Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety Planning Intervention to Reduce Short Term Risk

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03227991
Recruitment Status : Completed
First Posted : July 24, 2017
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
University of Pennsylvania
University of Massachusetts, Worcester
Columbia University
American Foundation for Suicide Prevention
Information provided by (Responsible Party):
Barbara Stanley, New York State Psychiatric Institute

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.

Condition or disease Intervention/treatment Phase
Suicide, Attempted Behavioral: Safety Planning Intervention Behavioral: Risk factors and Warning signs Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 422 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Safety Planning Intervention to Reduce Short Term Risk
Actual Study Start Date : September 10, 2017
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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 Name: 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 Name: RWI




Primary Outcome Measures :
  1. Suicide, attempted and suicide [ Time Frame: 1 month ]
    As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

  2. Suicide, attempted and suicide [ Time Frame: 3 months ]
    As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

  3. Suicide, attempted and suicide [ Time Frame: 6 months ]
    As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe


Secondary Outcome Measures :
  1. Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior [ Time Frame: 1 month ]
    As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

  2. Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior [ Time Frame: 3 months ]
    As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

  3. Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior [ Time Frame: 6 months ]
    As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

  4. Means restriction [ Time Frame: 1 month ]
    As measured by patient report about reducing access to lethal means

  5. Means restriction [ Time Frame: 3 months ]
    As measured by patient report about reducing access to lethal means

  6. Means restriction [ Time Frame: 6 months ]
    As measured by patient report about reducing access to lethal means

  7. Suicide related coping [ Time Frame: 1 month ]
    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).

  8. Suicide related coping [ Time Frame: 3 months ]
    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).

  9. Suicide related coping [ Time Frame: 6 months ]
    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).

  10. Treatment engagement [ Time Frame: 1 month ]
    As measured by attending one of more mental health/substance abuse treatment appointments

  11. Treatment engagement [ Time Frame: 3 months ]
    As measured by attending one of more mental health/substance abuse treatment appointments

  12. Treatment engagement [ Time Frame: 6 months ]
    As measured by attending one of more mental health/substance abuse treatment appointments

  13. Suicidal ideation intensity [ Time Frame: 1 month ]
    As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5

  14. Suicidal ideation intensity [ Time Frame: 3 months ]
    As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5

  15. Suicidal ideation intensity [ Time Frame: 6 months ]
    As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5

  16. Suicidal ideation severity [ Time Frame: 1 month ]
    As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe

  17. Suicidal ideation severity [ Time Frame: 3 months ]
    As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe

  18. Suicidal ideation severity [ Time Frame: 6 months ]
    As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03227991


Locations
Layout table for location information
United States, Massachusetts
University of Massachusetts
Worcester, Massachusetts, United States, 01655
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
New York State Psychiatric Institute
University of Pennsylvania
University of Massachusetts, Worcester
Columbia University
American Foundation for Suicide Prevention
Investigators
Layout table for investigator information
Principal Investigator: Barbara H Stanley, Ph.D. New York State Psychiatric Institute
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Barbara Stanley, Professor of Medical Psychology and Research Scientist, New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT03227991    
Other Study ID Numbers: 7383
First Posted: July 24, 2017    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barbara Stanley, New York State Psychiatric Institute:
Suicide
Additional relevant MeSH terms:
Layout table for MeSH terms
Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms