CClinicalTrials.gg
Status unknownNCT00443586Updated Jun 10, 2021

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

An interventional study of Developmental Screening and Screening plus Transportation in Risk Reduction Behavior, sponsored by University of Colorado, Denver. Status unknown at 1 site in United States. Open to participants aged 27 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-10.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Jun 2021), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Sep 2004, registered Mar 2007).
Phase
Not applicable
Study type
Interventional
Enrollment
345
Allocation
Randomized
Ages
27 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Risk Reduction Behavior

Keywords

  • Nurse
  • Home Visitation
  • Welfare
  • Social Behavior
03

In context

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
27 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
345 participants (estimated)

Study arms

  • 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

  • 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 · Behavioral: Screening plus Transportation

  • 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 · Behavioral: Screening plus Transportation · Behavioral: Screening, Transport, Prenatal Visits

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

Interventions

  • BehavioralDevelopmental 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

  • BehavioralScreening 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.

  • BehavioralScreening, 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.

  • BehavioralScreen, 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.

06

What researchers measure

Primary outcomes

  1. 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

  2. Quality of partnered relationships (violence, commitment, and communication)

    Time frame: Measured when child turns 27 years old

  3. Rates of child abuse and neglect

    Time frame: Measured when child turns 27 years old

  4. Rates of criminal behavior, arrests, convictions, and imprisonment

    Time frame: Measured when child turns 27 years old

  5. Mental health and abuse of substances

    Time frame: Measured when child turns 27 years old

  6. Government expenditures and higher tax revenues

    Time frame: Measured when child turns 27 years old

07

Study locations

1 site
  • Comprehensive Interdisciplinary Development Services (CIDS)
    Elmira, New York 14901, United States
08

References and documents

Publications

  • 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. PubMed 16075193 ↗
  • 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. PubMed 11771912 ↗
  • 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. PubMed 10989400 ↗
  • 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. PubMed 9272895 ↗
  • 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. Erratum In: Pediatrics 1994 Jun;93(6 Pt 1):973. PubMed 8121734 ↗
  • 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. Erratum In: Pediatrics 1994 Jun;93(6 Pt 1):973. PubMed 7510063 ↗
  • 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. PubMed 8265329 ↗
  • 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. PubMed 8433578 ↗
  • 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. PubMed 3052116 ↗
  • 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. PubMed 2425334 ↗

Individual participant data

Plan to share: Yes — 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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00443586
Lead sponsor
University of Colorado, Denver
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Mar 6, 2007
Start date
Sep 2004
Primary completion
Dec 2021 (estimated)
Completion
Dec 2021 (estimated)
Last update
Jun 10, 2021

Study contacts

David L. Olds, PhD
principal investigator · University of Colorado, Denver
John Eckenrode, PhD
study director · Cornell University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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