School Readiness Intervention for Preschool Children With Sickle Cell Disease

Part of paid clinical trials in Memphis, Tennessee.

Sponsor
St. Jude Children's Research Hospital
Study ID
NCT06367192
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
42 Months - 78 Months
Healthy Volunteers
Not accepted

Interventions

  • The adapted Kids in Transition to School 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 — BEHAVIORAL
    Information about local preschool programs and age appropriate books for children will be provided.

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Apr 2026
Primary completion
Oct 31, 2026
Completion
Oct 31, 2028

Study Design

Enrollment
36 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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

Primary Outcome Measure

Feasibility of Intervention Measure [ Time Frame: Collected immediately after the intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St. Jude Children's Research HospitalMemphisTennessee38105
ANDREW HEITZER, PhD
[email protected]
888-226-4343
ANDREW HEITZER, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Memphis, TN

By condition
Sickle cell disease
By research site
St. Jude Children's Research Hospital· Memphis, TN

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