Suicidal IdeationNCT04026308
Written vs Electronic Safety Planning Study
A study testing Safety Net App in people with Suicidal Ideation and Suicide Attempt, 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 Attempt, Mental Health
- What is being tested?
- Safety Net App
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Sep 2020to 28 Dec 2020
- 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 UAMS ED
- Willingness to engage in safety planning with trained non-clinical staff
- Have not already filled out a safety plan at the current visit
Who cannot join
- <18 or >89 years of age
- Incarcerated or in police custody
- Non-English-speaking or Non-English-writing (as translators will not be available for this study)
- Critically-ill (or appear to be critically-ill)
- Intoxicated with alcohol or other substance(s)
- ED staff objection to patient enrollment in study
Show all 9Show fewer
- Unwilling or unable to complete the safety plan electronically
- Unwilling or unable to use a tablet device to complete the safety plan
- Unwilling or unable to show/email the safety plan to clinical and research 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
Official title: Written Safety Planning vs the Safety Net App: A Prospective Randomized Pilot Trial
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.
This study aims to find out how valuable an electronic safety plan is compared to a traditional paper safety plan. People who are visiting the emergency department for thoughts of self-harm will be asked to participate.
Read the detailed description
This project has 3 aims: (1) Will ED patients with suicidal ideation/attempt accept coaching on safety planning from non-clinical personnel (i.e., medical students or peer supporters); (2) Are these safety plans of high-enough quality for clinical personnel; and finally, (3) Will ED patients with suicidal ideation/attempt complete safety plans electronically?
- Conditions
- Suicidal Ideation, Suicide Attempt, Mental Health
- Being tested
- Safety Net App
- Keywords
- Suicide, Suicide Prevention, Safety Planning, Safety Net App
- Medical subject headings
- Suicidal Ideation, Suicide, Attempted, Psychological Well-Being, Suicide, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safety Net AppOther
Also called Stanley-Brown Safety Plan App
The Safety Net app is an electronic version of a safety plan and it is available for download in Apple's App Store. A preview of the app is available at: https://apps.apple.com/us/app/stanley-brown-safety-plan/id695122998. This app is owned by Two Penguins Studios, LLC. It was developed in partnership with the New York State Office of Mental Health. Unlike the paper version, the Safety Net app allows participants to email a copy of their safety plan to whomever they wish. It also allows patients to dial 911 or the National Suicide Prevention Lifeline from the app.
| Study group | Role | What they receive |
|---|---|---|
| Written Safety Plan | No intervention | Participants will complete a traditional written suicide safety plan. |
| Electronic Safety Plan | Experimental | Participants will complete a suicide safety plan in the Safety Net app using a tablet. Receives: Other: Safety Net App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of Intervention
The number of patients approached who agree to allow trained non-clinical staff to assist with safety planning.
Measured: Up to 12 hours
Length of Stay
The length of stay in the ED for patients approached who agree to allow trained non-clinical staff to assist with safety planning.
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 posted19 Jul 2019
- Study start15 Sep 2020
- Primary completion28 Dec 2020
- Study completion28 Dec 2020
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.
- 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
- 30 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
- NCT04026308
- Sponsor's protocol ID
- 239731
- Status last verified
- Feb 2023
- First submitted
- 18 Jul 2019
- Last updated
- 21 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Written Safety Planning vs the Safety Net App: A Prospective Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT04026308
- Acronym / sponsor ID
- 239731
- Conditions
- Suicidal Ideation, Suicide Attempt, Mental Health
- Keywords
- Suicide, Suicide Prevention, Safety Planning, Safety Net App
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 28 Dec 2020 (actual)
- Study completion
- 28 Dec 2020 (actual)
- First posted
- 19 Jul 2019 (actual)
- Results
- Posted 16 Aug 2021
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.
This study aims to find out how valuable an electronic safety plan is compared to a traditional paper safety plan. People who are visiting the emergency department for thoughts of self-harm will be asked to participate.
Detailed description
This project has 3 aims: (1) Will ED patients with suicidal ideation/attempt accept coaching on safety planning from non-clinical personnel (i.e., medical students or peer supporters); (2) Are these safety plans of high-enough quality for clinical personnel; and finally, (3) Will ED patients with suicidal ideation/attempt complete safety plans electronically?
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Safety Plan | No intervention | –Participants will complete a traditional written suicide safety plan. |
| Electronic Safety Plan | Experimental | Other: Safety Net AppParticipants will complete a suicide safety plan in the Safety Net app using a tablet. |
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 UAMS ED
- Willingness to engage in safety planning with trained non-clinical staff
- Have not already filled out a safety plan at the current visit
Key exclusion criteria (9 listed)
- <18 or >89 years of age
- Incarcerated or in police custody
- Non-English-speaking or Non-English-writing (as translators will not be available for this study)
- Critically-ill (or appear to be critically-ill)
- Intoxicated with alcohol or other substance(s)
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 Net AppAlso: Stanley-Brown Safety Plan AppThe Safety Net app is an electronic version of a safety plan and it is available for download in Apple's App Store. A preview of the app is available at: https://apps.apple.com/us/app/stanley-brown-safety-plan/id695122998. This app is owned by Two Penguins Studios, LLC. It was developed in partnership with the New York State Office of Mental Health. Unlike the paper version, the Safety Net app allows participants to email a copy of their safety plan to whomever they wish. It also allows patients to dial 911 or the National Suicide Prevention Lifeline from the app. | Other | Electronic Safety Plan |
Primary outcome
Acceptability of Intervention
Time frame: Up to 12 hours
The number of patients approached who agree to allow trained non-clinical staff to assist with safety planning.
Length of Stay
Time frame: Up to 12 hours
The length of stay in the ED for patients approached who agree to allow trained non-clinical staff to assist with safety planning.
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 21 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Suicidal Ideation
Recruiting
Effects of Transcranial Direct Current Stimulation (tDCS) in the Management of Suicidal Ideation
Depression and Suicide
Not yet recruitingPhase 2
Intravenous Ketamine for Acute Suicidal Crisis and Psychiatric Hospital Length of Stay
Suicidal Ideation, Suicidal Behavior
Recruiting
Developing a Recovery-Oriented Suicide Prevention Program for Young People at Clinical High Risk for Psychosis
Clinical High Risk for Psychosis (CHR), Suicidal Ideation
Enrolling by invitationObservational study
Cannabis, Neuroinflammation, and Suicidal Ideation: A Supplemental Brain Imaging Study
PTSD, Suicidal Thoughts and Behaviors
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
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 Safety Net App in people with Suicidal Ideation and Suicide Attempt, 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 9 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 21 Mar 2023. 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 16 Aug 2021). 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?
Acceptability of Intervention (time frame: Up to 12 hours). 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?
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 21 Mar 2023.