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Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02227472
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Description
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Brief Summary:

Children with sickle cell disease (SCD) are at risk for neurobehavioral problems because of the impact the disease can have on the central nervous system. Specific impairments in working memory are particularly prevalent in school-aged children with SCD. Working memory is more strongly associated with school readiness and academic success than intellectual ability in the general population. The adverse effects of low socioeconomic status (SES) and poverty on cognition and neurodevelopment emerge early, before children have entered formal education. In addition, they affect language and executive function skills (e.g., working memory) more than other skills. SES is a proxy variable for other risk factors. Higher SES is associated with less parental stress, more supportive parenting practices, and better cognitive stimulation based on the availability of books, computers, and outings.

PRIMARY OBJECTIVE:

  • To examine working memory and school readiness in young children with sickle cell disease in comparison to demographically matched control children without sickle cell disease.

SECONDARY OBJECTIVE:

  • To examine the relationships of family/environmental factors (caregiver stress, parental responsiveness, and cognitive stimulation in the home) and disease severity to working memory and school readiness skills in preschool-aged children with SCD.

Condition or disease Intervention/treatment
Sickle Cell Disease Other: Evaluation of cognitive and pre-academic skills Other: Parent questionnaires

Detailed Description:

Participants will be recruited through the Pediatric Sickle Cell Clinic at St. Jude. All participants with SCD will be evaluated once with laboratory measures of cognitive and pre-academic skills and parent questionnaires. Medical history will be evaluated for purposes of characterizing the health status and disease severity of patients and determining how medical factors are related to school readiness and working memory in SCD population. The study expects to accrue up to 99 participants with SCD.

Demographically-matched control children will be selected from a database of participants enrolled in an ongoing longitudinal study of neurocognitive development in children born in Shelby County, Tennessee. The control group will be randomly selected from an existing study group and will not be enrolled on the MEMREAD protocol. Control group participants will be excluded if they have any sensory or motor impairment that would preclude valid testing (e.g., blindness, paresis), or if they have received treatment with non-stimulant psychotropic medication. A de-identified data file that includes the following results for up to 168 demographically-matched healthy control participants (approximately 1:2 ratio of SCD to healthy control) will be provided for control comparison purposes:

  • Health Evaluation (CV4)
  • Stanford binet - Fifth Edition (CV4)
  • Bracken Basic Concepts Scale - Third Edition (CV4)
  • The Behavior Rating Inventory of Executive Function - Preschool Version (BRIEF-P) (CV4)
  • The Scales of Independent Behavior - Revised, Early Development Form (SIB-R) (CV4)
  • Demographics (CV4)
  • Additional Covariates (if any) including gestational age at birth, developmental delays, major medical illnesses, surgery history, neurological event history, pre-kindergarten attendance, and daycare attendance
Study Design
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Study Type : Observational
Actual Enrollment : 84 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease: Family and Environmental Factors
Actual Study Start Date : September 8, 2014
Actual Primary Completion Date : August 20, 2018
Actual Study Completion Date : August 20, 2018

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Sickle Cell Disease
All participants who meet eligibility requirements and consent to the study will complete evaluation of cognitive and pre-academic skills, and parent questionnaires.
 Other: Evaluation of cognitive and pre-academic skills
Participants will complete testing to evaluate fluid reasoning, knowledge, quantitative reasoning, visual-spatial processing, verbal and non-verbal working memory, and knowledge of pre-academic skills (such as colors, letters, numbers, counting, sizes, comparisons, and shapes).
Other Name: Testing

Other: Parent questionnaires
Parents will complete questionnaires to assess behavioral manifestation of executive functions, functional independence and adaptive functioning, child and parent characteristics, situational/demographic life stress, demographics, education level, and household income.
Other Name: Parent report


Outcome Measures
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Primary Outcome Measures :
  1. Mean difference in working memory between SCD participants and control group [ Time Frame: Once, at enrollment ]
    Variables will be subjected to analyses to establish frequency distributions, means and standard deviations, and to determine if variables are normally distributed prior to use of parametric statistics. The primary dependent variable for working memory ability is the Working Memory Index from the SB-5. Primary dependent variables will be compared statistically using a paired sample one-side t-test.

  2. Mean difference in school readiness between SCD group and control group [ Time Frame: Once, at enrollment ]
    Variables will be subjected to analyses to establish frequency distributions, means and standard deviations, and to determine if variables are normally distributed prior to use of parametric statistics. The primary dependent variable for school readiness is the School Readiness Composite from the BBCS. Primary dependent variables will be compared statistically using a paired sample one-side t-test.

  3. Association between working memory and school readiness skills compared between SCD group and control group [ Time Frame: Once, at enrollment ]
    Variables will be subjected to analyses to establish frequency distributions, means and standard deviations, and to determine if variables are normally distributed prior to use of parametric statistics. Bivariate correlations will be used to investigate the association between working memory and school readiness skills.


Secondary Outcome Measures :
  1. Effect of family/environmental factors and disease severity on measures of working memory [ Time Frame: Once, within 6 months of enrollment ]
    Regression analyses will be used to examine the main effects of each family/environmental factor (caregiver stress, parental responsiveness, and cognitive stimulation in the home) and disease severity factors on measures of working memory and school readiness.

  2. Effect of family/environmental factors and disease severity on school readiness [ Time Frame: Once, within 6 months of enrollment ]
    Regression analyses will be used to examine the main effects of each family/environmental factor (caregiver stress, parental responsiveness, and cognitive stimulation in the home) and disease severity factors on measures of working memory and school readiness.


Eligibility Criteria
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Ages Eligible for Study:   48 Months to 68 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be between 4 and 5 years of age, have a diagnosis of sickle cell disease (SCD) and be patients at St. Jude Children's Research Hospital.
Criteria

Inclusion Criteria:

  • Patient at St. Jude Children's Research Hospital (SJCRH) with a primary diagnosis of sickle cell disease
  • 48-68 months of age at time of enrollment
  • English as primary language

Exclusion Criteria:

  • Sensory or motor impairment that would preclude valid testing (e.g., blindness, paresis)
  • Treatment with non-stimulant psychotropic medication
  • Enrollment in kindergarten at time of assessment
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02227472


Locations
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United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Jerlym Porter, PhD St. Jude Children's Research Hospital
More Information
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Additional Information:

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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02227472    
Other Study ID Numbers: MEMREAD
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
 Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn