- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00231179
The MOM Program: 5 Year Follow-up Study of a Home Visiting Program at The Children's Hospital of Philadelphia (MOM Program)
26 de octubre de 2015 actualizado por: Children's Hospital of Philadelphia
The MOM Program Continuation - 5 Year Follow-up
The purpose of the MOM Program Continuation is to promote child development by helping families become more competent in accessing and using available health, developmental and educational resources.
The program focuses are childhood immunizations, Early Intervention services, lead screening, Early Head Start and Head Start enrollment.
The Intervention consists of frequent phone calls and home visits to encourage mothers to have their babies immunized on schedule and to participate in needed developmental and educational services.
The program seeks to fill the gap between children's need for services and mothers' ability to assure their children's participation in those services.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
The MOM Program Continuation builds on the work of The MOM Program, a 3 year randomized intervention.
The premise of the MOM Program was that professional support through home visits and frequent phone contacts would improve children's cognitive and behavioral development, ultimately improving their early educational success.
The children were enrolled in the MOM Program at birth.
The MOM Program Continuation provides continued intervention for the children and mothers of the original cohort to assure that the children are prepared for kindergarten entry at 5 years of age and to evaluate the children's cognitive and behavioral outcomes at age 5 years.
The program will also create a longitudinal database to study the linkages between maternal cognitive ability and child cognitive, educational, and behavioral outcomes through entry into school.
Tipo de estudio
Intervencionista
Inscripción (Actual)
302
Fase
- Fase 3
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
-
-
Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19104
- The Children's Hospital of Philadelphia
-
-
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
4 años a 5 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria: Previous enrollment in The MOM Program; child age of 5 years (plus or minus 3 months); willingness to come to office for follow-up assessment visit; parental consent and child assent.
Exclusion Criteria: None.
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 |
---|---|
Experimental: Home visiting Intervention
Home visiting intervention group.
|
Home visits and telephone calls keyed to well child visits.
|
Comparador de placebos: Control
Control condition did not receive any services.
|
The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations.
They were called every 4 months to maintain contact information
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III)
Periodo de tiempo: 5 years of age (plus or minus 1 month)
|
Cognitive ability was assessed through the Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III).
The WPPSI-III has been developed and standardized for children ages 2 years, 6 months through 7 years, 3 months of age.
The WPPSI-III yields a Verbal Score, a Performance Score, a General Language Score, and a Full Scale Score.
These scores have a mean of 100 and a standard deviation of 15.
The range of possible values is 50 (worst value) to 150 (best value).
|
5 years of age (plus or minus 1 month)
|
Child Behavior Checklist Internalizing Scale at 5 Years of Age, Percentage of Participants
Periodo de tiempo: at child age of 5 years (plus or minus 1 month)
|
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA).
The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems.
Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months.
The range of possible values is 0-100.
Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
|
at child age of 5 years (plus or minus 1 month)
|
Child Behavior Checklist Externalizing Scale, Percentage of Abnormality in Participants
Periodo de tiempo: at child age of 5 years (plus or minus 1 month)
|
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA).
The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems.
Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months.
The range of possible values is 0-100.
Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
|
at child age of 5 years (plus or minus 1 month)
|
Child Behavior Checklist Aggressive Subscale, Percentage of Abnormality in Participants
Periodo de tiempo: at child age of 5 years (plus or minus 1 month)
|
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA).
The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems.
Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months.
The range of possible values is 0-100.
Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
|
at child age of 5 years (plus or minus 1 month)
|
Child Behavior Checklist Attention Subscale, Percentage of Abnormality in Participants
Periodo de tiempo: child age 5 years (plus or minus 1 month)
|
Caregivers completed The Child Behavior Checklist (CBCL) Preschool form from The Achenbach System of Empirically Based Assessment (ASEBA).
The CBCL is standardized for children ages 1.5 to 5 years and measures child internalizing and externalizing behaviors and total problems.
Respondents are asked to rate 99 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child" based on the past two months.
The range of possible values is 0-100.
Percentage of Participants with Abnormal Behavior is calculated by: % abnormal = # of Abnormal / (# of Normal + # of abnormal).
|
child age 5 years (plus or minus 1 month)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
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 primaria (Actual)
1 de febrero de 2007
Finalización del estudio (Actual)
1 de febrero de 2007
Fechas de registro del estudio
Enviado por primera vez
30 de septiembre de 2005
Primero enviado que cumplió con los criterios de control de calidad
30 de septiembre de 2005
Publicado por primera vez (Estimar)
4 de octubre de 2005
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
23 de noviembre de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
26 de octubre de 2015
Última verificación
1 de octubre de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2003-10-3495
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
producto fabricado y exportado desde los 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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