SuicideNCT01252927
Evaluation of a Gatekeeper Training Program
A study testing ASIST in people with Suicide, run by University of Manitoba at 1 site in Canada.
Trial summary
The main objective of the proposed study is to evaluate the efficacy of a gatekeeper training suicide intervention program, Applied Suicide Intervention Skills Training (ASIST), in improving medical students' knowledge about suicide intervention, impact of attitudes on someone at risk for suicide and competent use of… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Suicide
- What is being tested?
- ASIST
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteCanada
- Study dates
- 27 Mar 2011to 1 Aug 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- all medical students at University of Manitoba
Who cannot join
- those who choose not to participate
- those who have already taken ASIST training or related SafeTALK training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Gatekeeper Training Program as Suicide Intervention Training for Medical Students
The main objective of the proposed study is to evaluate the efficacy of a gatekeeper training suicide intervention program, Applied Suicide Intervention Skills Training (ASIST), in improving medical students' knowledge about suicide intervention, impact of attitudes on someone at risk for suicide and competent use of intervention skills to recognize risk and intervene effectively compared to medical education as usual. This research project will be undertaken using a randomized-controlled trial design. Questionnaires and objective structured clinical examinations using simulated patients will be completed at three time points: 1) before training, 2) after training, and 3) at one year following the training. Medical students' clinical skills in recognizing risk and intervening with simulated patients, as well as knowledge about suicide intervention and the impact of attitudes on someone at risk for suicide will be evaluated.
Read the detailed description
The current proposal plans to implement and evaluate a secondary suicide intervention skills training program (gatekeeper training) in medical school students in Winnipeg, Manitoba, Canada. The main objective of the current proposal is to evaluate the effectiveness of a gatekeeper training program, Applied Suicide Intervention Skills Training (ASIST), in improving medical students' intervention skills with suicidal patients compared to training as usual. Secondary aims include comparisons of changes in knowledge, perceived competence and attitudes around suicide.
Findings from previous studies have demonstrated a significant positive effect of gatekeeper training on suicide prevention attitudes, skills and knowledge. As well, general studies in medical education reveal that students who have been able to practice, observe, and receive feedback in small groups showed an improvement in skills and confidence over those who were given didactic teaching only. Therefore, the investigators anticipate that the ASIST training program will significantly improve medical students' knowledge about suicide intervention, and will increase their recognition and response to suicide risk compared to education as usual. The investigators also expect that ASIST training will help them to understand the impact of attitudes on suicide prevention, and will increase their perceived competence and ability to recognize and treat a suicidal individual compare over training as usual. It is hypothesized that medical students trained in ASIST will differ significantly in their ability to correctly recognize and intervene with suicidal individuals based on their use of a standardized suicide intervention model and objective assessment using standardized patients.
- Conditions
- Suicide
- Being tested
- ASIST
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASISTOther
The gatekeeper training intervention group will receive the Applied Suicide Intervention Skills Training (ASIST) workshop in addition to training as usual. ASIST is a 2-day intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide.
| Study group | Role | What they receive |
|---|---|---|
| ASIST intervention | Experimental | The gatekeeper training intervention group received the Applied Suicide Intervention Skills Training (ASIST) 10.0 in addition to TAU. ASIST is a two-day (fourteen hour), intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The intervention was offered to students on a weekend and was conducted by three senior ASIST trainers and one junior trainer, with two trainers assigned to each training group. Receives: Other: ASIST |
| Control group: training as usual | No intervention | Training as usual consisted of didactic teaching and a tutorial with case-based examples around suicide risk factors in their first year of medical school. Third- and fourth-year students may also have the opportunity to practice their skills with real patients during their clerkship rotations or in the emergency department. |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSCE checklist total score
Four Objective Structured Clinical Examinations (OSCEs) stations were developed for each time point in the study. All student-patient interactions were videotaped. Raters blind to the student's group assignment rated the videos according to a checklist of desired gatekeeper behaviors based on the key components of the ASIST program. A total score was the sum of all behaviours performed.
Measured: 1 week before training, 1 week following training, and 4 years following training
SIRI-2 score
The Suicide Intervention Response Inventory (SIRI-2) is a self-administered questionnaire designed to measure competence in choosing appropriate responses to a series of clinical scenarios with suicidal individuals. It contains 25 items, each of which consists of a "client" remark and two "helper" responses. Respondents were instructed to evaluate the appropriateness of each of the two helper responses on a 7-point Likert scale, ranging from +3 (highly appropriate response) through 0 (neither appropriate nor inappropriate response) to -3 (highly inappropriate response). Ratings by a group of expert suicidologists and crisis interventionists provided a mean expert response criterion against which individual respondents are compared. The sum of the absolute value of the differences between the students' rating and the mean response from experts was calculated to obtain an overall score of how well the student performed with respect to expert responses.
Measured: 1 week before training, 1 week following training, and 4 years following training
OSCE global rating total score
Four Objective Structured Clinical Examinations (OSCEs) stations were developed for each time point in the study. All student-patient interactions were videotaped. Raters blind to the student's group assignment rated the videos. Raters were asked to give a global rating score according to the performance of each student in each of the 3 key areas trained by the ASIST program, and a global rating of the student's performance on the station in general. The sum of all global ratings was used to determine a total score.
Measured: 1 week before training, 1 week following training, and 4 years following training
Secondary outcomes (6)
self-perceived knowledge about suicide
A single question measured the level of knowledge about suicide that the individual believes they have. Response options were on a 4-point Likert scale from very to not at all.
Measured: 1 week before training, 1 week following training, and 4 years following training
self-perceived skill in helping a suicidal individual
A single question measured the level of ability that the individual believes they have in helping a suicidal person. Response options were on a 4-point Likert scale from very to not at all.
Measured: 1 week before training, 1 week following training, and 4 years following training
self-perceived confidence in helping a suicidal individual
A single question measured the level of confidence that the individual believes they have in helping a suicidal person. Response options were on a 4-point Likert scale from very to not at all.
Measured: 1 week before training, 1 week following training, and 4 years following training
Attitudes towards suicide total score
The Attitudes Towards Suicide Questionnaire (ATTS) was used to measure attitudes toward suicide. This scale is comprised of 37 items. Each item is rated on a 5-point Likert scale ranging from Strongly Disagree (1) to Strongly Agree (5). The total score of all 37 items was used for evaluation.
Measured: 1 week before training, 1 week following training, and 4 years following training
self-perceived preparedness
A single question measured the level of preparedness that the individual believes they have in dealing with a suicidal individual. Response options were on a 4-point Likert scale from very to not at all.
Measured: 1 week before training, 1 week following training, and 4 years following training
Total score on Interpersonal Skills Rating Scale
Interpersonal skills as rated by standardized patients in the OSCE setting according to the Interpersonal Skills Rating Scale. The IPS Rating Scale used 13 items to evaluate communication skills in the OSCE setting between patient and student from the patient's perspective, and included concepts such as empathy, respect, sensitivity, and listening skills. Each item was scored on a 7-point Likert scale from strongly agree to strongly disagree. The sum score of all 13 items was used for analysis.
Measured: 1 week before training, 1 week following training, and 4 years following training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study start27 Mar 2011
- Primary completion1 May 2015
- Study completion1 Aug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- 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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Shay-Lee Bolton, University of Manitoba
- Investigators
- Shay-Lee Bolton, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252927
- Sponsor's protocol ID
- H2009:073
- Status last verified
- Sep 2021
- First submitted
- 18 Aug 2010
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Gatekeeper Training Program as Suicide Intervention Training for Medical Students
- ClinicalTrials.gov ID
- NCT01252927
- Acronym / sponsor ID
- H2009:073
- Conditions
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- 27 Mar 2011 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 Aug 2015 (actual)
- First posted
- 3 Dec 2010 (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.
The main objective of the proposed study is to evaluate the efficacy of a gatekeeper training suicide intervention program, Applied Suicide Intervention Skills Training (ASIST), in improving medical students' knowledge about suicide intervention, impact of attitudes on someone at risk for suicide and competent use of intervention skills to recognize risk and intervene effectively compared to medical education as usual. This research project will be undertaken using a randomized-controlled trial design. Questionnaires and objective structured clinical examinations using simulated patients will be completed at three time points: 1) before training, 2) after training, and 3) at one year following the training. Medical students' clinical skills in recognizing risk and intervening with simulated patients, as well as knowledge about suicide intervention and the impact of attitudes on someone at risk for suicide will be evaluated.
Detailed description
The current proposal plans to implement and evaluate a secondary suicide intervention skills training program (gatekeeper training) in medical school students in Winnipeg, Manitoba, Canada. The main objective of the current proposal is to evaluate the effectiveness of a gatekeeper training program, Applied Suicide Intervention Skills Training (ASIST), in improving medical students' intervention skills with suicidal patients compared to training as usual. Secondary aims include comparisons of changes in knowledge, perceived competence and attitudes around suicide.
Findings from previous studies have demonstrated a significant positive effect of gatekeeper training on suicide prevention attitudes, skills and knowledge. As well, general studies in medical education reveal that students who have been able to practice, observe, and receive feedback in small groups showed an improvement in skills and confidence over those who were given didactic teaching only. Therefore, the investigators anticipate that the ASIST training program will significantly improve medical students' knowledge about suicide intervention, and will increase their recognition and response to suicide risk compared to education as usual. The investigators also expect that ASIST training will help them to understand the impact of attitudes on suicide prevention, and will increase their perceived competence and ability to recognize and treat a suicidal individual compare over training as usual. It is hypothesized that medical students trained in ASIST will differ significantly in their ability to correctly recognize and intervene with suicidal individuals based on their use of a standardized suicide intervention model and objective assessment using standardized patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASIST intervention | Experimental | Other: ASISTThe gatekeeper training intervention group received the Applied Suicide Intervention Skills Training (ASIST) 10.0 in addition to TAU. ASIST is a two-day (fourteen hour), intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The intervention was offered to students on a weekend and was conducted by three senior ASIST trainers and one junior trainer, with two trainers assigned to each training group. |
| Control group: training as usual | No intervention | –Training as usual consisted of didactic teaching and a tutorial with case-based examples around suicide risk factors in their first year of medical school. Third- and fourth-year students may also have the opportunity to practice their skills with real patients during their clerkship rotations or in the emergency department. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- all medical students at University of Manitoba
Key exclusion criteria (2 listed)
- those who choose not to participate
- those who have already taken ASIST training or related SafeTALK training
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 |
|---|---|---|
| ASISTThe gatekeeper training intervention group will receive the Applied Suicide Intervention Skills Training (ASIST) workshop in addition to training as usual. ASIST is a 2-day intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. | Other | ASIST intervention |
Primary outcome
OSCE checklist total score
Time frame: 1 week before training, 1 week following training, and 4 years following training
Four Objective Structured Clinical Examinations (OSCEs) stations were developed for each time point in the study. All student-patient interactions were videotaped. Raters blind to the student's group assignment rated the videos according to a checklist of desired gatekeeper behaviors based on the key components of the ASIST program. A total score was the sum of all behaviours performed.
SIRI-2 score
Time frame: 1 week before training, 1 week following training, and 4 years following training
The Suicide Intervention Response Inventory (SIRI-2) is a self-administered questionnaire designed to measure competence in choosing appropriate responses to a series of clinical scenarios with suicidal individuals. It contains 25 items, each of which consists of a "client" remark and two "helper" responses. Respondents were instructed to evaluate the appropriateness of each of the two helper responses on a 7-point Likert scale, ranging from +3 (highly appropriate response) through 0 (neither appropriate nor inappropriate response) to -3 (highly inappropriate response). Ratings by a group of expert suicidologists and crisis interventionists provided a mean expert response criterion against which individual respondents are compared. The sum of the absolute value of the differences between the students' rating and the mean response from experts was calculated to obtain an overall score of how well the student performed with respect to expert responses.
OSCE global rating total score
Time frame: 1 week before training, 1 week following training, and 4 years following training
Four Objective Structured Clinical Examinations (OSCEs) stations were developed for each time point in the study. All student-patient interactions were videotaped. Raters blind to the student's group assignment rated the videos. Raters were asked to give a global rating score according to the performance of each student in each of the 3 key areas trained by the ASIST program, and a global rating of the student's performance on the station in general. The sum of all global ratings was used to determine a total score.
6 secondary outcomes
self-perceived knowledge about suicide
Time frame: 1 week before training, 1 week following training, and 4 years following training
self-perceived skill in helping a suicidal individual
Time frame: 1 week before training, 1 week following training, and 4 years following training
self-perceived confidence in helping a suicidal individual
Time frame: 1 week before training, 1 week following training, and 4 years following training
Attitudes towards suicide total score
Time frame: 1 week before training, 1 week following training, and 4 years following training
self-perceived preparedness
Time frame: 1 week before training, 1 week following training, and 4 years following training
Total score on Interpersonal Skills Rating Scale
Time frame: 1 week before training, 1 week following training, and 4 years following training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
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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.
Shay-Lee Bolton, PhD 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 ASIST in people with Suicide, 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 1 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: finished, as of the sponsor's last update on 17 Sep 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
OSCE checklist total score (time frame: 1 week before training, 1 week following training, and 4 years following training). The study lists 3 primary outcomes in all. 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 17 Sep 2021.