NCT Number: NCT03227991
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
University of Massachusetts, Worcester, Massachusetts, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Printed information sheet listing suicide risk factors and crisis hotlines
Other names: RWI
Time frame: 1 month
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time frame: 3 months
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time frame: 6 months
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time frame: 1 month
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time frame: 3 months
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time frame: 6 months
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Time frame: 1 month
As measured by patient report about reducing access to lethal means
Time frame: 3 months
As measured by patient report about reducing access to lethal means
Time frame: 6 months
As measured by patient report about reducing access to lethal means
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).
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).
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).
Time frame: 1 month
As measured by attending one of more mental health/substance abuse treatment appointments
Time frame: 3 months
As measured by attending one of more mental health/substance abuse treatment appointments
Time frame: 6 months
As measured by attending one of more mental health/substance abuse treatment appointments
Time frame: 1 month
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Time frame: 3 months
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Time frame: 6 months
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
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
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
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
New York State Psychiatric Institute
Other
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