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NCT06367192NARecruiting

School Readiness Intervention for Preschool Children With Sickle Cell Disease

St. Jude Children's Research Hospital

Start Date

3/31/2025

Completion Date

10/1/2028

Summary

The study participant is being asked to take part in this clinical trial, a type of research study, because the participant is a young child with sickle cell disease or the caregiver of a child with sickle cell disease. This study is being done to test a school readiness program for children with sickle cell disease (ages 3.5-6,5 years old). Primary Objective Assess feasibility and acceptability of an adapted school readiness intervention among preschool children (ages 3.5-6.5) diagnosed with sickle cell disease. Secondary Objectives Objective 1: Measure preliminary efficacy of the adapted school readiness intervention compared to routine care among preschool children ages (3.5-6.5) diagnosed with sickle cell disease. Objective 2: Examine implementation factors (i.e., barriers and facilitators) during post-intervention.

Detailed Description

* Group randomization- Parent and child will be randomly selected (like the flip of a coin) to receive either the school readiness intervention or the standard school resources. * Attend virtual classroom program sessions- If the participant is in the school readiness group, the caregiver, will attend about 8 weeks of sessions virtually with a teacher and a caregiver of a child with sickle cell, for a total of 8 sessions. The sessions will be during the summer and done in a group. Each session will last about 1 ½ hours and will be video recorded. These sessions will be shared with another researcher for feedback and consistency. * Complete a caregiver interview-If you are in the school readiness group, a member of the study team will interview you after the virtual classroom sessions are over. The interview will take about 15-20 minutes and will be audio recorded. The caregiver will be asked for suggestions and how satisfied with the program. * Complete assessments - Caregiver and child will complete a set of assessments that evaluate school readiness skills (e.g., early math and reading), child behaviors, and parent-child relationships before and after the intervention.

Eligibility Criteria

Age Range: No minimum to No maximum

Inclusion Criteria * Diagnosed with sickle cell disease of any genotype. * Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP) * Age 3.5-6.5 years inclusive at the time of enrollment * English as the primary language * Research participant and one parent willing to participate and provide consent/assent according to institutional guidelines Caregiver Participants * Have a child diagnosed with SCD of any genotype between the ages of 3.5-6.5 years and enrolled in SCCRIP * English as the primary language Exclusion Criteria * Do not have a child diagnosed with SCD of any genotype between the ages of 3.5-6.5 years and enrolled in SCCRIP * Non-English speakers

Interventions

BEHAVIORAL

The adapted Kids in Transition to School Intervention

BEHAVIORAL

Standard school resources

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Conditions

Sickle Cell Disease

Locations

St. Jude Children's Research Hospital

Memphis, Tennessee 38105

United States