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

NCT ID: NCT00443586

Last Updated: 2021-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

345 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Risk Reduction Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Assessors were masked to original treatment assignments.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Developmental Screening

Intervention Type BEHAVIORAL

Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age

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).

Group Type ACTIVE_COMPARATOR

Developmental Screening

Intervention Type BEHAVIORAL

Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age

Screening plus Transportation

Intervention Type BEHAVIORAL

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.

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.

Group Type ACTIVE_COMPARATOR

Developmental Screening

Intervention Type BEHAVIORAL

Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age

Screening plus Transportation

Intervention Type BEHAVIORAL

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.

Screening, Transport, Prenatal Visits

Intervention Type BEHAVIORAL

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.

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.

Group Type EXPERIMENTAL

Developmental Screening

Intervention Type BEHAVIORAL

Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age

Screening plus Transportation

Intervention Type BEHAVIORAL

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.

Screening, Transport, Prenatal Visits

Intervention Type BEHAVIORAL

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.

Screen, Transport, Prenatal/Inf Visits

Intervention Type BEHAVIORAL

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.

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

27 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David L. Olds, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

John Eckenrode, PhD

Role: STUDY_DIRECTOR

Cornell University

Locations

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Comprehensive Interdisciplinary Development Services (CIDS)

Elmira, New York, United States

Site Status

Countries

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United States

References

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Izzo CV, Eckenrode JJ, Smith EG, Henderson CR, Cole R, Kitzman H, Olds DL. Reducing the impact of uncontrollable stressful life events through a program of nurse home visitation for new parents. Prev Sci. 2005 Dec;6(4):269-74. doi: 10.1007/s11121-005-0010-5.

Reference Type BACKGROUND
PMID: 16075193 (View on PubMed)

Eckenrode J, Zielinski D, Smith E, Marcynyszyn LA, Henderson CR Jr, Kitzman H, Cole R, Powers J, Olds DL. Child maltreatment and the early onset of problem behaviors: can a program of nurse home visitation break the link? Dev Psychopathol. 2001 Fall;13(4):873-90.

Reference Type BACKGROUND
PMID: 11771912 (View on PubMed)

Eckenrode J, Ganzel B, Henderson CR Jr, Smith E, Olds DL, Powers J, Cole R, Kitzman H, Sidora K. Preventing child abuse and neglect with a program of nurse home visitation: the limiting effects of domestic violence. JAMA. 2000 Sep 20;284(11):1385-91. doi: 10.1001/jama.284.11.1385.

Reference Type BACKGROUND
PMID: 10989400 (View on PubMed)

Olds DL, Eckenrode J, Henderson CR Jr, Kitzman H, Powers J, Cole R, Sidora K, Morris P, Pettitt LM, Luckey D. Long-term effects of home visitation on maternal life course and child abuse and neglect. Fifteen-year follow-up of a randomized trial. JAMA. 1997 Aug 27;278(8):637-43.

Reference Type BACKGROUND
PMID: 9272895 (View on PubMed)

Olds DL, Henderson CR Jr, Tatelbaum R. Intellectual impairment in children of women who smoke cigarettes during pregnancy. Pediatrics. 1994 Feb;93(2):221-7.

Reference Type BACKGROUND
PMID: 8121734 (View on PubMed)

Olds DL, Henderson CR Jr, Tatelbaum R. Prevention of intellectual impairment in children of women who smoke cigarettes during pregnancy. Pediatrics. 1994 Feb;93(2):228-33.

Reference Type BACKGROUND
PMID: 7510063 (View on PubMed)

Olds DL, Henderson CR Jr, Kitzman H. Does prenatal and infancy nurse home visitation have enduring effects on qualities of parental caregiving and child health at 25 to 50 months of life? Pediatrics. 1994 Jan;93(1):89-98.

Reference Type BACKGROUND
PMID: 8265329 (View on PubMed)

Olds DL, Henderson CR Jr, Phelps C, Kitzman H, Hanks C. Effect of prenatal and infancy nurse home visitation on government spending. Med Care. 1993 Feb;31(2):155-74. doi: 10.1097/00005650-199302000-00006.

Reference Type BACKGROUND
PMID: 8433578 (View on PubMed)

Olds DL, Henderson CR Jr, Tatelbaum R, Chamberlin R. Improving the life-course development of socially disadvantaged mothers: a randomized trial of nurse home visitation. Am J Public Health. 1988 Nov;78(11):1436-45. doi: 10.2105/ajph.78.11.1436.

Reference Type BACKGROUND
PMID: 3052116 (View on PubMed)

Olds DL, Henderson CR Jr, Chamberlin R, Tatelbaum R. Preventing child abuse and neglect: a randomized trial of nurse home visitation. Pediatrics. 1986 Jul;78(1):65-78.

Reference Type BACKGROUND
PMID: 2425334 (View on PubMed)

Other Identifiers

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R01MH070761

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DSIR 84-CTP

Identifier Type: -

Identifier Source: secondary_id

04-0002

Identifier Type: -

Identifier Source: org_study_id

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