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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age11+
SponsorSunnybrook Health Sciences Centre

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Family Navigation Project

    Other 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. 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.

Treatment groups

480 Participants
are divided into 1 treatment group
Group A: Navigation InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.).

Time frame
Measured at 4 months, 6 months, and 12 months
2

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.

Time frame
Measured at baseline, 4 months, 6 months, and 12 months
3

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".

Time frame
Measured at baseline, 4 months, 6 months, and 12 months
4

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.

Time frame
Measured at 4 months, 6 months, and 12 months

Secondary outcomes

Other outcomes

1

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.

Time frame
Measured at 4 months, 6 months, and 12 months
2

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.

Time frame
Measured at 4 months, 6 months, and 12 months
3

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.

Time frame
Baseline, 4 months, 6 months, and 12 months
4

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.

Time frame
Measured at baseline, 4 months, 6 months, and 12 months

Sponsors and contacts

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Sunnybrook Health Sciences Centre

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Laurentian University

Collaborator

Sunnybrook Research Institute

Collaborator

Health Sciences North

Collaborator

This trial is not recruiting at the moment. You can still explore other options: