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Safety Planning Intervention to Reduce Short Term Risk

Safety Planning Intervention to Reduce Short Term Risk

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03227991
Enrollment
422
Registered
2017-07-24
Start date
2017-09-10
Completion date
2020-06-30
Last updated
2024-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide, Attempted

Keywords

Suicide

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.

Interventions

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.

BEHAVIORALRisk factors and Warning signs

Printed information sheet listing suicide risk factors and crisis hotlines

Sponsors

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

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Suicide, attempted and suicide1 monthAs measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe

Secondary

MeasureTime frameDescription
Means restriction1 monthAs measured by patient report about reducing access to lethal means
Suicide related coping1 monthAs 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, attempted, aborted, interrupted attempt or preparatory suicidal behavior1 monthAs measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Suicidal ideation intensity1 monthAs measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Suicidal ideation severity1 monthAs measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe
Treatment engagement1 monthAs measured by attending one of more mental health/substance abuse treatment appointments

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026