School Readiness Intervention for Preschool Children With Sickle Cell Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: The adapted Kids in Transition to School Intervention, Standard school resources.
- Who it may be relevant to
- Registry conditions: Sickle Cell Disease. Basic parameters: 42 months — 78 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Primary outcome measures
- Feasibility of Intervention Measure [Time frame: Collected immediately after the intervention]
- Acceptability of Intervention Measure [Time frame: Collected immediately after the intervention]
Secondary outcome measures (6)
- Bracken School Readiness Assessment - 3rd Edition [Time frame: Baseline and Collected immediately after the intervention]
- Woodcock Johnson Tests of Achievement - Fourth Edition [Time frame: Baseline and Collected immediately after the intervention]
- NIH Toolbox Flanker Test [Time frame: Baseline and Collected immediately after the intervention]
- Head-Toes-Knees-Shoulders Revised [Time frame: Baseline and Collected immediately after the intervention]
- Behavior Rating Inventory of Executive Functioning Preschool or Child [Time frame: Baseline and Collected immediately after the intervention]
- The Parenting Scale [Time frame: Baseline and Collected immediately after the intervention]
Eligibility criteria
Inclusion criteria
- Diagnosed with sickle cell disease of any genotype.
- Enrolled on the institutional protocol: Sickle Cell Clinical Research Intervention Program (SCCRIP)
- Age 3.5-6.5 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 3.5-6.5 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 3.5-6.5 years and enrolled in SCCRIP
- Non-English speakers
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- St. Jude Children's Research Hospital — Memphis
Publications
- Heitzer AM, Kang E, Tamboli M, Brazley-Rodgers M, Kolb-Quinn A, Carroll Y, Conklin HM, King AA, Hankins JS, Pears K, Fernandez ME. Adapting a school readiness intervention for children with sickle cell disease: an intervention mapping for adaptation approach. Front Public Health. 2026 Jul 6;14:1862943. doi: 10.3389/fpubh.2026.1862943. eCollection 2026. PMID 42524380
Identifiers
NCT: NCT06367192 · SKITS2 · K23HL166697