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

NCT04686162 | Unknown

• 2 other identifiers: RECHMPL20-01532020-A03150-39
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Suicide Attempt; Suicidal Ideation

Keywords

suicide attempt; suicidal ideation; e-Health; smartphone application; ecological momentary assessment; adolescents

Outcome Measures

Primary Outcomes (1)

• Acceptability

  Rate of completion of the ecological momentary assessment questionnaires.

  at 6 months

Secondary Outcomes (5)

• Prevention modules use

  6 months

• Call module use

  6 months

• Satisfation

  1, 2, 3, 4, 5 and 6 months

• Satisfaction

  6 months

• Occurrence of a suicidal event

  6 months

Study Arms (1)

Group using the smartphone application bae

EXPERIMENTAL

Patients with personal history of suicide attempt or with suicidal ideation, will use the application during 6 months.

Other: bae application

Interventions

bae application OTHER

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 : 1. 5 times a day during 3 days, every month (5 minutes) : patients can assess their emotions, their thoughts, their behavior and their occurrence context. 2. 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. 3. Monthly (5 minutes): assessment of the usefulness and satisfaction about the application. 4. 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.

Group using the smartphone application bae

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• Patient deprived of liberty (by judicial or administrative decision)
• Inability to understand, speak and write French

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• University Hospital, Lille: collaborator
• University Hospital, Nîmes: collaborator
• La Timone Hospital, Marseille: collaborator
• Association "Mal être des adolescents", Marseille: collaborator
• Salvator Hospital, Marseille: collaborator
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator
• Laboratoire d'Informatique, de Robotique et de Microélectronique de Montpellier: collaborator

MeSH Terms

Conditions

Suicide, Attempted; Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Central Study Contacts

Philippe Courtet, MD PhD

CONTACT

467338581; p-courtet@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 28, 2020
• Study Start: September 20, 2021
• Primary Completion: July 11, 2022
• Study Completion: July 11, 2022
• Last Updated: August 11, 2021

Record last verified: 2021-02