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.

Study Timeline

• Study First Submitted: 2024-04-05
• Study First Submitted QC: 2024-04-11
• Study First Posted: 2024-04-16
• Study Start: 2024-05-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-11
• Primary Completion: 2026-10
• Study Completion: 2028-10

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

Name	Time	Method
Feasibility of Intervention Measure	Collected 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 Measure	Collected 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

Name	Time	Method
Bracken School Readiness Assessment - 3rd Edition	Baseline and Collected immediately after the intervention	A Standardized assessment of school readiness skills for preschool children.
Woodcock Johnson Tests of Achievement - Fourth Edition	Baseline and Collected immediately after the intervention	A standardized measure of reading, mathematics, and spelling.
NIH Toolbox Flanker Test	Baseline and Collected immediately after the intervention	A computerized test of inhibitory control.
Head-Toes-Knees-Shoulders Revised	Baseline and Collected immediately after the intervention	A behavioral measure that examines self-regulation in preschool children.
The Parenting Scale	Baseline 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 Child	Baseline 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