dbGaP Study Accession: phs002947
NIH Institute/Center: NICHD
RADx Data Program: RADx-UP
Release Date: 08/29/2023
DOI: 10.60773/td0b-xf65
Study Description: Underserved populations are at dramatically higher risk of becoming infected with Severe Acute Respiratory Syndrome, Coronavirus-2 (SARS-CoV-2) and death from COVID-19. Children with IDD are vulnerable to the negative impact of school closure. School districts provide critical services beyond the education, including nutritional, social, therapy (physical, occupational, and speech-language) and healthcare services. Risks are heightened for children with IDD, as they are often unable to wear masks, practice social distancing and/or implement effective hand hygiene. Access to rapid and reliable SARS-CoV-2 testing is essential for children with IDD and school staff in order to safely return to school. Members of the research team developed an innovative, scalable, low-cost method for SARS-CoV-2 testing using saliva samples. Investigators at the Washington University Intellectual and Developmental Disabilities Research Center (IDDRC@WUSTL), in collaboration with the University of Missouri-Kansas City Institute of Human Development and the Kennedy Krieger Institute in Maryland (which includes an IDDRC, the Maryland Center for Developmental Disabilities, and the Kennedy Krieger School Programs), were ideally positioned to determine the best implementation strategies to maximize use of a saliva-based SARS-CoV-2 diagnostic test for vulnerable children and school staff in a school setting. The IDDRC@WUSTL has a long-standing relationship with the Special School District (SSD) of St. Louis County, whose mission is to serve children with IDD, and the national network of the Association of University Centers on Disabilities (AUCD). First, the study determined the most effective messaging and implementation strategies to maximize weekly SARS-CoV-2 testing in a school setting. In this adaptive clinical trial, 52,000 diagnostic tests were administered to students and school staff at SSD, whose student population is 48% Black. Second, the study measured national attitudes among parents/guardians of children with IDD and school staff regarding the impact of COVID-19 and the importance of SARS-CoV-2 testing. At the successful completion of this project, this study improved the acceptance, adoption, and process for SARS-CoV-2 diagnostic testing in a school-based setting to enable delivery of critical educational activities for children with IDD in an underserved community. By identifying the most effective methods for SARS-CoV-2 testing in a vulnerable population of children with IDD, the study established a blueprint for wider adoption of COVID-19 mitigation efforts, such as vaccination.
Updated Date: 04/17/2024
Principal Investigator: Kalb, Luther
Has Data Files: Yes
Study Domain: COVID in School Settings; Diagnostic Testing; Medical Device or Tool Development; Pandemic Perceptions or Decision-Making; Rapid Diagnostic Test (RDT); Testing Rate or Uptake
Data Collection Method: Interview or Focus Group; Molecular Nucleic Acid or PCR Testing Device; Survey
Keywords: Children with Intellectual Development Disorders; Families/Legal Guardians of School-aged Children/Young Adults; Risk Mitigation; School Staff/Stakeholders; School-aged Children/Young Adults
Study Design: Longitudinal Cohort
Multi-Center Study: Yes
Study Sites: Hugo W Moser Research Institute at Kennedy Krieger; Inc; Johns Hopkins Bloomberg School of Public Health; University of Missouri - Kansas City; and Johns Hopkins University School of Medicine: Washington University; St. Louis
Data Types: Behavioral; Questionnaire or Survey; Social
Study Start Date: 04/14/2021
Study End Date: 11/30/2022
Species: Human
Estimated Cohort Size: 350
Study Population Focus: Adults; African Americans; Children; Intellectual or Developmental Disabilities; Older Adults or Elderly; School Communities; Underserved or Vulnerable Populations
Publication URL: https://pubmed.ncbi.nlm.nih.gov/34737170/; https://pubmed.ncbi.nlm.nih.gov/34737170/; https://pubmed.ncbi.nlm.nih.gov/34737171/; https://pubmed.ncbi.nlm.nih.gov/34737171/; https://pubmed.ncbi.nlm.nih.gov/34737173/; https://pubmed.ncbi.nlm.nih.gov/34737173/; https://pubmed.ncbi.nlm.nih.gov/34737175/; https://pubmed.ncbi.nlm.nih.gov/34737175/; https://pubmed.ncbi.nlm.nih.gov/34737176/; https://pubmed.ncbi.nlm.nih.gov/34737176/; https://pubmed.ncbi.nlm.nih.gov/34737177/; https://pubmed.ncbi.nlm.nih.gov/34737178/; https://pubmed.ncbi.nlm.nih.gov/34737178/; https://pubmed.ncbi.nlm.nih.gov/34737179/; https://pubmed.ncbi.nlm.nih.gov/34737180/; https://pubmed.ncbi.nlm.nih.gov/34737180/; https://pubmed.ncbi.nlm.nih.gov/34737181/; https://pubmed.ncbi.nlm.nih.gov/35260896/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394503/; https://pubmed.ncbi.nlm.nih.gov/37394512/; https://pubmed.ncbi.nlm.nih.gov/37394512/
Acknowledgement Statement: This study was supported through funding, 1OT2HD107556-01, for the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) as part of the RADx-UP program. We want to acknowledge the community advisory committee's at Kennedy Krieger and Washington University who assisted the study team with recruitment and dissemination. Approved users should acknowledge the provision of data access by dbGaP for accession phs002947.v1.p1, and the NIH RADx Data Hub. Approved users should also acknowledge the specific version(s) of the dataset(s) obtained from the NIH RADx Data Hub.
NIH Grant or Contract Number(s): 1OT2HD107556-01
Consent/Data Use Limitations: General Research Use
Variable Name | Label |
---|---|
nih_record_id | User ID |
nih_race | What is your race? |
nih_ethnicity | Are you of Hispanic or Latino origin? May include Spanish origin. |
nih_age | What is your age? |
nih_sex | What is your biological sex assigned at birth? |
nih_education | What is the highest level of education you have achieved outside or in the United States? |
nih_zip | What is your zip code? |
nih_employment | Please specify your employment status. |
nih_insurance | What kind of health insurance do you have? |
nih_disability | Do you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities? |
nih_asthma | Asthma |
nih_cancer_past_yr | Cancer diagnosis and/or treatment within the past 12 months |
nih_chronic_kidney_disease | Chronic kidney disease |
nih_diabetes | Diabetes |
nih_hypertension | Hypertension |
nih_mental_health_disorder | Mental health disorder |
nih_sickle_cell_disease | Sickle cell disease |
nih_pregnancy | Pregnancy status |
nih_immunocompromised | Immunocompromised condition |
nih_autoimm | Autoimmune disease |
nih_copd | Chronic obstructive pulmonary disease (COPD) |
nih_chronic_lung | Other chronic lung disease |
nih_depression | Depression |
nih_alc_sub_abuse | Alcohol or substance use disorder |
nih_iv_drug_use | Intravenous drug use |
nih_other_chronic_cond | Other chronic condition |
nih_cough | Cough |
nih_fever_chills | Fever or Chills |
nih_diff_breath | Shortness of breath or difficulty breathing |
nih_headache | Headache |
nih_muscle_ache | Muscle ache |
nih_olfactory | New loss of taste or smell |
nih_fatigue | Excessive fatigue |
nih_nausea_vomiting_diarrhea | Nausea, vomiting, or diarrhea |
nih_abdom_pain | Abdominal pain |
nih_skin_rash | Skin rash |
nih_throat_congestion_nose | Sore throat, congestion or runny nose |
nih_other_symp | Other |
nih_height | What is your height in inches? |
nih_weight | What is your weight in pounds? |
age_yrs | Age For babies less than 1 year old, do not write the age in months. Write 0 as the age. (Years) |
bio_sex_birth_2 | What was your sex assigned at birth on your birth certificate? |
cc_asthma_2 | Asthma |
cc_asud_2 | Alcohol or substance use disorder |
cc_autoimm_2 | Autoimmune disease |
cc_cancer_2 | Cancer diagnosis and/or treatment within the past 12 months |
cc_chronickd_2 | Chronic kidney disease (CKD) |
cc_clung_2 | Other chronic lung disease |
cc_copd_2 | Chronic obstructive pulmonary disease (COPD) |
cc_depression_2 | Depression |
cc_diabetes_2 | Diabetes |
cc_hypertension_2 | Hypertension (HTN, high blood pressure) |
cc_imm_2 | Immunocompromised condition |
cc_intrav_2 | Intravenous drug use |
cc_otherchroniccond_2 | Other chronic condition |
cc_othermh_2 | Other mental health disorder |
cc_sickle_2 | Sickle Cell Anemia |
covid_abpain_2 | Abdominal Pain |
covid_cough_2 | Cough |
covid_diffbreath_2 | Shortness of breath or difficulty breathing |
covid_fever_2 | Fever or chills |
covid_headache_2 | Headache |
covid_myalgia_2 | Muscle or body aches |
covid_nausea_2 | Feeling sick to your stomach or vomiting, diarrhea |
covid_olfactory_2 | New loss of taste or smell |
covid_other_2 | Other |
covid_runnynose_2 | Sore throat, congestion or runny nose |
covid_skinrash_2 | Skin Rash |
current_employment_status | We would like to know about what you do -- are you working now, looking for work, retired, keeping house, a student, or something else? |
hi_coverage_type | What is the primary kind of health insurance or health care plan that you have now? (Exclude plans that pay for only one type of Service (such as, nursing home care, accidents, family planning, or dental care) and plans that only provide extra cash when hospitalized. ) |
pregnancy_status | Are you currently pregnant? |
race_ethn_hispanic | Are you of Hispanic, Latino, or Spanish origin? |
self_reported_disability | Do you have a disability that interferes with your ability to carry out daily activities? Examples of daily activities include walking, climbing stairs, shopping, balancing a checkbook, bathing or dressing. |
self_reported_height_centimeters | Centimeters |
self_reported_height_feet | Feet |
self_reported_height_inches | Inches |
self_reported_height_meters | Meters |
self_reported_weight_kgs | How much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy? |
self_reported_weight_lbs | How much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy? |
zip_code | Zip Code |
consent_given | - |
covid_fatique_2 | - |
covid_test_approval | - |
covid_test_collect_datetime | - |
covid_test_collection_setting | - |
covid_test_performed_location | - |
covid_test_result | - |
covid_test_result_datetime | - |
covid_test_result_sent_datetime | - |
covid_test_specimen_collector | - |
covid_test_specimen_type | - |
covid_test_study_setting | - |
covid_test_type | - |
covid_vaccine | - |
edu_years_of_school | - |
employed_ew | - |
employed_healthcare_2 | - |
family_income | - |
gender_identity_term_2 | - |
hi_loss_covid | - |
household_famgen_3 | - |
household_homeless | - |
jobloss_covid19_2 | - |
preferred_contact_method_2 | - |
race_ethn_asian_detail_3___1 | - |
race_ethn_asian_detail_3___2 | - |
race_ethn_asian_detail_3___3 | - |
race_ethn_asian_detail_3___4 | - |
race_ethn_asian_detail_3___5 | - |
race_ethn_hispanic_detail_2___1 | - |
race_ethn_hispanic_detail_2___2 | - |
race_ethn_hispanic_detail_2___3 | - |
race_ethn_hispanic_detail_2___4 | - |
race_ethn_islander_detail_2___1 | - |
race_ethn_islander_detail_2___10 | - |
race_ethn_islander_detail_2___11 | - |
race_ethn_islander_detail_2___12 | - |
race_ethn_islander_detail_2___13 | - |
race_ethn_islander_detail_2___14 | - |
race_ethn_islander_detail_2___2 | - |
race_ethn_islander_detail_2___3 | - |
race_ethn_islander_detail_2___4 | - |
race_ethn_islander_detail_2___5 | - |
race_ethn_islander_detail_2___6 | - |
race_ethn_islander_detail_2___7 | - |
race_ethn_islander_detail_2___8 | - |
race_ethn_islander_detail_2___9 | - |
race_ethn_race___1 | - |
race_ethn_race___15 | - |
race_ethn_race___2 | - |
race_ethn_race___3 | - |
race_ethn_race___4 | - |
race_ethn_race___5 | - |
race_ethn_race___99 | - |
redcap_event_name | - |
redcap_repeat_instance | - |
redcap_repeat_instrument | - |
self_reported_height_coded | - |
self_reported_weight_units_2 | - |
work_closecont_2 | - |
work_ppe_2 | - |
work_wash_2 | - |