Clinical trial NCT02118116: The Safety and Effectiveness of Gatekeeper Training in First Nations Communities
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Applied Suicide Intervention Skills Training
Keywords: ASIST, gatekeeper, suicide, intervention, First Nations, Aboriginal, educational, prevention, safety
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Manitoba Health
name: First Nations and Inuit Health
First posted: 2014-04-21
Enrollment: 0
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Gatekeeper training is where people in the community are trained to recognize and identify those who are at risk for suicide and assist them in getting care. Gatekeeper training has been widely implemented around the world. There are two types of gatekeepers: 1) Designated gatekeepers - individuals who have been trained in helping professions (medicine, psychology, social work, nursing), and 2) Emergent gatekeepers - individuals who are not in caregiving roles (family members, police, teachers, clergy). Applied Suicide Intervention Skills Training (ASIST) has been implemented in Manitoba. However, a recent randomized controlled trial in First Nations community members (emergent gatekeepers) from the Swampy Cree Tribal Council (Northwestern Manitoba) demonstrated that the training had no positive impact on self-reported gatekeeper skills or behavior. Also, compared to a resilience retreat, the ASIST training was associated with a slightly higher likelihood of reporting suicidal ideation. The demonstrated lack of efficacy and the possibility of adverse effects associated with this training program in this vulnerable group have raised concerns about the safety and efficacy of ASIST. There were several key limitations of the previous study. First, the study only recruited community members (emergent gatekeepers), therefore findings may not be generalizable to designated gatekeepers (clinicians, nurses, counselors). Second, the study had a small sample size (n=55) and may have not been large enough to detect small effects that are often associated with educational interventions. Finally, the increase in distress in the ASIST trained group may not have been directly related to the training. To overcome the above limitations, we aim to conduct a larger evaluation of the safety and effectiveness of gatekeeper training that is occurring in Manitoba First Nations, Inuit and Metis communities. Based on previous work that suggests designated gatekeepers are more likely to benefit from gatekeeper training than emergent gatekeepers, we will examine these groups separately.

Hypotheses: 1) ASIST will be associated with an increase in gatekeeper skills and behaviors; 2) ASIST will have a stronger impact on designated gatekeepers than emergent gatekeepers; 3) ASIST will not be associated with an increase in suicidal ideation or distress.


Eligibility criteria: Inclusion Criteria:

* English speaking
* currently living or working in First Nations, Inuit, or Metis communities in Manitoba
* 16 years of age or older

Exclusion Criteria:

* does not speak English
* \<16 years of age

Primary outcomes:
measure: Number of people asked about suicidal thoughts
timeFrame: up to 6 months follow-up
Secondary outcomes:
measure: Self-perceived Confidence in Helping a Suicidal Individual
timeFrame: up to 6 months follow-up
measure: Self-perceived Skill in Helping a Suicidal Individual
timeFrame: up to 6 months follow-up
measure: Self-perceived Knowledge About Suicide
timeFrame: up to 6 months follow-up
measure: Self-perceived Preparedness
timeFrame: up to 6 months follow-up
measure: Suicidal ideation in past 6 months
timeFrame: up to 6 months follow-up
measure: Suicidal Ideation in Past 2 Days
timeFrame: 2 days
measure: Suicide Attempt in Past 2 Days
timeFrame: 2 days
measure: Suicide Attempt in past 6 months
timeFrame: up to 6 months
measure: Two-item Conjoint Screen (TICS) for alcohol and drugs
timeFrame: up to 6 months follow-up
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: up to 6 months follow-up
measure: Lifetime Suicidal Ideation at Baseline
timeFrame: Baseline
measure: Lifetime Suicide Attempt at Baseline
timeFrame: Baseline
measure: Complicated grief at baseline
timeFrame: Baseline
measure: Number of respondents who asked someone about suicidal thoughts in past 6 months
timeFrame: up to 6 months follow-up
measure: How often asked a person about suicidal thoughts
timeFrame: up to 6 months follow-up
measure: Number of suicidal people identified
timeFrame: up to 6 months follow-up
measure: Number of suicidal people treated
timeFrame: up to 6 months follow-up
measure: Number of respondents who did not ask someone about suicidal thoughts in past 6 months
timeFrame: up to 6 months follow-up
measure: Suicide attitudes
timeFrame: up to 6 months follow-up
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Jitender Sareen, MD
role: PRINCIPAL_INVESTIGATOR
References: