School Board Health CentersNCT01676532
Feasibility Study on the Model School Pediatric Health Initiative Pilot Project
An observational study of School Board Health Centers, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This is a prospective cross sectional study to assess the feasibility of a school based health centre (SBHC) at Sprucecourt Public School, an inner-city elementary school in Toronto. Read more about this study
- Who is it for?
- Ages 1 day to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- School Board Health Centers
- What is being tested?
- Students attending SBHC
- How many people
- 127 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2012to Jan 2015
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All students of Sprucecourt Public School as well as the fourteen surrounding inner city public schools and their siblings. All children attending the on-site Parenting and Family Literacy Centre.
Who may be able to join
- All students at Sprucecourt Public School and the surrounding fourteen schools, as well as their siblings (ages 0-12 years), who are enrolled at and have consent to attend the SBHC
- All infants and preschool aged children attending the on-site Parenting and Family Literacy Centre who are enrolled at the SBHC
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective cross sectional study to assess the feasibility of a school based health centre (SBHC) at Sprucecourt Public School, an inner-city elementary school in Toronto. The SBHC allows inner-city children who face barriers to accessing health care the opportunity to receive health care in their school.The primary aim of this study is to determine utilization of the SBHC. Establishing feasibility of the SBHC would support further development and expansion of this program into other inner city schools.
Read the detailed description
A chart review of the first year of the SBHC was conducted. Feasibility metrics included the number of children who enrolled at the SBHC. Efficacy metrics included the proportion of enrolled children who enrolled at SBHC. Efficacy metrics included the proportion of enrolled children who attended and received new diagnoses and treatment plans
- Conditions
- School Board Health Centers
- Being tested
- Students attending SBHC
- Keywords
- School Board Health Center, Pediatrics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Students attending SBHCOther
School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC
| Study group | Role | What they receive |
|---|---|---|
| Students attending SBHC | Students who attend the SBHC from either Sprucecourt Public School or any other participating schools. Receives: Other: Students attending SBHC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Enrolled Participants Who Attended SBHC
The primary objectives are to determine utilization of the SBHC including:
- The number of students who are enrolled at the SBHC
- The number of enrolled students enrolled who attended the SBHC
Measured: 1 year
Secondary outcomes (3)
Number of Students Attending SBHC With New Treatment Plans
Proportion of children seen in the clinic with treatment plans
Measured: 1 year
Number of Students Attending SBHC With New Diagnoses
Number of students attending SBHC with new diagnoses
Measured: 1 year
Number of Referrals Made of Students Attending SBHC
Number of referrals of the 127 students who attended the SBHC from 8 months-1 year of the opening of the clinic
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for School Board Health CentersStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathon Maguire, The Hospital for Sick Children
- Investigators
- Jonathon Maguire, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01676532
- Sponsor's protocol ID
- 1000025631
- Status last verified
- Apr 2016
- First submitted
- 21 Aug 2012
- Last updated
- 24 May 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study on the Model School Pediatric Health Initiative Pilot Project
- ClinicalTrials.gov ID
- NCT01676532
- Acronym / sponsor ID
- 1000025631
- Conditions
- School Board Health Centers
- Keywords
- School Board Health Center, Pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 31 Aug 2012 (estimated)
- Results
- Posted 24 May 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective cross sectional study to assess the feasibility of a school based health centre (SBHC) at Sprucecourt Public School, an inner-city elementary school in Toronto. The SBHC allows inner-city children who face barriers to accessing health care the opportunity to receive health care in their school.The primary aim of this study is to determine utilization of the SBHC. Establishing feasibility of the SBHC would support further development and expansion of this program into other inner city schools.
Detailed description
A chart review of the first year of the SBHC was conducted. Feasibility metrics included the number of children who enrolled at the SBHC. Efficacy metrics included the proportion of enrolled children who enrolled at SBHC. Efficacy metrics included the proportion of enrolled children who attended and received new diagnoses and treatment plans
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Students attending SBHC | – | Other: Students attending SBHCStudents who attend the SBHC from either Sprucecourt Public School or any other participating schools. |
Who may qualify
- Ages
- 1 day to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All students of Sprucecourt Public School as well as the fourteen surrounding inner city public schools and their siblings. All children attending the on-site Parenting and Family Literacy Centre.
Key inclusion criteria (2 listed)
- All students at Sprucecourt Public School and the surrounding fourteen schools, as well as their siblings (ages 0-12 years), who are enrolled at and have consent to attend the SBHC
- All infants and preschool aged children attending the on-site Parenting and Family Literacy Centre who are enrolled at the SBHC
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Students attending SBHCSchool based health clinic. This is a cohort study as such there is only one group of children who used the SBHC | Other | Students attending SBHC |
Primary outcome
Number of Enrolled Participants Who Attended SBHC
Time frame: 1 year
The primary objectives are to determine utilization of the SBHC including: 1. The number of students who are enrolled at the SBHC 2. The number of enrolled students enrolled who attended the SBHC
3 secondary outcomes
Number of Students Attending SBHC With New Treatment Plans
Time frame: 1 year
Number of Students Attending SBHC With New Diagnoses
Time frame: 1 year
Number of Referrals Made of Students Attending SBHC
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Jonathon Maguire, MD principal investigator
The Hospital for Sick Children
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 School Board Health Centers, run by The Hospital for Sick Children 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 2 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 24 May 2016. 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?
Yes. Results are posted in the registry (first posted 24 May 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Enrolled Participants Who Attended SBHC (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2016.