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

Sickle Cell Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02227472
• Other study ID #: MEMREAD
• Status: Completed
• Start date: September 8, 2014
• Est. completion date: August 20, 2018

Study information

• Verified date: September 2018
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: August 20, 2018
• Est. primary completion date: August 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 48 Months to 68 Months

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• 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).
• 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.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference in working memory between SCD participants and control group	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.	Once, at enrollment
Primary	Mean difference in school readiness between SCD group and control group	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.	Once, at enrollment
Primary	Association between working memory and school readiness skills compared between SCD group and control group	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.	Once, at enrollment
Secondary	Effect of family/environmental factors and disease severity on measures of working memory	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.	Once, within 6 months of enrollment
Secondary	Effect of family/environmental factors and disease severity on school readiness	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.	Once, within 6 months of enrollment

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital