Protocol for a multimethods study evaluating a transition pathway between hospital settings and postsecondary institutions: the NavigateCAMPUS study

Abstract

Introduction

The surge in postsecondary students reporting mental health concerns, coupled with increased utilisation of on-campus and hospital-based mental healthcare, highlights a need to understand effective service navigation. To address this system gap, the University of Toronto and the Centre for Addiction and Mental Health (CAMH) leveraged their unique expertise and resources to develop the University of Toronto Navigation (UTN) service. UTN introduces care navigators to facilitate postsecondary student transitions from acute mental health services to community or campus mental healthcare. There has been limited implementation and evaluation of navigator models specific to the postsecondary context to date, which hinders scalability. This paper describes the study protocol of Navigation to Enhance Post-Secondary Students’ Acute Mental Health Care Transitions, a study that aims to collaborate with students, navigators and clinicians to evaluate the UTN service.

Methods and analysis

A one-stage, single-arm multimethods study design will be used to evaluate the UTN service. We will recruit 103 students following their UTN intake appointment. Students will complete quantitative measures assessing health outcomes, experiences of care and service utilisation at baseline and at three subsequent time points across a 6-month follow-up period. The quantitative data will be linked to administrative healthcare data. The primary evaluation outcome will be defined as attending an appointment with an appropriate care provider (in person or virtually) within 30 days of discharge from the hospital. We will conduct interviews with students and referring clinicians to gather perspectives regarding their experiences and satisfaction with the UTN service in greater depth.

Ethics and dissemination

Research ethics board approvals have been obtained from the University of Toronto and CAMH. Results will be disseminated through publications and presentations, and a toolkit will be cocreated to support implementation and adaptation of hospital-based navigator interventions in postsecondary contexts.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This is the first study to evaluate the impact of a navigator model aimed to facilitate acute mental healthcare transitions for postsecondary students.

• To support a robust evaluation of the model, Navigation to Enhance Post-Secondary Students’ Acute Mental Health Care Transitions includes both qualitative and quantitative data from students and clinicians. Student data are obtained at four time points over 6 months and linked to administrative health service databases.

• The study findings will be critical in planning for randomised controlled trials, including providing parameters for estimating sample size.

• This study will be restricted to a single postsecondary setting with students who can speak and read English; however, the sample is expected to be diverse in terms of cultural background, international student status, gender, sexual identity and academic programming.

• The study does not include a control group, thus not allowing for comparison between postsecondary students who have and have not used the navigator intervention.

Introduction

Mental health has become an increasing priority on college and university campuses worldwide given the increased prevalence of mental illness reported by postsecondary students.^{1 2} The transition into postsecondary school coincides with emerging adulthood (ages 18–25 years), a peak period for the onset of mental illness.³ Reflecting this, up to one-third of the postsecondary student population meets the diagnostic criteria for a mental illness, with the most common being depressive, anxiety and substance use disorders.^{4 5} The prevalence of mental health conditions reported among postsecondary students has also increased substantially over the last decade,² with a high proportion of students reporting co-occurring mental health conditions.⁶ Co-occurring mental health conditions contribute to a heightened risk for suicidal thoughts and behaviours among postsecondary students, particularly for those presenting with mania, hypomania and anxiety disorders.⁶

The surge in reported mental health conditions among postsecondary students is accompanied by a sharp increase in demand for mental health services both on-campus and through hospital-based acute care services.^{7 8} On-campus, postsecondary institutions have seen a significant increase in students accessing counselling and psychiatrist appointments,^{7 8} with on-campus service utilisation in the general postsecondary student population almost doubling over a 10-year period.⁷ Similarly, demand among postsecondary students is increasing for acute and ambulatory mental health services (AMHS), including emergency department (ED), inpatient and outpatient hospital services.^{7 8} International postsecondary students with mental health needs encounter uniquely complex challenges, including additional barriers to care, heightened alienation and discrimination within campus environments.^{5 9} Although acute concerns, including suicide attempts, are highly prevalent in this population,¹⁰ international students are less likely to access appropriate mental health services,^{11 12} often related to cultural stigma and lower mental health literacy.¹³

In Canada, postsecondary institutions are funded by provincial and territorial education ministries and are not mandated or allotted funds to provide comprehensive health services. This limits the ability of postsecondary institutions to address acute mental illness and/or mental health crises, such as psychosis or suicidality.¹⁴ In addition, the transition back to campus-centred care from hospital-based services is often poorly managed for postsecondary students who access AMHS¹⁵; the majority of students are discharged from the hospital without a coordinated care plan,¹⁶ resulting in high rates of rehospitalisation, worsening of illness and increased health costs.¹⁷ The limitations of specialised mental health services available on campus, coupled with the increased prevalence of mental illness and heightened demand for services and care coordination, indicate a substantial need for better solutions to manage the complex mental health needs of postsecondary students.

In response to this critical gap in mental health services, many postsecondary institutions have sought to improve student mental healthcare access, pathways and coordination by implementing innovative care models on campus, including stepped models of mental healthcare.^{18 19} Stepped models of care represent a multicomponent care approach, integrating various interventions to address mental health needs along a continuum of services that increase in intensity according to individual needs. An individual is matched to a mental health service based on their unique needs and preferences, with movement up or down the continuum of care guided collaboratively with a clinician as their needs evolve over time. Though the implementation of stepped models of mental health services varies across postsecondary institutions,²⁰ care provided to those with the most intensive mental health needs often includes linkages to AMHS and access to navigation to facilitate care transitions.¹⁸ Navigation models facilitate successful transitions between different mental health services (eg, hospital-based to community-based services) by assigning each individual a clinical navigator who provides complex care coordination, brief psychotherapy and discharge planning.²¹ In non-postsecondary student populations, navigation models have been found to decrease 30-day hospital readmissions22,24 and reduce²⁵ or maintain^{26 27} overall mental health symptomology. As such, in these models, a transition is considered successful when an individual attends an appointment with an appropriate care provider at the receiving mental healthcare service in a timely manner following hospital discharge. This definition aligns with consensus-based quality standards²⁸ and core components of effective transitions.^{29 30}

The University of Toronto (UofT) collaborated with the Centre for Addiction and Mental Health (CAMH) to implement a navigator model to support transitions between hospital and community or campus-based mental healthcare for postsecondary students. Launched in the fall of 2022, the University of Toronto Navigation (UTN) service was developed in partnership with students, service providers and clinicians using Expedited Experience-Based Co-Design³¹ to adapt the navigator model to the postsecondary context. The UTN service is described in detail below.

To date, there have been no evaluations of mental health navigation interventions for postsecondary students specifically. Assessing the effectiveness of navigator models tailored to the postsecondary context, such as UTN, is critical to improve transition success for postsecondary students and to support the continual improvement of postsecondary student mental healthcare.

Study aims

The Navigation to Enhance Post-Secondary Students’ Acute Mental Health Care Transitions (NavigateCAMPUS) study aims to collaborate with postsecondary students, clinicians and navigators to evaluate the UTN service, a novel hospital-based navigation programme. The goals are to (1) assess the effectiveness of UTN and (2) explore the experience and satisfaction of postsecondary students and clinicians with the service. The primary evaluation outcome is transition success, operationalised as attending an appointment with an appropriate care provider (in person or virtually) within 30 days of discharge from the hospital. The 30-day benchmark will be used given that the risk of psychiatric rehospitalisation among youth and adults is highest during the first 30 days postdischarge.³²

Specifically, the NavigateCAMPUS study aims to answer the following research questions (RQ).

Primary question (among postsecondary students using the UTN service):

1. Does the proportion attending an appointment (in person or virtual) with an appropriate care provider within 30 days of hospital discharge exceed the benchmark proportion of successful navigation (defined as 75%)?

Secondary questions:

• 2 1What is the median time to attend an appointment with an appropriate care provider following hospital discharge?
• 2 2Does having an appointment within the 30-day benchmark help prevent (a) deterioration in functioning/health symptoms and (b) use of hospital services (ED, inpatient) at 3 and 6-month follow-ups compared with not having an appointment within the 30-day benchmark?
• 2 3How do postsecondary students and clinicians perceive and evaluate their experience and satisfaction with the UTN service?

A protocol for the economic evaluation of the UTN will be described in a forthcoming manuscript, as it includes a detailed framework to assess service costs, outcomes and cost-effectiveness.

The Standard Protocol Items: Recommendations for Interventional Trials 2025³³ guidelines were followed in the creation of this protocol³⁴ (online supplemental table 1).

Methods and analysis

For brevity, the term ‘students’ will be used throughout the remainder of the manuscript, referring exclusively to postsecondary students.

The UTN service

CAMH and UofT partnered to implement UTN. Through extensive engagement with students, staff and clinicians, UTN builds on principles of mental health system navigation in youth mental health²¹ to tailor the navigator model to the postsecondary context. The UTN service is available to domestic and international, undergraduate and graduate students across all three UofT campuses who use mental health services at CAMH. Following assessment and admission to the appropriate CAMH clinical service (ie, ED, inpatient unit), a student is referred to the UTN service and then assigned a navigator. The navigator is a clinician who is trained to provide continuous, personalised support for students as they progress through care transitions.^{21 30} Navigators work collaboratively with the students to: (1) outline and prioritise transition goals; (2) assess transition readiness; and (3) determine the level and type of care needed posthospital discharge. The goal of UTN is to support students to re-engage with academic activities, access appropriate accommodations and mental health services on and off campus to prevent recurrent crises and reduce future hospital visits.^{35 36} In the first two years since UTN implementation, approximately 250 students have registered with the service. The length of service varies based on individual needs, with most students completing the pathway within 12 weeks. Sessions are held weekly or biweekly, either virtually or in person and may include interventions such as psychosocial and needs assessments, psychoeducational counselling, safety planning, interprofessional consultations, referrals and warm handovers. The development and implementation of the UTN service is described in a recently submitted manuscript by Cleverley and colleagues.³⁷

Study design

The NavigateCAMPUS study will follow a one-stage, single-arm multimethods study design. This study design was selected as it includes a statistical decision rule to allow for the determination of intervention efficacy.³⁸ We will assess 103 students at baseline (UTN intake appointment; T1), 30 days (T2), 3 months (T3) and 6 months (T4); additional details on sample size can be found in the ‘Sample size justification’ section. Students who complete the 3-month follow-up (T3) will be invited to participate in a semistructured interview to better understand their experiences with UTN. Clinicians who have referred a student to the UTN service or who have received a student via UTN referral will also be invited to participate in an interview. Clinician interviews will provide insight into the clinicians’ experience with UTN, including their experience with the referral pathway, feedback on the service and what components of the service are most helpful.

Study setting

UofT is Canada’s largest postsecondary institution, with a student population of nearly 100 000 across its three campuses. The St George campus is located in downtown Toronto, while the Mississauga and Scarborough campuses serve students in the western and eastern regions of the Greater Toronto Area, respectively. UofT has a highly diverse undergraduate and graduate student body; nearly one-third are international students from 178 countries and territories.³⁹ The UTN service is based at the CAMH, the largest mental health teaching hospital in Canada and one of the world’s leading mental health research centres.⁴⁰ CAMH provides a variety of inpatient and outpatient mental health and addiction services. CAMH is located in downtown Toronto and serves a large number of UofT students, particularly those enrolled at the St George campus.

Study population

Inclusion criteria

For the quantitative component, students need to be: (1) current UofT students receiving the UTN service at CAMH, (2) able to speak and read English and (3) able to provide informed consent. For the qualitative component, students must have completed the 3-month follow-up (T3) of the quantitative study. Clinicians are eligible if they have (1) referred UofT student(s) to UTN and/or (2) received a student via a navigator referral.

Exclusion criteria

The exclusion criteria for any component include any individual who is (1) unable to read, write or converse in English and/or (2) unable to provide informed consent.

Sampling, recruitment and consent

Quantitative recruitment

Student participants

A comprehensive recruitment plan was developed and tested in the evaluation of a youth navigator intervention led by the study team.⁴¹ Minor revisions were made in consultation with the UTN navigators to ensure feasibility of the recruitment plan for a postsecondary student population. For this study, we will recruit students over a 24-month period. The navigator(s) will identify potential participants following their UTN intake appointment after eligibility criteria are confirmed. The navigator will inform eligible clients of the research opportunity, and if the client is interested, they will refer them to a study research assistant (RA). This will be done in person or virtually by: (1) introducing the potential participant to the RA following the intake appointment; (2) providing the potential participant’s preferred contact information to the RA for follow-up with their consent; or (3) providing the study team’s contact information to the potential participant, based on client preference.

To further introduce the study, the RA will meet the potential participant in person or virtually immediately following their intake appointment or will contact them using the information provided by the navigator. The RA will schedule a consent discussion with interested participants. This discussion will take place in person or through a secure videoconferencing software (eg, Cisco Webex), depending on the participant’s preference. Once consent is obtained, the RA will administer the baseline survey package.

Given that the study is recruiting students with identified mental health challenges, clinical backup will always be available to the RA, and the students will be made aware of local mental health services should they need them.

Qualitative recruitment

Student participants

Student participants will be invited to an interview via their preferred contact method once they have either completed the 3-month follow-up (T3), or have been discharged from the service, whichever occurs first. The RA will set up a virtual consent discussion with participants who express interest. Once informed consent is obtained, the RA and participant will schedule a time to complete the interview.

Clinician participants

Clinician participants will be identified by the navigator who will then inform the RA. The RA will conduct the informed consent discussion in person or through a secure videoconferencing software. Once consent has been obtained, the RA will schedule a time to conduct the qualitative interview.

Data collection

Student participants will complete self-report NavigateCAMPUS study measures at baseline (T1), 30 days (T2), 3 months (T3) and 6 months (T4). The time required for data collection is expected to be 1.5 hours at each time point. Student participants will complete the study measures online using Research Electronic Data Capture (REDCap), a secured and encrypted web application.^{42 43} Student participants will be able to complete the study measures on-site (ie, in person) using a study laptop or remotely using their personal laptop. To ensure high completion rates, an RA will be available to answer any questions the participant has about the study measures during the assessment and conduct a data quality check (eg, review for missing or incomplete items) once the study measures have been submitted.

Interviews with student and clinician participants will take place on-site (ie, in person) or through a secure videoconferencing software (eg, Cisco Webex). Interviews will be conducted by a member of the research team who has experience in conducting and facilitating qualitative interviews. Each interview will take 30–45 min, will be audio recorded and will be transcribed verbatim. All identifying information will be removed at the time of transcription.

Quantitative measures

Please see the schedule of primary assessments in table 1.

Table 1. Schedule of primary assessments by study time point.

Source of data collection	Baseline (T1)	30 days (T2)	3 months (T3)	6 months (T4)
Demographics Questionnaire	√	√	√	√
CIS	√	√	√	√
BSI	√	√	√	√
CCET checklist		√	√	√
Satisfaction with Mental Health Navigator Tool (NAVSAT)			√	√
Health Service Use and Out-of-Pocket Expense Diary (custom measure)	√		√	√

BSI, Brief Symptom Inventory; CCET, Core Components of Effective Transitions; CIS, Columbia Impairment Scale; NAVSAT, Navigation Satisfaction Tool.

Sample characteristics

The Demographics Questionnaire, cocreated with a youth advisory team and previously used by the study team in similar populations,^{41 44} will be used. The Demographics Questionnaire has been slightly adapted for use in a postsecondary context based on feedback from student advisors. The demographic data capture key characteristics of the sample, including age, sex assigned at birth, current gender identity, sexual orientation, race and ethnicity, international student status, current living situation, campus, level of study and academic programme. Primary diagnosis will be captured as part of routine clinical care at CAMH, accessed via participants’ medical records in the I-CARE platform.

Primary outcome

30-day appointment attendance (RQ1). This outcome will be assessed via UTN service data obtained through participant records in I-CARE. Given variability in referred services, these data will be supplemented by self-report data collected from participants via the Core Components of Effective Transitions (CCET) survey.^{29 30} The CCET includes specific questions about the agencies referred to, confirmation of appointment attendance and date of appointments. The primary outcome is binary; participants will be classified as having attended a clinical appointment (in person or virtual) with an appropriate care provider within 30 days of discharge, or not.

Secondary outcomes

Time to attending appointment (RQ2). These data will be determined via the data sources described in RQ1. Time to attending appointment will be measured as the number of days from discharge to attendance of the first appointment (as defined above), or to last contact, if censored.

Mental health symptoms (RQ3). The Brief Symptom Inventory (BSI)⁴⁵ is a 53-item self-report inventory in which participants evaluate the extent to which they have been bothered in the past week by various symptoms, rated on a scale from 0 (‘not at all’) to 4 (‘extremely’). It comprises a Global Severity Index and nine subscales that target specific symptom categories: somatisation, obsessive-compulsive, interpersonal sensitivity, anxiety, depression, hostility, phobic anxiety, paranoid ideation and psychoticism. The BSI has excellent psychometric properties⁴⁶ and has student norms.⁴⁷

Functioning (RQ3). The Columbia Impairment Scale (CIS)⁴⁸ is a 13-item scale which provides a global measure of impairment in four major areas of functioning: interpersonal relations (family and friends), broad psychopathological domains, functioning in job or schoolwork and use of leisure time. One of the most common scales used in research involving children and adolescents,⁴⁹ the CIS is favourable through its self-administration capabilities and short completion time.^{50 51} The tool has been shown to have good internal consistency, test–retest reliability and sensitivity to change,^{48 50} and has been validated for use among similar populations.⁵²

Hospital service use (RQ3). The Health Service Use and Out-of-Pocket Expense Diary, a custom measure developed by the study team and adapted from the Health and Social Service Utilization measure,^{53 54} will be used to gather data on billable and non-billable health service usage.

Satisfaction (RQ4). The Satisfaction with Mental Health Navigator Tool is an 11-item measure of student satisfaction with the navigator model, adapted from the Navigation Satisfaction Tool (NAVSAT).⁵⁵ Participants are asked to respond to nine items about their satisfaction with the service, one item to capture their frequency of contact with the navigator and one item to assess the likelihood that they would recommend the navigation service to friends or family in need of similar care.

Qualitative interviews

Semistructured interviews will be conducted with student and clinician participants. Student interviews will focus on experiences and satisfaction with UTN. Example questions for students include: ‘What was the role of the navigator throughout the process of connecting to mental health services?’, ‘What do you feel was the most helpful aspect of the navigation program for you?’ and ‘If you could experience the transition out of CAMH to other mental health services again, is there anything you wish could have been different?’. Interviews will be conducted after a participant has completed the 3-month follow-up (T3) and will take place in person or via secure videoconferencing software.

Clinician interviews will focus on the clinicians’ interaction with, use of and satisfaction with UTN. Example questions for clinicians include: ‘Could you tell me a little bit about how you currently work with the navigation service, UTN, in your role?’ and ‘How do you think transitions or services for post-secondary students have changed since the implementation of UTN?’. The interviews will take place across the study period, as clinicians will be invited to participate in an interview once they have referred a student to the UTN service or received a student via a UTN referral.

Positionality will be actively considered throughout the qualitative interview process and in the analysis of interview data.⁵⁶ Reflexivity will be encouraged among interviewers, with attention to how their identities, experiences and relationships to the research context may shape data collection and interpretation.⁵⁷

Data analysis

Quantitative data

All statistical analyses will be performed using R.⁵⁸ Two-sided p values ≤0.05 will be considered statistically significant. Descriptive statistics (ie, means, SDs, frequencies, proportions) will be used to summarise the study sample.

Primary RQ (RQ1). The proportion of participants achieving the primary outcome (appointment attendance with an appropriate care provider within 30 days of hospital discharge) and its corresponding exact binomial 95% CI will be calculated. The observed proportion will be evaluated based on the benchmark of 75% intervention success. In the absence of existing data on 30-day outpatient appointment attendance, a benchmark was developed based on consultation with mental health experts using available ED data. Specifically, data show 75% of all postsecondary students using the CAMH ED do not return to the ED within a 6-month period (ie, 25% return rate).³⁷ This benchmark is based on standard care and includes those who would be indicated for navigation and those with less acute needs, making it a conservative benchmark. ED return rates that are less than 25% (ie, lower than standard care) therefore would provide evidence supporting a successful navigation intervention in a sample of postsecondary students indicated for navigation.

RQ2. The time to attend the first appointment will be summarised using a cumulative incidence function.⁵⁹ Point estimates (and 95% CI) of the proportion of participants who attended an appointment by 30 days, 3 months and 6 months will be calculated. The median time to attend the first appointment, along with the IQR, will be reported. In addition, proportional subdistributional hazards models⁶⁰ will be used to model cumulative incidence controlling for sex assigned at birth, baseline mental health symptoms and functioning.

RQ3. Participants will be dichotomised into two groups: those who attended an appointment by 30 days and those who did not. Linear mixed models⁶¹ will be used to compare each of the secondary mental health symptoms, functioning and hospital service use outcomes between groups over the study time points (30 days, 3 months and 6 months). Unadjusted models, and models adjusted for relevant demographic characteristics (eg, sex, age), baseline mental health symptoms and baseline functioning will be analysed.

RQ4-Quantitative. Student satisfaction with the intervention at 3 and 6 months will be evaluated with total scores (continuous) on the NAVSAT for the entire sample using descriptive statistics.

Exploratory subgroup analyses. For RQ1, proportions achieving the primary outcome will be compared by sex and campus type (downtown vs other) using χ² tests. Effect size will be calculated and used to assess for meaningful differences. Additional exploratory analyses for all RQs will examine whether outcomes differ based on the individual’s primary diagnosis, by stratifying the analysis where sample size allows.

Missing data. The primary outcome will have complete data by definition. For participants lost to follow-up before 30 days, they will be classified as not achieving the primary outcome, as the most conservative approach. Time to attending the first appointment (RQ2) is a time-to-event outcome; participants will be censored at their last contact date. Multiple imputation will be used to impute missing outcome data in RQ3 and RQ4.

Qualitative data

Qualitative analysis will follow the three-phase process outlined by Hsieh and Shannon⁶² for directed content analysis, described further by Assarroudi et al.⁶³ The research team will begin the preparation phase by developing a preliminary codebook based on existing core components of effective transitions.^{29 30} In the organisation phase, two research team members with qualitative expertise will read all interview transcripts and independently code using the preliminary codebook. Though initial coding will be guided by a preliminary codebook, the analysis will remain open to identifying new patterns and concepts that may not fit within the existing core components framework; these emergent codes will be inductively defined and organised using thematic analysis.⁶⁴ To enhance credibility and trustworthiness of the findings, researchers will independently analyse the data and compare interpretations, supported by an audit trail documenting analytical decisions.⁶⁵ Lastly, themes accompanied by supporting quotes will be shared with student and clinician participants and advisors for their feedback to enhance the trustworthiness of findings.⁶⁶ Qualitative analysis will be conducted separately for student and clinician interviews. NVivo software will be used for data management.⁶⁷

Sample size justification

Quantitative sample

Using a one-stage, single-arm design,^{38 68} a total of n=103 participants is needed to determine whether the proportion (P) of participants achieving the primary outcome (30-day appointment attendance) is under the null hypothesis H0: p≤75% versus the alternative hypothesis H1: p≥85%. The 10% difference in P between the null and alternative hypotheses represents the effect size in this single-arm study. The decision rule is: if ≥85 out of 103 participants achieve the primary outcome, H0 is rejected, and the intervention is declared worthy of further investigation. If ≤84 out of 103 participants achieve the primary outcome, H0 is not rejected. This design achieves 80.3% power (target power=80%) at α=4.6% (target α=5%). Power calculations were performed using the Power Analysis and Sample Size (PASS) 2025 software.⁶⁹

Qualitative sample

We will aim to have 20 students and 20 clinicians complete the qualitative interviews. This sample size may be adjusted once we achieve data sufficiency,⁷⁰ in line with guidelines for sample size determination during data collection.^{71 72}

Patient and public involvement

The NavigateCAMPUS study will engage students, navigators, clinicians and a core team of researchers in the development of this research. To date, this has included student and clinician engagement in the development and refinement of the UTN service, recruitment strategies and interview guide development. Additionally, students with lived experience and navigators with the UTN service are collaborators or coinvestigators on the Canadian Institutes of Health Research funding application. Two UofT students with lived experience accessing hospital-based mental health services have been hired to advise across the duration of the project, including supporting the interpretation of findings and knowledge dissemination.

Data management and confidentiality

All study data will be managed in accordance with the Canadian Tri-Agency principles of digital data management and the Ontario Personal Health Information Protection Act. All survey data will be entered into the secure online data capture platform REDCap, hosted on a secure server at the lead study site (CAMH). Audio recordings from qualitative interviews will be immediately transferred from the audio recording device to a secure server at CAMH in a password-protected file and deleted off the recording device. All study research data will be deidentified, coded numerically and password protected.

Study duration and accrual period

Assuming an accrual rate of approximately five participants per month, the study duration is expected to be approximately 27 months (21-month accrual plus 6-month follow-up for the final participant). Based on a navigation study with a similar population²⁶ and preliminary data from the navigation programme, this sample size is feasible. The study began enrolling participants in March 2024. The estimated completion date for study enrolment is Summer 2026.

Ethics and dissemination

The study protocol has been approved by the CAMH Research Ethics Board (REB 2023/063) and the UofT REB (REB 00046385).

Results from the study will be disseminated in alignment with a comprehensive knowledge translation plan developed by the study team, with a strong focus on supporting the sustainability of effective practices. Provisional components include: (1) the development of a knowledge translation toolkit to support adoption of mental health navigation interventions for postsecondary students; (2) peer-reviewed open access publications; and (3) presentations and/or workshops at national and international meetings.

The funding agency has no role in the design, management, analysis and reporting of the trial.