Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04540003
Other study ID # 13-341
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2016
Est. completion date January 20, 2022

Study information

Verified date April 2022
Source Unity Health Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date January 20, 2022
Est. primary completion date January 20, 2022
Accepts healthy volunteers No
Gender All
Age group 4 Years to 13 Years
Eligibility Inclusion Criteria: - All students identified at the SST meetings requiring a developmental assessment. Exclusion Criteria: - Students without a developmental concern and not identified at the SST meeting will be excluded. No other specific exclusion criteria will be applied.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Access to School Based Health Centre
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.

Locations

Country Name City State
Canada Unity Health Toronto Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
Unity Health Toronto Toronto District School Board

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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. change from baseline to 18 months after identification at SST
Secondary 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. date of SST meeting to date of developmental assessment
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02889640 - Increasing the Reach of Promising Dropout Prevention Programs: Examining the Trade-offs Between Scale and Effectiveness N/A
Completed NCT01678846 - Good Schools Study N/A
Active, not recruiting NCT02673645 - Remediating Academic Skill Deficits Among Disadvantaged Youth N/A
Active, not recruiting NCT01927523 - Improving Life Chances of Disadvantaged Youth: Testing Best-Practice Academic vs. Non-Academic Supports N/A

External Links