Follow-up Evaluation of Home Nurse Visitation Program for Socially Disadvantaged Women and Their Children
8. Juni 2021 aktualisiert von: University of Colorado, Denver
Age-27 Follow-up of Early Preventive Intervention
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.
Studienübersicht
Status
Aktiv, nicht rekrutierend
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Voraussichtlich)
345
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
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New York
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Elmira, New York, Vereinigte Staaten, 14901
- Comprehensive Interdisciplinary Development Services (CIDS)
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
27 Jahre bis 35 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver Komparator: Entwicklungsscreening
Die Teilnehmer erhielten ein sensorisches und entwicklungsbezogenes Screening und eine Überweisung zur weiteren Bewertung und Behandlung vermuteter Probleme im Alter von 12 und 24 Monaten.
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Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
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Aktiver Komparator: Screening plus Transport
Die Teilnehmer erhielten ein sensorisches und entwicklungsbezogenes Screening und eine Überweisung zur weiteren Bewertung und Behandlung vermuteter Probleme im Alter von 12 und 24 Monaten; Ihre Mütter erhielten einen kostenlosen Transport für die regelmäßige vorgeburtliche und gesunde Kinderbetreuung (bis zum Alter von zwei Jahren).
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Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
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.
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Aktiver Komparator: Screening, Transport, vorgeburtliche Besuche
Die Teilnehmer erhielten ein sensorisches und entwicklungsbezogenes Screening und eine Überweisung zur weiteren Bewertung und Behandlung vermuteter Probleme im Alter von 12 und 24 Monaten; Ihre Mütter erhielten einen kostenlosen Transport für die regelmäßige vorgeburtliche und gesunde Kinderbetreuung (bis zum Alter von zwei Jahren) sowie den Besuch eines Pflegeheims während der Schwangerschaft.
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Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
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.
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.
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Experimental: Bildschirm, Transport, pränatale/inf. Besuche
Die Teilnehmer erhielten im Alter von 12 und 24 Monaten ein regelmäßiges sensorisches und entwicklungsbezogenes Screening und eine Überweisung zur weiteren Bewertung und Behandlung von vermuteten Problemen; Ihre Mütter erhielten einen kostenlosen Transport für die regelmäßige vorgeburtliche und gesunde Kinderbetreuung (bis zum Alter von zwei Jahren) sowie den Besuch eines Pflegeheims während der Schwangerschaft und bis zum Alter von zwei Jahren.
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Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
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.
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.
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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
|---|---|
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Economic productivity (e.g., unemployment, employment in jobs with limited opportunities for career growth, use of welfare, rates of out-of-wedlock births)
Zeitfenster: Measured when child turns 27 years old
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Measured when child turns 27 years old
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Quality of partnered relationships (violence, commitment, and communication)
Zeitfenster: Measured when child turns 27 years old
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Measured when child turns 27 years old
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Rates of child abuse and neglect
Zeitfenster: Measured when child turns 27 years old
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Measured when child turns 27 years old
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Rates of criminal behavior, arrests, convictions, and imprisonment
Zeitfenster: Measured when child turns 27 years old
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Measured when child turns 27 years old
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Mental health and abuse of substances
Zeitfenster: Measured when child turns 27 years old
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Measured when child turns 27 years old
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Government expenditures and higher tax revenues
Zeitfenster: Measured when child turns 27 years old
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Measured when child turns 27 years old
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: David L. Olds, PhD, University of Colorado, Denver
- Studienleiter: John Eckenrode, PhD, Cornell University
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
- 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. doi: 10.1001/jama.284.11.1385.
- 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. doi: 10.1097/00005650-199302000-00006.
- 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.
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. September 2004
Primärer Abschluss (Voraussichtlich)
1. Dezember 2021
Studienabschluss (Voraussichtlich)
1. Dezember 2021
Studienanmeldedaten
Zuerst eingereicht
2. März 2007
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
5. März 2007
Zuerst gepostet (Schätzen)
6. März 2007
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
10. Juni 2021
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
8. Juni 2021
Zuletzt verifiziert
1. Juni 2021
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 04-0002
- DSIR 84-CTP (NIH)
- R01MH070761 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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