Circle of Life. Improving Capacity of Swampy Cree Community Members to Recognize People at Risk for Suicide

Suicide Clinical Trial

Official title:

Circle of Life.Improving Capacity of Swampy Cree Community Members to Recognize People at Risk for Suicide: A Randomized Controlled Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01287416
• Other study ID #: H2010:192
• Status: Completed
• Phase: N/A
• First received: January 10, 2011
• Last updated: April 9, 2014
• Start date: July 2010
• Est. completion date: February 2011

Study information

• Verified date: April 2014
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial Summary

Primary Hypothesis: Participants in the Applied Suicide Intervention Skills Training (ASIST) gatekeeper training will be significantly more likely to have increased knowledge and preparedness to help people with suicidal ideation than participants who receive the resilience retreat.

Secondary Hypotheses:

1. Participants in ASIST gatekeeper training will not have higher levels of post-intervention distress or suicidal ideation compared to the resilience retreat.

2. High levels of distress, grief, and alcohol abuse will significantly impact on the learning and retention of suicide intervention skills.

Description:

Inclusion criterion: All members of the Swampy Cree Tribal communities who are currently residing on the reserves will be eligible to participate in the study.

Exclusion criterion: Exclusion criteria for the study include being less than 16 years of age, prior training in SafeTALK or ASIST, being an elected official in a First Nations community, and inability to read or write.

Primary outcome: Skills in Suicide Intervention: Suicide Intervention Response Inventory.The Suicide Intervention Response Inventory (SIRI) will be used to detect enhancement of intervention skills in participants. The SIRI is a self-administered test that was designed to measure competence in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI has shown its good psychometric properties, freedom from social desirability effects, and responsiveness to training in suicide prevention. It contains 25 items, each of which consists of a "client" remark and two "helper" responses. Responses are judged based on response options made by highly expert suicidologists. The SIRI has shown good internal consistency with alpha of 0.834, and good test-retest reliability.

Secondary Outcomes:

• Knowledge about suicide, attitudes toward suicide, and self-reported preparedness to intervene with suicidal behavior will be measured by a series of questions that were developed by LivingWorks Inc.

• Gatekeeper behaviors will be measured similar to questions utilized by Wyman in the school-based study that assess how many people had the person asked others about suicide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• All members of the Swampy Cree Tribal communities who are currently residing on the reserves will be eligible to participate in the study.

Exclusion Criteria:

• being less than 16 years of age

• prior training in SafeTALK or ASIST

• being an elected official in a First Nations community

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Suicide

Intervention

Behavioral:
• Applied Suicide Intervention Skills Training
Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop.
• Resilience Retreat
The Resilience Retreat is a 2-day, 14 hour session

Locations

Country	Name	City	State
Canada	University of Manitoba Department of Psychiatry	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIRI Questionnaire Score	The Suicide Intervention Response Inventory (SIRI-2) will be used to detect enhancement of intervention skills in participants. The 25-item SIRI-2 is a self-administered test that was designed to measure competnce in choosing appropriate response to a series of clinical scenarios with suicidal individuals. Research on the SIRI-2 has shown its good psychometric properties, freedom from social desirabiity effects and responsiveness to training in suicide prevention.	pre-training, post-training and 6 mo follow up	No
Secondary	Self-perceived Confidence in Helping a Suicidal Individual	Meaures the level of confidence that the individual believes they have in helping a suicidal person based on a 4 point Likert scale ranging from 1 (not at all confident) to 4 (very confident).	pre-training, post-training and 6 month 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 4 point Likert scale ranging from 1 (not at all skilled) to 4 (very skilled).	pre-training, post-training and 6 month 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 4 point Likert scale ranging from 1 (not at all knowledgeable) to 4 (very knowledgeable).	pre-training, post-training and 6 month follow-up	No
Secondary	Self-perceived Preparedness	Measures the level of preparedness of the individual to help someone who is suicidal based on a 4 point Likert scale ranging from 1 (not at all prepared) to 4 (very prepared).	pre-training, post-training and 6 month follow-up	No
Secondary	Self-reported Distress	Measures the level of distress in the participant using the K6 distress scale. The scale is comprised of six questions which are scored from 0 (none of the time) to 4 (all of the time). The sum of the scores from all six questions was used to determine a total scale score which ranges from 0 (not at all distressed) to 24 (very distressed).	pre-training and 6 month follow-up	No
Secondary	Self-reported Alcohol Use	Details participants' level of alcohol consumption and if it may be harmful according to the AUDIT. The AUDIT scale is comprised of ten questions with most questions being scored from 0 (never) to 4 (4 or more times per week). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (no risk related to alcohol) to 40 (high risk related to alcohol). Total scores of 8 or more are recommended as indicators of hazardous and harmful alcohol use, as well as possible alcohol dependence.	pre-training and 6 month follow-up	No
Secondary	Self-reported Resiliency Score	Assesses resiliency in the participant according to the Connor-Davidson Resilience Scale, 10-item. The CD-RISC 10 is comprised of ten questions scored from 0 (Not at all true) to 4 (True nearly all of the time). The sum of the scores from all ten questions was used to determine a total scale score which ranges from 0 (low resiliency) to 40 (highly resilient).	pre-training and 6 month follow-up	No
Secondary	Lifetime Suicidal Ideation at Baseline	Number of people who endorsed having thought about suicide in their lifetime as measured at baseline	July 19-20, 2010	Yes
Secondary	Lifetime Suicide Attempt at Baseline	Number of people who endorsed having made a suicide attempt in their lifetime as measured at baseline	July 19-20, 2010	Yes
Secondary	Suicidal Ideation in Past 2 Days at Baseline	Number of people who endorsed having thought about suicide in the past 2 days as measured at baseline (not at all vs a little to a lot)	July 19-20, 2010	Yes
Secondary	Number of People With Suicidal Ideation in Past 2 Days Immediately Post Training	Number of people who endorsed having thought about suicide in the past 2 days as measured immediately post training (not at all vs a little to a lot)	July 22-23, 2010	Yes
Secondary	Suicidal Ideation Since Training at 6 mo Follow-up	Number of people who endorsed having thought about suicide since the training as measured at 6 month follow-up (not at all vs a little to a lot)	January 28-31, 2011	Yes
Secondary	Attempted Suicide Since Training at 6 mo Follow-up	Number of people who endorsed having made a suicide attempt since the training as measured at 6 month follow-up	January 28-31, 2011	Yes
Secondary	Gatekeeper Behaviors - Asked Person at Risk About Suicidal Thoughts	Number of participants who have asked someone that they thought was at risk about suicidal thoughts since the training, measured at 6 month follow-up assessment.	January 28-31, 2011	No
Secondary	Gatekeeper Behaviours - Did Not Ask Person at Risk	Number of participants who did not ask someone about their suicidal thoughts even though they thought they were at risk, measured at 6 month follow-up assessment based on time since training.	January 28-31, 2011	No