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

NCT07707492 | Not Yet Recruiting

• 2 other identifiers: 5831DC0190GP
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Mental Health; Addictions; Patient Navigation; Health Services

Keywords

Mental Health; Addictions; Navigation; Youth; Family; Northern Ontario; Patient Navigation; Health Services

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (8)

• Healthcare utilization: use of FNP-recommended resources

  Measured at 4 months, 6 months, and 12 months

• Healthcare utilization: engagement with the intervention

  Measured at 4 months, 6 months, and 12 months

• Healthcare utilization: use of emergency services and hospitalizations

  Baseline, 4 months, 6 months, and 12 months

Study Arms (1)

Navigation Intervention

EXPERIMENTAL

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

Interventions

Family Navigation Project OTHER

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.

Navigation Intervention

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants must enroll in the clinical trial within the two-month period following the date of their intake with FNP Sudbury-Manitoulin.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnybrook Health Sciences Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Laurentian University: collaborator
• Sunnybrook Research Institute: collaborator
• Health Sciences North: collaborator

Study Sites (2)

Laurentian University

Greater Sudbury, Ontario, P3E 2C6, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location

MeSH Terms

Conditions

Psychological Well-Being; Behavior, Addictive

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Compulsive Behavior; Impulsive Behavior

Central Study Contacts

Roula Markoulakis, PhD

CONTACT

1-416-482-0566; roula.markoulakis@sunnybrook.ca

Poppy Jackson, MA

CONTACT

fnpresearch@sunnybrook.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Roula Markoulakis

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: July 16, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)