Written vs Electronic Safety Planning Study

NCT ID: NCT04026308

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2020-12-28

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Written Safety Plan

Participants will complete a traditional written suicide safety plan.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Electronic Safety Plan

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

Group Type: EXPERIMENTAL

Safety Net App

Intervention Type: OTHER

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.

Interventions

Safety 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.

Intervention Type: OTHER

Other Intervention Names

Stanley-Brown Safety Plan App

Eligibility Criteria

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

• <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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Arkansas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael P Wilson, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Arkansas

Locations

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

239731

Identifier Type: -

Identifier Source: org_study_id