Applied Suicide Intervention Skills TrainingNCT02118116
The Safety and Effectiveness of Gatekeeper Training in First Nations Communities
A study testing Applied Suicide Intervention Skills Training in people with Applied Suicide Intervention Skills Training, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Applied Suicide Intervention Skills Training
- What is being tested?
- Applied Suicide Intervention Skills Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- English speaking
- currently living or working in First Nations, Inuit, or Metis communities in Manitoba
- 16 years of age or older
Who cannot join
- does not speak English
- <16 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Applied Suicide Intervention Skills Training
- Keywords
- ASIST, gatekeeper, suicide, intervention, First Nations, Aboriginal, educational, prevention, safety
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Applied Suicide Intervention Skills TrainingOther
Also called ASIST
Applied Suicide Intervention Skills Training is a 2-day, 14-hour intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The ASIST program has five learning sections: 1) Preparing - Sets the tone, norms, and expectations of the workshop; 2) Connecting - allows participants to explore their own attitudes towards suicide and creates an understanding of the impact that attitudes have on the intervention process. 3) Understanding - Describes the intervention needs of a person at risk. 4) Assisting - Presents a model for suicide intervention. 5) Networking - Generates information about resources in the local community.
| Study group | Role | What they receive |
|---|---|---|
| Wait-list Control | No intervention | No training, wait-listed for ASIST at a later date |
| ASIST | Experimental | Applied Suicide Intervention Skills Training is a 2-day, 14 hour intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The course, facilitated by 2 trained facilitators, allows for a maximum enrollment of 30 participants. Receives: Other: Applied Suicide Intervention Skills Training |
| ASIST uncontrolled arm | Experimental | The ASIST workshop will be offered to participants who refuse to be part of the waitlist control arm. This is due to the reality in gathering data in these communities. Many times it is not possible for participants to be waitlisted, and therefore we would still want to gather data on those that refuse to participate in the RCT design and will collect uncontrolled data on these participants only. Receives: Other: Applied Suicide Intervention Skills Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months follow-up
Secondary outcomes (19)
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).
Measured: up to 6 months follow-up
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)
Measured: up to 6 months follow-up
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)
Measured: up to 6 months follow-up
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).
Measured: up to 6 months follow-up
Suicidal ideation in past 6 months
Number of people who endorsed having thought about suicide in the past 6 months.
Measured: up to 6 months follow-up
Suicidal Ideation in Past 2 Days
Number of people who endorsed having thought about suicide in the past 2 days
Measured: 2 days
Suicide Attempt in Past 2 Days
Number of people who endorsed having attempted suicide in the past 2 days
Measured: 2 days
Suicide Attempt in past 6 months
Number of people who endorsed having attempted suicide in the past 6 months.
Measured: up to 6 months
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.
Measured: up to 6 months follow-up
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.
Measured: up to 6 months follow-up
Lifetime Suicidal Ideation at Baseline
Number of people who endorsed having thought about suicide in their lifetime as measured at baseline
Measured: Baseline
Lifetime Suicide Attempt at Baseline
Number of people who endorsed having made a suicide attempt in their lifetime as measured at baseline
Measured: Baseline
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."
Measured: Baseline
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.
Measured: up to 6 months follow-up
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.
Measured: up to 6 months follow-up
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.
Measured: up to 6 months follow-up
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.
Measured: up to 6 months follow-up
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.
Measured: up to 6 months follow-up
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.
Measured: up to 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: unable to recruit participants due to political issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Applied Suicide Intervention Skills TrainingStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Health, First Nations and Inuit Health
- Responsible party
- Sponsor
- Investigators
- Jitender Sareen, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118116
- Sponsor's protocol ID
- 2013:380
- Status last verified
- Jan 2014
- First submitted
- 16 Apr 2014
- Last updated
- 21 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness of Gatekeeper Training in First Nations Communities
- ClinicalTrials.gov ID
- NCT02118116
- Acronym / sponsor ID
- 2013:380
- Keywords
- ASIST, gatekeeper, suicide, intervention, First Nations, Aboriginal, educational, prevention, safety
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to recruit participants due to political issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Health, First Nations and Inuit Health
- Study start
- Jun 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Wait-list Control | No intervention | –No training, wait-listed for ASIST at a later date |
| ASIST | Experimental | Other: Applied Suicide Intervention Skills TrainingApplied Suicide Intervention Skills Training is a 2-day, 14 hour intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The course, facilitated by 2 trained facilitators, allows for a maximum enrollment of 30 participants. |
| ASIST uncontrolled arm | Experimental | Other: Applied Suicide Intervention Skills TrainingThe ASIST workshop will be offered to participants who refuse to be part of the waitlist control arm. This is due to the reality in gathering data in these communities. Many times it is not possible for participants to be waitlisted, and therefore we would still want to gather data on those that refuse to participate in the RCT design and will collect uncontrolled data on these participants only. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- English speaking
- currently living or working in First Nations, Inuit, or Metis communities in Manitoba
- 16 years of age or older
Key exclusion criteria (2 listed)
- does not speak English
- <16 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Applied Suicide Intervention Skills TrainingAlso: ASISTApplied Suicide Intervention Skills Training is a 2-day, 14-hour intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The ASIST program has five learning sections: 1) Preparing - Sets the tone, norms, and expectations of the workshop; 2) Connecting - allows participants to explore their own attitudes towards suicide and creates an understanding of the impact that attitudes have on the intervention process. 3) Understanding - Describes the intervention needs of a person at risk. 4) Assisting - Presents a model for suicide intervention. 5) Networking - Generates information about resources in the local community. | Other | ASIST, ASIST uncontrolled arm |
Primary outcome
Number of people asked about suicidal thoughts
Time frame: up to 6 months follow-up
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.
19 secondary outcomes
Self-perceived Confidence in Helping a Suicidal Individual
Time frame: up to 6 months follow-up
Self-perceived Skill in Helping a Suicidal Individual
Time frame: up to 6 months follow-up
Self-perceived Knowledge About Suicide
Time frame: up to 6 months follow-up
Self-perceived Preparedness
Time frame: up to 6 months follow-up
Suicidal ideation in past 6 months
Time frame: up to 6 months follow-up
Suicidal Ideation in Past 2 Days
Time frame: 2 days
Suicide Attempt in Past 2 Days
Time frame: 2 days
Suicide Attempt in past 6 months
Time frame: up to 6 months
Two-item Conjoint Screen (TICS) for alcohol and drugs
Time frame: up to 6 months follow-up
Patient Health Questionnaire (PHQ-9)
Time frame: up to 6 months follow-up
Lifetime Suicidal Ideation at Baseline
Time frame: Baseline
Lifetime Suicide Attempt at Baseline
Time frame: Baseline
Complicated grief at baseline
Time frame: Baseline
Number of respondents who asked someone about suicidal thoughts in past 6 months
Time frame: up to 6 months follow-up
How often asked a person about suicidal thoughts
Time frame: up to 6 months follow-up
Number of suicidal people identified
Time frame: up to 6 months follow-up
Number of suicidal people treated
Time frame: up to 6 months follow-up
Number of respondents who did not ask someone about suicidal thoughts in past 6 months
Time frame: up to 6 months follow-up
Suicide attitudes
Time frame: up to 6 months follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jitender Sareen, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Applied Suicide Intervention Skills Training in people with Applied Suicide Intervention Skills Training, run by University of Manitoba 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 3 inclusion and 2 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: withdrawn, as of the sponsor's last update on 21 Oct 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of people asked about suicidal thoughts (time frame: up to 6 months follow-up). 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 21 Oct 2016.