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| ID | Type | Description | Link |
|---|---|---|---|
| K23HL166697 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Readiness Intervention | Experimental |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Collected immediately after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Bracken School Readiness Assessment - 3rd Edition | A Standardized assessment of school readiness skills for preschool children. | Baseline and Collected immediately after the intervention |
| Woodcock Johnson Tests of Achievement - Fourth Edition |
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Inclusion Criteria
Caregiver Participants
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ANDREW HEITZER, PhD | Contact | 888-226-4343 | referralinfo@stjude.org |
| Name | Affiliation | Role |
|---|---|---|
| ANDREW Heitzer, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Recruiting | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| Clinical Trials Open at St. Jude | View source |
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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.
Data will be made available at the time of article publication.
Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| Standard school resources | Behavioral | Information about local preschool programs and age appropriate books for children will be provided. |
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A standardized measure of reading, mathematics, and spelling.
| Baseline and Collected immediately after the intervention |
| NIH Toolbox Flanker Test | A computerized test of inhibitory control. | Baseline and Collected immediately after the intervention |
| Head-Toes-Knees-Shoulders Revised | A behavioral measure that examines self-regulation in preschool children. | 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. | Baseline and Collected immediately after the intervention |
| The Parenting Scale | A self-report measure completed by caregivers assessing their parenting skills. | Baseline and Collected immediately after the intervention |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |