- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02573441
CLAVES para el Éxito: Programa de Intervención Cognitiva y Académica para Niños y Adolescentes Sobrevivientes de Cáncer
The study will examine whether school liaison services and home-based parental tutoring can help with academic difficulties of paediatric brain tumour survivors who received cranial spinal radiation and have returned to school. Forty-five patients will participate in the project. All patients will receive psychology liaison services to link resources at the hospital with those in the community. Patients will participate in one of two tutoring programs designed to directly or indirectly improve math skills over 12 weeks. Weekly phone calls will be used to support parents using the program. Patients will be tested before, immediately after, and six months following each tutoring program to assess growth in mathematics and working memory abilities.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Paediatric brain tumour survivors who receive cranial spinal radiation have learning problems, particularly in mathematics and working memory. Working memory is often described as a "mental workspace" where relevant information is held in mind and processed. Working memory is important in mathematics for holding in mind relevant information and carrying out steps necessary to solve problems.
This study will examine whether school liaison support and home-based parental tutoring can help address the academic difficulties of paediatric brain tumour survivors who have received cranial spinal radiation and who have returned to their community school. Forty five patients will participate in the project. First, all patients will receive psychology liaison services to link resources at the hospital with those in the community in order to provide information regarding the effects of pediatric cancer on learning and facilitate the implementation of appropriate assistive technology and remediation programs. Patients will then participant in one of two tutoring programs over the course of a 12 week period. One group of patients will participate in a program that addresses working memory with the intent of indirectly helping with mathematics skills. This program will be delivered over the internet. Another group of patients will participate in a program using a work book to directly help improve mathematics skills. Weekly phone calls will be used to support parents in doing the program. Patients will be tested before, immediately after, and six months following each tutoring program to assess growth in mathematics and working memory abilities. The two intervention programs will be compared to a waitlist control group that receives only the liaison service (including academic support through weekly phone calls over the 12 weeks).
The findings from this study will provide evidence about the type of intervention that is most effective at helping paediatric brain tumour survivors improve their mathematics skills and working memory ability.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M5G 1X8
- Hospital for Sick Children
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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:
- Has been diagnosed with a brain tumour and treated with cranial radiation
- Is between 1 and 10 years following diagnosis
- Has English as his or her native language or has had at least two years of schooling in English
- Is between the ages of 6 and 17
- Less than a Grade 8 equivalent math score
Exclusion Criteria:
- Is younger than 6 years or older than 17 years of age
- Is receiving palliative care
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Math + Liaison Service
To help with mathematics, participants will be assigned to a workbook based version of the JUMP Math program which will be completed at home with a parent. This intervention focuses on mental math skills. In addition all participants will receive the liaison service program. |
Jump Math is a workbook based program aimed at improving math skills Liaison Services will include working closely with schools to help explain the strengths and weaknesses of a child based on cognitive testing and to help with the implementation of recommendations |
|
Experimental: Working Memory + Liaison Service
To help with working memory, participants will be assigned to Cogmed, a game-like computer exercise focusing on improving working memory. In addition all participants will receive the liaison service program. |
Liaison Services will include working closely with schools to help explain the strengths and weaknesses of a child based on cognitive testing and to help with the implementation of recommendations Cogmed is an online computer program aimed at improving working memory skills |
|
Otro: Liaison Services
Participants in this group will only receive the liaison service program for 12 weeks before being assigned to one of the intervention groups. |
Liaison Services will include working closely with schools to help explain the strengths and weaknesses of a child based on cognitive testing and to help with the implementation of recommendations |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Woodcock Johnson Academic-Third Edition
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of math Fluency, applied math problems, and qualitative concepts |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Wechsler Intelligence Scale for Children - Fourth Edition Integrated
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of verbal and visual working memory |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Wide Range Assessment of Memory and Learning - Second Edition
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of verbal and visual working memory |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Automated Working Memory Assessment
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of verbal and visual working memory |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Connors' Continuous Performance Test-Second Edition
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of sustained attention |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Behaviour Rating Inventory of Executive Function-Parent Version
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of executive functioning |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Monitoring Basic Skills Progress
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of mathematics |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
SAM
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of participants attitude towards math |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Wide Range Assessment of Memory and Learning - Second Edition
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of visual learning and memory |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
California Verbal Learning Test, Children's Version
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of verbal learning and memory |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
CANTAB
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
Measures of processing speed |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Wechsler Abbreviated Scale of Intelligence - Second Edition
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
A measure of vocabulary and abstract visual reasoning |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
|
Delis-Kaplan Executive Function System
Periodo de tiempo: Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
Measures of processing speed and switching attention |
Pre-intervention, 12 weeks after intervention and 6 months follow-up
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Donald Mabbott, Ph.D., The Hospital for Sick Children
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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 (Estimado)
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
Otros números de identificación del estudio
- 1000043747
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