Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367192
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-04-05
Brief Title:
School Readiness Intervention for Preschool Children With Sickle Cell Disease
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
School Readiness Intervention for Preschool Children With Sickle Cell Disease
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 4-6 years old
Primary Objective
Assess feasibility and acceptability of an adapted school readiness intervention among preschool children ages 4-6 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 4-6 diagnosed with sickle cell disease
Objective 2
Examine implementation factors ie barriers and facilitators during post-intervention
Primary Objective
Assess feasibility and acceptability of an adapted school readiness intervention among preschool children ages 4-6 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 4-6 diagnosed with sickle cell disease
Objective 2
Examine implementation factors ie 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 eg early math and reading child behaviors and parent-child relationships before and after the intervention
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 eg early math and reading child behaviors and parent-child relationships before and after the intervention
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K23HL166697 | NIH | None | httpsreporternihgovquickSearchK23HL166697 |