COVID-19 Experience Clinical Trial
— SBHCOfficial title:
Data Collection on the Model Schools Pediatric Health Initiative at 5 School Based Health Clinic (SBHC) Sites: COVID-19 Questionnaire
| NCT number | NCT04534595 |
| Other study ID # | 19-060 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | April 30, 2019 |
| Est. completion date | November 12, 2021 |
| Verified date | May 2023 |
| Source | Unity Health Toronto |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 851 |
| Est. completion date | November 12, 2021 |
| Est. primary completion date | November 12, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 4 Years to 13 Years |
| Eligibility | 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: - |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Unity Health Toronto | Toronto | Ontario |
| Lead Sponsor | Collaborator |
|---|---|
| Unity Health Toronto |
Canada,
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| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Direct Experience with COVID-19 virus | Survey question asking whether you or any of your family developed COVID-19 symptoms, to select the symptoms that apply, and to indicate whether you or anyone in your family tested positive for COVID-19. | baseline to 12 months | |
| Primary | Family's overall experience with COVID-19 pandemic | Survey question asking the participant to identify and describe whether their family had a positive and/or negative experience resulting from the COVID-19 crisis. Has the quality of the relationship with the child attending SBHC changed. | baseline to 12 months | |
| Primary | Child's experience with cancellations and access to services | Identify which of the listed options relating to a child's health were experienced during the pandemic. Also identify whether any of the listed health or education services were not accessed during the pandemic. How difficult has cancellations during the pandemic been for the child. | baseline to 12 months | |
| Primary | Caregiver's experience during COVID-19 | Survey questions asking to what degree has the listed situations bothered the caregiver. To what degree do you (the caregiver) agree with the listed situations during the pandemic. Have you (the caregiver) been unemployed due to the pandemic and have/had trouble making ends meet. Was there enough groceries and other essentials during the pandemic. | baseline to 12 months | |
| Primary | stress or unpleasant experiences endured by the caregiver during COVID-19 | The questions in this component of the survey includes rating how bothered you were about the listed options. Over the specified period of time, rate your stress level, describe the quality and duration of your sleep per night. How frequently did you use the listed options to relieve your stress. | baseline to 12 months | |
| Primary | Activities the caregiver engaged in during COVID-19 | How frequent and for how long did you engage in the listed activities. | Baseline to 12 months | |
| Primary | Describe the caregiver's parenting during COVID-19 | Questions asking to what degree do you agree with the following statements describing your parenting ability over the specified period of time. | baseline to 12 months | |
| Primary | The impact of school closure on the child | Questions asking what other childcare services were used during the pandemic. If they received child subsidy. If the child stayed home during the pandemic, and how long did they spend doing schoolwork and other activities (academic and non-academic) during COVID-19. Does the family have the resources to engage in online learning, if so what are the resources used. Describe any challenges faced with online learning. | baseline to 12 months. | |
| Primary | Describing the child's character | Questions asking to what extent do the statements provided describe the child. Identify the age group the child described is in. | baseline to 12 months | |
| Primary | Childs daily routine | Questions asking to rate the quality and quantity of the child's sleep. Describe and rate the child's eating behaviour/practices during the pandemic. | baseline to 12 months | |
| Primary | Childs interest about COVID-19 | Questions asking how interested the child is about COVID-19, how often are they asking/reading about COVID-19. How hopeful is the child about COVID-19 ending. | baseline to 12 months. | |
| Primary | COVID-19 preventative measures. | This question asks you to describe how frequent the child and the caregiver practiced the preventative measures to protect against COVID-19. | baseline to 12 months. | |
| Primary | How can the SBHC help? | An open ended question for the family to indicate what kind of help they would like during the pandemic | baseline to 12 months. |