Data Collection on the Model Schools Pediatric Health Initiative at 5 SBHC Sites: COVID-19 Questionnaire (SBHC)

May 8, 2023 updated by: Unity Health Toronto

Data Collection on the Model Schools Pediatric Health Initiative at 5 School Based Health Clinic (SBHC) Sites: COVID-19 Questionnaire

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

851

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B 1W8
        • Unity Health Toronto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

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.

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Students attending SBHCs
The students enrolled in 5 schools with the school based health clinic implemented would be studied in terms of their experience during the COVID-19 pandemic.
Other: COVID-19
To study the experience of students and their families during the COVID-19 pandemic an online questionnaire will be utilized. This COVID-19 questionnaire will be administered at three time points: baseline, 6 months upon completion of the baseline questionnaire, and 12 months upon completion of the baseline questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Direct Experience with COVID-19 virus
Time Frame: baseline to 12 months
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
Family's overall experience with COVID-19 pandemic
Time Frame: baseline to 12 months
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
Child's experience with cancellations and access to services
Time Frame: baseline to 12 months
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
Caregiver's experience during COVID-19
Time Frame: baseline to 12 months
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
stress or unpleasant experiences endured by the caregiver during COVID-19
Time Frame: baseline to 12 months
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
Activities the caregiver engaged in during COVID-19
Time Frame: Baseline to 12 months
How frequent and for how long did you engage in the listed activities.
Baseline to 12 months
Describe the caregiver's parenting during COVID-19
Time Frame: baseline to 12 months
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
The impact of school closure on the child
Time Frame: baseline to 12 months.
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.
Describing the child's character
Time Frame: baseline to 12 months
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
Childs daily routine
Time Frame: baseline to 12 months
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
Childs interest about COVID-19
Time Frame: baseline to 12 months.
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.
COVID-19 preventative measures.
Time Frame: baseline to 12 months.
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.
How can the SBHC help?
Time Frame: baseline to 12 months.
An open ended question for the family to indicate what kind of help they would like during the pandemic
baseline to 12 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Investigators

  • Principal Investigator: Sloane Freeman, MSc,MD,FRCPC, Unity Health Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2019

Primary Completion (Actual)

November 12, 2021

Study Completion (Actual)

November 12, 2021

Study Registration Dates

First Submitted

August 31, 2020

First Submitted That Met QC Criteria

August 31, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-060

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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