Back to resultsRefinement of Suicide Risk Management Intervention
Primary Purpose
Structured Interview, Narrative Assessment, Safety Plan
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Plan
Crisis Response Plan
Structured interview
Narrative Assessment
Sponsored by
About this trial
This is an interventional prevention trial for Structured Interview
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of suicide Ideation
- History of suicide attempts
Exclusion Criteria:
- Geographic location outside the U.S.
Sites / Locations
- The Ohio State
- University of Utah
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Structured interview and Safety Plan
Structured interview and Crisis Response Plan
Narrative assessment and Safety Plan
Narrative assessment and Crisis Response Plan
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04888845
First Posted
April 29, 2021
Last Updated
July 14, 2023
Sponsor
University of Utah
Collaborators
Ohio State University
1. Study Identification
Unique Protocol Identification Number
NCT04888845
Brief Title
Refinement of Suicide Risk Management Intervention
Official Title
Refinement of Suicide Risk Management Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 22, 2021 (Actual)
Primary Completion Date
April 23, 2024 (Anticipated)
Study Completion Date
April 23, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
Collaborators
Ohio State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Structured Interview, Narrative Assessment, Safety Plan, Crisis Response Plan
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Structured interview and Safety Plan
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Structured interview and Crisis Response Plan
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Narrative assessment and Safety Plan
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Narrative assessment and Crisis Response Plan
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Safety Plan
Intervention Description
The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.
Intervention Type
Behavioral
Intervention Name(s)
Crisis Response Plan
Intervention Description
Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.
Intervention Type
Behavioral
Intervention Name(s)
Structured interview
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Narrative Assessment
Intervention Description
In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis.
Primary Outcome Measure Information:
Title
Change in suicide relevant thoughts and behaviors after the intervention (Self Injurious Thoughts and Behaviors questionnaire)
Description
Items from the Self Injurious Thoughts and Behaviors questionnaire (Fox et al., 2020) will be used to assess suicide relevant thoughts and behaviors
Time Frame
During an average of 2-weeks pre-intervention, 2-weeks post-intervention, 1 month follow-up after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of suicide Ideation
History of suicide attempts
Exclusion Criteria:
Geographic location outside the U.S.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monika Lohani, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Refinement of Suicide Risk Management Intervention
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