NCT04534595

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
851

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 30, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 12, 2021

Completed
Last Updated

May 9, 2023

Status Verified

May 1, 2023

Enrollment Period

2.5 years

First QC Date

August 31, 2020

Last Update Submit

May 8, 2023

Conditions

Keywords

COVID-19School-based health centermental health

Outcome Measures

Primary Outcomes (13)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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

  • 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

  • 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.

  • 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.

  • 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.

Study Arms (1)

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

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.

Students attending SBHCs

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (9)

  • 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.

    PMID: 10980797BACKGROUND
  • 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.

    PMID: 9285867BACKGROUND
  • 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.

    PMID: 12361447BACKGROUND
  • 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.

    PMID: 10086399BACKGROUND
  • 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.

    PMID: 19711655BACKGROUND
  • 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.

    PMID: 12580680BACKGROUND
  • 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.

    PMID: 8476879BACKGROUND
  • 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.

    PMID: 10981284BACKGROUND
  • 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.

    PMID: 19711658BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19Psychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesPersonal SatisfactionBehavior

Study Officials

  • Sloane Freeman, MSc,MD,FRCPC

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 1, 2020

Study Start

April 30, 2019

Primary Completion

November 12, 2021

Study Completion

November 12, 2021

Last Updated

May 9, 2023

Record last verified: 2023-05

Locations