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

8 de junio de 2021 actualizado por: 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.

Descripción general del estudio

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

Intervencionista

Inscripción (Anticipado)

345

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • New York
      • Elmira, New York, Estados Unidos, 14901
        • Comprehensive Interdisciplinary Development Services (CIDS)

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

27 años a 35 años (Adulto)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
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.
Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment at ages 12 and 24 months of age
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).
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.
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.
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.
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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
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
Measured when child turns 27 years old
Quality of partnered relationships (violence, commitment, and communication)
Periodo de tiempo: Measured when child turns 27 years old
Measured when child turns 27 years old
Rates of child abuse and neglect
Periodo de tiempo: Measured when child turns 27 years old
Measured when child turns 27 years old
Rates of criminal behavior, arrests, convictions, and imprisonment
Periodo de tiempo: Measured when child turns 27 years old
Measured when child turns 27 years old
Mental health and abuse of substances
Periodo de tiempo: Measured when child turns 27 years old
Measured when child turns 27 years old
Government expenditures and higher tax revenues
Periodo de tiempo: Measured when child turns 27 years old
Measured when child turns 27 years old

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: David L. Olds, PhD, University of Colorado, Denver
  • Director de estudio: John Eckenrode, PhD, Cornell University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de septiembre de 2004

Finalización primaria (Anticipado)

1 de diciembre de 2021

Finalización del estudio (Anticipado)

1 de diciembre de 2021

Fechas de registro del estudio

Enviado por primera vez

2 de marzo de 2007

Primero enviado que cumplió con los criterios de control de calidad

5 de marzo de 2007

Publicado por primera vez (Estimar)

6 de marzo de 2007

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

10 de junio de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

8 de junio de 2021

Última verificación

1 de junio de 2021

Más información

Términos relacionados con este estudio

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)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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