Applied Suicide Intervention Skills Training Clinical Trial
| Verified date | January 2014 |
| Source | University of Manitoba |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Canadian Institutes of Health Research |
| Study type | Interventional |
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 16 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| Canada | University of Manitoba | Winnipeg | Manitoba |
| Lead Sponsor | Collaborator |
|---|---|
| University of Manitoba | First Nations and Inuit Health, Manitoba Health |
Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of people asked about suicidal thoughts | This measure asks how many people the respondent asked about suicidal thoughts in a 6 month time frame. The measure asks about 3 different life domains: in their personal life (e.g., friend or family member), in their professional life (e.g., client or work colleague), or other (person not work related or family/friend). Respondents provide a response to the number of people in each of these three domains. The total score will be the sum of the number of people asked across all 3 life domains. | up to 6 months follow-up | No |
| Secondary | Self-perceived Confidence in Helping a Suicidal Individual | Measures the level of confidence that the individual believes they have in helping a suicidal person based on a 5 point Likert scale ranging from 1 (very low) to 5 (very high). | up to 6 months follow-up | No |
| Secondary | Self-perceived Skill in Helping a Suicidal Individual | Measures the level of ability that the individual believes they have in helping a suicidal person based on a 5 point Likert scale ranging from 1 (very low) to 5 (very high) | up to 6 months follow-up | No |
| Secondary | Self-perceived Knowledge About Suicide | Measures the level of knowledge about suicide that the individual believes they have based on a 5 point Likert scale ranging from 1 (very low) to 5 (very high) | up to 6 months follow-up | No |
| Secondary | Self-perceived Preparedness | Measures the level of preparedness of the individual to help someone who is suicidal based on a 5 point Likert scale ranging from 1 (very low) to 5 (very high). | up to 6 months follow-up | No |
| Secondary | Suicidal ideation in past 6 months | Number of people who endorsed having thought about suicide in the past 6 months. | up to 6 months follow-up | Yes |
| Secondary | Suicidal Ideation in Past 2 Days | Number of people who endorsed having thought about suicide in the past 2 days | 2 days | Yes |
| Secondary | Suicide Attempt in Past 2 Days | Number of people who endorsed having attempted suicide in the past 2 days | 2 days | Yes |
| Secondary | Suicide Attempt in past 6 months | Number of people who endorsed having attempted suicide in the past 6 months. | up to 6 months | Yes |
| Secondary | Two-item Conjoint Screen (TICS) for alcohol and drugs | The Two-Item Conjoint Screen (TICS) has been used in primary care to identify patients with current alcohol or other drug problems [Brown RL et al, 2001]. At least one positive response to the TICS in the last year detected current substance use disorders with nearly 80% sensitivity and specificity. The scale is composed of two-items which have yes/no responses. | up to 6 months follow-up | Yes |
| Secondary | Patient Health Questionnaire (PHQ-9) | The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 scores of 5, 10, 15, and 20 represents mild, moderate, moderately severe and severe depression. The PHQ-9 is comprised of 10 items with questions 1-9 being scored from 0 (not at all) to 3 (nearly every day). Question 10 is answered only if the individual score 1 or higher on any of questions 1-9 and is scored from 0 (not at all difficult) to 3 (extremely difficult). To determine severity, the individual must score a 2 or 3 on either of questions 1 or 2 and question 10 must score 1 or higher. Total severity is determined from adding scores from questions 1-9. | up to 6 months follow-up | Yes |
| Secondary | Lifetime Suicidal Ideation at Baseline | Number of people who endorsed having thought about suicide in their lifetime as measured at baseline | Baseline | Yes |
| Secondary | Lifetime Suicide Attempt at Baseline | Number of people who endorsed having made a suicide attempt in their lifetime as measured at baseline | Baseline | Yes |
| Secondary | Complicated grief at baseline | The Inventory of Complicated Grief (ICG) is designed to assess indicators of pathological grief, such as anger, disbelief, and hallucinations. The instrument consists of 19 first-person statements concerning the immediate bereavement-related thoughts and behaviors of the client. There are 5 response options, ranging from "Never" to "Always." | Baseline | No |
| Secondary | Number of respondents who asked someone about suicidal thoughts in past 6 months | The question asks: In the past 6 months have you personally asked someone about suicidal thoughts when you were concerned they might be suicidal? Respondents can say yes or no. The total number of people who said yes at both time points will be reported. | up to 6 months follow-up | No |
| Secondary | How often asked a person about suicidal thoughts | Respondent was asked how often in the past 6 months that they asked a person about suicidal thoughts in four situations: 1) When the person said something about ending their life, 2) when the person seemed depressed, 3) when the person experienced a stressful life event, 4) when they had a feeling that there was something wrong. Responses options are a 5-point Likert scale ranging from never (0) to always (4). The total score was calculated based on the sum of scores across the four situations. | up to 6 months follow-up | No |
| Secondary | Number of suicidal people identified | The respondent is asked to give a count of the number of people who endorsed feeling suicidal when they were asked which gives an estimate of the number of suicidal people identified by the respondent (gatekeeper). Three life domains are assessed (personal life, professional life, and other). The total score is the sum of counts across the 3 life domains. | up to 6 months follow-up | No |
| Secondary | Number of suicidal people treated | The respondent is asked to give a count of the number of people who sought help for suicidal thoughts after they had asked them, providing some idea of how the gatekeeper model operated in getting people to care. Three life domains are assessed (personal life, professional life, and other). The total score is the sum of counts across the 3 life domains. | up to 6 months follow-up | No |
| Secondary | Number of respondents who did not ask someone about suicidal thoughts in past 6 months | The question asks: In the past 6 months were you ever unable or chose not to talk to someone directly about their suicidal thoughts even though you were concerned? Respondents can say yes or no. The total number of people who said yes at both time points will be reported. | up to 6 months follow-up | No |
| Secondary | Suicide attitudes | This measure was created by our group to assess attitudes about suicide based on items from previously published suicide attitudes questionnaires. It contains 9 first-person statements and is measured on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). The total score on the measure will be used. | up to 6 months follow-up | No |