A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study
2019年4月23日 更新者：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.
研究概览
详细说明
The primary aims of this clinical trial are:
- Determine the effectiveness of targeted learning and memory strategy remediation in students with sickle cell disease and cognitive deficits.
- Determine if there is improvement in academic achievement after targeted memory strategy remediation.
研究类型
介入性
注册 (实际的)
21
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Missouri
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Saint Louis、Missouri、美国、63110
- Washington University School of Medicine/St. Louis Children's Hospital
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
8年 至 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：General Tutoring Group
Participants will receive general tutoring in the subject of his/her choice.
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Participants will be tutored for approximately 8-10 hours per month during the school year.
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实验性的：Tutoring + Memory Training Group
Participants will receive tutoring and memory training.
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Participants will be tutored for approximately 8-10 hours per month during the school year.
Participants will receive memory training for approximately 8-10 hours per month during the school year.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Full Scale IQ (FSIQ) (WASI)
大体时间：After >/= 50 hours of tutoring
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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.
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After >/= 50 hours of tutoring
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Verbal IQ (PIQ) (WASI)
大体时间：After >/= 50 hours of tutoring
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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.
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After >/= 50 hours of tutoring
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Performance IQ (PIQ) (WASI)
大体时间：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.
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After >/= 50 hours of tutoring
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Letter Word Identification T Score (WJ-III)
大体时间：After >/= 50 hours of tutoring
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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.
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After >/= 50 hours of tutoring
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Reading Fluency T Score (WJ-III)
大体时间：After >/= 50 hours of tutoring
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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.
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After >/= 50 hours of tutoring
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Calculations T Score (WJ-III)
大体时间：After >/= 50 hours of tutoring
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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.
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After >/= 50 hours of tutoring
|
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Math Fluency T Score (WJ-III)
大体时间：After >/= 50 hours of tutoring
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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
|
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Spelling T Score (WJ-III)
大体时间：After >/= 50 hours of tutoring
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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.
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After >/= 50 hours of tutoring
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California Verbal Learning Test-Children's Version (CVLT-C) List A Trials 1-5 Immediate Recall T Score
大体时间：After >/= 50 hours of tutoring
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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.
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After >/= 50 hours of tutoring
|
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CVLT-C Trials 1-5 Semantic Clustering T Score
大体时间：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.
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After >/= 50 hours of tutoring
|
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CVLT-C Trials 1-5 Short Delay Recall T Score
大体时间：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
|
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CVLT-C Trials 1-5 Long Delay Recall T Score
大体时间：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.
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T scores were obtained at baseline and again at follow-up (after partcipant completed 50 hours of tutoring)
|
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CVLT-C Trials 1-5 Recognition Discriminability T Score
大体时间：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.
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After >/= 50 hours of tutoring
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Delis Kaplan Executive Function System (D-KEFS) Number/Letter Switching T Score
大体时间：After >/= 50 hours of tutoring
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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.
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After >/= 50 hours of tutoring
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 首席研究员：Allison King, MD, MPH、Washington University School of Medicine
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Yerys BE, White DA, Salorio CF, McKinstry R, Moinuddin A, DeBaun M. Memory strategy training in children with cerebral infarcts related to sickle cell disease. J Pediatr Hematol Oncol. 2003 Jun;25(6):495-8. doi: 10.1097/00043426-200306000-00014.
- King AA, White DA, McKinstry RC, Noetzel M, Debaun MR. A pilot randomized education rehabilitation trial is feasible in sickle cell and strokes. Neurology. 2007 Jun 5;68(23):2008-11. doi: 10.1212/01.wnl.0000264421.24415.16.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2003年9月1日
初级完成 (实际的)
2014年7月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2009年5月6日
首先提交符合 QC 标准的
2009年5月6日
首次发布 (估计)
2009年5月8日
研究记录更新
最后更新发布 (实际的)
2019年5月15日
上次提交的符合 QC 标准的更新
2019年4月23日
最后验证
2019年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.