School Readiness Intervention for Preschool Children With Sickle Cell Disease

School Readiness Intervention for Preschool Children With Sickle Cell Disease

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.

• 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.

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