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Completed

NCT Number: NCT00895154

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

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

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Key information

Conditions

Sickle Cell Disease Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Anemia, Sickle Cell Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinopathies

Age range

8 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine/St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

General Tutoring

Behavioral

Participants will be tutored for approximately 8-10 hours per month during the school year.

memory training

Behavioral

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

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

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

Registry information

Important dates

Study start
2003
Primary completion
2014
Study completion
2014
First posted
May 8, 2009
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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