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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00895154
Recruitment Status : Completed
First Posted : May 8, 2009
Results First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
American Society of Hematology
Medical College of Wisconsin
Information provided by (Responsible Party):
Allison King, Washington University School of Medicine

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

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: General Tutoring Behavioral: Memory Training Not Applicable

Detailed Description:

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study
Study Start Date : September 2003
Actual Primary Completion Date : July 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: General Tutoring Group
Participants will receive general tutoring in the subject of his/her choice.
 Behavioral: 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.
 Behavioral: General Tutoring
Participants will be tutored for approximately 8-10 hours per month during the school year.

Behavioral: Memory Training
Participants will receive memory training for approximately 8-10 hours per month during the school year.


Outcome Measures
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Primary Outcome Measures :
  1. Full Scale IQ (FSIQ) (WASI) [ Time Frame: 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.

  2. Verbal IQ (PIQ) (WASI) [ Time Frame: 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.

  3. Performance IQ (PIQ) (WASI) [ Time Frame: 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.

  4. Letter Word Identification T Score (WJ-III) [ Time Frame: 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.

  5. Reading Fluency T Score (WJ-III) [ Time Frame: 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.

  6. Calculations T Score (WJ-III) [ Time Frame: 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.

  7. Math Fluency T Score (WJ-III) [ Time Frame: 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.

  8. Spelling T Score (WJ-III) [ Time Frame: 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.

  9. California Verbal Learning Test-Children's Version (CVLT-C) List A Trials 1-5 Immediate Recall T Score [ Time Frame: 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.

  10. CVLT-C Trials 1-5 Semantic Clustering T Score [ Time Frame: 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.

  11. CVLT-C Trials 1-5 Short Delay Recall T Score [ Time Frame: 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.

  12. CVLT-C Trials 1-5 Long Delay Recall T Score [ Time Frame: 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.

  13. CVLT-C Trials 1-5 Recognition Discriminability T Score [ Time Frame: 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.

  14. Delis Kaplan Executive Function System (D-KEFS) Number/Letter Switching T Score [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895154


Locations
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United States, Missouri
Washington University School of Medicine/St. Louis Children's Hospital
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
American Society of Hematology
Medical College of Wisconsin
Investigators
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Principal Investigator: Allison King, MD, MPH Washington University School of Medicine
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Allison King, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00895154    
Other Study ID Numbers: 653
K23HL079073 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2009    Key Record Dates
Results First Posted: May 15, 2019
Last Update Posted: May 15, 2019
Last Verified: April 2019
Keywords provided by Allison King, Washington University School of Medicine:
Sickle Cell Disease
Sickle Cell
Memory
Learning
Achievement
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Cognition Disorders
Cognitive Dysfunction
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Neurocognitive Disorders
Mental Disorders