Suicide, AttemptedNCT03227991
Safety Planning Intervention to Reduce Short Term Risk
A study testing Safety Planning Intervention and Risk factors and Warning signs in people with Suicide, Attempted, run by New York State Psychiatric Institute at 3 sites in United States.
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)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- Safety Planning Intervention and Risk factors and Warning signs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 422 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Sep 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
New York State Psychiatric Institute
New York, New York, 10032
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
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.
Read the 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.
- Conditions
- Suicide, Attempted
- Being tested
- Safety Planning Intervention, Risk factors and Warning signs
- Keywords
- Suicide
- Medical subject headings
- Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Planning InterventionBehavioural
Also called SPI
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 signsBehavioural
Also called RWI
Printed information sheet listing suicide risk factors and crisis hotlines
| Study group | Role | What they receive |
|---|---|---|
| Safety Planning Intervention | Active comparator | 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. Receives: Behavioral: Safety Planning Intervention |
| Risk factors and Warning signs | Active comparator | Patients will receive a generic suicide risk factors and warning signs information handout. Receives: Behavioral: Risk factors and Warning signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide, attempted and suicide
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Measured: 1 month
Suicide, attempted and suicide
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Measured: 3 months
Suicide, attempted and suicide
As measured by the Columbia Suicide Severity Rating Scale (C-SSRS); responses are yes-no with yes more severe
Measured: 6 months
Secondary outcomes (18)
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
Measured: 1 month
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
Measured: 3 months
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
Measured: 6 months
Means restriction
As measured by patient report about reducing access to lethal means
Measured: 1 month
Means restriction
As measured by patient report about reducing access to lethal means
Measured: 3 months
Means restriction
As measured by patient report about reducing access to lethal means
Measured: 6 months
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).
Measured: 1 month
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).
Measured: 3 months
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).
Measured: 6 months
Treatment engagement
As measured by attending one of more mental health/substance abuse treatment appointments
Measured: 1 month
Treatment engagement
As measured by attending one of more mental health/substance abuse treatment appointments
Measured: 3 months
Treatment engagement
As measured by attending one of more mental health/substance abuse treatment appointments
Measured: 6 months
Suicidal ideation intensity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Measured: 1 month
Suicidal ideation intensity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Measured: 3 months
Suicidal ideation intensity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 1-5
Measured: 6 months
Suicidal ideation severity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe
Measured: 1 month
Suicidal ideation severity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe
Measured: 3 months
Suicidal ideation severity
As measured by the Columbia Suicide Severity Rating Scale (CSSRS) on a scale from 2-25 with higher scores more severe
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start10 Sep 2017
- Primary completion30 Jan 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 422 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, University of Massachusetts, Worcester, Columbia University, American Foundation for Suicide Prevention
- Responsible party
- Principal investigator, Beth Brodsky, New York State Psychiatric Institute
- Investigators
- Barbara H Stanley, Ph.D., Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227991
- Sponsor's protocol ID
- 7383
- Status last verified
- Jan 2024
- First submitted
- 15 Dec 2016
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33515785
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Planning Intervention to Reduce Short Term Risk
- ClinicalTrials.gov ID
- NCT03227991
- Acronym / sponsor ID
- 7383
- Conditions
- Suicide, Attempted
- Keywords
- Suicide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 422 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- University of Pennsylvania, University of Massachusetts, Worcester, Columbia University, American Foundation for Suicide Prevention
- Study start
- 10 Sep 2017 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 24 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safety Planning Intervention | Active comparator | Behavioral: Safety Planning InterventionSPI 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. |
| Risk factors and Warning signs | Active comparator | Behavioral: Risk factors and Warning signsPatients will receive a generic suicide risk factors and warning signs information handout. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safety Planning InterventionAlso: SPIThe 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. | Behavioural | Safety Planning Intervention |
| Risk factors and Warning signsAlso: RWIPrinted information sheet listing suicide risk factors and crisis hotlines | Behavioural | Risk factors and Warning signs |
Primary outcome
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
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
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
18 secondary outcomes
Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior
Time frame: 1 month
Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior
Time frame: 3 months
Suicide, attempted, aborted, interrupted attempt or preparatory suicidal behavior
Time frame: 6 months
Means restriction
Time frame: 1 month
Means restriction
Time frame: 3 months
Means restriction
Time frame: 6 months
Suicide related coping
Time frame: 1 month
Suicide related coping
Time frame: 3 months
Suicide related coping
Time frame: 6 months
Treatment engagement
Time frame: 1 month
Treatment engagement
Time frame: 3 months
Treatment engagement
Time frame: 6 months
Suicidal ideation intensity
Time frame: 1 month
Suicidal ideation intensity
Time frame: 3 months
Suicidal ideation intensity
Time frame: 6 months
Suicidal ideation severity
Time frame: 1 month
Suicidal ideation severity
Time frame: 3 months
Suicidal ideation severity
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 33515785Boudreaux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara H Stanley, Ph.D. principal investigator
New York State Psychiatric Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safety Planning Intervention and Risk factors and Warning signs in people with Suicide, Attempted, run by New York State Psychiatric Institute at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicide, attempted and suicide (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03227991, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024; AzTrials last refreshed its copy on 5 Nov 2026.