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CaregiverFIRSTNCT07902089

Friends/Family of Individuals at Risk of Suicide Training Program

An observational study of Caregiver and Caregiver Mental Health, run by Unity Health Toronto at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
What is being tested?
FIRST Program
How many people
72 participants
Where
1 siteCanada
Study dates
30 Sep 2026to 31 Mar 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Participants are individuals who identify as caring for a loved one who is experiencing suicidal thoughts or behaviours.

Who may be able to join

  • Aged 19 years or older
  • In-person (Toronto) and Virtual (Toronto) group: live in the Greater Toronto Area
  • Virtual (National) group: live in Canada
  • Able to communicate in English
  • Self-identify as FF-STB
  • For participants completing the study virtually: Access to a computer, tablet, or mobile phone with a camera and Internet access
  • 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).

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site, 1 recruiting
  • Unity Health Toronto

    Toronto, Ontario, M5B 1W8

    Elise Jackson, 416-360-4000 ext. 7844, Elise.Jackson@unityhealth.to

    Recruiting

Other trials in Canada

About this study

Official title: A Pilot Feasibility Study of the Friends/Family of Individuals at Risk of Suicide Training Program

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.

Read the detailed description

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:

  • Education: information about mental health conditions, emphasizing that suicidality is a spectrum; warning signs and next steps; medication safety (side effects, what to watch out for); understanding cultural aspects including historical and current contexts
  • Day-to-day management: knowing when it is safe to leave a loved one alone/when in the journey it is safe to decrease intensity of support; managing time between emergency visit and outpatient appointment; navigating if loved one refuses help; managing long-distance support
  • Managing practical aspects: how to integrate return to school/employment; how to manage supporting a loved one with suicide risk amid other life stressors and transitions (e.g., marital separation)
  • Skills building: how to validate loved one's experience; dos and don'ts of what to say; how to speak with other family and friends; how to sit in discomfort, strategies to step away/holding manageable expectations from being the 'fixer'
  • Navigating the health care system: navigating local resources and crisis supports, including non-police response; strategies to effectively communicate with health care providers (including how to write an effective written summary, how to track medications, etc.); knowing how to advocate and push the system; understanding the limitations and potential harms of the healthcare system
  • Self-care for FF-STB: how to balance supporting oneself and loved one and set healthy boundaries: how to build a support network for self and loved one.

STUDY OBJECTIVES

Study Aims

This study has two main objectives:

  1. To evaluate the feasibility and acceptability of the FIRST Program with a community sample of FF-STB using a mixed-methods approach; and
  2. To collect preliminary effectiveness data regarding the impact of the FIRST Program on improving FF-STB self-efficacy, caring competence, knowledge and attitudes toward suicide, and caregiver mental health.

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:

  1. In-person (Toronto): group session in Toronto at SMH location
  2. Virtual (Toronto): group session over a institutionally approved videoconferencing platform for participants within the Greater Toronto Area
  3. Virtual or In-person (Toronto): group session for racialized individuals either in Toronto at SMH location or over a institutionally approved videoconferencing platform depending on participant preference within the Greater Toronto Area
  4. Virtual (Nova Scotia): two group sessions over a institutionally approved videoconferencing platform for participants currently residing in Nova Scotia
  5. Virtual (national): group session over a institutionally approved videoconferencing platform for participants across Canada To allow for comparability between cohorts, caregiver participants in groups 1 and 2 (in person and virtual) will both be recruited from the Toronto area. This will ensure that any similarities or differences we may observe between these two groups are likely due to the program's delivery method and not participants' location and access to services. A third group will be run for self-identified racialized individuals. A fourth group (2 FIRST sessions) will be run out of the province of Nova Scotia in partnership with Nova Scotia Health. Additionally a fifth group will also be run to evaluate the feasibility of running the FIRST Program nationally, which if successful, could significantly improve access to caregiver services across the country.
Being tested
FIRST Program
Keywords
suicide caregiver, loved one suicide, mental health caregiver
Medical subject headings
Caregiver Burden, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FIRST ProgramOther

    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.

Study groups in NCT07902089
Study groupRoleWhat they receive
FIRST ProgramAll participants will undergo the FIRST program
Receives: Other: FIRST Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From enrollment until the end of the study period at 10 weeks.

Secondary outcomes (1)
  1. 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.

    Measured: From enrollment until the end of the study period at 10 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2026
  2. Study start30 Sep 2026
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07902089
Sponsor's protocol ID
FFSI-02
Acronym
FIRST
Status last verified
Oct 2026
First submitted
14 Oct 2026
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Caregiver and Caregiver Mental Health, run by Unity Health Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Elise Jackson (416-360-4000 ext. 7844, elise.jackson@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility of running the FIRST program in different settings/groups across Canada. (time frame: From enrollment until the end of the study period at 10 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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