Age 9 Follow-up of Preventive Intervention (Denver) (DenverY09)
29 de enero de 2013 actualizado por: University of Colorado, Denver
Age 9 Follow-up of Preventive Intervention
To examine the impact of prenatal and infancy home visiting by paraprofessionals and by nurses from child age 2 through 9.
Descripción general del estudio
Estado
Terminado
Intervención / Tratamiento
Descripción detallada
This project supports a 9-year follow-up of 650 children and their families who were enrolled in a randomized trial of prenatal and infancy home visiting by paraprofessionals and by nurses; participating families were assigned to control, paraprofessional-, or nurse-visited conditions. Earlier phases of assessment found significant benefits for nurse- and paraprofessional-visited families and children, although the nurse effects tended to be larger. The current phase of follow-up is designed to determine whether the effects of the nurse and paraprofessional programs endure and grow through the child age 9.5.
The project is organized around seven questions:
- Do the programs of nurse and paraprofessional home-visiting produce enduring effects on: a) mothers' life-course; b) qualities of care parents provide to their children; c) children's early-onset behavior problems; d) children's incoherence and aggression/destruction in response to story stems; e) children's executive, language, and intellectual functioning and school achievement?
- To what extent are the beneficial effects of the programs on parental care-giving and children's development concentrated on those born to mothers with few psychological resources?
- To what extent are the benefits of the programs on mothers and children equivalent for Mexican- Americans and European-Americans?
- To what extent are the effects of the programs on antisocial behavior concentrated on boys? 5. To what extent are program effects moderated by school and neighborhood contexts?
6. To what extent are the effects of the programs on children's development explained by impacts of the programs on women's prenatal smoking, maternal life-course, qualities of parental caregiving, and children's earlier language development, executive functioning, and emotional regulation? 7. To what extent are the initial costs of the programs recovered in reduced expenditures for other government services during the first nine years of the first child's life?
Tipo de estudio
Intervencionista
Inscripción (Actual)
584
Fase
- No aplica
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
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Descripción
Inclusion Criteria:
- Women from 21 antepartum clinics serving low-income women in Denver recruited if they had no previous live births and either qualified for Medicaid or had no private insurance.
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: Grupo de control
|
|
|
Experimental: Paraprofessional home visits
home visitation by Paraprofessional
|
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
|
|
Experimental: Nurse home visits
home visitation by Nurse
|
Home visits from mid-pregnancy until child age 2. Group 2 is visits by a paraprofessional; group 3 is visits by nurses.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
fewer subsequent pregnancies
Periodo de tiempo: When first child is 9
|
When first child is 9
|
|
increased interval between the birth of the first and second child
Periodo de tiempo: When first child is 9
|
When first child is 9
|
|
reduced use of welfare
Periodo de tiempo: When first child is 9
|
When first child is 9
|
|
increased participation in the work force
Periodo de tiempo: When first child is 9
|
When first child is 9
|
|
reduced behavioral problems due to use of alcohol and drugs
Periodo de tiempo: When first child is 9
|
When first child is 9
|
|
fewer arrests
Periodo de tiempo: When first child is 9
|
When first child is 9
|
|
increased qualities of care parents provide to their children as reflected in fewer verified reports of child abuse and neglect and observations of coercive mother-child interaction.
Periodo de tiempo: When first child is 9
|
When first child is 9
|
|
children's early-onset behavior problems (both externalizing and internalizing) reported by parents and teachers at home, at school, and with peers.
Periodo de tiempo: At child age 9
|
At child age 9
|
|
children's aggressive and destructive themes and narrative coherence in their responses to story stems.
Periodo de tiempo: At child age 9
|
At child age 9
|
|
executive functions and school achievement.
Periodo de tiempo: At child age 9
|
At child age 9
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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
- Olds DL, Robinson J, Pettitt L, Luckey DW, Holmberg J, Ng RK, Isacks K, Sheff K, Henderson CR Jr. Effects of home visits by paraprofessionals and by nurses: age 4 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1560-8. doi: 10.1542/peds.2004-0961.
- Olds DL, Robinson J, O'Brien R, Luckey DW, Pettitt LM, Henderson CR Jr, Ng RK, Sheff KL, Korfmacher J, Hiatt S, Talmi A. Home visiting by paraprofessionals and by nurses: a randomized, controlled trial. Pediatrics. 2002 Sep;110(3):486-96. doi: 10.1542/peds.110.3.486.
- Olds DL, Holmberg JR, Donelan-McCall N, Luckey DW, Knudtson MD, Robinson J. Effects of home visits by paraprofessionals and by nurses on children: follow-up of a randomized trial at ages 6 and 9 years. JAMA Pediatr. 2014 Feb;168(2):114-21. doi: 10.1001/jamapediatrics.2013.3817.
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
1 de febrero de 2004
Finalización del estudio (Actual)
1 de abril de 2006
Fechas de registro del estudio
Enviado por primera vez
20 de febrero de 2007
Primero enviado que cumplió con los criterios de control de calidad
21 de febrero de 2007
Publicado por primera vez (Estimar)
22 de febrero de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
31 de enero de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
29 de enero de 2013
Última verificación
1 de enero de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 03-0776
- R01MH069891 (Subvención/contrato del NIH de EE. UU.)
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. .