Better Access to and Integration of Mental Health and Addiction Services Through Navigation: A Mixed-Methods Adaptive Pragmatic Clinical Trial

Background and Objectives: The Family Navigation Project (FNP) is navigation service for youth ages 11 to 29 with mental health and/or addictions (MHA) concerns and their family of choice. FNP is expanding to northern Ontario by setting up a new site in the Sudbury-Manitoulin region (including Sudbury, Greater Sudbury, and Manitoulin). Following the implementation of FNP in Sudbury-Manitoulin, the service will be evaluated through an adaptive pragmatic mixed-methods clinical trial, which will assess whether access to navigation support leads to improved outcomes and more efficient healthcare utilization for youth and families, specifically in terms of:

1. access to care (primary outcome),
2. appropriateness and continuity of care (primary outcome),
3. quality of life (primary outcome),
4. healthcare utilization (exploratory outcome), and
5. wellbeing (exploratory outcome).

Research Design: This project uses a community-based participatory research approach, ensuring that community members and local partners are actively involved in shaping the study's development, implementation, and interpretation. Embedded within this framework is an adaptive pragmatic clinical trial to assess whether access to navigation support leads to improved outcomes and more efficient healthcare utilization for youth and families. An adaptive design will allow for planned modifications in response to data being collected, which will lead to improved efficiency in the conduct of clinical trials. A pragmatic approach will allow for the evaluation of the effectiveness of navigation in routine clinical practice. Mixing methods to include a concurrent descriptive qualitative approach will allow for an exploration of youth and families' experiences in relation to the outcomes, to help elucidate their perceptions of particular aspects of the navigation process or self-navigation which led to observed outcomes. This is an open clinical trial with a quasi-experimental design (i.e., participants act as their own control). There is no control group or randomization, so that any youth/family in need of and seeking navigation will receive navigation, which was a stipulation made by local partners.

Participants: Participants will be those who meet the client criteria for FNP. That is, youth ages 11 to 29 experiencing a MHA concern and/or their family of choice, who reside in the geographical catchment area of Sudbury-Manitoulin.

Navigation Procedure: Potential clients can reach out to FNP via phone or email. FNP is a free service, with no diagnosis, referral, or OHIP/IFHP required. After reaching out to FNP, they will be contacted for an intake assessment, where a navigator will discuss what FNP is, determine eligibility, and gather preliminary information. Within two business days of completing intake, the client will be contacted by their assigned navigator. During the initial assessment with the navigator, the client (youth or caregiver/family of choice) will describe the youth's service history, social history, functioning, and family background. The navigator will then present the case to the navigation team, which involves other navigators and a psychiatrist. The team will generate a "navigation plan," including potential treatment and resource options for the youth and/or supports, coaching, counselling, and other services for the family. In almost all cases, the navigator will contact resources identified in the navigation plan to explain the clinical situation of the client and ensure appropriate fit. The navigator will present these options to the youth/family and address any questions or concerns they may have. If or when the youth/family decides to move forward with any options, the navigator will support them in making contact with services, compiling documentation, and letting them know what to expect. Navigators then check in with clients to learn whether the resource(s) was/were a good fit and if they are satisfied, or if they would like to explore other options. Clients may also be connected with peer support at FNP. FNP Sudbury-Manitoulin will employ one Youth Advocate with Lived Experience and one Caregiver Advocate with Lived Experience, who will draw on their lived experience to offer emotional support, validation, hope, and practical, real-world insights about services and systems to clients. Navigation can last anywhere from a few weeks to a few months, with an average length of stay of four months. Clients will be able to contact their navigator to re-engage with FNP services at any time, as long as they remain within the eligibility criteria.

Study Procedure: As there is no control group or randomization, all individuals who meet the inclusion criteria and who consent to participate in the study will receive the above navigation procedure. Participants can choose to enroll in the study any time during the two-month period since the date of their intake with FNP Sudbury-Manitoulin (as long as they are a client of FNP at the time of enrollment). This is to ensure the navigation process is not delayed for any individual who is interested in participating. Participants will be able to take part in navigation for as long as necessary; however, data will be collected for one year, regardless of the length of stay with FNP Sudbury-Manitoulin, to assess longevity of observed effects. Thus, data collection time points (via surveys) include baseline, 4 months (average length of stay), 6 months (study endpoint; when over 90% of participants are expected to have completed an episode of navigation), and 12 months (exploratory longitudinal impact). Surveys will be administered to participants via email. Focus group and interview data collection will take place at these four time points as well, with a subset of participants (n=76) taking part at each time point. Each participant may partake in up to two focus groups/interviews.

Duration: The FNP Sudbury-Manitoulin service is expected to launch in fall 2026, with the clinical trial commencing at that time. Recruitment will last for up to two years. The clinical trial will therefore take about three years to complete.

Location/Sites Involved: Individuals may access FNP Sudbury-Manitoulin in-person, by phone, video call, or email. Navigators will be located at Compass offices and at the Youth Wellness Hub in Sudbury. Sunnybrook Health Sciences Centre will be one of the sites involved in this study, as this is where the Nominated Principal Investigator and other research staff are located, and where the study data will be stored. Laurentian University will be the study site local to Sudbury-Manitoulin, as this is where a Principal Investigator and other supporting research staff are located. Other partners in Sudbury-Manitoulin include Health Sciences North, Noojmowin Teg Health Centre, Future North, and Parents and Caregivers for Mental Health (Sudbury Chapter).