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

Suicidal Ideation Clinical Trial

— BAE  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04686162
• Other study ID #: RECHMPL20-0153
• Secondary ID: 2020-A03150-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: July 11, 2022

Study information

• Verified date: February 2021
• Source: University Hospital, Montpellier
• Contact: Philippe Courtet, MD PhD
• Phone: 467338581
• Email: p-courtet[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 11, 2022
• Est. primary completion date: July 11, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide Attempt
• Suicide, Attempted

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (8)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability	Rate of completion of the ecological momentary assessment questionnaires.	at 6 months
Secondary	Prevention modules use	The number of times the patient uses prevention modules	6 months
Secondary	Call module use	The number of calls made through the application to relatives/psychiatry/samu services	6 months
Secondary	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
Secondary	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
Secondary	Occurrence of a suicidal event	The occurrence of a suicidal event will be assessed by The Columbia-Suicide Severity Rating Scale	6 months