COVID-19 ExperienceSBHCNCT04534595
Data Collection on the Model Schools Pediatric Health Initiative at 5 SBHC Sites: COVID-19 Questionnaire
An observational study of COVID-19 Experience, run by Unity Health Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 13 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Experience
- What is being tested?
- COVID-19
- How many people
- 851 participants
- Where
- 1 siteCanada
- Study dates
- 30 Apr 2019to 12 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 13 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- All students attending a school-based health centre (SBHC) will be included in the chart review and asked to complete an online questionnaire.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- COVID-19 Experience
- Being tested
- COVID-19
- Keywords
- COVID-19, School-based health center, mental health
- Medical subject headings
- COVID-19, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: baseline to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start30 Apr 2019
- Primary completion12 Nov 2021
- Study completion12 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for COVID-19 ExperienceStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 851 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sloane Freeman, MSc,MD,FRCPC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534595
- Sponsor's protocol ID
- 19-060
- Acronym
- SBHC
- Status last verified
- May 2023
- First submitted
- 31 Aug 2020
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 10980797Symons 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 9285867Glied 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 12361447Kaplan 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 10086399Wade 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 19711655Webber 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 12580680McCord 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 8476879Gall 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 10981284Guo 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
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection on the Model Schools Pediatric Health Initiative at 5 School Based Health Clinic (SBHC) Sites: COVID-19 Questionnaire
- ClinicalTrials.gov ID
- NCT04534595
- Acronym / sponsor ID
- SBHC / 19-060
- Conditions
- COVID-19 Experience
- Keywords
- COVID-19, School-based health center, mental health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 851 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 12 Nov 2021 (actual)
- First posted
- 1 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Students attending SBHCs | – | Other: COVID-19The 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. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- All students attending a school-based health centre (SBHC) will be included in the chart review and asked to complete an online questionnaire.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| COVID-19To 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. | Other | Students attending SBHCs |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Background: PubMed 10980797Diette 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.
- Background: PubMed 9285867Symons 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.
- Background: PubMed 12361447Glied 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.
- Background: PubMed 10086399Kaplan 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.
- Background: PubMed 19711655Wade 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.
- Background: PubMed 12580680Webber 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.
- Background: PubMed 8476879McCord 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.
- Background: PubMed 10981284Gall 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.
- Background: PubMed 19711658Guo 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.
- School-based health centers: national census school year 2004-2005Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sloane Freeman, MSc,MD,FRCPC principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Experience, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Direct Experience with COVID-19 virus (time frame: baseline to 12 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534595, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.