- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00443586
Follow-up Evaluation of Home Nurse Visitation Program for Socially Disadvantaged Women and Their Children
Age-27 Follow-up of Early Preventive Intervention
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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New York
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Elmira, New York, Stati Uniti, 14901
- Comprehensive Interdisciplinary Development Services (CIDS)
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Screening dello sviluppo
I partecipanti hanno ricevuto lo screening sensoriale e dello sviluppo e il rinvio per un'ulteriore valutazione e trattamento dei problemi sospetti a 12 e 24 mesi di età.
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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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Comparatore attivo: Screening più trasporto
I partecipanti hanno ricevuto screening sensoriale e dello sviluppo e rinvio per un'ulteriore valutazione e trattamento di problemi sospetti a 12 e 24 mesi di età; le loro madri ricevevano il trasporto gratuito per la regolare assistenza prenatale e per l'infanzia (fino all'età di due anni).
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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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Comparatore attivo: Screening, Trasporti, Visite Prenatali
I partecipanti hanno ricevuto screening sensoriale e dello sviluppo e rinvio per un'ulteriore valutazione e trattamento di problemi sospetti a 12 e 24 mesi di età; le loro madri hanno ricevuto il trasporto gratuito per la regolare assistenza prenatale e per l'infanzia (fino all'età di due anni), oltre a visite a domicilio dell'infermiera durante la gravidanza.
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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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Sperimentale: Screen, Trasporti, Visite Prenatali/Inf
I partecipanti hanno ricevuto regolari screening sensoriali e dello sviluppo e rinvio per un'ulteriore valutazione e trattamento di sospetti problemi a 12 e 24 mesi di età; le loro madri hanno ricevuto il trasporto gratuito per la regolare assistenza prenatale e per l'infanzia (fino all'età di due anni), oltre a visite a domicilio dell'infermiera durante la gravidanza e fino all'età di due anni.
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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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Measured when child turns 27 years old
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Measured when child turns 27 years old
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: David L. Olds, PhD, University of Colorado, Denver
- Direttore dello studio: John Eckenrode, PhD, Cornell University
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- 04-0002
- DSIR 84-CTP (NIH)
- R01MH070761 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
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