Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,143
- 试验地点
- 3
- 主要终点
- Enrollment Into Weekly Testing by Each Participant - Special School District
研究概览
简要总结
The primary goal of this project is to identify the best messaging and implementation strategies to maximize SARS-CoV-2 testing for children with intellectual and developmental disabilities (IDD) and their teachers to help ensure a safe school environment. Additionally, we will understand nationally the perceptions of COVID-19 and identify facilitators and barriers to help with the adoption of testing in other parts of the US and the necessary strategies to address other mitigation strategies including vaccination.
详细描述
This research study will occur at six schools dedicated to children with IDD that are a part of the Special School Districts in St. Louis, MO.
Additionally, surveys, focus groups, and fuzzy cognitive mapping sessions will be conducted at these six schools and at schools within the Kennedy Krieger School Programs in Baltimore, MD. Finally, a national survey will be administered to families, teachers, and staff of the 67 University Centers for Excellence in Developmental Disabilities (UCEDD) which is sponsored by the Association of University Centers for Disability (AUCD).
The first aim will involve focus groups of parents/guardians, teachers, and school staff to identify the barriers and facilitators to frequent SARS-CoV-2 testing, impressions of COVID-19, and best messages and implementation strategies to promote increase testing and vaccination. A formal process for developing two types of messages (general versus focused) will be performed using focus group data and involving key stakeholders to test the messages. A cluster randomized adaptive clinical trial will then occur at the six special school district schools. In phase 1, the schools will be randomized initially to either the general or focused message to promote the adoption of weekly SARS-CoV-2 testing by the students and teachers. After 5 months, data analysis will be conducted to determine which strategy led to the highest percentage of testing. Phase 2 will begin at 7 months after the schools are randomized to either the best message determined from phase 1 or best message plus an augmented implementation strategy.
Beginning in April 2021 the first aim was expanded to include weekly testing and message development at the Kennedy Krieger Institutes and Sheppard Pratt Schools in Baltimore, MD. In phase 1, these schools will be randomized initially to either the general or focused message to promote the adoption of weekly SARS-CoV-2 testing by the students and teachers. After 5 months, data analysis will be conducted to determine which strategy led to the highest percentage of testing. Phase 2 will begin at 7 months after these schools are randomized to either the best message determined from phase 1 or best message plus an augmented implementation strategy.
The second aim will assess the national perspectives among parents of children with IDD and school staff regarding the impact of COVID-19 and importance of SARS-CoV-2 testing. Fuzzy cognitive mapping (FCM) and the administration of local and national surveys will be used to accomplish this aim. FCM will involve in-person sessions with parents from the schools in aim 1 and Kennedy Krieger Institute/Sheppard Pratt schools in Baltimore, MD for children with IDD. These sessions will help identify the facilitators and barriers SARS-CoV-2 testing and other mitigation strategies including COVID-19 vaccine. Since no accepted measures have been developed for understanding parent and school staff concerns for children with IDD around COVID-19, local (St. Louis and Baltimore) and national surveys will be conducted. Custom surveys will be deployed across two stakeholder groups: parent/guardians and school staff. We will administer the survey at baseline and during the trial across school settings (St. Louis and Baltimore).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Students enrolled in the St. Louis Special School District or the Kennedy Krieger Institutes/Sheppard Pratt Schools in Maryland.
- •Teachers/Staff working at the St. Louis Special Schools or the Kennedy Krieger Institutes/Sheppard Pratt Schools in Maryland dedicated to teaching children with IDD.
- •Parents/ of students, teachers and/or staff employed by the St. Louis Special School District or Kennedy Krieger Institute/Sheppard Pratt schools in Maryland or
- •Families, teachers, and staff of the 67 University Centers for Excellence in Developmental Disabilities (UCEDD) which is sponsored by the Association of University Centers for Disability (AUCD).
排除标准
- •Members of the research team will not be eligible to participate in the focus groups.
研究组 & 干预措施
SSD: Standard Messaging - Standard Messaging
In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging.
干预措施: Standard Messaging (Behavioral)
SSD: Standard Messaging - Standard Messaging
In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to standard messaging.
干预措施: COVID-19 Testing (Diagnostic Test)
SSD: Standard Messaging - Enhanced Messaging
In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.
干预措施: Standard Messaging (Behavioral)
SSD: Standard Messaging - Enhanced Messaging
In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.
干预措施: Enhanced Messaging (Behavioral)
SSD: Standard Messaging - Enhanced Messaging
In phase 1, all schools received standard messaging. In phase 2, three schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.
干预措施: COVID-19 Testing (Diagnostic Test)
KKI: Standard Messaging - Standard Messaging
In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to standard messaging.
干预措施: Standard Messaging (Behavioral)
KKI: Standard Messaging - Standard Messaging
In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to standard messaging.
干预措施: COVID-19 Testing (Diagnostic Test)
KKI: Standard Messaging - Enhanced Messaging
In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.
干预措施: Standard Messaging (Behavioral)
KKI: Standard Messaging - Enhanced Messaging
In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.
干预措施: Enhanced Messaging (Behavioral)
KKI: Standard Messaging - Enhanced Messaging
In phase 1, all schools received standard messaging. In phase 2, two schools were randomized to a messaging strategy that was developed from focus groups that were targeted to address specific concerns of the different communities.
干预措施: COVID-19 Testing (Diagnostic Test)
Focus Groups
Focus group were completed in Phase 1 to develop enhanced messaging. Focus group participants were not required to be enrolled in testing.
干预措施: Focus Groups (Behavioral)
Fuzzy Cognitive Mapping
FCMs were completed to assess the facilitators and barriers to testing. FCM participants were not required to be enrolled testing.
干预措施: Fuzzy Cognitive Mapping (Behavioral)
结局指标
主要结局
Enrollment Into Weekly Testing by Each Participant - Special School District
时间窗: 22 months
Assuming the binomial distribution for each primary outcome, generalized estimating equation (GEE) models with logit link function were utilized to investigate the primary outcome changes across the weeks. The denominators for the enrollment and test rate per school were the total number of staff and students; and the total number of consented participants for a specific week, respectively. For the weeks after randomization, the GEE model included the indicator of week, group indicator, and the interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The reported values reflect the percentage of participants enrolled per week.
Overall Testing Rate - Special School District
时间窗: 22 months
Assuming the binomial distribution for each primary outcome, generalized estimating equation (GEE) models with logit link function were utilized to investigate the primary outcome changes across the weeks. The denominators for the enrollment and test rate per school were the total number of staff and students; and the total number of consented participants for a specific week, respectively. For the weeks after randomization, the GEE model included the indicator of week, group indicator, and the interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The outcome measure reflects the percentage of participants tested per week.
Enrollment Into Weekly Testing by Each Participant - Kennedy Krieger Institute
时间窗: 22 months
Assuming the binomial distribution for each primary outcome, generalized estimating equation (GEE) models with logit link function were utilized to investigate the primary outcome changes across the weeks. The denominators for the enrollment and test rate per school were the total number of staff and students; and the total number of consented participants for a specific week, respectively. For the weeks after randomization, the GEE model included the indicator of week, group indicator, and the interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The outcome measure reflects the percentage of participants enrolled per week.
Overall Testing Rate - Kennedy Krieger Institute
时间窗: 22 months
Assuming the binomial distribution for each primary outcome, generalized estimating equation (GEE) models with logit link function were utilized to investigate the primary outcome changes across the weeks. The denominators for the enrollment and test rate per school were the total number of staff and students; and the total number of consented participants for a specific week, respectively. For the weeks after randomization, the GEE model included the indicator of week, group indicator, and the interaction term between week and group indicator. P-values of the interaction term from type-3 test were used to test the difference between 2 groups across the weeks. At Kennedy, GEE models were conducted separately using participants with non-missing data and participants with missing data to assess the impact of missing data. The outcome measure reflects the percentage of participants tested per week.
次要结局
- Key Themes and Subthemes: Communication (Messages)(2 months)
- Key Themes and Subthemes: Communication (Messengers)(2 month)
- Key Themes and Subthemes: Perceptions of Returning to In-person Learning(2 months)
- Key Themes and Subthemes: Facilitators to Participation in SARS-CoV-2 Screening Testing(2 months)
- Structural Equation Modeling (SEM) for Effects of Facilitators and Barriers Related to a Successful SARS-COV-2 Test(up to 52 weeks)
- Structural Equation Modeling (SEM) for Successful SARS-COV-2 Test(up to 52 weeks)