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Recruiting Not applicable NCT06367192

School Readiness Intervention for Preschool Children With Sickle Cell Disease

No applicable phase (e.g. observational)
Conditions: Sickle Cell Disease

Sponsor: St. Jude Children's Research Hospital

trial.available_in: БГ
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.
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.
Who can participate
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
Interventions
The adapted Kids in Transition to School Intervention
BEHAVIORAL
Standard school resources
BEHAVIORAL
Locations 1
United States (1)
St. Jude Children's Research Hospital
Memphis , Tennessee
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
42 Months
Maximum age
78 Months
Healthy volunteers
No
Start date
31.03.2025
Completion date
01.10.2028
Registry ID
NCT06367192
Source
clinicaltrials.gov
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