NCT04540003

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Longer than P75 for not_applicable

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

September 1, 2016

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2022

Completed
Last Updated

April 27, 2022

Status Verified

April 1, 2022

Enrollment Period

5.4 years

First QC Date

August 31, 2020

Last Update Submit

April 19, 2022

Conditions

Keywords

school-based health centreSBHCSchool Support TeamSSTacademicinner city schoolsstandardized test scoresdevelopmental pediatricseducationachievement

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Change from baseline to 18 months after identification at SST

Secondary Outcomes (2)

  • Socio-demographic data and relationships to educational achievement

    change from baseline to 18 months after identification at SST

  • Wait time data will be determined retrospectively from chart review for the intervention group

    date of SST meeting to date of developmental assessment

Study Arms (2)

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.

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.

Interventions

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.

Access to School Based Health Centre

Eligibility Criteria

Age4 Years - 13 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All students identified at the SST meetings requiring a developmental assessment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unity Health Toronto

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (4)

  • 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.

    PMID: 19482756BACKGROUND
  • Reynolds 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.

    PMID: 17679653BACKGROUND
  • Shevell 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.

    PMID: 11575603BACKGROUND
  • Rasiah 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.

Study Officials

  • Sloane Freeman, MSc,MD,FRCPC

    Unity Health Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
It is not feasible to blind students or their families or SST members as there are obvious differences in care procedures between the two groups.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 7, 2020

Study Start

September 1, 2016

Primary Completion

January 20, 2022

Study Completion

January 20, 2022

Last Updated

April 27, 2022

Record last verified: 2022-04

Locations