Sickle Cell DiseaseNCT06367192
School Readiness Intervention for Preschool Children With Sickle Cell Disease
A study testing The adapted Kids in Transition to School Intervention and Standard school resources in people with Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 42 to 78 months
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- The adapted Kids in Transition to School Intervention and Standard school resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to Oct 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 78 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
ANDREW HEITZER, PhD, 888-226-4343, referralinfo@stjude.org
ANDREW HEITZER, PhD
About this study
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
Read more
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.
Read the detailed 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.
- Conditions
- Sickle Cell Disease
- Being tested
- The adapted Kids in Transition to School Intervention, Standard school resources
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The adapted Kids in Transition to School InterventionBehavioural
Also called Kids in Transition to School (KITS)
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 resourcesBehavioural
Information about local preschool programs and age appropriate books for children will be provided.
| Study group | Role | What they receive |
|---|---|---|
| Readiness Intervention | Experimental | * 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. Receives: Behavioral: The adapted Kids in Transition to School Intervention |
| Control: Standard school resources | Other | Parents will be provided with information about preschool programs available in the community and age appropriate books for their children Receives: Behavioral: Standard school resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Intervention Measure
A brief (4-items) Likert-scale questionnaire assessing feasibility of the intervention. This measure is completed by care givers and intervention providers.
Measured: Collected immediately after the intervention
Acceptability of Intervention Measure
A brief (4-items) Likert-scale questionnaire assessing acceptability of the intervention. This measure is completed by care givers and intervention providers.
Measured: Collected immediately after the intervention
Secondary outcomes (6)
Bracken School Readiness Assessment - 3rd Edition
A Standardized assessment of school readiness skills for preschool children.
Measured: Baseline and Collected immediately after the intervention
Woodcock Johnson Tests of Achievement - Fourth Edition
A standardized measure of reading, mathematics, and spelling.
Measured: Baseline and Collected immediately after the intervention
NIH Toolbox Flanker Test
A computerized test of inhibitory control.
Measured: Baseline and Collected immediately after the intervention
Head-Toes-Knees-Shoulders Revised
A behavioral measure that examines self-regulation in preschool children.
Measured: Baseline and Collected immediately after the intervention
Behavior Rating Inventory of Executive Functioning Preschool or Child
A parent rating form that assesses executive functioning using a set of standardized questions.
Measured: Baseline and Collected immediately after the intervention
The Parenting Scale
A self-report measure completed by caregivers assessing their parenting skills.
Measured: Baseline and Collected immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start31 Mar 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- ANDREW Heitzer, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06367192
- Sponsor's protocol ID
- SKITS2
- Other IDs
- K23HL166697
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Publications
Heitzer AM, Kang E, Tamboli M, Brazley-Rodgers M, Kolb-Quinn A, Carroll Y, Conklin HM, King AA, Hankins JS, Pears K, Fernandez ME. Adapting a school readiness intervention for children with sickle cell disease: an intervention mapping for adaptation approach. Front Public Health. 2026 Jul 6;14:1862943. doi: 10.3389/fpubh.2026.1862943. eCollection 2026.
PubMed 42524380
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Readiness Intervention for Preschool Children With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06367192
- Acronym / sponsor ID
- SKITS2
- Conditions
- Sickle Cell Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Readiness Intervention | Experimental | Behavioral: The adapted Kids in Transition to School 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. |
| Control: Standard school resources | Other | Behavioral: Standard school resourcesParents will be provided with information about preschool programs available in the community and age appropriate books for their children |
Who may qualify
- Ages
- 42 to 78 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The adapted Kids in Transition to School InterventionAlso: Kids in Transition to School (KITS)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. | Behavioural | Readiness Intervention |
| Standard school resourcesInformation about local preschool programs and age appropriate books for children will be provided. | Behavioural | Control: Standard school resources |
Primary outcome
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.
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.
6 secondary outcomes
Bracken School Readiness Assessment - 3rd Edition
Time frame: Baseline and Collected immediately after the intervention
Woodcock Johnson Tests of Achievement - Fourth Edition
Time frame: Baseline and Collected immediately after the intervention
NIH Toolbox Flanker Test
Time frame: Baseline and Collected immediately after the intervention
Head-Toes-Knees-Shoulders Revised
Time frame: Baseline and Collected immediately after the intervention
Behavior Rating Inventory of Executive Functioning Preschool or Child
Time frame: Baseline and Collected immediately after the intervention
The Parenting Scale
Time frame: Baseline and Collected immediately after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Derived from this study: PubMed 42524380Heitzer AM, Kang E, Tamboli M, Brazley-Rodgers M, Kolb-Quinn A, Carroll Y, Conklin HM, King AA, Hankins JS, Pears K, Fernandez ME. Adapting a school readiness intervention for children with sickle cell disease: an intervention mapping for adaptation approach. Front Public Health. 2026 Jul 6;14:1862943. doi: 10.3389/fpubh.2026.1862943. eCollection 2026.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ANDREW Heitzer, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The adapted Kids in Transition to School Intervention and Standard school resources in people with Sickle Cell Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ANDREW HEITZER, PhD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Intervention Measure (time frame: Collected immediately after the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06367192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.