An observational study in Caregiver, Caregiver Mental Health and Caregiver Stress, sponsored by Unity Health Toronto. Recruiting at 1 site in Canada. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Unity Health Toronto · Observational
The Friends/Family of Individuals at Risk of Suicide Training (FIRST) program is a six-week program designed to provide knowledge and practical skills to help caregivers care for their loved one while also supporting their own mental health and wellbeing during highly stressful situations. Throughout the program, participants will develop skills to better communicate with their loved one, manage emotions, navigate the health-care system, practice self-care in moments where it feels impossible, and set healthy personal boundaries. FIRST consists of six weekly 90-minute group sessions delivered either online via videoconference or in-person in Toronto, Ontario. Each session is facilitated by a clinician and a peer facilitator with lived experience.
Suicide is a global health issue. In Canada alone, there are approximately 4500 suicide deaths each year, and each day there are about 200 people who will make an attempt. Suicide impacts families and entire communities for generations, and it is vital that researchers, knowledge users, and individuals and families with lived experience work together to tackle this issue. While friends and families of individuals who experience suicide-related thoughts or behaviours (FF-STB) play a crucial role in support networks, healing, and crisis intervention, they are often not highly effective in these roles because of stigma and limited skills to understand and manage what their loved one is experiencing. As caregivers, FF-STB frequently experience a decrease in their own mental health. There is an immense lack of resources for FF-STB to learn how to support others' and their own mental health needs alongside a dearth of resources for individuals at risk of suicide, with waitlists being up to 1 year. Thus, other support strategies are essential and building capacity within communities to effectively support their loved ones is a critical suicide prevention imperative. People with lived experience (PLE) of suicide risk and FF-STB who comprise the Suicide \& Depression Studies Program Community Advisory Committee (CAC) at St. Michael's Hospital (SMH) have stated that training for friends and family developed in collaboration with PLE is a huge unmet need that will have a significant impact on suicide prevention.
To address this gap, the study team conducted a national needs assessment to understand the specific challenges and barriers FF-STB experience while supporting their loved ones. The findings were used to create the novel Family/Friends of Individuals at Risk of Suicide Training (FIRST) Program specifically for FF-STB. The current study aims to evaluate the feasibility, acceptability, and preliminary effectiveness of the FIRST Program in a community setting.
Needs Assessment Outcomes To ensure the content of the FIRST Program is aligned with community needs, the research team conducted a national needs assessment among FF-STB, people impacted by suicide loss and PLE of suicide risk. The goal was to comprehensively understand the specific training needs and barriers experienced by FF-STB across Canada in supporting their loved ones, as well as gaps in support received by people at risk of suicide. The themes and questions in the interviews were determined by our systematic review. These included: suicide education, attitudes about suicide, skills building (e.g., emotion regulation, crisis intervention, self-care), helpful/unhelpful aspects of previous support experiences, and any other aspects that participants deemed relevant. Participants in the FF-STB group were also asked about their preferences for a future training program, including logistics (e.g., preferred # sessions, duration, location, group size, delivery mode), content needs, and preferred leadership (e.g., FF-STB; clinician).
Participants throughout the needs assessment emphasized the immense lack of resources for FF-STB. Many emphasized their feelings of burnout, exhaustion, anger, and fear (e.g., feeling constantly on 'high alert', fear of leaving their loved one alone, anxiety about having their phone on at all times). Participants noted several barriers to seeking support for their loved one, including financial barriers, long waitlists, and the need to strongly advocate for their loved one with institutions (e.g., hospitals, schools) to ensure their loved one received the care they needed. Some participants also described systemic barriers in their experiences with the healthcare system, including lack of cultural competency, leading to their concerns being dismissed and invalidated when they and their loved one did seek care. Another common theme involved barriers to FF-STB seeking support for themselves. This took the form of (1) FF-STB feeling exhausted in their support role, with no energy left to support themselves; (2) limited ability to engage in self-care activities, whether due to limited time or fear of leaving their loved one alone; and (3) privacy concerns about confiding in social support systems if their loved one did not want others to know about their suicidality.
Suggested FIRST Program topics included how to manage the day-to-day support experience (e.g., how to support their loved one in the time between discharge from crisis care at a hospital and follow-up with community service; information about medication safety, side effects, and warning signs). Participants described the immense feelings of responsibility being a sole supporter, expressing a need for strategies to create a support network for their loved one beyond just themselves. Some also suggested additional guidance on how to advocate for their loved one in healthcare settings, including how to effectively communicate with healthcare professionals (e.g., key information to include, how to prepare written documents). Regarding program format, participants noted preferences for both in-person and virtual options, with some noting the accessibility advantages of virtual sessions for those who are unable to leave their loved one alone due to safety concerns. Some suggested FIRST include information tailored to specific groups' needs (e.g., parent, spouse, friend).
FIRST Program The structure and content of FIRST was directly informed by the pilot data above and by the CAC, composed of 5 individuals with lived experience of suicide risk, caregiving, or loss. The FIRST Program is designed as a 6-week program with flexibility for both in-person and virtual delivery based on caregiver participant preference.
Structure: The FIRST Program consists of six 90-minute group sessions (12 people), each co-facilitated by a mental health clinician and a trained peer facilitator with lived experience of suicide risk. Trained peer facilitators will be on boarded as an independent contractor and provided with institutional access.
Format: It is designed to be delivered in person within community/hospital settings or virtually.
Program modules include the following topics:
STUDY OBJECTIVES
Study Aims
This study has two main objectives:
This protocol consists of a mixed-methods, single-arm pilot feasibility study of the FIRST Program with approximately 72 FF-STB participants.
Groups will be delivered in both in person and virtual formats, with some sessions offered in-person only and others virtual-only to increase accessibility. There will be no hybrid option offered throughout the duration of the session to maintain group dynamics and help with understanding which delivery method is preferred/suitable for FF-STB. To ensure the FIRST Program is feasible to implement with different delivery methods, we will run 6 rounds of the program:
500 studies on the registry are indexed under Caregiver Burden; 164 are open to participants now.
This study's planned enrollment of 72 is below the median of 100 across 80 observational studies indexed under Caregiver Burden.
Browse Caregiver Burden studies →Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Participants are individuals who identify as caring for a loved one who is experiencing suicidal thoughts or behaviours.
Inclusion Criteria:
Exclusion Criteria: impairment that would limit understanding of the FIRST Program (e.g., under the influence of substances or alcohol during FIRST sessions, cognitive impairment, active psychosis).
All participants will undergo the FIRST program
Other: FIRST Program
FIRST is a 6-week program co-facilitated by one peer facilitator with lived experience and one mental health professional. Each session will be approximately 90 minutes in length with \~12 caregiver participants per group.
Feasibility of running the FIRST program in different settings/groups across Canada.
Feasibility will be measured by capturing enrollment rates, attendance, completeness of data, and adverse events.
Time frame: From enrollment until the end of the study period at 10 weeks.
Effectiveness of running the FIRST program in different settings/groups across Canada.
After each week of the program, caregiver participants will complete brief measures of knowledge, satisfaction, and caring confidence. A follow-up visit will be conducted 1 month after program completion, during which caregiver participants will complete the same questionnaires as baseline to evaluate potential longer-term impacts of the program.
Time frame: From enrollment until the end of the study period at 10 weeks.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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