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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00895154
First received: May 6, 2009
Last updated: May 11, 2009
Last verified: May 2009
History of Changes
  Purpose

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


Condition Intervention Phase
Hemoglobin SC Disease
 Behavioral: General Tutoring
Behavioral: Memory Training
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Rehabilitation Program in Children With Sickle Cell Disease and Cognitive Deficits: a Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • The proportion of children who complete the trial [ Time Frame: If the child completes 50 contact hours over two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure of working memory [ Time Frame: After the 50 hours of intervention ] [ Designated as safety issue: No ]
  • Measure of academic achievement [ Time Frame: After the 50 hours of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 61
Study Start Date: September 2003
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • SCD 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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00895154

Locations
United States, Missouri
Washington University School of Medicine/St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Allison King, MD, MPH Washington University School of Medicine
  More Information

Publications:

Responsible Party: Allison King, MD, MPH, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT00895154     History of Changes
Other Study ID Numbers: 653, K23 HL079073
Study First Received: May 6, 2009
Last Updated: May 11, 2009
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Sickle Cell Disease
Sickle Cell
Memory
Learning
Achievement

Additional relevant MeSH terms:
Anemia, Sickle Cell
Hemoglobin SC Disease
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 21, 2013