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

NCT00895154 | Completed Results

• 2 other identifiers: 653K23HL079073
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sickle Cell Disease

Keywords

Sickle Cell Disease; Sickle Cell; Memory; Learning; Achievement

Outcome Measures

Primary Outcomes (14)

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

• 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.

  T scores were obtained at baseline and again at follow-up (after partcipant completed 50 hours of tutoring)

• 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.

  After >/= 50 hours of tutoring

• 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.

  After >/= 50 hours of tutoring

Study Arms (2)

General Tutoring Group

ACTIVE COMPARATOR

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

Behavioral: General Tutoring

Tutoring + Memory Training Group

EXPERIMENTAL

Participants will receive tutoring and memory training.

Behavioral: General Tutoring; Behavioral: Memory Training

Interventions

General Tutoring BEHAVIORAL

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

General Tutoring Group; Tutoring + Memory Training Group

Memory Training BEHAVIORAL

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

Tutoring + Memory Training Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• American Society of Hematology: collaborator
• Medical College of Wisconsin: collaborator

Study Sites (1)

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

St Louis, Missouri, 63110, United States

Location

Related Publications (2)

• 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.

  PMID: 12794531 BACKGROUND

• 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.

  PMID: 17548550 RESULT

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Allison King
• Organization: Washington University

king_a@wustl.edu

314-454-4291

Study Officials

• Allison King, MD, MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 8, 2009
• Study Start: September 1, 2003
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 15, 2019
• Results First Posted: May 15, 2019

Record last verified: 2019-04

Locations

US (1)