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Follow-up Evaluation of Home Nurse Visitation Program for Socially Disadvantaged Women and Their Children
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), August 2008
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00443586
  Purpose

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 Intervention
Risk Reduction Behavior
Behavioral: Nurse home visitation
Behavioral: Comparison services

U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title: Age-27 Follow-up of Early Preventive Intervention

Further study details as provided by National Institute of Mental Health (NIMH):

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) [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: No ]
  • Quality of partnered relationships (violence, commitment, and communication) [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: No ]
  • Rates of child abuse and neglect [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: No ]
  • Rates of criminal behavior, arrests, convictions, and imprisonment [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: No ]
  • Mental health and abuse of substances [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: Yes ]
  • Government expenditures and higher tax revenues [ Time Frame: Measured when child turns 27 years old ] [ Designated as safety issue: No ]

Estimated Enrollment: 345
Study Start Date: September 2004
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
Participants who have received nurse home visitation
Behavioral: 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.
B: Active Comparator
Participants who have received comparison services
Behavioral: 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.

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Any woman in Elmira, NY in 1977 who was pregnant with her first child
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00443586

Contacts
Contact: Darlene Batrowny 607-733-6533 andylanie452@aol.com
Contact: Alise Mahr 607-733-6533 almwpm@aol.com

Locations
United States, New York
Comprehensive Interdisciplinary Development Services (CIDS) Recruiting
Elmira, New York, United States, 14901
Sponsors and Collaborators
Investigators
Principal Investigator: David L. Olds, PhD University of Colorado at Denver and Health Sciences Center
Study Director: John Eckenrode, PhD Cornell University
  More Information

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Responsible Party: University of Colorado Denver ( David Olds )
Study ID Numbers: MH070761, DSIR 84-CTP
Study First Received: March 2, 2007
Last Updated: August 25, 2008
ClinicalTrials.gov Identifier: NCT00443586  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Nurse
Home Visitation
Welfare
Social Behavior

ClinicalTrials.gov processed this record on January 16, 2009