Better Access to and Integration of Mental Health and Addiction Services Through Navigation: A Mi… (NCT07707492) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Better Access to and Integration of Mental Health and Addiction Services Through Navigation: A Mixed-Methods Adaptive Pragmatic Clinical Trial
Canada480 participantsStarted 2026-10
Plain-language summary
The Family Navigation Project (FNP), a youth and family mental health and addictions (MHA) navigation service that currently operates in the Greater Toronto Area (GTA), is expanding to northern Ontario by setting up a new site in the Sudbury and Manitoulin districts. This work is being done in partnership with Compass/Boussole/Akii-Izhinoogan, the lead child and youth mental health agency for Sudbury-Manitoulin. An innovative clinical trial will be conducted following the setup of FNP in Sudbury-Manitoulin, which will test how well the model works for the community in this area. The team will collect information about the experiences and outcomes of the youth and families who use the service. The goal is to see whether FNP leads to better outcomes for youth and families, such as getting help sooner, feeling more supported, and being able to use the healthcare system more efficiently. The trial will use a mixed methods approach, meaning it gathers both numbers (e.g., wait times and service use) and personal experiences (e.g., whether families feel supported). This will provide a rich, in-depth picture of how navigation services work in a northern community and how they impact the lives of young people and their families living there.
Who can participate
Age range
11 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Individuals who meet the established eligibility criteria for the Family Navigation Project (FNP), specifically:
* Youth ages 11 to 29 years old who are experiencing a mental health and/or addictions (MHA) concern OR
* Family members or caregivers (broadly defined, including family of choice) of youth ages 11 to 29 years old who are experiencing a MHA concern.
* No maximum age limit for participants who are the family of a youth experiencing a MHA concern, as long as the youth is within the eligible age range.
* The youth experiencing a MHA concern OR the family member must reside within the districts of Sudbury, Greater Sudbury, or Manitoulin to be eligible for inclusion.
* Participants must enroll in the clinical trial within the two-month period following the date of their intake with FNP Sudbury-Manitoulin.
Exclusion Criteria:
* Individuals will be excluded if they fall outside of the eligible age range for the Family Navigation Project (i.e., younger than 11, older than 29) or if they are not experiencing a mental health and/or addictions concern.
* Participants will also be excluded if the youth with MHA concerns or the family member do not reside within the designated catchment area of Sudbury, Greater Sudbury, or Manitoulin.
* Individuals older than 29 may only be included if they are participating in this study as a family member of an eligible youth (aged 11-29) who is experiencing a MHA concern.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Access to care: FNP-recommended resources accessed by participants
Timeframe: Measured at 4 months, 6 months, and 12 months
2
Access to care: navigation literacy/self-efficacy
Timeframe: Measured at baseline, 4 months, 6 months, and 12 months
3
Access to care: readiness for care
Timeframe: Measured at baseline, 4 months, 6 months, and 12 months
4
Appropriateness and continuity of care
Timeframe: Measured at 4 months, 6 months, and 12 months
5
Quality of life, assessed via the EQ-5D-5L
Timeframe: Measured at baseline, 4 months, 6 months, and 12 months