- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00443586
Follow-up Evaluation of Home Nurse Visitation Program for Socially Disadvantaged Women and Their Children
Age-27 Follow-up of Early Preventive Intervention
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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 de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Elmira, New York, Estados Unidos, 14901
- Comprehensive Interdisciplinary Development Services (CIDS)
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Evaluación del desarrollo
Los participantes recibieron una evaluación sensorial y del desarrollo y una derivación para una evaluación y tratamiento adicionales de los problemas sospechosos a los 12 y 24 meses de edad.
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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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Comparador activo: Detección más transporte
Los participantes recibieron una evaluación sensorial y del desarrollo y derivación para una evaluación y tratamiento adicionales de los problemas sospechosos a los 12 y 24 meses de edad; sus madres recibieron transporte gratuito para la atención prenatal y del niño sano (hasta los dos años de edad).
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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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Comparador activo: Detección, Transporte, Visitas Prenatales
Los participantes recibieron una evaluación sensorial y del desarrollo y derivación para una evaluación y tratamiento adicionales de los problemas sospechosos a los 12 y 24 meses de edad; sus madres recibieron transporte gratuito para el cuidado regular prenatal y de niño sano (hasta los dos años de edad), además de visitas domiciliarias de enfermeras durante el embarazo.
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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: Detección, Transporte, Visitas Prenatales/Inf.
Los participantes recibieron evaluaciones sensoriales y de desarrollo periódicas y derivaciones para una evaluación y tratamiento adicionales de los problemas sospechosos a los 12 y 24 meses de edad; sus madres recibieron transporte gratuito para el cuidado regular prenatal y de niño sano (hasta los dos años de edad), además de visitas domiciliarias de enfermeras durante el embarazo y hasta los dos años de edad.
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Measured when child turns 27 years old
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Measured when child turns 27 years old
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: David L. Olds, PhD, University of Colorado, Denver
- Director de estudio: John Eckenrode, PhD, Cornell University
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 04-0002
- DSIR 84-CTP (NIH)
- R01MH070761 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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