A Comprehensive Program to Increase Sickle Cell Trait Knowledge and Awareness Among Parents of Young Children Identified in Newborn Screening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Feasibility of implementing of a Sickle Cell Trait education Program: The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured
研究概览
简要总结
This is a study for parents of young children with Sickle Cell Trait (SCT) identified by newborn screening who are referred and present for in person SCT education at the Institution.
The study will determine the feasibility of implementing a SCT education program (SCTaware) that is appropriate for all parents, including those with low base knowledge and low health literacy and then test if results in high and sustained SCT knowledge.
详细描述
This is a single center, observational study to develop an education program for parents of young children diagnosed with Sickle Cell Trait. This will be accomplish by evaluating the current Ohio education in-person program, and assessing, through a set of questionnaires, how much participants are understanding about this diagnosis.
During phase I of the study, participants will be video-taped, and a set of questionnaires will be answer before and after education is given. This data will then be analyzed by the SCT Team in order to develop the Program.
During phase II of the study, population with the same criteria as phase I will be enrolled, however they will receive the revised "SCTaware" education. Pre and post education questionnaires will also be answered. In addition, participants during this phase will receive follow-up calls at 1 and 6 months to complete additional surveys.
In addition, the investigators will be using the Decisional Conflict Scale (DCS) to explore if parents experience decisional conflict about whether or not to obtain SCT testing and if SCTaware reduces this conflict
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult biological parents of children <3 years old with Hemoglobin S-trait identified by NBS who present for SCT education at NCH.
- •English proficiency will be required
排除标准
- •Parents who self-report that they do not have functional verbal English (report that they are not proficient) or if they request an interpreter for the education session.
- •Parents who have previously attended an education session about an abnormal hemoglobinopathy trait
- •Parents who self-report that they have a child with SCD
- •Parents who self-report that they have SCD.
- •Parents who report that they or their partner is currently pregnant
研究组 & 干预措施
Education
During phase 1 of this study parents who attend in person education sessions will be recruited to have their standard sessions video-taped, timed, and reviewed by the SCTaware Team. Subjects will complete before and after education questionnaires that will then be reviewed to see how much participants learned about SCT, how education was not clear and/or appropriate (too much medical jargon). The SCTaware education will then be created based on review of these videos and participants' survey responses.
For phase 2 of the study, the same recruitment strategy will be utilized. Participants will receive SCTaware and complete before and after questionnaires for evaluation. Participants in this phase will also complete follow-up questionnaires at 1 and 6 months.
干预措施: Education (Other)
结局指标
主要结局
Feasibility of implementing of a Sickle Cell Trait education Program: The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured
时间窗: 2 years
The time required to train a sickle cell trait educator and to deliver the revised sickle cell trait education will be measured. The program will be feasible if the time to train the educator and deliver the education can be completed within the context of the current sickle cell trait education program in Ohio.
Parental Sickle Cell Trait Knowledge
时间窗: 2 years
Parental Sickle Cell Trait Knowledge will be measured before the education, immediately after the education, and 6 months after the education is provided using the 8-question Sickle Cell Trait Knowledge Assessment Measure. Parents that score 75% correct on this measure or higher will be considered to have high knowledge. The proportion of those parents who have high knowledge prior to the education will be compared to the percentage of parents that have high knowledge 6-months after receiving the education.
次要结局
- Percentage of Parents who receive on-site Sickle Cell Trait testing(2 years)
- Parental Anxiety(2 years)
- Sickle Cell Trait Testing Cost(2 years)
- Decisional Conflict Scale(2 years)
研究者
Susan Creary
Assistant Professor of Pediatrics
Nationwide Children's Hospital