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A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study

23 de abril de 2019 actualizado por: Allison King, Washington University School of Medicine
The overall goal of this project is to determine the feasibility of conducting a cognitive intervention for children with sickle cell disease.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

The primary aims of this clinical trial are:

  1. Determine the effectiveness of targeted learning and memory strategy remediation in students with sickle cell disease and cognitive deficits.
  2. Determine if there is improvement in academic achievement after targeted memory strategy remediation.

Tipo de estudio

Intervencionista

Inscripción (Actual)

21

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

  • Estados Unidos
    • Missouri
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Washington University School of Medicine/St. Louis Children's Hospital

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

8 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Sickle cell disease that is confirmed by hemoglobin analysis
  • Has a brain magnetic resonance imaging (MRI) document reading by a neuroradiologist
  • Cognitive deficits, which are defined by one standard deviation lower than the normal ranges of an age-based standard score in cognitive tests that are evaluated by a psychologist
  • Must be a student who will remain in school for at least 2 years
  • Must provide informed consent with assent in accordance with the institutional policies (institutional review board approval)

Exclusion Criteria:

  • Known developmental delays (these participants are ineligible because their learning potential may be biased from a prior insult)
  • Intelligent quotient is less than 50 (may have impaired learning potential)
  • Aphasic (i.e., unable to produce intelligible speech)

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: General Tutoring Group
Participants will receive general tutoring in the subject of his/her choice.
Conductual: General Tutoring
Participants will be tutored for approximately 8-10 hours per month during the school year.
Experimental: Tutoring + Memory Training Group
Participants will receive tutoring and memory training.
Conductual: General Tutoring
Participants will be tutored for approximately 8-10 hours per month during the school year.
Conductual: Memory Training
Participants will receive memory training for approximately 8-10 hours per month during the school year.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Full Scale IQ (FSIQ) (WASI)
Periodo de tiempo: After >/= 50 hours of tutoring
The WASI is a brief, reliable measure of intelligence. Participants engage in 4 subtests: Block Design, Vocabulary, Similarities, and Matrix Reasoning. Participants receive a raw score on each of these 4 subtests. This raw score is converted to a T score using a score chart in the WASI manual. The T scores from all 4 subtests are summed together to obtain a Full Scale Sum of T Scores. This Full Scale Sum of T Scores is converted to a Full Scale IQ-4 Composite Score using a score chart published in the WASI manual. Higher scores indicate better intelligence. FSIQ-4 Range: 40-160. Average FSIQ-4 =100, standard deviation is +/- 15.
After >/= 50 hours of tutoring
Verbal IQ (PIQ) (WASI)
Periodo de tiempo: After >/= 50 hours of tutoring
The VIQ score is comprised from the Vocabulary and Similarities subtests of the WASI-4. The raw scores from these subtests are converted to T scores using score charts in the manual. The T scores are summed together for a Verbal Sum of T Scores. This score is converted to a Composite VIQ score using a score chart in the manual. Higher scores = better Verbal IQ. Range = 45-160. Average = 100; standard deviation +/- 15.
After >/= 50 hours of tutoring
Performance IQ (PIQ) (WASI)
Periodo de tiempo: After >/= 50 hours of tutoring
The PIQ score is comprised from the Matrix Reasoning and Block Design subtests of the WASI-4. The raw scores from these subtests are converted to T scores using score charts in the manual. The T scores are summed together for a Performance Sum of T Scores. This score is converted to a Composite PIQ score using a score chart in the manual. Higher scores = better Performance IQ. Range = 45-160. Average = 100; standard deviation +/- 15.
After >/= 50 hours of tutoring
Letter Word Identification T Score (WJ-III)
Periodo de tiempo: After >/= 50 hours of tutoring
This sub-test measures a student's word identification skills. A participant's raw score (# of items answered correctly) is converted to a T score using a program (Compuscore for the WJ III, Version 2.1). Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.
After >/= 50 hours of tutoring
Reading Fluency T Score (WJ-III)
Periodo de tiempo: After >/= 50 hours of tutoring
This sub-test measures a student's ability to read simple sentences quickly. A participant's raw score (# of items answered correctly) is converted to a T score using a program (Compuscore for the WJ III, Version 2.1). Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.
After >/= 50 hours of tutoring
Calculations T Score (WJ-III)
Periodo de tiempo: After >/= 50 hours of tutoring
This sub-test measures a student's ability to perform paper and pencil math computations.A participant's raw score (# of items answered correctly) is converted to a T score using a program (Compuscore for the WJ III, Version 2.1). Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.
After >/= 50 hours of tutoring
Math Fluency T Score (WJ-III)
Periodo de tiempo: After >/= 50 hours of tutoring
This sub-test measures a student's ability to solve simple addition, subtraction and multiplication facts quickly. A participant's raw score (# of items answered correctly) is converted to a T score using a program (Compuscore for the WJ III, Version 2.1). Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.
After >/= 50 hours of tutoring
Spelling T Score (WJ-III)
Periodo de tiempo: After >/= 50 hours of tutoring
This sub-test measures a student's ability to write orally presented words correctly. A participant's raw score (# of items answered correctly) is converted to a T score using a program (Compuscore for the WJ III, Version 2.1). Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.
After >/= 50 hours of tutoring
California Verbal Learning Test-Children's Version (CVLT-C) List A Trials 1-5 Immediate Recall T Score
Periodo de tiempo: After >/= 50 hours of tutoring
The CVLT®-C measures multi-trial learning and long-term recall abilities for verbal information. The Raw scores from all trials (1-5) are summed to calculate a Total Raw Score for Trials 1-5. This Raw score is converted to a T score using the CVLT-II Comprehensive Scoring System (computer system). A higher T score indicates better performance. Range = 0-100. Average =50 with a standard deviation of =/- 10 points.
After >/= 50 hours of tutoring
CVLT-C Trials 1-5 Semantic Clustering T Score
Periodo de tiempo: After >/= 50 hours of tutoring
The CVLT®-C measures multi-trial learning and long-term recall abilities for verbal information. The CVLT-C consists of five learning trials of 15 words which can be organized into three semantic categories. The Raw scores from all trials (1-5) are summed to calculate a Total Raw Score for Trials 1-5. This Raw score is converted to a T score using the CVLT-II Comprehensive Scoring System (computer system). A higher T score indicates better performance. Range = 0-100. Average =50 with a standard deviation of =/- 10 points.
After >/= 50 hours of tutoring
CVLT-C Trials 1-5 Short Delay Recall T Score
Periodo de tiempo: After >/= 50 hours of tutoring
The CVLT®-C measures multi-trial learning and long-term recall abilities for verbal information. The Raw scores from all trials (1-5) are summed to calculate a Total Raw Score for Trials 1-5. This Raw score is converted to a T score using the CVLT-II Comprehensive Scoring System (computer system). A higher T score indicates better performance. Range = 0-100. Average =50 with a standard deviation of =/- 10 points.
After >/= 50 hours of tutoring
CVLT-C Trials 1-5 Long Delay Recall T Score
Periodo de tiempo: T scores were obtained at baseline and again at follow-up (after partcipant completed 50 hours of tutoring)
The CVLT®-C measures multi-trial learning and long-term recall abilities for verbal information. The Raw scores from all trials (1-5) are summed to calculate a Total Raw Score for Trials 1-5. This Raw score is converted to a T score using the CVLT-II Comprehensive Scoring System (computer system). A higher T score indicates better performance. Range = 0-100. Average =50 with a standard deviation of =/- 10 points.
T scores were obtained at baseline and again at follow-up (after partcipant completed 50 hours of tutoring)
CVLT-C Trials 1-5 Recognition Discriminability T Score
Periodo de tiempo: After >/= 50 hours of tutoring
TThe CVLT®-C measures multi-trial learning and long-term recall abilities for verbal information. The Raw scores from all trials (1-5) are summed to calculate a Total Raw Score for Trials 1-5. This Raw score is converted to a T score using the CVLT-II Comprehensive Scoring System (computer system). A higher T score indicates better performance. Range = 0-100. Average =50 with a standard deviation of =/- 10 points.
After >/= 50 hours of tutoring
Delis Kaplan Executive Function System (D-KEFS) Number/Letter Switching T Score
Periodo de tiempo: After >/= 50 hours of tutoring
The D-KEFS allows for the assessment of executive functions. There are 9 stand alone tests that can be individually or group administered. The Number-Letter Switching condition of the Trails Making sub-test specifically assesses flexibility of thinking on a visual-motor sequencing task. A participant's raw score (# of items answered correctly) is converted to a T score using tables provided in the manual. Higher T scores = better performance. Range: 0-100. Average T score = 50; standard deviation =/- 10.
After >/= 50 hours of tutoring

Colaboradores e Investigadores

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

Patrocinador

Washington University School of Medicine

Colaboradores

National Heart, Lung, and Blood Institute (NHLBI)
Medical College of Wisconsin
American Society of Hematology

Investigadores

  • Investigador principal: Allison King, MD, MPH, Washington University School of Medicine

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

1 de septiembre de 2003

Finalización primaria (Actual)

1 de julio de 2014

Finalización del estudio (Actual)

1 de diciembre de 2014

Fechas de registro del estudio

Enviado por primera vez

6 de mayo de 2009

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2009

Publicado por primera vez (Estimar)

8 de mayo de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2019

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

23 de abril de 2019

Última verificación

1 de abril de 2019

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 653
  • K23HL079073 (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. .

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