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Safety Planning Intervention to Reduce Short Term Risk

Primary Purpose

Suicide, Attempted

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Safety Planning Intervention
Risk factors and Warning signs
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Suicide, Attempted focused on measuring Suicide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Massachusetts
  • New York State Psychiatric Institute
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Safety Planning Intervention

Risk factors and Warning signs

Arm Description

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.

Patients will receive a generic suicide risk factors and warning signs information handout.

Outcomes

Primary Outcome Measures

Suicide, attempted and suicide
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Suicide, attempted and suicide
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Suicide, attempted and suicide
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

Secondary Outcome Measures

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
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
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
Means restriction
As measured by patient report about reducing access to lethal means
Means restriction
As measured by patient report about reducing access to lethal means
Means restriction
As measured by patient report about reducing access to lethal means
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).
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).
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).
Treatment engagement
As measured by attending one of more mental health/substance abuse treatment appointments
Treatment engagement
As measured by attending one of more mental health/substance abuse treatment appointments
Treatment engagement
As measured by attending one of more mental health/substance abuse treatment appointments
Suicidal ideation intensity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Suicidal ideation intensity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Suicidal ideation intensity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Suicidal ideation severity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe
Suicidal ideation severity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe
Suicidal ideation severity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe

Full Information

First Posted
December 15, 2016
Last Updated
October 6, 2020
Sponsor
New York State Psychiatric Institute
Collaborators
University of Pennsylvania, University of Massachusetts, Worcester, Columbia University, American Foundation for Suicide Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03227991
Brief Title
Safety Planning Intervention to Reduce Short Term Risk
Official Title
Safety Planning Intervention to Reduce Short Term Risk
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 10, 2017 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute
Collaborators
University of Pennsylvania, University of Massachusetts, Worcester, Columbia University, American Foundation for Suicide Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
Suicide

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
422 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Safety Planning Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Risk factors and Warning signs
Arm Type
Active Comparator
Arm Description
Patients will receive a generic suicide risk factors and warning signs information handout.
Intervention Type
Behavioral
Intervention Name(s)
Safety Planning Intervention
Other Intervention Name(s)
SPI
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Risk factors and Warning signs
Other Intervention Name(s)
RWI
Intervention Description
Printed information sheet listing suicide risk factors and crisis hotlines
Primary Outcome Measure Information:
Title
Suicide, attempted and suicide
Description
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time Frame
1 month
Title
Suicide, attempted and suicide
Description
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time Frame
3 months
Title
Suicide, attempted and suicide
Description
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior
Description
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time Frame
1 month
Title
Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior
Description
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time Frame
3 months
Title
Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior
Description
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time Frame
6 months
Title
Means restriction
Description
As measured by patient report about reducing access to lethal means
Time Frame
1 month
Title
Means restriction
Description
As measured by patient report about reducing access to lethal means
Time Frame
3 months
Title
Means restriction
Description
As measured by patient report about reducing access to lethal means
Time Frame
6 months
Title
Suicide related coping
Description
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).
Time Frame
1 month
Title
Suicide related coping
Description
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).
Time Frame
3 months
Title
Suicide related coping
Description
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).
Time Frame
6 months
Title
Treatment engagement
Description
As measured by attending one of more mental health/substance abuse treatment appointments
Time Frame
1 month
Title
Treatment engagement
Description
As measured by attending one of more mental health/substance abuse treatment appointments
Time Frame
3 months
Title
Treatment engagement
Description
As measured by attending one of more mental health/substance abuse treatment appointments
Time Frame
6 months
Title
Suicidal ideation intensity
Description
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Time Frame
1 month
Title
Suicidal ideation intensity
Description
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Time Frame
3 months
Title
Suicidal ideation intensity
Description
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Time Frame
6 months
Title
Suicidal ideation severity
Description
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe
Time Frame
1 month
Title
Suicidal ideation severity
Description
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe
Time Frame
3 months
Title
Suicidal ideation severity
Description
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Are 18 years of age or older Able to speak and read English Able to understand the nature of the study, provide written informed consent, and complete study procedures Have been evaluated by a health care professional who provides permission for research staff to approach the patient. Exclusion Criteria: Under 18 years of age Cannot speak or read English Unable to understand the nature of the study, provide written informed consent, or complete study procedures Unable or unwilling to provide a personal phone number for follow up purposes.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara H Stanley, Ph.D.
Organizational Affiliation
New York State Psychiatric Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Massachusetts
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33515785
Citation
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.
Results Reference
derived

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Safety Planning Intervention to Reduce Short Term Risk

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