Safety Planning Intervention to Reduce Short Term Risk

Study Overview
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Brief Summary
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This study will determine the efficacy of Safety Planning Intervention (SPI) compared to receiving risk factors and warning sign information (RWI) in recent suicide attempters during the 6 months following an acute care visit on: (1) suicidal behaviors; (2) mental health/substance use treatment engagement; (3) suicide-related coping strategies; (4) suicidal ideation; and (5) use of means restriction.

Detailed Description
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There is a pressing need for improved acute care setting suicide prevention interventions. The Safety Planning Intervention (SPI) is a protocol driven, brief suicide prevention strategy that is a good fit for acute care settings (i.e., emergency departments (ED) and inpatient units). The SPI involves a clinician working collaboratively with the patient to build a personalized safety plan that is documented using a templated paper form and includes warning sign identification, means restriction and personalized strategies to deescalate a suicide crisis. It is easy to learn and administer, acceptable to patients, brief, firmly rooted in an empirical base and has preliminary studies supporting its feasibility and potential to impact patient outcomes, including suicidal behavior and treatment engagement. However, while it is being adopted widely, it lacks a randomized controlled trial (RCT) to definitively determine its efficacy. The purpose of this study to conduct a randomized control trial of the Safety Planning Intervention (SPI) compared with receiving risk factors and warning sign information (RWI) in acute care settings. All participants in this study will complete some baseline assessments, following which they will be randomly assigned to one of two study conditions: Safety Plan Intervention (SPI) or receiving risk factors and warning sign information (RWI). If assigned to SPI, participants will receive the assigned intervention by the research clinician. They will receive a paper copy of their safety plan while in the ED or on the inpatient unit and a back-up copy will be sent approximately 1 week after discharge to participants. For RWI participants, ED and inpatient unit care will be delivered as usual, with the addition of a printed information sheet listing suicide risk factors and crisis hotlines. In addition to the baseline assessment, multi-method outcome assessment will be conducted at 1, 3, and 6 months. This will include telephone evaluations by a blinded assessor (not the research clinician), medical record review, and vital statistics registry review.

Official Title
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Safety Planning Intervention to Reduce Short Term Risk

Conditions
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Suicide, Attempted

Intervention / Treatment
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* Behavioral: Safety Planning Intervention
* Behavioral: Risk factors and Warning signs


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presented for an acute care visit within 8 weeks of a suicide attempt, interrupted or aborted attempt, or suicidal ideation with intent and plan within 4 weeks. Are 18 years of age or older Able to speak and read English Able to understand the nature of the study, provide written informed consent, and complete study procedures Have been evaluated by a health care professional who provides permission for research staff to approach the patient. Exclusion Criteria: Under 18 years of age Cannot speak or read English Unable to understand the nature of the study, provide written informed consent, or complete study procedures Unable or unwilling to provide a personal phone number for follow up purposes.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Safety Planning Intervention<br>SPI is a personalized approach that focuses on early identification of warning signs and execution of systematic steps to manage suicidal thoughts, created collaboratively by the patient and clinician. | Behavioral: Safety Planning Intervention<br>* The Safety Planning Intervention is a protocol driven, brief suicide prevention strategy that is a good fit for acute care settings. It involves a clinician working collaboratively with the patient to build a personalized safety plan that is documented using a templated paper form and includes warning sign identification, means restriction and personalized strategies to deescalate a suicide crisis.<br>* Other names: SPI;|
| Active Comparator: Risk factors and Warning signs<br>Patients will receive a generic suicide risk factors and warning signs information handout. | Behavioral: Risk factors and Warning signs<br>* Printed information sheet listing suicide risk factors and crisis hotlines<br>* Other names: RWI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide, attempted and suicide | As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe | 1 month | 
| Suicide, attempted and suicide | As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe | 3 months | 
| Suicide, attempted and suicide | As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior | As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe | 1 month | 
| Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior | As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe | 3 months | 
| Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior | As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe | 6 months | 
| Means restriction | As measured by patient report about reducing access to lethal means | 1 month | 
| Means restriction | As measured by patient report about reducing access to lethal means | 3 months | 
| Means restriction | As measured by patient report about reducing access to lethal means | 6 months | 
| Suicide related coping | As measured by the total score on the Suicide-Related Coping Measure, a scale developed by Stanley, Brown and Holloway (2010). The scale is a 21 item self-report measure using a Likert scale. Examples of items are: I am at the mercy of my suicidal thoughts. and I have several things I can do to get through a suicidal crisis. The scale has high in internal reliability (Cronbach's alpha = .88), and, as predicted, moderate convergent validity with help-seeking attitudes (r = .47) and divergent validity with a pain measure (r= -.31). It is also sensitive to change (t(65) = 6.8, p < .001). | 1 month | 
| Suicide related coping | As measured by the total score on the Suicide-Related Coping Measure, a scale developed by Stanley, Brown and Holloway (2010). The scale is a 21 item self-report measure using a Likert scale. Examples of items are: I am at the mercy of my suicidal thoughts. and I have several things I can do to get through a suicidal crisis. The scale has high in internal reliability (Cronbach's alpha = .88), and, as predicted, moderate convergent validity with help-seeking attitudes (r = .47) and divergent validity with a pain measure (r= -.31). It is also sensitive to change (t(65) = 6.8, p < .001). | 3 months | 
| Suicide related coping | As measured by the total score on the Suicide-Related Coping Measure, a scale developed by Stanley, Brown and Holloway (2010). The scale is a 21 item self-report measure using a Likert scale. Examples of items are: I am at the mercy of my suicidal thoughts. and I have several things I can do to get through a suicidal crisis. The scale has high in internal reliability (Cronbach's alpha = .88), and, as predicted, moderate convergent validity with help-seeking attitudes (r = .47) and divergent validity with a pain measure (r= -.31). It is also sensitive to change (t(65) = 6.8, p < .001). | 6 months | 
| Treatment engagement | As measured by attending one of more mental health/substance abuse treatment appointments | 1 month | 
| Treatment engagement | As measured by attending one of more mental health/substance abuse treatment appointments | 3 months | 
| Treatment engagement | As measured by attending one of more mental health/substance abuse treatment appointments | 6 months | 
| Suicidal ideation intensity | As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5 | 1 month | 
| Suicidal ideation intensity | As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5 | 3 months | 
| Suicidal ideation intensity | As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5 | 6 months | 
| Suicidal ideation severity | As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe | 1 month | 
| Suicidal ideation severity | As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe | 3 months | 
| Suicidal ideation severity | As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Suicide