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Study Information

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 Information
Total Variables: 142
Study Variables Information Table
Variable Name
Label
nih_record_idUser ID
nih_raceWhat is your race?
nih_ethnicityAre you of Hispanic or Latino origin? May include Spanish origin.
nih_ageWhat is your age?
nih_sexWhat is your biological sex assigned at birth?
nih_educationWhat is the highest level of education you have achieved outside or in the United States?
nih_zipWhat is your zip code?
nih_employmentPlease specify your employment status.
nih_insuranceWhat kind of health insurance do you have?
nih_disabilityDo you have a disability, including serious physical or mental conditions, that interfere with your ability to carry out daily activities?
nih_asthmaAsthma
nih_cancer_past_yrCancer diagnosis and/or treatment within the past 12 months
nih_chronic_kidney_diseaseChronic kidney disease
nih_diabetesDiabetes
nih_hypertensionHypertension
nih_mental_health_disorderMental health disorder
nih_sickle_cell_diseaseSickle cell disease
nih_pregnancyPregnancy status
nih_immunocompromisedImmunocompromised condition
nih_autoimmAutoimmune disease
nih_copdChronic obstructive pulmonary disease (COPD)
nih_chronic_lungOther chronic lung disease
nih_depressionDepression
nih_alc_sub_abuseAlcohol or substance use disorder
nih_iv_drug_useIntravenous drug use
nih_other_chronic_condOther chronic condition
nih_coughCough
nih_fever_chillsFever or Chills
nih_diff_breathShortness of breath or difficulty breathing
nih_headacheHeadache
nih_muscle_acheMuscle ache
nih_olfactoryNew loss of taste or smell
nih_fatigueExcessive fatigue
nih_nausea_vomiting_diarrheaNausea, vomiting, or diarrhea
nih_abdom_painAbdominal pain
nih_skin_rashSkin rash
nih_throat_congestion_noseSore throat, congestion or runny nose
nih_other_sympOther
nih_heightWhat is your height in inches?
nih_weightWhat is your weight in pounds?
age_yrsAge For babies less than 1 year old, do not write the age in months. Write 0 as the age. (Years)
bio_sex_birth_2What was your sex assigned at birth on your birth certificate?
cc_asthma_2Asthma
cc_asud_2Alcohol or substance use disorder
cc_autoimm_2Autoimmune disease
cc_cancer_2Cancer diagnosis and/or treatment within the past 12 months
cc_chronickd_2Chronic kidney disease (CKD)
cc_clung_2Other chronic lung disease
cc_copd_2Chronic obstructive pulmonary disease (COPD)
cc_depression_2Depression
cc_diabetes_2Diabetes
cc_hypertension_2Hypertension (HTN, high blood pressure)
cc_imm_2Immunocompromised condition
cc_intrav_2Intravenous drug use
cc_otherchroniccond_2Other chronic condition
cc_othermh_2Other mental health disorder
cc_sickle_2Sickle Cell Anemia
covid_abpain_2Abdominal Pain
covid_cough_2Cough
covid_diffbreath_2Shortness of breath or difficulty breathing
covid_fever_2Fever or chills
covid_headache_2Headache
covid_myalgia_2Muscle or body aches
covid_nausea_2Feeling sick to your stomach or vomiting, diarrhea
covid_olfactory_2New loss of taste or smell
covid_other_2Other
covid_runnynose_2Sore throat, congestion or runny nose
covid_skinrash_2Skin Rash
current_employment_statusWe 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_typeWhat 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_statusAre you currently pregnant?
race_ethn_hispanicAre you of Hispanic, Latino, or Spanish origin?
self_reported_disabilityDo 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_centimetersCentimeters
self_reported_height_feetFeet
self_reported_height_inchesInches
self_reported_height_metersMeters
self_reported_weight_kgsHow much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy?
self_reported_weight_lbsHow much do you weigh without clothes or shoes? If you are currently pregnant, how much did you weigh before your pregnancy?
zip_codeZip 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-
Study Documents
Study Documents Table
Document
Document Name
File Size
Download
READMEproject78_README.html274.74 KB
Study Documentationphs002947_Project 78_Protocol.pdf630.76 KB
Data Files
Total Files: 6
Data Files: 2
Metadata Files: 2
Dictionary Files: 2
Study Datasets Table
File Name
File Type
File Format(s)
# of Records
# of Variables
Metadata
Dictionary
project78_DATA_transformcopy.csvTabular Data - Harmonizedcsv8258
project78_DATA_origcopy.csvTabular Data - Non-harmonizedcsv8258