NCT04026308

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 19, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2020

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 16, 2021

Completed
Last Updated

March 21, 2023

Status Verified

February 1, 2023

Enrollment Period

3 months

First QC Date

July 18, 2019

Results QC Date

June 23, 2021

Last Update Submit

March 17, 2023

Conditions

Keywords

SuicideSuicide PreventionSafety PlanningSafety Net App

Outcome Measures

Primary Outcomes (3)

  • Acceptability of Intervention

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

    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.

    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.

    Up to 12 hours

Study Arms (2)

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.

Other: Safety Net App

Interventions

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
Electronic Safety Plan

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \<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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Suicidal IdeationSuicide, AttemptedPsychological Well-BeingSuicideSuicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehaviorPersonal Satisfaction

Results Point of Contact

Title
Michael Wilson
Organization
UAMS

Study Officials

  • Michael P Wilson, M.D., Ph.D.

    University of Arkansas

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2019

First Posted

July 19, 2019

Study Start

September 15, 2020

Primary Completion

December 28, 2020

Study Completion

December 28, 2020

Last Updated

March 21, 2023

Results First Posted

August 16, 2021

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations