Trial results for a study investigating messaging and implementation strategies to maximize SARS-CoV-2 testing for children with intellectual and developmental disabilities (IDD) during the COVID-19 pandemic were posted on ClinicalTrials.gov on 2026-02-23, with 1143 participants enrolled.
Background
The COVID-19 pandemic presented unique challenges for vulnerable populations, including children with intellectual and developmental disabilities (IDD). Ensuring a safe school environment for these children and their educators required effective mitigation strategies, with SARS-CoV-2 testing being a critical component. Understanding the perceptions of COVID-19 and identifying facilitators and barriers to testing adoption were essential for developing successful public health interventions and informing broader mitigation strategies, such as vaccination efforts, for this specific population.
Trial design
This completed study, designated as Phase NA, enrolled 1143 participants. The trial focused on conditions including Covid19, Intellectual Disability, Developmental Disability, and Child Development Disorder. The primary goal was to identify the best messaging and implementation strategies to maximize SARS-CoV-2 testing for children with IDD and their teachers to help ensure a safe school environment. Additionally, the study aimed to understand national perceptions of COVID-19 and identify factors influencing testing adoption and other mitigation strategies.
Key results
The trial reported several key measurements related to weekly testing enrollment and rates across two institutions:
- For the Special School District, weekly enrollment into testing ranged from a least squares mean of 0.47% to 0.49% of participants, with overall weekly testing rates from 0.46% to 0.57%.
- For the Kennedy Krieger Institute, weekly enrollment into testing ranged from a least squares mean of 0.25% to 0.36% of participants, with overall weekly testing rates from 0.43% to 0.63%.
Qualitative data on perceptions of returning to in-person learning identified 1 theme for Parents/Caregivers and 1 theme for Teachers/Staff in one instance, and 1 theme for Parents/Caregivers and 0 themes for Teachers/Staff in another.
Key analyses using generalized estimating equation (GEE) models to investigate outcome changes across weeks reported p-values of 0.99, 0.9, 0.99, and 0.71, assuming a binomial distribution for each primary outcome.
What this means
The posted results offer insights into the weekly enrollment and testing rates for SARS-CoV-2 among children with intellectual and developmental disabilities and their teachers across two different institutions. The reported percentages for enrollment and overall testing rates, ranging from 0.25% to 0.63% per week, provide quantitative data on the uptake of testing strategies. Additionally, qualitative data on perceptions of returning to in-person learning highlights key themes from parents/caregivers and teachers/staff. The high p-values from the generalized estimating equation models suggest that there were no statistically significant changes in the primary outcomes across weeks, indicating that the observed weekly rates remained relatively stable throughout the study period. These findings can inform future public health initiatives aimed at promoting health and well-being in this vulnerable population during pandemics.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04565509, titled "Supporting the Health and Well-being of Children With Intellectual and Developmental Disability During COVID-19 Pandemic", were posted on 2026-02-23 on clinicaltrials.gov.