Clinical trial NCT06367192: School Readiness Intervention for Preschool Children With Sickle Cell Disease
Official title: School Readiness Intervention for Preschool Children With Sickle Cell Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sickle Cell Disease
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2024-04-16
Enrollment: 36
Sex: ALL
Minimum age (years): 42
Maximum age (years): 78
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of Intervention Measure
timeFrame: Collected immediately after the intervention
measure: Acceptability of Intervention Measure
timeFrame: Collected immediately after the intervention
Secondary outcomes:
measure: Bracken School Readiness Assessment - 3rd Edition
timeFrame: Baseline and Collected immediately after the intervention
measure: Woodcock Johnson Tests of Achievement - Fourth Edition
timeFrame: Baseline and Collected immediately after the intervention
measure: NIH Toolbox Flanker Test
timeFrame: Baseline and Collected immediately after the intervention
measure: Head-Toes-Knees-Shoulders Revised
timeFrame: Baseline and Collected immediately after the intervention
measure: Behavior Rating Inventory of Executive Functioning Preschool or Child
timeFrame: Baseline and Collected immediately after the intervention
measure: The Parenting Scale
timeFrame: Baseline and Collected immediately after the intervention
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: ANDREW Heitzer, PhD
role: PRINCIPAL_INVESTIGATOR
References: