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

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

Recruiting
100 years and younger
All
Phase 0

Overview

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.

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
  • 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)

Study details
    Covid
    Covid-19

19 February 2024

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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