School Readiness Intervention for Preschool Children With Sickle Cell Disease
- Conditions
- Sickle Cell Disease
- Interventions
- Device: The adapted Kids in Transition to School InterventionDevice: Standard school resources
- Registration Number
- NCT06367192
- Lead Sponsor
- St. Jude Children's Research Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 36
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Readiness Intervention 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 Standard school resources Parents will be provided with information about preschool programs available in the community and age appropriate books for their children
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
The Parenting Scale Baseline and Collected immediately after the intervention A self-report measure completed by caregivers assessing their parenting skills.
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.
Trial Locations
- Locations (1)
St. Jude Children's Research Hospital
🇺🇸Memphis, Tennessee, United States