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

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Updated on 19 February 2024
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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.

Description

  1. Number of students infected with COVID-19 [ Time Frame: 16 months ]
    Number of students who test positive for COVID-19 at least once using a nasal swab test.

  2. Number of staff infected with COVID-19 [ Time Frame: 16 months ]
    Number of staff who test positive for COVID-19 at least once using a nasal swab test.

  3. Mean change in anxiety in students [ Time Frame: baseline to 16 months ]
    Anxiety will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher anxiety.

  4. Mean change in anxiety in staff [ Time Frame: baseline to 16 months ]
    Anxiety will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher anxiety.

  5. Mean change in depression in students [ Time Frame: baseline to 16 months ]
    Depression will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher depression.

  6. Mean change in depression in staff [ Time Frame: baseline to 16 months ]
    Depression will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher depression.

  7. Mean change in fatigue in students [ Time Frame: baseline to 16 months ]
    Fatigue will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher fatigue.

  8. Mean change in fatigue in staff [ Time Frame: baseline to 16 months ]
    Fatigue will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher fatigue.

  9. Mean change in social functioning in students [ Time Frame: baseline to 16 months ]
    Social functioning will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher social disfunction.

  10. Mean change in social functioning in staff [ Time Frame: baseline to 16 months ]
    Social functioning will be measured using the PROMIS-29 assessment. The assessment is comprised of 4 questions. The scale ranges from 4-20 with higher scores indicating higher social disfunction.

Details
Condition Covid, Covid-19
Age 100years or below
Clinical Study IdentifierTX13102
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

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
Age 18 - 72
Able give informed consent
Anticipated duration of remaining employment less than 1 month (e.g. retiring)
Must be willing to participate in RT-PCR and antibody testing

Exclusion Criteria

Students
Contraindication to nasal swab
Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
Staff
Contraindication to nasal swab
Contraindication to phlebotomy (e.g. anticoagulated, bleeding diathesis)
Clear my responses
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How to participate?

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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