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

• ClinicalTrials.gov Identifier: NCT02227472
• Recruitment Status: Completed
• First Posted: August 28, 2014
• Last Update Posted: September 12, 2018
• Sponsor: St. Jude Children's Research Hospital
• Information provided by (Responsible Party): St. Jude Children's Research Hospital

Tracking Information

• First Submitted Date: August 22, 2014
• First Posted Date: August 28, 2014
• Last Update Posted Date: September 12, 2018
• Actual Study Start Date: September 8, 2014
• Actual Primary Completion Date: August 20, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 26, 2014)

• 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.
• 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.
• 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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 22, 2016)

• 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.
• 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.

Original Secondary Outcome Measures (submitted: August 26, 2014)

• Effect of family/environmental factors and disease severity on measures of working memory [ Time Frame: Once, with 2 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.
• Effect of family/environmental factors and disease severity on school readiness [ Time Frame: Once, with 2 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.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease
• Official Title: Working Memory and School Readiness in Preschool-Aged Children With Sickle Cell Disease: Family and Environmental Factors

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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Sickle Cell Disease

Intervention

• 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

Study Groups/Cohorts

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.

Interventions:

• Other: Evaluation of cognitive and pre-academic skills
• Other: Parent questionnaires

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 11, 2018): 84
• Original Estimated Enrollment (submitted: August 26, 2014): 99
• Actual Study Completion Date: August 20, 2018
• Actual Primary Completion Date: August 20, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 48 Months to 68 Months (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02227472
• Other Study ID Numbers: MEMREAD
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: St. Jude Children's Research Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: St. Jude Children's Research Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Jerlym Porter, PhD; St. Jude Children's Research Hospital

• PRS Account: St. Jude Children's Research Hospital
• Verification Date: September 2018