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Behavioural Intervention
School Readiness Program for Sickle Cell Disease
N/A
Recruiting
Led By ANDREW Heitzer, PhD
Research Sponsored by St. Jude Children's Research Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up collected immediately after the intervention
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to test a school readiness program for young children (ages 4-6) with sickle cell disease. The main goal is to see if this program is feasible and well-received
Who is the study for?
This trial is for preschool children aged 4-6 with sickle cell disease, or their caregivers. It aims to test a school readiness program specifically adapted for these children. Participants should be ready to engage in the study's activities and assessments.
What is being tested?
The trial is testing an adapted Kids in Transition to School Intervention against standard school resources provided to young children with sickle cell disease. The goal is to assess how feasible and acceptable this tailored intervention is.
What are the potential side effects?
Since this trial involves educational and support interventions rather than medical treatments, there are no direct physical side effects expected from participating in the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ collected immediately after the intervention
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~collected immediately after the intervention
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Acceptability of Intervention Measure
Feasibility of Intervention Measure
Secondary study objectives
Behavior Rating Inventory of Executive Functioning Preschool or Child
Bracken School Readiness Assessment - 3rd Edition
Head-Toes-Knees-Shoulders Revised
+3 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Group I: Readiness InterventionExperimental Treatment1 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.
Group II: Control: Standard school resourcesExperimental Treatment1 Intervention
Parents will be provided with information about preschool programs available in the community and age appropriate books for their children
Find a Location
Who is running the clinical trial?
St. Jude Children's Research HospitalLead Sponsor
443 Previous Clinical Trials
5,305,415 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,797,897 Total Patients Enrolled
ANDREW Heitzer, PhDPrincipal InvestigatorSt. Jude Children's Research Hospital