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

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ClinicalTrials.gov Identifier: NCT00895154
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : December 12, 2014
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

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 Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 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

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1
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: 2
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.



Primary Outcome Measures :
  1. The proportion of children who complete the trial [ Time Frame: If the child completes 50 contact hours over two years ]

Secondary Outcome Measures :
  1. Measure of working memory [ Time Frame: After the 50 hours of intervention ]
  2. Measure of academic achievement [ Time Frame: After the 50 hours of intervention ]


Information from the National Library of Medicine

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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)

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
United States, Missouri
Washington University School of Medicine/St. Louis Children's Hospital
St. 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
Principal Investigator: Allison King, MD, MPH Washington University School of Medicine

Publications of Results:
Other Publications:
Responsible Party: Allison King, Assistant Professor, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00895154     History of Changes
Other Study ID Numbers: 653
K23HL079073 ( U.S. NIH Grant/Contract )
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by Allison King, Washington University School of Medicine:
Sickle Cell Disease
Sickle Cell
Memory
Learning
Achievement

Additional relevant MeSH terms:
Anemia, Sickle Cell
Cognition Disorders
Cognitive Dysfunction
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Neurocognitive Disorders
Mental Disorders