School Readiness Intervention for Preschool Children With Sickle Cell Disease

St. Jude Children's Research Hospital36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

Interventions

The adapted Kids in Transition to School InterventionBEHAVIORAL

An intensive, school readiness intervention designed to improve preschoolers' social skills, early literacy, numeracy, and self-regulation skills at high risk for academic difficulties. The intervention is delivered virtually over 8 weeks with caregivers and intentionally occurs over the summer when there is a gap in preschool services.

Standard school resourcesBEHAVIORAL

Information about local preschool programs and age appropriate books for children will be provided.

Eligibility

Sex: ALLMin age: 42 MonthsMax age: 78 Months

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility of Intervention Measure

A brief (4-items) Likert-scale questionnaire assessing feasibility of the intervention. This measure is completed by care givers and intervention providers.

Time frame: Collected immediately after the intervention

Acceptability of Intervention Measure

A brief (4-items) Likert-scale questionnaire assessing acceptability of the intervention. This measure is completed by care givers and intervention providers.

Time frame: Collected immediately after the intervention