MedPath

School Readiness Intervention for Preschool Children With Sickle Cell Disease

Not Applicable
Recruiting
Conditions
Sickle Cell Disease
Registration Number
NCT06367192
Lead Sponsor
St. Jude Children's Research Hospital
Brief 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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
36
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Feasibility of Intervention MeasureCollected immediately after the intervention

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

Acceptability of Intervention MeasureCollected immediately after the intervention

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

Secondary Outcome Measures
NameTimeMethod
Bracken School Readiness Assessment - 3rd EditionBaseline and Collected immediately after the intervention

A Standardized assessment of school readiness skills for preschool children.

Woodcock Johnson Tests of Achievement - Fourth EditionBaseline and Collected immediately after the intervention

A standardized measure of reading, mathematics, and spelling.

NIH Toolbox Flanker TestBaseline and Collected immediately after the intervention

A computerized test of inhibitory control.

Head-Toes-Knees-Shoulders RevisedBaseline and Collected immediately after the intervention

A behavioral measure that examines self-regulation in preschool children.

The Parenting ScaleBaseline and Collected immediately after the intervention

A self-report measure completed by caregivers assessing their parenting skills.

Behavior Rating Inventory of Executive Functioning Preschool or ChildBaseline and Collected immediately after the intervention

A parent rating form that assesses executive functioning using a set of standardized questions.

Trial Locations

Locations (1)

St. Jude Children's Research Hospital

🇺🇸

Memphis, Tennessee, United States

St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States
ANDREW HEITZER, PhD
Principal Investigator

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.