School Readiness Intervention for Preschool Children With Sickle Cell Disease
Overview
- Phase
- N/A
- Intervention
- The adapted Kids in Transition to School Intervention
- Conditions
- Sickle Cell Disease
- Sponsor
- St. Jude Children's Research Hospital
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Feasibility of Intervention Measure
- Status
- Recruiting
- Last Updated
- 8 days ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Readiness 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.
Intervention: The adapted Kids in Transition to School Intervention
Control: Standard school resources
Parents will be provided with information about preschool programs available in the community and age appropriate books for their children
Intervention: Standard school resources
Outcomes
Primary Outcomes
Feasibility of Intervention Measure
Time Frame: 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
Time Frame: 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 Outcomes
- Bracken School Readiness Assessment - 3rd Edition(Baseline and Collected immediately after the intervention)
- Woodcock Johnson Tests of Achievement - Fourth Edition(Baseline and Collected immediately after the intervention)
- NIH Toolbox Flanker Test(Baseline and Collected immediately after the intervention)
- Head-Toes-Knees-Shoulders Revised(Baseline and Collected immediately after the intervention)
- The Parenting Scale(Baseline and Collected immediately after the intervention)
- Behavior Rating Inventory of Executive Functioning Preschool or Child(Baseline and Collected immediately after the intervention)