School Readiness Intervention for Preschool Children With Sickle Cell Disease

Sickle Cell Disease Clinical Trial

Official title:

School Readiness Intervention for Preschool Children With Sickle Cell Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06367192
• Other study ID #: SKITS2
• Secondary ID: K23HL166697
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: October 2028

Study information

• Verified date: May 2024
• Source: St. Jude Children's Research Hospital
• Contact: ANDREW HEITZER, PhD
• Phone: 866-278-5833
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 4-6 years old).

Primary Objective

Assess feasibility and acceptability of an adapted school readiness intervention among preschool children (ages 4-6) 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 (4-6) diagnosed with sickle cell disease.

Objective 2:

Examine implementation factors (i.e., barriers and facilitators) during post-intervention.

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 information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: October 2028
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 6 Years

Eligibility

Inclusion Criteria

• Diagnosed with sickle cell disease of any genotype.

• Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)

• Age 4.0-6.0 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 4.0-6.0 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 4.0-6.0 years and enrolled in SCCRIP

• Non-English speakers

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Device:
• The adapted Kids in Transition to School Intervention
An intensive, school readiness intervention designed to improve preschoolers' 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 resources
Information about local preschool programs and age appropriate books for children will be provided.

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	collected immediately after the intervention
Primary	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.	collected immediately after the intervention
Secondary	Bracken School Readiness Assessment - 3rd Edition	A Standardized assessment of school readiness skills for preschool children.	collected immediately after the intervention
Secondary	Woodcock Johnson Tests of Achievement - Fourth Edition	A standardized measure of reading, mathematics, and spelling.	collected immediately after the intervention
Secondary	NIH Toolbox Flanker Test	A computerized test of inhibitory control.	collected immediately after the intervention
Secondary	Head-Toes-Knees-Shoulders Revised	A behavioral measure that examines self-regulation in preschool children.	collected immediately after the intervention
Secondary	Behavior Rating Inventory of Executive Functioning Preschool or Child	A parent rating form that assesses executive functioning using a set of standardized questions.	collected immediately after the intervention
Secondary	The Parenting Scale	A self-report measure completed by caregivers assessing their parenting skills.	collected immediately after the intervention

External Links

•   Clinical Trials Open at St. Jude