Clinical trial NCT04534595: Data Collection on the Model Schools Pediatric Health Initiative at 5 SBHC Sites: COVID-19 Questionnaire
Official title: Data Collection on the Model Schools Pediatric Health Initiative at 5 School Based Health Clinic (SBHC) Sites: COVID-19 Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Experience
Keywords: COVID-19
School-based health center
mental health
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2020-09-01
Enrollment: 851
Sex: ALL
Minimum age (years): 4
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study collects data on demographic characteristics, clinical features, and COVID-19 experience of Toronto's most vulnerable children living in the inner city neighbourhoods attending five selected SHBCs.

Brief summary: The Model School Pediatric Health Initiative arose out of concern about health access inequities and disparities among some of Toronto's most vulnerable children living in our inner-city neighborhoods. It is well documented that illness, emotional difficulties and self-esteem impacts a variety of educational markers including school attendance and performance. Providing health care in schools may be the most direct and efficient way to ensure that all children have access to the care they need including diagnosis, management and follow up of multiple health and school related concerns. American research has demonstrated that inner city children who had access to an elementary school-based health clinic (SBHC) had less difficulty receiving treatment for illnesses and injuries, immunizations, and physical examinations. In addition, rates of enrolment and utilization of elementary SBHCs are higher in those children who traditionally have poorer access to health care. Given the vast differences in the Canadian and American health systems it is important to evaluate SBHCs in Canada before long-term implementation.

The objective of this study is to collect data including demographic characteristics and clinical features of students attending a SHBC at five selected sites in Toronto. In light of the COVID-19 pandemic, the research team is additionally interested in asking about families' experiences with the pandemic and school closures. It is hypothesized, that these vulnerable children who come from lower income families and/or are newcomers to Canada attending these SHBCs, are likely to experience more mental health symptoms with the heightened uncertainty surrounding the COVID-19 pandemic.

This study will be a prospective chart review design. A COVID-19 questionnaire will be constructed and administered online at three time points: baseline, 6 months upon completion of the baseline questionnaire, and 12 months upon completion of the baseline questionnaire.


Eligibility criteria: Inclusion Criteria:

* All students attending a school-based health centre (SBHC) will be included in the chart review and asked to complete an online questionnaire.

Exclusion Criteria:

-

Primary outcomes:
measure: Direct Experience with COVID-19 virus
timeFrame: baseline to 12 months
measure: Family's overall experience with COVID-19 pandemic
timeFrame: baseline to 12 months
measure: Child's experience with cancellations and access to services
timeFrame: baseline to 12 months
measure: Caregiver's experience during COVID-19
timeFrame: baseline to 12 months
measure: stress or unpleasant experiences endured by the caregiver during COVID-19
timeFrame: baseline to 12 months
measure: Activities the caregiver engaged in during COVID-19
timeFrame: Baseline to 12 months
measure: Describe the caregiver's parenting during COVID-19
timeFrame: baseline to 12 months
measure: The impact of school closure on the child
timeFrame: baseline to 12 months.
measure: Describing the child's character
timeFrame: baseline to 12 months
measure: Childs daily routine
timeFrame: baseline to 12 months
measure: Childs interest about COVID-19
timeFrame: baseline to 12 months.
measure: COVID-19 preventative measures.
timeFrame: baseline to 12 months.
measure: How can the SBHC help?
timeFrame: baseline to 12 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Unity Health Toronto
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Sloane Freeman, MSc,MD,FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
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