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School Readiness Intervention for Preschool Children With Sickle Cell Disease

NCT06367192 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2026-04-24

No results posted yet for this study

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.

Conditions

Interventions

BEHAVIORAL

The adapted Kids in Transition to School Intervention

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.

BEHAVIORAL

Standard school resources

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

Sponsors & Collaborators

Principal Investigators

  • ANDREW Heitzer, PhD · St. Jude Children's Research Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
42 Months
Max Age
78 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-10-31
Completion
2028-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06367192 on ClinicalTrials.gov