NCT02118116

Brief 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. 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

October 21, 2016

Status Verified

January 1, 2014

Enrollment Period

1.5 years

First QC Date

April 16, 2014

Last Update Submit

October 19, 2016

Conditions

Keywords

ASIST, gatekeeper, suicide, intervention, First Nations, Aboriginal, educational, prevention, safety

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (19)

  • Self-perceived Confidence in Helping a Suicidal Individual

    up to 6 months follow-up

  • Self-perceived Skill in Helping a Suicidal Individual

    up to 6 months follow-up

  • Self-perceived Knowledge About Suicide

    up to 6 months follow-up

  • Self-perceived Preparedness

    up to 6 months follow-up

  • Suicidal ideation in past 6 months

    up to 6 months follow-up

  • +14 more secondary outcomes

Study Arms (3)

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.

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.

Other: Applied Suicide Intervention Skills Training

Interventions

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.

Also known as: ASIST
ASISTASIST uncontrolled arm

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • currently living or working in First Nations, Inuit, or Metis communities in Manitoba
  • years of age or older

You may not qualify if:

  • does not speak English
  • \<16 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, R3E 3N4, Canada

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Jitender Sareen, MD

    University of Manitoba

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2014

First Posted

April 21, 2014

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

October 21, 2016

Record last verified: 2014-01

Locations