Refinement of Suicide Risk Management Intervention

NCT04888845 | Active Not Recruiting

• 1 other identifier: IRB_00135355
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Structured Interview; Narrative Assessment; Safety Plan; Crisis Response Plan

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (4)

Structured interview and Safety Plan

ACTIVE COMPARATOR

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; Behavioral: Structured interview

Structured interview and Crisis Response Plan

ACTIVE COMPARATOR

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; Behavioral: Structured interview

Narrative assessment and Safety Plan

ACTIVE COMPARATOR

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; Behavioral: Narrative Assessment

Narrative assessment and Crisis Response Plan

ACTIVE COMPARATOR

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; Behavioral: Narrative Assessment

Interventions

Safety Plan BEHAVIORAL

The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.

Narrative assessment and Safety Plan; Structured interview and Safety Plan

Crisis Response Plan BEHAVIORAL

Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.

Narrative assessment and Crisis Response Plan; Structured interview and Crisis Response Plan

Structured interview BEHAVIORAL

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.

Structured interview and Crisis Response Plan; Structured interview and Safety Plan

Narrative Assessment BEHAVIORAL

In the narrative assessment approach, clinicians ask patients to "tell the story" of their suicidal crisis.

Narrative assessment and Crisis Response Plan; Narrative assessment and Safety Plan

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Clinical diagnosis of suicide Ideation
• History of suicide attempts

You may not qualify if:

• Geographic location outside the U.S.

Sponsors & Collaborators

• University of Utah: lead
• Ohio State University: collaborator

Study Sites (2)

The Ohio State

Columbus, Ohio, 43214, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 39533271 DERIVED

Study Officials

• Monika Lohani, PhD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 17, 2021
• Study Start: April 22, 2021
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)