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

NCT02227472 | Completed

• 1 other identifier: MEMREAD
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (2)

• Effect of family/environmental factors and disease severity on measures of working memory

  Once, within 6 months of enrollment

• Effect of family/environmental factors and disease severity on school readiness

  Once, within 6 months of enrollment

Study Arms (1)

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; Other: Parent questionnaires

Interventions

Evaluation of cognitive and pre-academic skills OTHER

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).

Also known as: Testing

Sickle Cell Disease

Parent questionnaires OTHER

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.

Also known as: Parent report

Sickle Cell Disease

Eligibility Criteria

• Age: 48 Months - 68 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

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

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Jerlym Porter, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 28, 2014
• Study Start: September 8, 2014
• Primary Completion: August 20, 2018
• Study Completion: August 20, 2018
• Last Updated: September 12, 2018

Record last verified: 2018-09

Locations

US (1)