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Written vs Electronic Safety Planning Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04026308
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : August 29, 2019
Information provided by (Responsible Party):
University of Arkansas

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Suicidal Ideation Mental Health Other: My3 App Not Applicable

Detailed Description:
This project has 3 aims: (1) Will patients 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 patients complete safety plans electronically?

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Written Safety Planning vs the My3 App: A Prospective Randomized Pilot Trial
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
No Intervention: Written Safety Plan
Patients will complete a traditional written suicide safety plan.
Experimental: Electronic Safety Plan
Patients will complete a suicide safety plan on the My3 app using an iPad.
Other: My3 App
The My3 app is an electronic version of a safety plan, and is available for download at: This app is owned by Link2HealthSolutions, Inc, which is the administrator for the National Suicide Prevention Lifeline. It was created in partnership with the California Mental Health Services Act. Unlike the paper version, the My3 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 Name: My3 Support Network

Primary Outcome Measures :
  1. Acceptability of intervention [ Time Frame: Up to 12 hours ]
    The proportion of patients approached who agree to allow trained non-clinical staff to assist with safety planning.

  2. Proportion of eligible patients [ Time Frame: Up to 12 hours ]
    The proportion of patients approached who meet all inclusion/exclusion criteria.

  3. 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. The assessment of quality will use the same measures as Gamarra et al, namely an assessment of how many items are filled out and to what degree the answers reflect personalization. The number of safety plans that must be repeated or redone by the ED mental health clinician will also be tracked.

  4. 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 6-point Likert scale (strongly disagree; disagree; moderately disagree; moderately agree; agree; strongly agree). A Likert scale measures how much someone disagrees or agrees with a particular statement.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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
  • English-speaking and English-writing (as translators will not be available for this study)

Exclusion Criteria:

  • <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 electronically
  • Unwilling or unable to use an iPad to complete the safety plan
  • Unwilling or unable to show/email the safety plan to clinical staff

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04026308

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Contact: Michael P Wilson, M.D., Ph.D. 501-686-5515
Contact: Manuel G Alvarez Romero, B.A. 501-214-2035

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United States, Arkansas
University of Arkansas for Medical Sciences Not yet recruiting
Little Rock, Arkansas, United States, 72205
Contact: Michael P Wilson, M.D., Ph.D.    501-686-5515   
Sponsors and Collaborators
University of Arkansas
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Principal Investigator: Michael P Wilson, M.D., Ph.D. University of Arkansas

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Responsible Party: University of Arkansas Identifier: NCT04026308     History of Changes
Other Study ID Numbers: 239731
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: August 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Arkansas:
Suicide Prevention
Safety Planning
My3 App
Additional relevant MeSH terms:
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Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms