Back to resultsA Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
General Tutoring
Memory Training
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring Sickle Cell Disease, Sickle Cell, Memory, Learning, Achievement
Eligibility Criteria
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)
Sites / Locations
- Washington University School of Medicine/St. Louis Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
General Tutoring Group
Tutoring + Memory Training Group
Arm Description
Participants will receive general tutoring in the subject of his/her choice.
Participants will receive tutoring and memory training.
Outcomes
Primary Outcome Measures
Full Scale IQ (FSIQ) (WASI)
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)
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.
Performance IQ (PIQ) (WASI)
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.
Letter Word Identification T Score (WJ-III)
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)
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)
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)
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.
Spelling T Score (WJ-III)
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
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
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 Short Delay Recall T Score
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 Long Delay Recall T Score
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 Recognition Discriminability T Score
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT00895154
First Posted
May 6, 2009
Last Updated
April 23, 2019
Sponsor
Washington University School of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Society of Hematology, Medical College of Wisconsin
1. Study Identification
Unique Protocol Identification Number
NCT00895154
Brief Title
A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study
Official Title
A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), American Society of Hematology, Medical College of Wisconsin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The overall goal of this project is to determine the feasibility of conducting a cognitive intervention for children with sickle cell disease.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
Sickle Cell Disease, Sickle Cell, Memory, Learning, Achievement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
General Tutoring Group
Arm Type
Active Comparator
Arm Description
Participants will receive general tutoring in the subject of his/her choice.
Arm Title
Tutoring + Memory Training Group
Arm Type
Experimental
Arm Description
Participants will receive tutoring and memory training.
Intervention Type
Behavioral
Intervention Name(s)
General Tutoring
Intervention Description
Participants will be tutored for approximately 8-10 hours per month during the school year.
Intervention Type
Behavioral
Intervention Name(s)
Memory Training
Intervention Description
Participants will receive memory training for approximately 8-10 hours per month during the school year.
Primary Outcome Measure Information:
Title
Full Scale IQ (FSIQ) (WASI)
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
Verbal IQ (PIQ) (WASI)
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
Performance IQ (PIQ) (WASI)
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
Letter Word Identification T Score (WJ-III)
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
Reading Fluency T Score (WJ-III)
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
Calculations T Score (WJ-III)
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
Math Fluency T Score (WJ-III)
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
Spelling T Score (WJ-III)
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
California Verbal Learning Test-Children's Version (CVLT-C) List A Trials 1-5 Immediate Recall T Score
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
CVLT-C Trials 1-5 Semantic Clustering T Score
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
CVLT-C Trials 1-5 Short Delay Recall T Score
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
CVLT-C Trials 1-5 Long Delay Recall T Score
Description
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.
Time Frame
T scores were obtained at baseline and again at follow-up (after partcipant completed 50 hours of tutoring)
Title
CVLT-C Trials 1-5 Recognition Discriminability T Score
Description
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.
Time Frame
After >/= 50 hours of tutoring
Title
Delis Kaplan Executive Function System (D-KEFS) Number/Letter Switching T Score
Description
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.
Time Frame
After >/= 50 hours of tutoring
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison King, MD, MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine/St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
12794531
Citation
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.
Results Reference
background
PubMed Identifier
17548550
Citation
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.
Results Reference
result
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A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study
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