Safety Planning Intervention to Reduce Short Term Risk

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.

Study Overview

• Status: Completed
• Conditions: Suicide, Attempted
• Intervention / Treatment: Behavioral: Safety Planning Intervention; Behavioral: Risk factors and Warning signs

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 422
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • University of Massachusetts
  • New York
    • New York, New York, United States, 10032
      • New York State Psychiatric Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Are 18 years of age or older
3. Able to speak and read English
4. Able to understand the nature of the study, provide written informed consent, and complete study procedures
5. Have been evaluated by a health care professional who provides permission for research staff to approach the patient.

Exclusion Criteria:

1. Under 18 years of age
2. Cannot speak or read English
3. Unable to understand the nature of the study, provide written informed consent, or complete study procedures
4. Unable or unwilling to provide a personal phone number for follow up purposes.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Safety Planning Intervention; 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; 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.; Other Names: SPI
Active Comparator: Risk factors and Warning signs; Patients will receive a generic suicide risk factors and warning signs information handout.	Behavioral: Risk factors and Warning signs; Printed information sheet listing suicide risk factors and crisis hotlines; Other Names: RWI

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: New York State Psychiatric Institute
• Collaborators: University of Pennsylvania; Columbia University; University of Massachusetts, Worcester; American Foundation for Suicide Prevention
• Investigators: Principal Investigator: Barbara H Stanley, Ph.D., New York State Psychiatric Institute

Publications and helpful links

General Publications

• Boudreaux ED, Stanley B, Green KL, Galfalvy H, Brown GK. A randomized, controlled trial of the safety planning intervention: Research design and methods. Contemp Clin Trials. 2021 Apr;103:106291. doi: 10.1016/j.cct.2021.106291. Epub 2021 Jan 27.

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2017
• Primary Completion (Actual): January 30, 2020
• Study Completion (Actual): June 30, 2020

Study Registration Dates

• First Submitted: December 15, 2016
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: January 3, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Suicide
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicide, Attempted
• Other Study ID Numbers: 7383

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