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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mental Health; Health Services; Addictions; Patient Navigation
• Intervention / Treatment: Other: Family Navigation Project

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Roula Markoulakis, PhD; Phone Number: 1-416-482-0566; Email: roula.markoulakis@sunnybrook.ca
• Study Contact Backup: Name: Poppy Jackson, MA; Email: fnpresearch@sunnybrook.ca

Study Locations

• Canada
  • Ontario
    • Greater Sudbury, Ontario, Canada, P3E 2C6
      • Laurentian University
      • Contact: Diana Urajnik, PhD; Email: durajnik@laurentian.ca
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Navigation Intervention; The intervention that will be administered to all participants is the Family Navigation Project (FNP). FNP is a navigation service for youth ages 11 to 29 with mental health and/or addictions (MHA) concerns and their family of choice. See the intervention description for additional information.

Other: Family Navigation Project; The intervention that will be administered to all participants is the Family Navigation Project (FNP). FNP is a navigation service for youth ages 11 to 29 with mental health and/or addictions (MHA) concerns and their family of choice. Youth and/or their family of choice work with a Family Navigator who supports them in finding and accessing MHA resources. Navigators also support clients with sequencing care, connecting and communicating with resources, care coordination and integration, etc. After connecting clients to care, navigators will continue to check in with clients to learn whether the resources have been a good fit and if they are satisfied, or if they would like to explore other options. Navigators may also connect clients to FNP's lived experience team members, who provide peer support to youth and caregiver clients. There is no time limit to navigation and clients may re-connect with their navigator at any time. Clients can meet with navigators virtually or in-person.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Access to care: FNP-recommended resources accessed by participants	Participants will report whether they (the youth and/or the family of choice) accessed any of the resources recommended to them by their FNP navigator, how many of these resources they accessed, and reasons for not accessing any of the resources (e.g., financial barriers, long wait times or lack of available appointments, transportation or distance-related barriers, language barriers, etc.).	Measured at 4 months, 6 months, and 12 months
Access to care: navigation literacy/self-efficacy	Participants will respond to a series of questions adapted from the Navigation Health Literacy (HL-NAV) Health Literacy Population Survey 2019 (HLS19), such as how easy it is to understand information on how the health care system works, to find resources that fit my needs/the needs of my youth, stand up for myself/my youth if our care does not meet our needs, etc.	Measured at baseline, 4 months, 6 months, and 12 months
Access to care: readiness for care	Participants will be asked to what extent they agree with the statement, "I am ready to participate in mental health and/or addictions care/my youth is ready to participate in mental health and/or addictions care".	Measured at baseline, 4 months, 6 months, and 12 months
Appropriateness and continuity of care	Participants will respond to a series of questions about each resource they (the youth and/or family of choice) accessed to determine if the resource was appropriate based on their needs, the length of time it took for them to access the resource, and how long they accessed the resource for.	Measured at 4 months, 6 months, and 12 months
Quality of life, assessed via the EQ-5D-5L	The EQ-5D-5L assesses the quality of life of participants (youth and/or family of choice), including the following aspects of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.	Measured at baseline, 4 months, 6 months, and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization: use of FNP-recommended resources	Participants will report on the resources they (the youth and/or family of choice) accessed that were recommended to them by their FNP navigator.	Measured at 4 months, 6 months, and 12 months
Healthcare utilization: engagement with the intervention	Information related to participant's (youth and/or family of choice) engagement with the intervention, such as number of interactions with the navigator, purpose of contact, and resources provided, will be extracted from participant's FNP charts.	Measured at 4 months, 6 months, and 12 months
Healthcare utilization: use of emergency services and hospitalizations	At baseline, information on youth emergency service utilization and hospitalizations related to mental health and/or addictions concerns will be extracted from FNP charts. At follow-up time points, this information will be reported by the participant.	Baseline, 4 months, 6 months, and 12 months
Wellbeing: symptoms, assessed via the Kessler Psychological Distress Scale (6 items)	The Kessler Psychological Distress Scale - 6 items (K6) measures non-specific psychological distress on a scale of 0 to 4, where 0 indicates none of the time (better outcome) and 4 indicates all of the time (worse outcome). Participants (youth and/or family of choice) will complete this scale.	Measured at baseline, 4 months, 6 months, and 12 months
Wellbeing: functioning, assessed via the Columbia Impairment Scale	The Columbia Impairment Scale (CIS) is a 13-item instrument that measures four areas of youth functioning, including interpersonal relations, broad psychopathological domains, functioning in school/job, and use of leisure time. The scale ranges from 0 (no problem; better outcome) to 4 (very bad problem; worse outcome), with 5 indicating not applicable/don't know. Youth participants will complete this scale about their own functioning, and family of choice participants will complete this scale about their youth's functioning.	Measured at baseline, 4 months, 6 months, and 12 months
Wellbeing: family satisfaction, assessed via the Olson Family Satisfaction Scale	The Olson Family Satisfaction Scale (OFSS) is a 10-item scale measuring the degree to which family members feel happy and fulfilled with each other, including aspects of family functioning such as closeness, flexibility, and communication. The scale ranges from 1 (very dissatisfied; worse outcome) to 5 (extremely satisfied; better outcome). Youth and family of choice participants will complete this scale.	Measured at baseline, 4 months, 6 months, and 12 months
Wellbeing: family quality of life	Participants (youth and/or family of choice) will respond to family quality of life questions regarding satisfaction with their relationship with the service providers who work with them, and time spent per week on finding/coordinating and accessing mental health and/or addictions-related care (for themselves or their youth).	Measured at baseline, 4 months, 6 months, and 12 months
Wellbeing: caregiver strain, assessed via the Caregiver Strain Questionnaire	The Caregiver Strain Questionnaire (CGSQ) is a 21-item survey measuring the effect of the demands associated with caring for a youth with emotional and behavioral issues. The scale ranges from 1 (not at all; better outcome) to 5 (very much; worse outcome). Family of choice participants will respond to this survey.	Measured at baseline, 4 months, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Collaborators: Canadian Institutes of Health Research (CIHR); Sunnybrook Research Institute; Laurentian University; Health Sciences North

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: July 9, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Family; Mental Health; Patient Navigation; Navigation; Youth; Health Services; Addictions; Northern Ontario
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior; Personal Satisfaction; Behavior, Addictive; Psychological Well-Being
• Other Study ID Numbers: 5831; DC0190GP (Other Grant/Funding Number: Canadian Institutes of Health Research)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No