Sickle Cell Disease
Conditions
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.
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.
Interventions
BEHAVIORALThe 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.
BEHAVIORALStandard school resources
Information about local preschool programs and age appropriate books for children will be provided.
Sponsors
St. Jude Children's Research Hospital
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Months to 78 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Intervention Measure | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Bracken School Readiness Assessment - 3rd Edition | Baseline and Collected immediately after the intervention | A Standardized assessment of school readiness skills for preschool children. |
| Woodcock Johnson Tests of Achievement - Fourth Edition | Baseline and Collected immediately after the intervention | A standardized measure of reading, mathematics, and spelling. |
| NIH Toolbox Flanker Test | Baseline and Collected immediately after the intervention | A computerized test of inhibitory control. |
| Head-Toes-Knees-Shoulders Revised | Baseline and Collected immediately after the intervention | A behavioral measure that examines self-regulation in preschool children. |
| Behavior Rating Inventory of Executive Functioning Preschool or Child | Baseline and Collected immediately after the intervention | A parent rating form that assesses executive functioning using a set of standardized questions. |
| The Parenting Scale | Baseline and Collected immediately after the intervention | A self-report measure completed by caregivers assessing their parenting skills. |
Countries
United States
Contacts
CONTACTANDREW HEITZER, PhD
PRINCIPAL_INVESTIGATORANDREW Heitzer, PhD
St. Jude Children's Research Hospital
Outcome results
None listed