School Readiness Intervention for Preschool Children With Sickle Cell Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Feasibility of Intervention Measure
研究概览
简要总结
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.
详细描述
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 42 Months 至 78 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: The adapted Kids in Transition to School Intervention (Behavioral)
Control: Standard school resources
Parents will be provided with information about preschool programs available in the community and age appropriate books for their children
干预措施: Standard school resources (Behavioral)
结局指标
主要结局
Feasibility of Intervention Measure
时间窗: 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
时间窗: 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.
次要结局
- 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)