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TARGet Kids! COVID-19 Study of Children and Families

TARGet Kids! COVID-19 Study of Children and Families

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04449978
Enrollment
1145
Registered
2020-06-29
Start date
2020-04-09
Completion date
2023-12-31
Last updated
2024-12-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus, COVID-19, Family and Household, Infection Viral, Virus

Brief summary

The novel coronavirus (COVID-19) was declared a global pandemic in March 2020. Early research suggests that children are no more susceptible to COVID-19 infection than adults and that children with confirmed COVID-19 have generally presented with milder symptoms. However, the impact of COVID-19 among Canadian children remains unclear. The prevalence of COVID-19 in children in Canada is currently unknown and no published research exists regarding the risk factors of COVID-19 in children or its potential long-term health effects on physical health or development. Using TARGet Kids!, Canada's largest children's cohort study with over 11,000 children involved, the researchers will conduct a longitudinal observational study aimed to evaluate the cumulative incidence of COVID-19 in children and parents; differences among infected and uninfected children in terms of age, sex, and income; risk factors of COVID-19; and longer term health effects of COVID-19 among children. Given the rapid spread of COVID-19 and the unknown health effects of the virus in children, research must be conducted to determine the extent of infections of COVID-19 in children, disease severity, risk factors for infection, and how the virus affects children as they become older.

Detailed description

The novel coronavirus (COVID-19) was declared a global pandemic in March 2020. Early research has suggested that children may experience less severe clinical symptoms than adults, and infected children with minimal or no symptoms may be an underrecognized source of community disease transmission. COVID-19 infections in children were occurring very early in the epidemic but the impact of COVID-19 infection among children remains unclear. The number of COVID-19 infections in children and parents in Canada is unknown and studies have not evaluated the symptom severity of COVID-19 in children and parents, risk factors for infection and severe disease, and whether current preventive efforts are effective. Using TARGet Kids!, Canada's largest children's cohort study, the researchers will conduct an observational study to evaluate key epidemiological characteristics of COVID-19 among parents and children, as well as to determine the spectrum of disease severity, seroprevalence, risk factors for COVID-19 infection and severe disease, effectiveness of social isolation recommendations, risk to family members with a COVID-19 infected family member, and potential new strategies to prevent COVID-19 infection and minimize disease severity. Parents of 1082 existing TARGet Kids! participants will be asked to provide a nasal swab from themselves and their child during the pandemic in addition to a respiratory tract symptom checklist. Preventive efforts (e.g. social distancing), parent-reported illness, laboratory-confirmed infections and healthcare encounters (e.g. emergency department visits, hospitalizations and ICU care) will be measured. Children will subsequently be followed through the TARGet Kids! cohort study over the next 6 months and long term, with interim analyses at 3 months. By understanding every stage of COVID-19 infection from prevention to transmission in the community and home, to outpatient and hospital care utilization, the researchers will rapidly develop new interventions to prevent COVID-19 transmission and minimize disease severity among children and their families. Descriptive statistics will be used to determine the prevalence of COVID-19 in healthy children.

Interventions

None listed

Sponsors

Unity Health Toronto
CollaboratorOTHER
The Hospital for Sick Children
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
0 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* Families with existing participants of the TARGet Kids! cohort with children between the ages of 0-16 years.

Exclusion criteria

* Families who are not participating in the TARGet Kids! cohort or participating families with no children within the age of eligibility.

Design outcomes

Primary

MeasureTime frameDescription
Cumulative Incidence of COVID-1912 monthsTo evaluate the cumulative incidence of laboratory-confirmed COVID-19 among healthy children and parents in Toronto, Canada

Secondary

MeasureTime frameDescription
Effects of preventive measures on family functioning12 monthsTo determine the effect of preventive measures on family functioning
Risk Factors for COVID-1912 monthsTo determine the risk factors for COVID-19 infection in children and parents to inform preventive interventions
Effects of preventive measures on health behaviours12 monthsTo determine the effect of preventive measures on health behaviours
Effects of preventive measures on healthcare utilization12 monthsTo determine the effect of preventive measures on healthcare utilization
Parent-reported probable case definition of COVID-1912 monthsTo determine the cumulative incidence of parent-reported probable case definition of COVID-19 among children and parents.
Dynamics of COVID-1912 monthsTo determine the dynamics of COVID-19 infection using a susceptible-infected-recovered (SIR) multi-state model.
Risk to family members12 monthsTo determine the risk to family members with a laboratory-confirmed COVID-19 infected family member.
Severity of COVID-1912 monthsTo determine the severity of laboratory-confirmed COVID-19 in healthy children and parents
Effects of preventive measures on child development12 monthsTo determine the effect of preventive measures on child development
Longer term effects of COVID-19 on mental health12 monthsTo determine the longer term effects of COVID-19 infection in healthy children and parents on mental health
Longer term effects of COVID-19 on child development12 monthsTo determine the longer term effects of COVID-19 infection in healthy children and parents on child development
Longer term effects of COVID-19 on family functioning12 monthsTo determine the longer term effects of COVID-19 infection in healthy children and parents on family functioning
Longer term effects of COVID-19 on health behaviours12 monthsTo determine the longer term effects of COVID-19 infection in healthy children and parents on health behaviours
Longer term effects of COVID-19 on healthcare utilization12 monthsTo determine the longer term effects of COVID-19 infection in healthy children and parents on healthcare utilization
Effects of preventive measures on infection12 monthsTo determine the effect of preventive measures on COVID-19 infection
Effects of preventive measures on physical health12 monthsTo determine the effect of preventive measures on physical health
Effects of preventive measures on mental health12 monthsTo determine the effect of preventive measures on mental health
Longer term effects of COVID-19 on physical health12 monthsTo determine the longer term effects of COVID-19 infection in healthy children and parents on physical health

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026