Clinical trial NCT00895154: 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
Overall status: COMPLETED
Phase: NA
Conditions: Sickle Cell Disease
Keywords: Sickle Cell Disease
Sickle Cell
Memory
Learning
Achievement
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: American Society of Hematology
name: Medical College of Wisconsin
First posted: 2009-05-08
Enrollment: 21
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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:

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.

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)

Primary outcomes:
measure: Full Scale IQ (FSIQ) (WASI)
timeFrame: After >/= 50 hours of tutoring
measure: Verbal IQ (PIQ) (WASI)
timeFrame: After >/= 50 hours of tutoring
measure: Performance IQ (PIQ) (WASI)
timeFrame: After >/= 50 hours of tutoring
measure: Letter Word Identification T Score (WJ-III)
timeFrame: After >/= 50 hours of tutoring
measure: Reading Fluency T Score (WJ-III)
timeFrame: After >/= 50 hours of tutoring
measure: Calculations T Score (WJ-III)
timeFrame: After >/= 50 hours of tutoring
measure: Math Fluency T Score (WJ-III)
timeFrame: After >/= 50 hours of tutoring
measure: Spelling T Score (WJ-III)
timeFrame: After >/= 50 hours of tutoring
measure: California Verbal Learning Test-Children's Version (CVLT-C) List A Trials 1-5 Immediate Recall T Score
timeFrame: After >/= 50 hours of tutoring
measure: CVLT-C Trials 1-5 Semantic Clustering T Score
timeFrame: After >/= 50 hours of tutoring
measure: CVLT-C Trials 1-5 Short Delay Recall T Score
timeFrame: After >/= 50 hours of tutoring
measure: CVLT-C Trials 1-5 Long Delay Recall T Score
timeFrame: T scores were obtained at baseline and again at follow-up (after partcipant completed 50 hours of tutoring)
measure: CVLT-C Trials 1-5 Recognition Discriminability T Score
timeFrame: After >/= 50 hours of tutoring
measure: Delis Kaplan Executive Function System (D-KEFS) Number/Letter Switching T Score
timeFrame: After >/= 50 hours of tutoring
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine/St. Louis Children's Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Allison King, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.