- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00438165
Age 12 Follow-up of Early Preventive Intervention (Memphis) (MemphisY12)
Age 12 Follow-up of Early Preventive Intervention
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
This study is a longitudinal follow-up of 679 low-income women (89% African American) and their firstborn and subsequent children who have participated in a randomized trial of prenatal and infancy home visiting by nurses in Memphis, Tennessee since 1988. The study was conducted when the first-born children completed sixth grade, at around their 12th birthday.
The current follow-up was designed to determine whether: a) nurse-visited women differ from comparison group women in their life-course outcomes (the number and spacing of subsequent pregnancies and births; the rates of marriage and cohabitation with the father of the child; their employment, career growth, economic self-sufficiency, and welfare dependence; and behavioral problems due to substance abuse; arrests for serious misdemeanors and felonies); b) children of nurse-visited women differ from comparison-children in their academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement; c) there are lower rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children born to nurse-visited women; d) nurse-visited families have fewer government expenditures and higher taxes paid; e) the effects of the program on child outcomes are concentrated on children born to women with low psychological resources; f) the effects of the program on maternal life course and government costs are concentrated on women with high psychological resources; g) the effects of the program on children are greater in schools and neighborhoods that contain greater risks for academic and behavioral problems; h) the effect of the program on children's disruptive behavior problems is explained by the combined effects of the program on maternal life-course, qualities of parental care-giving, and children's sequential processing skills, and aggressive and violent themes, reliance on adults, and story incoherence in their responses to the McArthur Story Stem Battery at earlier assessments. Data will be derived from maternal interviews and reviews of state administrative and school records. Results from this trial will provide policy makers with an estimate of likely long-term effects of this program when it is conducted in close to real-life conditions.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
New York
-
Rochester, New York, Estados Unidos, 14642
- University of Rochester School of Nursing
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Women <29 weeks gestation
- No previous live births
- At least 2 socio-demographic risk characteristics; e.g. unmarried, <12 years of education, unemployed.
Plan de estudios
¿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: 1
Grupo de control
|
|
|
Experimental: 2
Nurse home visits
|
Home visitation by nurses from midway through pregnancy until child age 12
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
the number and spacing of subsequent pregnancies and births
Periodo de tiempo: When first child is 12
|
When first child is 12
|
|
the rates of marriage and cohabitation with the father of the child
Periodo de tiempo: When first child is 12
|
When first child is 12
|
|
mothers' employment, career growth, economic self-sufficiency, and welfare dependence
Periodo de tiempo: When first child is 12
|
When first child is 12
|
|
mothers' behavioral problems due to substance abuse
Periodo de tiempo: When first child is 12
|
When first child is 12
|
|
children's academic achievement, placements in special education, rates of grade retention, conduct in school, and academic achievement
Periodo de tiempo: At age 12
|
At age 12
|
|
rates of developmental disability, grade retention, placement in special education, and school disciplinary actions among subsequent children
Periodo de tiempo: At age 12
|
At age 12
|
|
mothers' arrests for serious misdemeanors and felonies
Periodo de tiempo: When first child is 12
|
When first child is 12
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Olds DL, Kitzman H, Cole R, Robinson J, Sidora K, Luckey DW, Henderson CR Jr, Hanks C, Bondy J, Holmberg J. Effects of nurse home-visiting on maternal life course and child development: age 6 follow-up results of a randomized trial. Pediatrics. 2004 Dec;114(6):1550-9. doi: 10.1542/peds.2004-0962.
- Kitzman H, Olds DL, Sidora K, Henderson CR Jr, Hanks C, Cole R, Luckey DW, Bondy J, Cole K, Glazner J. Enduring effects of nurse home visitation on maternal life course: a 3-year follow-up of a randomized trial. JAMA. 2000 Apr 19;283(15):1983-9. doi: 10.1001/jama.283.15.1983.
- Kitzman H, Olds DL, Henderson CR Jr, Hanks C, Cole R, Tatelbaum R, McConnochie KM, Sidora K, Luckey DW, Shaver D, Engelhardt K, James D, Barnard K. Effect of prenatal and infancy home visitation by nurses on pregnancy outcomes, childhood injuries, and repeated childbearing. A randomized controlled trial. JAMA. 1997 Aug 27;278(8):644-52.
- Olds DL, Kitzman H, Hanks C, Cole R, Anson E, Sidora-Arcoleo K, Luckey DW, Henderson CR Jr, Holmberg J, Tutt RA, Stevenson AJ, Bondy J. Effects of nurse home visiting on maternal and child functioning: age-9 follow-up of a randomized trial. Pediatrics. 2007 Oct;120(4):e832-45. doi: 10.1542/peds.2006-2111.
- Olds DL, Kitzman HJ, Cole RE, Hanks CA, Arcoleo KJ, Anson EA, Luckey DW, Knudtson MD, Henderson CR Jr, Bondy J, Stevenson AJ. Enduring effects of prenatal and infancy home visiting by nurses on maternal life course and government spending: follow-up of a randomized trial among children at age 12 years. Arch Pediatr Adolesc Med. 2010 May;164(5):419-24. doi: 10.1001/archpediatrics.2010.49.
- Kitzman HJ, Olds DL, Cole RE, Hanks CA, Anson EA, Arcoleo KJ, Luckey DW, Knudtson MD, Henderson CR Jr, Holmberg JR. Enduring effects of prenatal and infancy home visiting by nurses on children: follow-up of a randomized trial among children at age 12 years. Arch Pediatr Adolesc Med. 2010 May;164(5):412-8. doi: 10.1001/archpediatrics.2010.76.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
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 (Estimar)
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
- 02-0683
- R01MH068790 (Subvención/contrato del NIH de EE. UU.)
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