CClinicalTrials.gg
CompletedNCT04534595SBHCUpdated May 9, 2023

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

An observational study in COVID-19 Experience, sponsored by Unity Health Toronto. Completed at 1 site in Canada. Open to participants aged 4 Years to 13 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-05-09.

Sponsored by Unity Health Toronto · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
851
Ages
4 Years to 13 Years
Sex
All
01

Study 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.

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Conditions studied

  • COVID-19 Experience

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Keywords

  • COVID-19
  • School-based health center
  • mental health
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 851 is above the median of 261 across 3,136 observational studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Unity Health Toronto is the lead sponsor of 434 studies on the registry; 76 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 13 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

-

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
851 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

Interventions

  • OtherCOVID-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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline to 12 months

  2. 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.

    Time frame: baseline to 12 months

  3. 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.

    Time frame: baseline to 12 months

  4. 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.

    Time frame: baseline to 12 months

  5. 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.

    Time frame: baseline to 12 months

  6. Activities the caregiver engaged in during COVID-19

    How frequent and for how long did you engage in the listed activities.

    Time frame: Baseline to 12 months

  7. 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.

    Time frame: baseline to 12 months

  8. 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.

    Time frame: baseline to 12 months.

  9. 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.

    Time frame: baseline to 12 months

  10. 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.

    Time frame: baseline to 12 months

  11. 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.

    Time frame: baseline to 12 months.

  12. 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.

    Time frame: baseline to 12 months.

  13. How can the SBHC help?

    An open ended question for the family to indicate what kind of help they would like during the pandemic

    Time frame: baseline to 12 months.

07

Study locations

1 site
  • Unity Health Toronto
    Toronto, Ontario M5B 1W8, Canada
08

References and documents

Publications

  • Diette GB, Markson L, Skinner EA, Nguyen TT, Algatt-Bergstrom P, Wu AW. Nocturnal asthma in children affects school attendance, school performance, and parents' work attendance. Arch Pediatr Adolesc Med. 2000 Sep;154(9):923-8. doi: 10.1001/archpedi.154.9.923. PubMed 10980797 ↗
  • Symons CW, Cinelli B, James TC, Groff P. Bridging student health risks and academic achievement through comprehensive school health programs. J Sch Health. 1997 Aug;67(6):220-7. doi: 10.1111/j.1746-1561.1997.tb06309.x. PubMed 9285867 ↗
  • Glied S, Pine DS. Consequences and correlates of adolescent depression. Arch Pediatr Adolesc Med. 2002 Oct;156(10):1009-14. doi: 10.1001/archpedi.156.10.1009. PubMed 12361447 ↗
  • Kaplan DW, Brindis CD, Phibbs SL, Melinkovich P, Naylor K, Ahlstrand K. A comparison study of an elementary school-based health center: effects on health care access and use. Arch Pediatr Adolesc Med. 1999 Mar;153(3):235-43. doi: 10.1001/archpedi.153.3.235. PubMed 10086399 ↗
  • Wade TJ, Mansour ME, Guo JJ, Huentelman T, Line K, Keller KN. Access and utilization patterns of school-based health centers at urban and rural elementary and middle schools. Public Health Rep. 2008 Nov-Dec;123(6):739-50. doi: 10.1177/003335490812300610. PubMed 19711655 ↗
  • Webber MP, Carpiniello KE, Oruwariye T, Lo Y, Burton WB, Appel DK. Burden of asthma in inner-city elementary schoolchildren: do school-based health centers make a difference? Arch Pediatr Adolesc Med. 2003 Feb;157(2):125-9. doi: 10.1001/archpedi.157.2.125. PubMed 12580680 ↗
  • McCord MT, Klein JD, Foy JM, Fothergill K. School-based clinic use and school performance. J Adolesc Health. 1993 Mar;14(2):91-8. doi: 10.1016/1054-139x(93)90091-3. PubMed 8476879 ↗
  • Gall G, Pagano ME, Desmond MS, Perrin JM, Murphy JM. Utility of psychosocial screening at a school-based health center. J Sch Health. 2000 Sep;70(7):292-8. doi: 10.1111/j.1746-1561.2000.tb07254.x. PubMed 10981284 ↗
  • Guo JJ, Wade TJ, Keller KN. Impact of school-based health centers on students with mental health problems. Public Health Rep. 2008 Nov-Dec;123(6):768-80. doi: 10.1177/003335490812300613. PubMed 19711658 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04534595
Lead sponsor
Unity Health Toronto
Responsible party
Sponsor
First posted
Sep 1, 2020
Start date
Apr 30, 2019
Primary completion
Nov 12, 2021
Completion
Nov 12, 2021
Last update
May 9, 2023

Study contacts

Sloane Freeman, MSc,MD,FRCPC
principal investigator · Unity Health Toronto

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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