Bae: A Smartphone Application for a Better Following Adolescents at Risk of Suicidal Behavior: Study of Acceptability and Preliminary Results of Efficacy (BAE)

Bae: A Smartphone Application for a Better Following Adolescents at Risk of Suicidal

Suicidal behavior among adolescents is a major public health problem. Exacerbation of suicidal risk most often occurs when the young person is in his or her natural environment, far from the health care system. Therefore, real-time risk detection would make it possible to deploy immediate action interventions. A smartphone application for personalized assessment and intervention would enable patients to better anticipate and manage suicidal crises and stay connected to the healthcare system. The increasing use of smartphones and mobile applications among adolescents supports the feasibility and value of such follow-up among young people. In a first phase of this project, investigators first undertook to develop bae: a smartphone application adapted to a population of adolescents collecting information on their suicidal behaviour in a contextualized manner, with the added benefit of offering emotion management modules as well as personalized psychoeducational messages and alerts delivered to young people in the event of a crisis. The application is intended to be a complementary tool to the usual treatment. Before testing its effectiveness and due to the novelty of the intervention, a rigorous feasibility study in a real clinical context is necessary to ensure acceptability and satisfaction with the use of the bae application.

The objective is to evaluate, over a 6-month period, the acceptability of a follow-up of a population of 100 adolescents (12-17 years) at risk of suicidal driving via the bae smartphone application.

Study Overview

• Status: Not yet recruiting
• Conditions: Suicidal Ideation; Suicide Attempt
• Intervention / Treatment: Other: bae application

Detailed Description

100 patients having recently attempted suicide or having suicidal ideation will be recruited. They will be asked to use the application bae during 6 months and will be followed up during this period.

Initial visit (inclusion) : clinical assessment and installation of the application bae.

Last visit (6th month) : clinical assessment.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Courtet, MD PhD; Phone Number: +33 467338581; Email: p-courtet@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Criteria for inclusion

All subjects will be required to meet the following inclusion criteria:

• Having consulted in the context of a suicidal crisis according to the criteria defined according to the consensus conference of the High Authority of Health (HAS 2000) ("psychic crisis for which the major risk is suicide. It can be represented as the trajectory that goes from the pejorative feeling of being in a situation of failure to a perceived impossibility of escaping this impasse. It is accompanied by suicidal ideas that become more and more pervasive and pervasive until the eventual act is carried out") in the previous 7 days.
• Possess a compatible smartphone (operating system: iOs or Androïd)
• Subject affiliated to or beneficiary of a French social security scheme
• Be able to understand the nature, purpose and methodology of the study
• Informed consent signed by the patient and his/her parent(s) or legal representative(s)

Exclusion Criteria:

• Patient deprived of liberty (by judicial or administrative decision)
• Inability to understand, speak and write French
• Participation in another study with an exclusion period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Group using the smartphone application bae; Patients with personal history of suicide attempt or with suicidal ideation, will use the application during 6 months.

Other: bae application; Patients will be assisted by a research team member to install and configure the application bae on their smartphone; then, they will be trained to use it. Bae proposes 4 types of assessments : 5 times a day during 3 days, every month (5 minutes) : patients can assess their emotions, their thoughts, their behavior and their occurrence context.; Weekly (7 minutes) : consists of a summary of the week, about their emotions, thoughts, behavior, their relationships (family, work, friends), and their quality of life.; Monthly (5 minutes): assessment of the usefulness and satisfaction about the application.; Assessment available at any time An action plan is designed to support the participants, to help them facing difficult emotions and feelings, and to encourage them to ask for help. They can contact a relative or call the psychiatric emergency service directly by clicking on a button. Patients can try to identify their own warning signs, to prevent suicidal behavior.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability	Rate of completion of the ecological momentary assessment questionnaires.	at 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention modules use	The number of times the patient uses prevention modules	6 months
Call module use	The number of calls made through the application to relatives/psychiatry/samu services	6 months
Satisfation	Satisfaction is assessed by monthly questionnaires in the application (Likert scales from 0 to 10, 0 is the worst and 10 the best)	1, 2, 3, 4, 5 and 6 months
Satisfaction	Satisfaction is assessed by a self administrated questionnaire to be completed during the telephone interview at 6 months by a Likert scales from 0 to 10, 0 is the worst and 10 the best)	6 months
Occurrence of a suicidal event	The occurrence of a suicidal event will be assessed by The Columbia-Suicide Severity Rating Scale	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: University Hospital, Lille; University Hospital, Nîmes; La Timone Hospital, Marseille; Association "Mal être des adolescents", Marseille; Salvator Hospital, Marseille; Unit Inserm U1061, Montpellier; Laboratoire d'Informatique, de Robotique et de Microélectronique de Montpellier

Study record dates

Study Major Dates

• Study Start (Anticipated): September 20, 2021
• Primary Completion (Anticipated): July 11, 2022
• Study Completion (Anticipated): July 11, 2022

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 22, 2020
• First Posted (Actual): December 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: adolescents; suicide attempt; smartphone application; suicidal ideation; ecological momentary assessment; e-Health
• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: RECHMPL20-0153; 2020-A03150-39 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No