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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00895154
• Other study ID #: 653
• Secondary ID: K23HL079073
• Status: Completed
• Phase: N/A
• Start date: September 2003
• Est. completion date: December 2014

Study information

• Verified date: April 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Cognition Disorders
• Cognitive Dysfunction
• Sickle Cell Disease

Intervention

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine/St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	American Society of Hematology, Medical College of Wisconsin, National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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)
Primary	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
Primary	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