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

NCT00443586 | Unknown DMC

• 3 other identifiers: 04-0002R01MH070761DSIR 84-CTP
• Study Type: interventional
• Target: 345
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Risk Reduction Behavior

Keywords

Nurse; Home Visitation; Welfare; Social Behavior

Outcome Measures

Primary Outcomes (6)

• Economic productivity (e.g., unemployment, employment in jobs with limited opportunities for career growth, use of welfare, rates of out-of-wedlock births)

  Measured when child turns 27 years old

• Quality of partnered relationships (violence, commitment, and communication)

  Measured when child turns 27 years old

• Rates of child abuse and neglect

  Measured when child turns 27 years old

• Rates of criminal behavior, arrests, convictions, and imprisonment

  Measured when child turns 27 years old

• Mental health and abuse of substances

  Measured when child turns 27 years old

• Government expenditures and higher tax revenues

  Measured when child turns 27 years old

Study Arms (4)

Developmental Screening

ACTIVE COMPARATOR

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

Screening plus Transportation

ACTIVE COMPARATOR

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

Screening, Transport, Prenatal Visits

ACTIVE COMPARATOR

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

Screen, Transport, Prenatal/Inf Visits

EXPERIMENTAL

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

Developmental Screening 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

Developmental Screening; Screen, Transport, Prenatal/Inf Visits; Screening plus Transportation; Screening, Transport, Prenatal Visits

Screening plus Transportation 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.

Screen, Transport, Prenatal/Inf Visits; Screening plus Transportation; Screening, Transport, Prenatal Visits

Screening, Transport, Prenatal Visits 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; Screening, Transport, Prenatal Visits

Screen, Transport, Prenatal/Inf Visits 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.

Screen, Transport, Prenatal/Inf Visits

Eligibility Criteria

• Age: 27 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Comprehensive Interdisciplinary Development Services (CIDS)

Elmira, New York, 14901, United States

Location

Related Publications (10)

• 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.

  PMID: 16075193 BACKGROUND

• 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.

  PMID: 11771912 BACKGROUND

• 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.

  PMID: 10989400 BACKGROUND

• 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.

  PMID: 9272895 BACKGROUND

• 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.

  PMID: 8121734 BACKGROUND

• 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.

  PMID: 7510063 BACKGROUND

• 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.

  PMID: 8265329 BACKGROUND

• 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.

  PMID: 8433578 BACKGROUND

• 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.

  PMID: 3052116 BACKGROUND

• 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.

  PMID: 2425334 BACKGROUND

MeSH Terms

Conditions

Risk Reduction Behavior; Social Behavior

Interventions

Mass Screening; Transportation; Parturition

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice; Technology, Industry, and Agriculture; Pregnancy; Reproduction; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• David L. Olds, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• John Eckenrode, PhD

  Cornell University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors were masked to original treatment assignments.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2007
• First Posted: March 6, 2007
• Study Start: September 1, 2004
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 10, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)