What this study is
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.
What's being tested
- The adapted Kids in Transition to School Intervention
Intervention · BEHAVIORAL
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.
- Standard school resources
Intervention · BEHAVIORAL
Information about local preschool programs and age appropriate books for children will be provided.
Study details
- Sponsor
- St. Jude Children's Research Hospital
- Conditions
- Sickle Cell Disease
- Enrolling
- 36 people
- Starts
- 2025-03-31
- Est. completion
- 2028-10
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 42 Months – 78 MonthsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openSt. Jude Children's Research Hospital
Memphis, Tennessee, United States
- ANDREW HEITZER, PhD · Contact888-226-4343referralinfo@stjude.org
- ANDREW HEITZER, PhD · Principal investigator
Recruiting
Study team
Sponsor
St. Jude Children's Research Hospital
Study ID SKITS2
Principal investigator
ANDREW Heitzer, PhD
St. Jude Children's Research Hospital
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.