Suicidal IdeationNCT04068142
The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention
A study testing Peer Supporter Safety Planning in people with Suicidal Ideation and Suicide, Attempted, run by University of Arkansas at 1 site in United States.
Trial summary
Safety planning is a brief, ED-feasible intervention which has been demonstrated to save lives, and has been universally recommended by every recent expert consensus panel on suicide prevention strategies. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Suicidal Ideation, Suicide, Attempted, Mental Health Issue
- What is being tested?
- Peer Supporter Safety Planning
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Nov 2019to 1 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting for suicidal ideation (SI) or after a suicide attempt to the University of Arkansas for Medical Sciences (UAMS) Emergency Department (ED)
- Willingness to engage in safety planning with trained non-clinical staff
- English-speaking and English-writing (as translators will not be available for this study)
Who cannot join
- <18 or >89 years of age
- Patients appearing critically-ill
- Incarcerated or in police custody
- Currently intoxicated with alcohol or other substance
- ED staff objection to patient enrollment in study
- Unwilling or unable to complete the safety plan with a peer supporter
- Unwilling or unable to show the safety plan to clinical staff
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Safety planning is a brief, ED-feasible intervention which has been demonstrated to save lives, and has been universally recommended by every recent expert consensus panel on suicide prevention strategies. In one popular version of the safety plan developed by Stanley et al, the patient is encouraged to write out the following items: identifying personal signs of a crisis; helpful internal coping strategies; social contacts or settings which may distract from a crisis; using family members or friends for help when in crisis; mental health professionals who can be contacted when in crisis; and restricting access to lethal means. In most emergency departments, safety-planning is done by clinical personnel such as psychologists or social workers, but these providers are often too busy to perform safety-planning well or have multiple other patient care responsibilities.
This study aims to find out if ED patients prefer to complete a safety plan with a peer supporter or clinical personnel. People who are visiting the emergency department for thoughts of self-harm will be asked to participate.
Read the detailed description
This project aims to answer the following three research questions: (1) In general, do ED patients with suicidal ideation/attempt prefer to interact with/receive support from peers with life experiences of suicide or clinical professionals who might have such life experiences or not? (2) Will patients with suicidal ideation/attempt accept a peer-delivered safety planning intervention as opposed to one delivered by clinical personnel? (3) Are peer-delivered safety plans of equal quality as those delivered by clinical personnel?
- Conditions
- Suicidal Ideation, Suicide, Attempted, Mental Health Issue
- Being tested
- Peer Supporter Safety Planning
- Keywords
- Suicide, Suicide Prevention, Safety Planning
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer Supporter Safety PlanningOther
The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers
| Study group | Role | What they receive |
|---|---|---|
| Clinical Personnel Safety Planning | No intervention | Patients will complete a traditional written suicide safety plan with clinical personnel. |
| Peer Supporter Safety Planning | Experimental | Patients will complete a traditional written suicide safety plan with peer supporters. Receives: Other: Peer Supporter Safety Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Suicidal Ideology (SI) Participants Who Agree to Receive a Safety Plan
Evaluate the number of suicidal ideology (SI) patients approached in the ED who agree to receive a safety plan.
Measured: approach in the ED (typically <1 hour)
Proportion of Eligible Patients
Evaluate the proportion of patients approached who meet all inclusion/exclusion criteria.
Measured: Up to 12 hours
Quality of Safety Plans
Evaluate the quality of the completed safety plans. This will be done by retrospective review after the patient has left the ED. Safety plans will be graded individually, then resolved by consensus, for quality (0=blank, 1=boilerplate, 2=some evidence of personalization, 3=highly personalized; range=0-24) by the investigators using materials developed by Brown and Stanley for this purpose. Using a "safety checklist," responses for each of the 6 safety plan steps will be classified according to the personalization of the information in each step.
Measured: Up to 12 hours
Satisfaction With Safety Planning
Evaluate patient satisfaction with safety planning. This will be assessed by having the patient rate their experience with the safety planning process on a 7-point Likert scale (1 - strongly disagree; 2 - disagree; 3 - moderately disagree; 4 - neutral; 5 - moderately agree; 6 - agree; 7 - strongly agree). A Likert scale measures how much someone disagrees or agrees with a particular statement.
Measured: Up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start6 Nov 2019
- Primary completion1 Sep 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael P Wilson, M.D., Ph.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068142
- Sponsor's protocol ID
- 239486
- Status last verified
- Oct 2021
- First submitted
- 22 Aug 2019
- Last updated
- 27 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wilson MP, Waliski A, Thompson RG Jr. Feasibility of Peer-Delivered Suicide Safety Planning in the Emergency Department: Results From a Pilot Trial. Psychiatr Serv. 2022 Oct 1;73(10):1087-1093. doi: 10.1176/appi.ps.202100561. Epub 2022 May 3.
PubMed 35502515
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acceptability and Feasibility of an ED-based, Peer-delivered, Suicide Safety Planning Intervention
- ClinicalTrials.gov ID
- NCT04068142
- Acronym / sponsor ID
- 239486
- Conditions
- Suicidal Ideation, Suicide, Attempted, Mental Health Issue
- Keywords
- Suicide, Suicide Prevention, Safety Planning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 27 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety planning is a brief, ED-feasible intervention which has been demonstrated to save lives, and has been universally recommended by every recent expert consensus panel on suicide prevention strategies. In one popular version of the safety plan developed by Stanley et al, the patient is encouraged to write out the following items: identifying personal signs of a crisis; helpful internal coping strategies; social contacts or settings which may distract from a crisis; using family members or friends for help when in crisis; mental health professionals who can be contacted when in crisis; and restricting access to lethal means. In most emergency departments, safety-planning is done by clinical personnel such as psychologists or social workers, but these providers are often too busy to perform safety-planning well or have multiple other patient care responsibilities.
This study aims to find out if ED patients prefer to complete a safety plan with a peer supporter or clinical personnel. People who are visiting the emergency department for thoughts of self-harm will be asked to participate.
Detailed description
This project aims to answer the following three research questions: (1) In general, do ED patients with suicidal ideation/attempt prefer to interact with/receive support from peers with life experiences of suicide or clinical professionals who might have such life experiences or not? (2) Will patients with suicidal ideation/attempt accept a peer-delivered safety planning intervention as opposed to one delivered by clinical personnel? (3) Are peer-delivered safety plans of equal quality as those delivered by clinical personnel?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical Personnel Safety Planning | No intervention | –Patients will complete a traditional written suicide safety plan with clinical personnel. |
| Peer Supporter Safety Planning | Experimental | Other: Peer Supporter Safety PlanningPatients will complete a traditional written suicide safety plan with peer supporters. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients presenting for suicidal ideation (SI) or after a suicide attempt to the University of Arkansas for Medical Sciences (UAMS) Emergency Department (ED)
- Willingness to engage in safety planning with trained non-clinical staff
- English-speaking and English-writing (as translators will not be available for this study)
Key exclusion criteria (7 listed)
- <18 or >89 years of age
- Patients appearing critically-ill
- Incarcerated or in police custody
- Currently intoxicated with alcohol or other substance
- ED staff objection to patient enrollment in study
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 |
|---|---|---|
| Peer Supporter Safety PlanningThe rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers | Other | Peer Supporter Safety Planning |
Primary outcome
Number of Suicidal Ideology (SI) Participants Who Agree to Receive a Safety Plan
Time frame: approach in the ED (typically <1 hour)
Evaluate the number of suicidal ideology (SI) patients approached in the ED who agree to receive a safety plan.
Proportion of Eligible Patients
Time frame: Up to 12 hours
Evaluate the proportion of patients approached who meet all inclusion/exclusion criteria.
Quality of Safety Plans
Time frame: Up to 12 hours
Evaluate the quality of the completed safety plans. This will be done by retrospective review after the patient has left the ED. Safety plans will be graded individually, then resolved by consensus, for quality (0=blank, 1=boilerplate, 2=some evidence of personalization, 3=highly personalized; range=0-24) by the investigators using materials developed by Brown and Stanley for this purpose. Using a "safety checklist," responses for each of the 6 safety plan steps will be classified according to the personalization of the information in each step.
Satisfaction With Safety Planning
Time frame: Up to 12 hours
Evaluate patient satisfaction with safety planning. This will be assessed by having the patient rate their experience with the safety planning process on a 7-point Likert scale (1 - strongly disagree; 2 - disagree; 3 - moderately disagree; 4 - neutral; 5 - moderately agree; 6 - agree; 7 - strongly agree). A Likert scale measures how much someone disagrees or agrees with a particular statement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35502515Wilson MP, Waliski A, Thompson RG Jr. Feasibility of Peer-Delivered Suicide Safety Planning in the Emergency Department: Results From a Pilot Trial. Psychiatr Serv. 2022 Oct 1;73(10):1087-1093. doi: 10.1176/appi.ps.202100561. Epub 2022 May 3.
- 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.
Michael P Wilson, M.D., Ph.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer Supporter Safety Planning in people with Suicidal Ideation and Suicide, Attempted, run by University of Arkansas at 1 site 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 3 inclusion and 7 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 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 27 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Suicidal Ideology (SI) Participants Who Agree to Receive a Safety Plan (time frame: approach in the ED (typically <1 hour)). The study lists 4 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 NCT04068142, 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 27 Jan 2022.