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临床试验/NCT00895154
NCT00895154已完成不适用

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

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2003年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Performance IQ (PIQ) (WASI)

研究概览

简要总结

The overall goal of this project is to determine the feasibility of conducting a cognitive intervention for children with sickle cell disease.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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)

排除标准

  • 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)

研究组 & 干预措施

General Tutoring Group

Active Comparator

Participants will receive general tutoring in the subject of his/her choice.

干预措施: General Tutoring (Behavioral)

Tutoring + Memory Training Group

Experimental

Participants will receive tutoring and memory training.

干预措施: General Tutoring (Behavioral)

Tutoring + Memory Training Group

Experimental

Participants will receive tutoring and memory training.

干预措施: Memory Training (Behavioral)

结局指标

主要结局

Performance IQ (PIQ) (WASI)

时间窗: 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.

Full Scale IQ (FSIQ) (WASI)

时间窗: 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.

Verbal IQ (PIQ) (WASI)

时间窗: 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.

Letter Word Identification T Score (WJ-III)

时间窗: 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.

Reading Fluency T Score (WJ-III)

时间窗: 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.

Calculations T Score (WJ-III)

时间窗: 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.

Math Fluency T Score (WJ-III)

时间窗: 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.

CVLT-C Trials 1-5 Long Delay Recall T Score

时间窗: 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.

Spelling T Score (WJ-III)

时间窗: 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.

California Verbal Learning Test-Children's Version (CVLT-C) List A Trials 1-5 Immediate Recall T Score

时间窗: 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.

CVLT-C Trials 1-5 Short Delay Recall T Score

时间窗: 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.

CVLT-C Trials 1-5 Semantic Clustering T Score

时间窗: 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.

CVLT-C Trials 1-5 Recognition Discriminability T Score

时间窗: 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.

Delis Kaplan Executive Function System (D-KEFS) Number/Letter Switching T Score

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Allison King

Assistant Professor

Washington University School of Medicine

研究点 (2)

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