- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01287416
Circle of Life. Improving Capacity of Swampy Cree Community Members to Recognize People at Risk for Suicide
Circle of Life.Improving Capacity of Swampy Cree Community Members to Recognize People at Risk for Suicide: A Randomized Controlled Pilot Study
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:
- Participants in ASIST gatekeeper training will not have higher levels of post-intervention distress or suicidal ideation compared to the resilience retreat.
- High levels of distress, grief, and alcohol abuse will significantly impact on the learning and retention of suicide intervention skills.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3E 3N4
- University of Manitoba Department of Psychiatry
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Applied Suicide Intervention Skills Training (ASIST)
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.
The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community.
Participants range from those in caring roles to people concerned about family members or friends.
The theory is that suicide can be pre¬vented with the help of prepared caregivers.
ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk.
Just as "CPR" skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid.
|
Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop.
Other Names:
|
|
Active Comparator: Resilience Retreat
The two days will be divided into cultural activities, sharing circles, small group discussions, story telling and dance.
Two First Nations community leaders will be identified to lead each of the two retreats.
|
The Resilience Retreat is a 2-day, 14 hour session
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
SIRI Questionnaire Score
Time Frame: pre-training, post-training and 6 mo follow up
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-perceived Confidence in Helping a Suicidal Individual
Time Frame: pre-training, post-training and 6 month follow-up
|
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
|
|
Self-perceived Skill in Helping a Suicidal Individual
Time Frame: pre-training, post-training and 6 month follow-up
|
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
|
|
Self-perceived Knowledge About Suicide
Time Frame: pre-training, post-training and 6 month follow-up
|
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
|
|
Self-perceived Preparedness
Time Frame: pre-training, post-training and 6 month follow-up
|
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
|
|
Self-reported Distress
Time Frame: pre-training and 6 month follow-up
|
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
|
|
Self-reported Alcohol Use
Time Frame: pre-training and 6 month follow-up
|
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
|
|
Self-reported Resiliency Score
Time Frame: pre-training and 6 month follow-up
|
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
|
|
Lifetime Suicidal Ideation at Baseline
Time Frame: July 19-20, 2010
|
Number of people who endorsed having thought about suicide in their lifetime as measured at baseline
|
July 19-20, 2010
|
|
Lifetime Suicide Attempt at Baseline
Time Frame: July 19-20, 2010
|
Number of people who endorsed having made a suicide attempt in their lifetime as measured at baseline
|
July 19-20, 2010
|
|
Suicidal Ideation in Past 2 Days at Baseline
Time Frame: July 19-20, 2010
|
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
|
|
Number of People With Suicidal Ideation in Past 2 Days Immediately Post Training
Time Frame: July 22-23, 2010
|
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
|
|
Suicidal Ideation Since Training at 6 mo Follow-up
Time Frame: January 28-31, 2011
|
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
|
|
Attempted Suicide Since Training at 6 mo Follow-up
Time Frame: January 28-31, 2011
|
Number of people who endorsed having made a suicide attempt since the training as measured at 6 month follow-up
|
January 28-31, 2011
|
|
Gatekeeper Behaviors - Asked Person at Risk About Suicidal Thoughts
Time Frame: January 28-31, 2011
|
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
|
|
Gatekeeper Behaviours - Did Not Ask Person at Risk
Time Frame: January 28-31, 2011
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jitender Sareen, MD, Department of Psychiatry, Faculty of Medicine, University of Manitoba
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H2010:192
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Suicide
-
University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts
-
Dartmouth-Hitchcock Medical CenterNational Institute of Nursing Research (NINR); Trustees of Dartmouth CollegeNot yet recruitingSuicide Attempt | Suicide IdeationUnited States
-
University of North Carolina, Chapel HillVillage Heartbeat, Inc.RecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Fundació Institut de Recerca de l'Hospital de la...Not yet recruitingSuicide | Suicide Risk | Suicide Attempt | Suicide Ideation | Suicide PreventionSpain
-
University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH); Robert Wood Johnson FoundationRecruitingSuicide | Suicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
VA Office of Research and DevelopmentRecruitingSuicide Attempt | Suicide Ideation | Suicide PreventionUnited States
-
Syeda AYAT E ZAINAB AliUniversity of Leicester; University of WuerzburgRecruitingSuicide, Attempted | Suicide | Suicide Prevention | Completed SuicidePakistan
-
Seattle Children's HospitalNationwide Children's HospitalRecruitingSuicidal Ideation | Suicide Threat | Suicide and Self-harm | Suicide AttemptsUnited States
-
University of ChicagoNational Institute of Mental Health (NIMH)RecruitingSuicidal Ideation | Suicide | Suicide AttemptUnited States
-
Franciscan Hospital For Children, INC.National Institute of Mental Health (NIMH); Harvard UniversityRecruitingSuicidal Ideation | Self-Injurious Behavior | Suicide AttemptsUnited States
Clinical Trials on Applied Suicide Intervention Skills Training
-
University of ManitobaManitoba Health; First Nations and Inuit HealthWithdrawnApplied Suicide Intervention Skills TrainingCanada
-
University of WashingtonCompleted
-
Aydin Adnan Menderes UniversityThe Scientific and Technological Research Council of TurkeyRecruitingSuicidal Ideation | Suicide Prevention | School CounselingTurkey (Türkiye)
-
VA Office of Research and DevelopmentCompletedSchizophrenia | Schizoaffective DisorderUnited States
-
Arizona State UniversityCompletedDementia | Alzheimer Disease | Memory LossUnited States
-
Arizona State UniversityNational Institute on Aging (NIA)RecruitingDementia | Mild Cognitive Impairment (MCI) | Alzheimer DiseaseUnited States
-
Johns Hopkins UniversityNational Heart, Lung, and Blood Institute (NHLBI)Completed
-
University of Sao PauloUnknownSchizophrenia and Disorders With Psychotic FeaturesBrazil
-
Mayo ClinicNational Institute on Drug Abuse (NIDA)Completed
-
Duke UniversityNational Brain Tumor Foundation(NBTF)Terminated