Educational AchievementNCT04540003
School Based Health Care: A Model for Improving Educational Achievement for Children in Inner City Schools
A study testing Access to School Based Health Centre in people with Educational Achievement, run by Unity Health Toronto at 1 site in Canada.
Trial summary
Developmental problems have tremendous impact on children, affecting academic achievement and mental health later in life.The process of receiving a developmental assessment is long and arduous, and may require multiple physician visits taking over one year. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Educational Achievement
- What is being tested?
- Access to School Based Health Centre
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2016to 20 Jan 2022
- Phase
- Interventional
- 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
- No healthy volunteers
- Child
Who may be able to join
- All students identified at the SST meetings requiring a developmental assessment.
Who cannot join
- Students without a developmental concern and not identified at the SST meeting will be excluded. No other specific exclusion criteria will be applied.
Trial locations and contacts
1 site in 1 country.
About this study
Developmental problems have tremendous impact on children, affecting academic achievement and mental health later in life.The process of receiving a developmental assessment is long and arduous, and may require multiple physician visits taking over one year. Although a relatively new concept in Canada, School-Based Health Centres (SBHCs) have been successfully implemented in over 1900 schools in the United States.The first SBHC in Ontario, and Canada as a whole, was established through the Model Schools Pediatric Health Initiative (MSPHI) and is dedicated to reducing health inequities for inner city children by reducing barriers and providing accessible clinical care. To provide more conclusive evidence on the relative benefits of SBHCs as compared to traditional health care access, this study will use a prospective cohort quasi-experimental study design to compare differences in educational achievement for developmental assessments in the SBHC model relative to standard care. As per standard of care, students having difficulty in school are identified by the Toronto District School Board (TDSB) internal research staff and are presented to the monthly School Support team (SST) meetings. Historically physicians do not attend SST meetings, however, as a part of the SBHC program, pediatricians will participate in monthly SST meetings. Schools assigned to the intervention group will have SBHC physicians attend SST meetings, while schools assigned to the control group will not.
The overall objective of this study is to examine educational achievement, as defined by standardized test scores and report cards in students who use an inner city SBHCs for developmental concerns relative to those who do not. We hypothesize students attending schools in which SST meetings have a pediatrician present, that are referred to a SBHC, will score higher and show a greater increase in standardized test scores and report cards (from baseline to follow-up) than students attending schools in which SST meetings do not have a pediatrician present and access services through traditional means in the community (standard of care).The secondary objectives are: a) to examine socio-demographic data for these students and its relationship to educational achievement and b) to determine wait times to developmental assessment for students in the intervention group who attend the SBHCs using retrospective chart review.
- Conditions
- Educational Achievement
- Being tested
- Access to School Based Health Centre
- Keywords
- school-based health centre, SBHC, School Support Team, SST, academic, inner city schools, standardized test scores, developmental pediatrics, education, achievement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to School Based Health CentreOther
The SBHC will be staffed by a family physician, two pediatricians and a developmental pediatrician, each with at least one half-day of clinic time per week from September through June. The SBHC is also staffed by a clinic coordinator who is responsible for booking appointments on a first-referral, first-serve basis.
| Study group | Role | What they receive |
|---|---|---|
| Access to School Based Health Centre | Experimental | Of the eight school in the intervention arm, four schools will be linked to a school based health center (SBHC) at Sprucecourt or Nelson Mandela Park Public Schools (established in partnership with the department of Pediatrics at St. Michael's hospital) and four schools will be linked to a SBHC at Parkdale Public School (established in partnership with St. Joseph's Health Centre). SBHC pediatricians will attend School Support Team (SST) meetings at all intervention schools and students with developmental concerns identified at the SST meetings will be referred to the SBHC. Receives: Other: Access to School Based Health Centre |
| Control Arm: Standard of care | No intervention | Of the eight schools assigned to the control condition, four will be in the South East area of the city closer to Nelson Mandela Park PS and four will be in the South West area of the city closer to St. Josephs Health Center. The eight schools will be subject to standard of care which is: when a child is identified by the SST (no pediatrician present), students identified with developmental concerns are advised to access a pediatric/developmental assessment in the community. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Educational achievement as assessed by numeric data from report cards.
For each student attending the schools enrolled in this study, the report cards have the student's grade for all the core subjects reported as a percentage (0-100%). The higher the grade the better the academic performance. There is also the class median reported as a percentage so that the student's academic performance in that particular subject can be compared to that of their class's average performance for that same subject.
Numeric data from report cards will be analyzed using a linear mixed effect model where the schools are the random effects and the baseline report cards are adjusted for by including it as a covariate. Baseline report cards will be determined as those that have occurred most proximal to the SST date. The treatment effect will be expressed as the mean adjusted difference in standardized test scores with 95% confidence interval.
Measured: Change from baseline to 18 months after identification at SST
Educational achievement as assessed by Canadian Achievement Test 4 (CAT4) scores.
The Canadian Achievement Test 4 (CAT4) is a standardized test administered to students in grades 1-6 across Canada to assess basic skill areas: reading, writing, and mathematics. Higher scores mean better outcome. The raw score (0-100%) on each test section is converted to a national stanine range (1-9), where scores in the range of 1-3 is considered below-average (i.e. Low (L)), scores in the range of 4-6 are considered average (i.e. Competent (C)) and scores 7-9 are considered above average (i.e. Proficient (P)) performence.
Standardized test scores will be analyzed using a linear mixed effect model where the schools are the random effects and the baseline test scores are adjusted for by including it as a covariate. Baseline test scores will be determined as those that have occurred most proximal to the SST date.The treatment effect will be expressed as the mean adjusted difference in standardized test scores with 95% confidence interval.
Measured: Change from baseline to 18 months after identification at SST
Education achievement as assessed by Education Quality and Accountability Office (EQAO) scores
Toronto District School Board (TDSB) Standardized tests include the Education Quality and Accountability Office (EQAO) test. The EQAO is a test that assesses literacy and math skills and is administered to students in grades 3 and 6. Based on the student's performance on the EQAO, the student's raw score is converted into a score on a scale from 200 (level 2) to 400 points (level 4). A score of 300 (level 3) (i.e. average student score) is required to be successful. A score above 300 (i.e. level 4 (400 points)) is considered above average.
Standardized test scores will be analyzed using a linear mixed effect model where the schools are the random effects and the baseline test scores are adjusted for by including it as a covariate. Baseline test scores will be determined as those that have occurred most proximal to the SST date.The treatment effect will be expressed as the mean adjusted difference in standardized test scores with 95% confidence interval.
Measured: Change from baseline to 18 months after identification at SST
Secondary outcomes (2)
Socio-demographic data and relationships to educational achievement
Children from inner city schools may face additional difficulties accessing healthcare to address developmental and mental health concerns, particularly when they come from families with socioeconomic challenges, language barriers and limited means of transportation. Data collection will entail the collection of in-depth, in-person interviews with each participant 18 months after the SST meeting in both arms. During baseline interviews, participants will be asked questions regarding their current experiences (and contexts) at the outset of the trial. At the end of the trial, participants will be asked to reflect on their experiences before the trial began, how their experiences and perspectives changed as a result of the trial, and their reflections on trial implementation. Interviews will be conducted by experienced qualitative research personnel, audio taped and transcribed verbatim.
Measured: change from baseline to 18 months after identification at SST
Wait time data will be determined retrospectively from chart review for the intervention group
Charts of students attending the SBHC from the schools in the intervention arm will assessed for the following only: date of SST meeting, date of first visit to SBHC, date of developmental assessment. This will be used to determine the wait time. Wait times will be reported as a mean and standard deviation. Since data from the TDSB is de-identified, we will not be linking wait time data with outcomes or any other data provided by the TDSB.
Measured: date of SST meeting to date of developmental assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2020
- Study start1 Sep 2016
- Primary completion20 Jan 2022
- Study completion20 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Educational AchievementStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This project will be a prospective cohort quasi-experimental study design to compare the benefits of using SBHCs as opposed to the traditional health care by evaluating educational achievements. The study period includes September 2017-June 2018 and September 2018-June 2019. Of 16 inner city schools not previously exposed to the SBHC in the TDSB, some schools (n=8) will be in the control arm following the standard of care while others (n=8) will have access to SBHC. Students presented to SST meetings whose outcomes include the need for a developmental/pediatric assessment at the 16 schools will be identified by TDSB internal research staff. To conduct our primary analysis, standardized test scores and numeric data from report cards will be analyzed using a linear mixed effect model where the schools are the random effects and the baseline test scores and report cards are adjusted for by including it as a covariate.
- Masking
- None (open label)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto District School Board
- Responsible party
- Sponsor
- Investigators
- Sloane Freeman, MSc,MD,FRCPC, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04540003
- Sponsor's protocol ID
- 13-341
- Status last verified
- Apr 2022
- First submitted
- 31 Aug 2020
- Last updated
- 27 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Breslau J, Miller E, Breslau N, Bohnert K, Lucia V, Schweitzer J. The impact of early behavior disturbances on academic achievement in high school. Pediatrics. 2009 Jun;123(6):1472-6. doi: 10.1542/peds.2008-1406.
PubMed 19482756Reynolds AJ, Temple JA, Ou SR, Robertson DL, Mersky JP, Topitzes JW, Niles MD. Effects of a school-based, early childhood intervention on adult health and well-being: a 19-year follow-up of low-income families. Arch Pediatr Adolesc Med. 2007 Aug;161(8):730-9. doi: 10.1001/archpedi.161.8.730.
PubMed 17679653Shevell MI, Majnemer A, Rosenbaum P, Abrahamowicz M. Profile of referrals for early childhood developmental delay to ambulatory subspecialty clinics. J Child Neurol. 2001 Sep;16(9):645-50. doi: 10.1177/088307380101600904.
PubMed 11575603Rasiah S, Juni P, Sgro MD, Thorpe KE, Maguire J, Freeman SJ. School-based health care: improving academic outcomes for inner-city children-a prospective cohort quasi-experimental study. Pediatr Res. 2023 Oct;94(4):1488-1495. doi: 10.1038/s41390-023-02473-w. Epub 2023 Feb 8.
PubMed 36755187
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School Based Health Care: A Model for Improving Educational Achievement for Children in Inner City Schools
- ClinicalTrials.gov ID
- NCT04540003
- Acronym / sponsor ID
- 13-341
- Conditions
- Educational Achievement
- Keywords
- school-based health centre, SBHC, School Support Team, SST, academic, inner city schools, standardized test scores, developmental pediatrics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Collaborators
- Toronto District School Board
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 20 Jan 2022 (actual)
- First posted
- 7 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.
Developmental problems have tremendous impact on children, affecting academic achievement and mental health later in life.The process of receiving a developmental assessment is long and arduous, and may require multiple physician visits taking over one year. Although a relatively new concept in Canada, School-Based Health Centres (SBHCs) have been successfully implemented in over 1900 schools in the United States.The first SBHC in Ontario, and Canada as a whole, was established through the Model Schools Pediatric Health Initiative (MSPHI) and is dedicated to reducing health inequities for inner city children by reducing barriers and providing accessible clinical care. To provide more conclusive evidence on the relative benefits of SBHCs as compared to traditional health care access, this study will use a prospective cohort quasi-experimental study design to compare differences in educational achievement for developmental assessments in the SBHC model relative to standard care. As per standard of care, students having difficulty in school are identified by the Toronto District School Board (TDSB) internal research staff and are presented to the monthly School Support team (SST) meetings. Historically physicians do not attend SST meetings, however, as a part of the SBHC program, pediatricians will participate in monthly SST meetings. Schools assigned to the intervention group will have SBHC physicians attend SST meetings, while schools assigned to the control group will not.
The overall objective of this study is to examine educational achievement, as defined by standardized test scores and report cards in students who use an inner city SBHCs for developmental concerns relative to those who do not. We hypothesize students attending schools in which SST meetings have a pediatrician present, that are referred to a SBHC, will score higher and show a greater increase in standardized test scores and report cards (from baseline to follow-up) than students attending schools in which SST meetings do not have a pediatrician present and access services through traditional means in the community (standard of care).The secondary objectives are: a) to examine socio-demographic data for these students and its relationship to educational achievement and b) to determine wait times to developmental assessment for students in the intervention group who attend the SBHCs using retrospective chart review.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This project will be a prospective cohort quasi-experimental study design to compare the benefits of using SBHCs as opposed to the traditional health care by evaluating educational achievements. The study period includes September 2017-June 2018 and September 2018-June 2019. Of 16 inner city schools not previously exposed to the SBHC in the TDSB, some schools (n=8) will be in the control arm following the standard of care while others (n=8) will have access to SBHC. Students presented to SST meetings whose outcomes include the need for a developmental/pediatric assessment at the 16 schools will be identified by TDSB internal research staff. To conduct our primary analysis, standardized test scores and numeric data from report cards will be analyzed using a linear mixed effect model where the schools are the random effects and the baseline test scores and report cards are adjusted for by including it as a covariate.
| Arm | Type | Receives |
|---|---|---|
| Access to School Based Health Centre | Experimental | Other: Access to School Based Health CentreOf the eight school in the intervention arm, four schools will be linked to a school based health center (SBHC) at Sprucecourt or Nelson Mandela Park Public Schools (established in partnership with the department of Pediatrics at St. Michael's hospital) and four schools will be linked to a SBHC at Parkdale Public School (established in partnership with St. Joseph's Health Centre). SBHC pediatricians will attend School Support Team (SST) meetings at all intervention schools and students with developmental concerns identified at the SST meetings will be referred to the SBHC. |
| Control Arm: Standard of care | No intervention | –Of the eight schools assigned to the control condition, four will be in the South East area of the city closer to Nelson Mandela Park PS and four will be in the South West area of the city closer to St. Josephs Health Center. The eight schools will be subject to standard of care which is: when a child is identified by the SST (no pediatrician present), students identified with developmental concerns are advised to access a pediatric/developmental assessment in the community. |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All students identified at the SST meetings requiring a developmental assessment.
Key exclusion criteria (1 listed)
- Students without a developmental concern and not identified at the SST meeting will be excluded. No other specific exclusion criteria will be applied.
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 |
|---|---|---|
| Access to School Based Health CentreThe SBHC will be staffed by a family physician, two pediatricians and a developmental pediatrician, each with at least one half-day of clinic time per week from September through June. The SBHC is also staffed by a clinic coordinator who is responsible for booking appointments on a first-referral, first-serve basis. | Other | Access to School Based Health Centre |
Primary outcome
Educational achievement as assessed by numeric data from report cards.
Time frame: Change from baseline to 18 months after identification at SST
For each student attending the schools enrolled in this study, the report cards have the student's grade for all the core subjects reported as a percentage (0-100%). The higher the grade the better the academic performance. There is also the class median reported as a percentage so that the student's academic performance in that particular subject can be compared to that of their class's average performance for that same subject. Numeric data from report cards will be analyzed using a linear mixed effect model where the schools are the random effects and the baseline report cards are adjusted for by including it as a covariate. Baseline report cards will be determined as those that have occurred most proximal to the SST date. The treatment effect will be expressed as the mean adjusted difference in standardized test scores with 95% confidence interval.
Educational achievement as assessed by Canadian Achievement Test 4 (CAT4) scores.
Time frame: Change from baseline to 18 months after identification at SST
The Canadian Achievement Test 4 (CAT4) is a standardized test administered to students in grades 1-6 across Canada to assess basic skill areas: reading, writing, and mathematics. Higher scores mean better outcome. The raw score (0-100%) on each test section is converted to a national stanine range (1-9), where scores in the range of 1-3 is considered below-average (i.e. Low (L)), scores in the range of 4-6 are considered average (i.e. Competent (C)) and scores 7-9 are considered above average (i.e. Proficient (P)) performence. Standardized test scores will be analyzed using a linear mixed effect model where the schools are the random effects and the baseline test scores are adjusted for by including it as a covariate. Baseline test scores will be determined as those that have occurred most proximal to the SST date.The treatment effect will be expressed as the mean adjusted difference in standardized test scores with 95% confidence interval.
Education achievement as assessed by Education Quality and Accountability Office (EQAO) scores
Time frame: Change from baseline to 18 months after identification at SST
Toronto District School Board (TDSB) Standardized tests include the Education Quality and Accountability Office (EQAO) test. The EQAO is a test that assesses literacy and math skills and is administered to students in grades 3 and 6. Based on the student's performance on the EQAO, the student's raw score is converted into a score on a scale from 200 (level 2) to 400 points (level 4). A score of 300 (level 3) (i.e. average student score) is required to be successful. A score above 300 (i.e. level 4 (400 points)) is considered above average. Standardized test scores will be analyzed using a linear mixed effect model where the schools are the random effects and the baseline test scores are adjusted for by including it as a covariate. Baseline test scores will be determined as those that have occurred most proximal to the SST date.The treatment effect will be expressed as the mean adjusted difference in standardized test scores with 95% confidence interval.
2 secondary outcomes
Socio-demographic data and relationships to educational achievement
Time frame: change from baseline to 18 months after identification at SST
Wait time data will be determined retrospectively from chart review for the intervention group
Time frame: date of SST meeting to date of developmental assessment
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 27 Apr 2022.
- Background: PubMed 19482756Breslau J, Miller E, Breslau N, Bohnert K, Lucia V, Schweitzer J. The impact of early behavior disturbances on academic achievement in high school. Pediatrics. 2009 Jun;123(6):1472-6. doi: 10.1542/peds.2008-1406.
- Background: PubMed 17679653Reynolds AJ, Temple JA, Ou SR, Robertson DL, Mersky JP, Topitzes JW, Niles MD. Effects of a school-based, early childhood intervention on adult health and well-being: a 19-year follow-up of low-income families. Arch Pediatr Adolesc Med. 2007 Aug;161(8):730-9. doi: 10.1001/archpedi.161.8.730.
- Background: PubMed 11575603Shevell MI, Majnemer A, Rosenbaum P, Abrahamowicz M. Profile of referrals for early childhood developmental delay to ambulatory subspecialty clinics. J Child Neurol. 2001 Sep;16(9):645-50. doi: 10.1177/088307380101600904.
- Derived from this study: PubMed 36755187Rasiah S, Juni P, Sgro MD, Thorpe KE, Maguire J, Freeman SJ. School-based health care: improving academic outcomes for inner-city children-a prospective cohort quasi-experimental study. Pediatr Res. 2023 Oct;94(4):1488-1495. doi: 10.1038/s41390-023-02473-w. Epub 2023 Feb 8.
- 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?
A study testing Access to School Based Health Centre in people with Educational Achievement, 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 27 Apr 2022. 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?
Educational achievement as assessed by numeric data from report cards. (time frame: Change from baseline to 18 months after identification at SST). The study lists 3 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 NCT04540003, which also lists 4 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 27 Apr 2022.