Using a Safety Planning Mobile App to Address Suicidality in Young People Attending Community Mental Health Services in Ireland: Protocol for a Pilot Randomized Controlled Trial
Authors: Melia Ruth , Francis Kady , Duggan Jim , Bogue John , O'Sullivan Mary , Young Karen , Chambers Derek , McInerney Shane J , O'Dea Edmond , Bernert Rebecca 
Published: January 2023

Background
Over 700,000 people die by suicide annually, making it the fourth leading cause of death among those aged 15-29 years globally. Safety planning is recommended best practice when individuals at risk of suicide present to health services. A safety plan, developed in collaboration with a health care practitioner, details the steps to be taken in an emotional crisis. SafePlan, a safety planning mobile app, was designed to support young people experiencing suicidal thoughts and behaviors and to record their plan in a way that is accessible immediately and in situ.

Objective
The aim of this study is to assess the feasibility and acceptability of the SafePlan mobile app for patients experiencing suicidal thoughts and behaviors and their clinicians within Irish community mental health services, examine the feasibility of study procedures for both patients and clinicians, and determine if the SafePlan condition yields superior outcomes when compared with the control condition.

Methods
A total of 80 participants aged 16-35 years accessing Irish mental health services will be randomized (1:1) to receive the SafePlan app plus treatment as usual or treatment as usual plus a paper-based safety plan. The feasibility and acceptability of the SafePlan app and study procedures will be evaluated using both qualitative and quantitative methodologies. The primary outcomes are feasibility outcomes and include the acceptability of the app to participants and clinicians, the feasibility of delivery in this setting, recruitment, retention, and app use. The feasibility and acceptability of the following measures in a full randomized controlled trial will also be assessed: the Beck Scale for Suicide Ideation, Columbia Suicide Severity Rating Scale, Coping Self-Efficacy Scale, Interpersonal Needs Questionnaire, and Client Service Receipt Inventory. A repeated measures design with outcome data collected at baseline, post intervention (8 weeks), and at 6-month follow-up will be used to compare changes in suicidal ideation for the intervention condition relative to the waitlist control condition. A cost-outcome description will also be undertaken. Thematic analyses will be used to analyze the qualitative data gathered through semistructured interviews with patients and clinicians.

Results
As of January 2023, funding and ethics approval have been acquired, and clinician champions across mental health service sites have been established. Data collection is expected to commence by April 2023. The submission of completed manuscript is expected by April 2025.

Conclusions
The framework for Decision-making after Pilot and feasibility Trials will inform the decision to progress to a full trial. The results will inform patients, researchers, clinicians, and health services of the feasibility and acceptability of the SafePlan app in community mental health services. The findings will have implications for further research and policy regarding the broader integration of safety planning apps.

Trial Registration
OSF Registries osf.io/3y54m; https://osf.io/3y54m

International Registered Report Identifier (IRRID)
PRR1-10.2196/44205