The Safety and Effectiveness of Gatekeeper Training in First Nations Communities

NCT ID: NCT02118116

Last Updated: 2016-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Applied Suicide Intervention Skills Training

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Wait-list Control

No training, wait-listed for ASIST at a later date

Group Type NO_INTERVENTION

No interventions assigned to this group

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 course, facilitated by 2 trained facilitators, allows for a maximum enrollment of 30 participants.

Group Type EXPERIMENTAL

Applied Suicide Intervention Skills Training

Intervention Type OTHER

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.

ASIST uncontrolled arm

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.

Group Type EXPERIMENTAL

Applied Suicide Intervention Skills Training

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Applied Suicide Intervention Skills Training

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ASIST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* does not speak English
* \<16 years of age
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Manitoba Health

UNKNOWN

Sponsor Role collaborator

First Nations and Inuit Health

UNKNOWN

Sponsor Role collaborator

University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jitender Sareen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013:380

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Family Safety Net - Aim 3: Randomized Control Trial
NCT05657119 ACTIVE_NOT_RECRUITING NA