developmental Screening
Screening plus Transportation
Active Comparator group
Description:
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).
Treatment:
Behavioral: Screening plus Transportation
Behavioral: Developmental Screening
Screening, Transport, Prenatal Visits
Active Comparator group
Description:
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.
Treatment:
Behavioral: Screening, Transport, Prenatal Visits
Behavioral: Screening plus Transportation
Behavioral: Developmental Screening
Screen, Transport, Prenatal/Inf Visits
Experimental group
Description:
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.
Treatment:
Behavioral: Screening, Transport, Prenatal Visits
Behavioral: Screening plus Transportation
Behavioral: Screen, Transport, Prenatal/Inf Visits
Behavioral: Developmental Screening

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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