School Readiness Intervention for Preschool Children With Sickle Cell Disease

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sickle Cell Disease
• Intervention / Treatment: Device: The adapted Kids in Transition to School Intervention; Device: Standard school resources

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ANDREW HEITZER, PhD; Phone Number: 866-278-5833; Email: referralinfo@stjude.org

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38105
      • St. Jude Children's Research Hospital
      • Contact: ANDREW HEITZER, PhD
      • Principal Investigator: ANDREW HEITZER, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Readiness Intervention; Attend virtual classroom program sessions- If participants are in the school readiness group, the caregiver, will attend about 8 weeks of sessions virtually with a teacher or social worker 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. > •Complete a caregiver interview-If participants 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. Participants will be asked for suggestions and how satisfied you were with the program.; Complete assessments - Caregiver and participant 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.	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.; Other Names: Kids in Transition to School (KITS)
Other: Control: Standard school resources; Parents will be provided with information about preschool programs available in the community and age appropriate books for their children	Device: Standard school resources; Information about local preschool programs and age appropriate books for children will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bracken School Readiness Assessment - 3rd Edition	A Standardized assessment of school readiness skills for preschool children.	collected immediately after the intervention
Woodcock Johnson Tests of Achievement - Fourth Edition	A standardized measure of reading, mathematics, and spelling.	collected immediately after the intervention
NIH Toolbox Flanker Test	A computerized test of inhibitory control.	collected immediately after the intervention
Head-Toes-Knees-Shoulders Revised	A behavioral measure that examines self-regulation in preschool children.	collected immediately after the intervention
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
The Parenting Scale	A self-report measure completed by caregivers assessing their parenting skills.	collected immediately after the intervention

Collaborators and Investigators

• Sponsor: St. Jude Children's Research Hospital
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: ANDREW Heitzer, PhD, St. Jude Children's Research Hospital

Publications and helpful links

Helpful Links

• Clinical Trials Open at St. Jude

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: April 5, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Anemia, Sickle Cell
• Other Study ID Numbers: SKITS2; K23HL166697 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
• IPD Sharing Time Frame: Data will be made available at the time of article publication.
• IPD Sharing Access Criteria: Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes