Refinement of Suicide Risk Management Intervention

Study Overview
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Brief Summary
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Participants will be randomly assigned to 1 of the 4 interventions using a sequential stratified randomization procedure. We will use sex (M, F) and history of suicide attempts (never, 1, and multiple) as our randomization strata. Participants will be assessed before and after the intervention to study the potential effects of each approach on suicide-related clinical outcomes.

Official Title
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Refinement of Suicide Risk Management Intervention

Conditions
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Structured Interview, Narrative Assessment, Safety Plan, Crisis Response Plan

Intervention / Treatment
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* Behavioral: Safety Plan
* Behavioral: Crisis Response Plan
* Behavioral: Structured interview
* Behavioral: Narrative Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of suicide Ideation History of suicide attempts Exclusion Criteria: Geographic location outside the U.S.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Structured interview and Safety Plan<br>In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk. | Behavioral: Safety Plan<br>* The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.<br>Behavioral: Structured interview<br>* In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach.<br>|
| Active Comparator: Structured interview and Crisis Response Plan<br>In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach. Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation. | Behavioral: Crisis Response Plan<br>* Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.<br>Behavioral: Structured interview<br>* In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach.<br>|
| Active Comparator: Narrative assessment and Safety Plan<br>In the narrative assessment approach, clinicians ask patients to tell the story of their suicidal crisis. The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk. | Behavioral: Safety Plan<br>* The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.<br>Behavioral: Narrative Assessment<br>* In the narrative assessment approach, clinicians ask patients to tell the story of their suicidal crisis.<br>|
| Active Comparator: Narrative assessment and Crisis Response Plan<br>In the narrative assessment approach, clinicians ask patients to tell the story of their suicidal crisis. Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation. | Behavioral: Crisis Response Plan<br>* Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.<br>Behavioral: Narrative Assessment<br>* In the narrative assessment approach, clinicians ask patients to tell the story of their suicidal crisis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in suicide relevant thoughts and behaviors after the intervention (Self Injurious Thoughts and Behaviors questionnaire) | Items from the Self Injurious Thoughts and Behaviors questionnaire (Fox et al., 2020) will be used to assess suicide relevant thoughts and behaviors | During an average of 2-weeks pre-intervention, 2-weeks post-intervention, 1 month follow-up after intervention |