Recruiting

School Readiness Intervention

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06367192

Conditions

Sickle Cell Disease

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Not accepted

Interventions

The adapted Kids in Transition to School Intervention

Standard school resources

Study Details

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.

Conditions

Sickle Cell Disease

Study ID

NCT06367192

Start date

Mar 31, 2025

Status verified date

Apr, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

Standard school resources

Information about local preschool programs and age appropriate books for children will be provided.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

ANDREW HEITZER, PhD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

ANDREW HEITZER, PhD

888-226-4343referralinfo@stjude.org

Principal Investigator:

ANDREW HEITZER, PhD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-04-24.