Longitudinal Follow Up of Subjects Enrolled in Randomized Trial of Prenatal and Infancy Home Visitation

NCT ID: NCT00443638

Last Updated: 2013-01-31

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

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-05-31

Study Completion Date

2000-04-30

Brief Summary

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The Elmira follow-up study is designed to assess the extent to which prenatal and infancy home visitation by nurses affects the life-course development of 19-year-old youth whose mothers received those services during pregnancy and the first two years of the child's life.

Detailed Description

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Conditions

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Risk Reduction Behavior Reproductive Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Control Group

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Home visitation through pregnancy

Nurse home visitation through pregnancy

Group Type EXPERIMENTAL

nurse home visitation

Intervention Type BEHAVIORAL

Nurse home visitation

Home visitation through age 2

Nurse home visitation through child age 2.

Group Type EXPERIMENTAL

nurse home visitation

Intervention Type BEHAVIORAL

Nurse home visitation

Interventions

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nurse home visitation

Nurse home visitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pregnant women prior to the 25th week of gestation
* no previous live births
* one of the following sociodemographic risk characteristics:

* young age (\< 19 years at registration);
* unmarried
* low socioeconomic status (Medicaid status or no private insurance)
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Smith-Richardson Foundation

UNKNOWN

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 Olds, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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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)

Lane C, Hogg E, Karwatowska LA, French L, Ranieri VF, Jesnick LGD, Roberts C, Scott S, Senior R, Skinner GC, Kennedy EMM. Personalised interventions for subgroups of children with conduct problems. Cochrane Database Syst Rev. 2023 Apr 28;4(4):CD012746. doi: 10.1002/14651858.CD012746.pub2.

Reference Type DERIVED
PMID: 37115724 (View on PubMed)

Eckenrode J, Campa M, Luckey DW, Henderson CR Jr, Cole R, Kitzman H, Anson E, Sidora-Arcoleo K, Powers J, Olds D. Long-term effects of prenatal and infancy nurse home visitation on the life course of youths: 19-year follow-up of a randomized trial. Arch Pediatr Adolesc Med. 2010 Jan;164(1):9-15. doi: 10.1001/archpediatrics.2009.240.

Reference Type DERIVED
PMID: 20048236 (View on PubMed)

Other Identifiers

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98-0568

Identifier Type: -

Identifier Source: org_study_id

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