CClinicalTrials.gg
CompletedNCT04026308Updated Mar 21, 2023Results posted

Written vs Electronic Safety Planning Study

An interventional study of Safety Net App in Suicidal Ideation, Suicide Attempt and Mental Health, sponsored by University of Arkansas. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-03-21.

Sponsored by University of Arkansas · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

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?

02

Conditions studied

  • Suicidal Ideation
  • Suicide Attempt
  • Mental Health

Keywords

  • Suicide
  • Suicide Prevention
  • Safety Planning
  • Safety Net App
03

In context

Suicide

701 studies on the registry are indexed under Suicide; 183 are open to participants now.

This study's enrollment of 30 is below the median of 104 across 560 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

University of Arkansas is the lead sponsor of 391 studies on the registry; 39 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 34 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
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
  • Have not already filled out a safety plan at the current visit

Exclusion criteria

Exclusion Criteria:

  • \<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
  • 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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • No intervention
    Written Safety Plan

    Participants will complete a traditional written suicide safety plan.

  • Experimental
    Electronic Safety Plan

    Participants will complete a suicide safety plan in the Safety Net app using a tablet.

    Other: Safety Net App

Interventions

  • OtherSafety Net 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.

    Also known as: Stanley-Brown Safety Plan App

06

What researchers measure

Primary outcomes

  1. Acceptability of Intervention

    The number of patients approached who agree to allow trained non-clinical staff to assist with safety planning.

    Time frame: Up to 12 hours

  2. 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.

    Time frame: Up to 12 hours

  3. 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.

    Time frame: Up to 12 hours

07

Results

Posted Aug 16, 2021

Participant flow

Participant flow — Overall Study
MilestoneWritten Safety PlanElectronic Safety Plan
Started1416
Completed1416
Not completed00

Outcome measures

PrimaryAcceptability of Intervention

The number of patients approached who agree to allow trained non-clinical staff to assist with safety planning.

Time frame:
Up to 12 hours
Reported as:
Count of participants · Participants
Acceptability of Intervention
ParticipantsWritten Safety PlanElectronic Safety Plan
Acceptability of Intervention1416
PrimaryLength 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.

Time frame:
Up to 12 hours
Reported as:
Mean · minutes
Length of Stay
minutesWritten Safety PlanElectronic Safety Plan
Length of Stay250 (12 to 626)288 (13 to 978)
PrimarySatisfaction 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.

Time frame:
Up to 12 hours
Reported as:
Mean · units on a scale
Satisfaction With Safety Planning
units on a scaleWritten Safety PlanElectronic Safety Plan
Satisfaction With Safety Planning5.29 (3 to 7)5.31 (4 to 7)

Adverse events

Collected over Through participant's ED visit at enrollment, usually <1 day. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Written Safety Plan0/14 (0%)0/14 (0%)0/14 (0%)
Electronic Safety Plan0/16 (0%)0/16 (0%)0/16 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Written Safety PlanElectronic Safety PlanTotal
<=18 years000
Between 18 and 65 years131629
>=65 years101
Age, Continuous
Age, Continuous(years)Written Safety PlanElectronic Safety PlanTotal
Mean40 (21 to 69)39 (21 to 56)40 (21 to 69)
Sex: Female, Male
Sex: Female, Male(Participants)Written Safety PlanElectronic Safety PlanTotal
Female6511
Male81119
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Written Safety PlanElectronic Safety PlanTotal
Count of participants——0
08

Study locations

1 site
  • University of Arkansas for Medical Sciences
    Little Rock, Arkansas 72205, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Aug 28, 2020
  • Informed consent form · Aug 28, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT04026308
Lead sponsor
University of Arkansas
Responsible party
Sponsor
First posted
Jul 19, 2019
Start date
Sep 15, 2020
Primary completion
Dec 28, 2020
Completion
Dec 28, 2020
Results posted
Aug 16, 2021
Last update
Mar 21, 2023

Study contacts

Michael P Wilson, M.D., Ph.D.
principal investigator · University of Arkansas

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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