Refinement of Suicide Risk Management Intervention

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Structured Interview; Narrative Assessment; Safety Plan; Crisis Response Plan
• Intervention / Treatment: Behavioral: Safety Plan; Behavioral: Structured interview; Behavioral: Crisis Response Plan; Behavioral: Narrative Assessment

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43214
      • The Ohio State
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • University of Utah

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Clinical diagnosis of suicide Ideation
• History of suicide attempts

Exclusion Criteria:

• Geographic location outside the U.S.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Structured interview and Safety Plan; 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; The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.; Behavioral: Structured interview; 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.
Active Comparator: Structured interview and Crisis Response Plan; 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: Structured interview; 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.; Behavioral: Crisis Response Plan; Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.
Active Comparator: Narrative assessment and Safety Plan; 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; The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.; Behavioral: Narrative Assessment; In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis.
Active Comparator: Narrative assessment and Crisis Response Plan; 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; Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.; Behavioral: Narrative Assessment; In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Ohio State University
• Investigators: Principal Investigator: Monika Lohani, PhD, University of Utah

Publications and helpful links

General Publications

• Lohani M, Baker JC, Elsey JS, Dutton S, Findley SP, Langenecker SA, Do AS, Bryan CJ. Suicide prevention via telemental health services: insights from a randomized control trial of crisis response plan and self-guided safety planning approaches. BMC Health Serv Res. 2024 Nov 12;24(1):1389. doi: 10.1186/s12913-024-11739-w.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2021
• Primary Completion (Estimated): July 30, 2028
• Study Completion (Estimated): July 30, 2028

Study Registration Dates

• First Submitted: April 29, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 17, 2021

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide
• Other Study ID Numbers: IRB_00135355

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No