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

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

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: COVID-19 RT-PCR test; Other: COVID-19 Vaccine Education Campaign

• Study Type: Interventional
• Enrollment (Actual): 392
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14620
      • Mary Cariola Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 72 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Students and staff at Mary Cariola Center; All students enrolled at the Mary Cariola Center in Rochester, NY. All staff working at the Mary Cariola Center in Rochester, NY.

Diagnostic test: COVID-19 RT-PCR test; Participating individuals (students and employees) will be tested for COVID-19 (RT-PCR) using a specimen collected using a mid-turbinate swab. This asymptomatic testing regime starts on or after (if scheduling testing requires this to begin on a different day) enrollment and is repeated every 5-14 days for up to 16 months . Anyone testing positive is followed up as described below for symptomatic individuals. Those presenting with symptoms will be also tested for COVID-19 (RT-PCR). Those with negative test results will return to the asymptomatic testing protocol. Students who test positive are retested then 3 days until two negative tests. Employees who test positive also be tested every 3 days until two negative tests.; Other: COVID-19 Vaccine Education Campaign; Utilizing information from focus groups, the investigators will develop and deploy an educational campaign aimed at improving vaccine hesitancy and student health

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number Infected With COVID-19	Number of students or staff who test positive for COVID-19 at least once using a nasal swab test.	16 months
Change in the Percentage of Participants Reporting Anxiety	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.	baseline to 16 months
Change in the Percentage of Participants Classified as Depressed	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.	baseline to 16 months
Change in the Percentage of Participants Classified With Fatigue	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.	baseline to 16 months
Change in Percentage of Participants With Deficits in Social Functioning	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.	baseline to 16 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2021
• Primary Completion (Actual): August 31, 2023
• Study Completion (Actual): March 31, 2024

Study Registration Dates

• First Submitted: May 13, 2021
• First Submitted That Met QC Criteria: May 13, 2021
• First Posted (Actual): May 14, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 27, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Neurodevelopmental Disorders; COVID-19; Developmental Disabilities
• Other Study ID Numbers: STUDY00005294; OT2HD107553-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No