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NCT Number: NCT06367192

School Readiness Intervention for Preschool Children With Sickle Cell Disease

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.

Recruiting

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Key information

Age range

42 month–78 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location status: Recruiting

Location contact

ANDREW HEITZER, PhD

CONTACT

[email protected]

888-226-4343

ANDREW HEITZER, PhD

PRINCIPAL_INVESTIGATOR

About this study

  • 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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Kids in Transition to School (KITS)

Standard school resources

Behavioral

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

Primary outcomes

  1. Feasibility of Intervention Measure

    Time frame: Collected immediately after the intervention

    A brief (4-items) Likert-scale questionnaire assessing feasibility of the intervention. This measure is completed by care givers and intervention providers.

  2. Acceptability of Intervention Measure

    Time frame: Collected immediately after the intervention

    A brief (4-items) Likert-scale questionnaire assessing acceptability of the intervention. This measure is completed by care givers and intervention providers.

Secondary outcomes

  1. Bracken School Readiness Assessment - 3rd Edition

    Time frame: Baseline and Collected immediately after the intervention

    A Standardized assessment of school readiness skills for preschool children.

  2. Woodcock Johnson Tests of Achievement - Fourth Edition

    Time frame: Baseline and Collected immediately after the intervention

    A standardized measure of reading, mathematics, and spelling.

  3. NIH Toolbox Flanker Test

    Time frame: Baseline and Collected immediately after the intervention

    A computerized test of inhibitory control.

  4. Head-Toes-Knees-Shoulders Revised

    Time frame: Baseline and Collected immediately after the intervention

    A behavioral measure that examines self-regulation in preschool children.

  5. Behavior Rating Inventory of Executive Functioning Preschool or Child

    Time frame: Baseline and Collected immediately after the intervention

    A parent rating form that assesses executive functioning using a set of standardized questions.

  6. The Parenting Scale

    Time frame: Baseline and Collected immediately after the intervention

    A self-report measure completed by caregivers assessing their parenting skills.

Study contacts

Contact information is provided by the study sponsor or research team.

ANDREW HEITZER, PhD

CONTACT

[email protected]

888-226-4343

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Apr 16, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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