Clinical Trials Directory

Trials / Completed

CompletedNCT02227472

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
84 (actual)
Sponsor
St. Jude Children's Research Hospital · Academic / Other
Sex
All
Age
48 Months – 68 Months
Healthy volunteers
Not accepted

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

Conditions

Interventions

TypeNameDescription
OTHEREvaluation of cognitive and pre-academic skillsParticipants 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).
OTHERParent questionnairesParents 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.

Timeline

Start date
2014-09-08
Primary completion
2018-08-20
Completion
2018-08-20
First posted
2014-08-28
Last updated
2018-09-12

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02227472. Inclusion in this directory is not an endorsement.