Safety Planning Intervention to Reduce Short Term Risk

Suicide, Attempted Clinical Trial

Official title:

Safety Planning Intervention to Reduce Short Term Risk

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03227991
• Other study ID #: 7383
• Status: Completed
• Phase: N/A
• Start date: September 10, 2017
• Est. completion date: June 30, 2020

Study information

• Verified date: January 2024
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 422
• Est. completion date: June 30, 2020
• Est. primary completion date: January 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

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.
• Risk factors and Warning signs
Printed information sheet listing suicide risk factors and crisis hotlines

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Massachusetts	Worcester	Massachusetts

Sponsors (5)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	American Foundation for Suicide Prevention, Columbia University, University of Massachusetts, Worcester, University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Means restriction	As measured by patient report about reducing access to lethal means	1 month
Secondary	Means restriction	As measured by patient report about reducing access to lethal means	3 months
Secondary	Means restriction	As measured by patient report about reducing access to lethal means	6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Treatment engagement	As measured by attending one of more mental health/substance abuse treatment appointments	1 month
Secondary	Treatment engagement	As measured by attending one of more mental health/substance abuse treatment appointments	3 months
Secondary	Treatment engagement	As measured by attending one of more mental health/substance abuse treatment appointments	6 months
Secondary	Suicidal ideation intensity	As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5	1 month
Secondary	Suicidal ideation intensity	As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5	3 months
Secondary	Suicidal ideation intensity	As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5	6 months
Secondary	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
Secondary	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
Secondary	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