Testing for COVID-19 in High Risk Children With Intellectual and Developmental Disabilities (COV-IDD)

Not Applicable

Completed

Interventions: Diagnostic Test: COVID-19 RT-PCR test
Other: COVID-19 Vaccine Education Campaign

Brief Summary: The purpose of this study is to understand how to prevent COVID-19 spread in a school like the Mary Cariola Center (MCC) in Rochester, NY by answering questions like these: how do activities in the school alter chances of infection? Are there people infected with the COVID-19 virus who have no symptoms? How is spread of COVID-19 affected by vaccination rates? Is there any hesitancy to get the vaccine and what are the reasons? This information will be used to help keep the school open and the students and staff safe.

Eligible participants are those that work at the Mary Cariola Center (MCC) and interact with the students at MCC who have a high risk of infection from COVID-19.

The study lasts for up to 16 months.

Recruitment & Eligibility

Inclusion Criteria

Students:

IDD Student of the Mary Cariola Center
Age 3 - 18
Have a parent/guardian who can give informed consent
In the judgement of the Mary Cariola Medical Staff will be able to safely participate in the study procedures (nasal swab, phlebotomy)

Staff

Exclusion Criteria

Students

Staff

Arm && Interventions

Group	Intervention	Description
Students and staff at Mary Cariola Center	COVID-19 Vaccine Education Campaign	All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.
Students and staff at Mary Cariola Center	COVID-19 RT-PCR test	All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.

Primary Outcome Measures

Name	Time	Method
Number Infected With COVID-19	16 months	Number of students or staff who test positive for COVID-19 at least once using a nasal swab test.
Change in the Percentage of Participants Reporting Anxiety	baseline to 16 months	Anxiety will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having anxiety if they were moderate or severe.
Change in the Percentage of Participants Classified as Depressed	baseline to 16 months	Depression was measured using the PROMIS-29 assessment. Students or staff were classified within normal range, mild, moderate or severe. They were counted as having depression if they were moderate or severe.
Change in the Percentage of Participants Classified With Fatigue	baseline to 16 months	Fatigue will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having fatigue if they were moderate or severe.
Change in Percentage of Participants With Deficits in Social Functioning	baseline to 16 months	Social functioning will be measured using the PROMIS-29 assessment. Participants were classified within normal range, mild, moderate or severe. They were counted as having social functioning deficits if they were moderate or severe.