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

Primary Purpose

Suicide Attempt, Suicidal Ideation

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
bae application
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Suicide Attempt focused on measuring suicide attempt, suicidal ideation, e-Health, smartphone application, ecological momentary assessment, adolescents

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Group using the smartphone application bae

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Acceptability
    Rate of completion of the ecological momentary assessment questionnaires.

    Secondary Outcome Measures

    Prevention modules use
    The number of times the patient uses prevention modules
    Call module use
    The number of calls made through the application to relatives/psychiatry/samu services
    Satisfation
    Satisfaction is assessed by monthly questionnaires in the application (Likert scales from 0 to 10, 0 is the worst and 10 the best)
    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)
    Occurrence of a suicidal event
    The occurrence of a suicidal event will be assessed by The Columbia-Suicide Severity Rating Scale

    Full Information

    First Posted
    December 22, 2020
    Last Updated
    August 10, 2021
    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
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04686162
    Brief Title
    Bae: A Smartphone Application for a Better Following Adolescents at Risk of Suicidal Behavior: Study of Acceptability and Preliminary Results of Efficacy
    Acronym
    BAE
    Official Title
    Bae: A Smartphone Application for a Better Following Adolescents at Risk of Suicidal
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 20, 2021 (Anticipated)
    Primary Completion Date
    July 11, 2022 (Anticipated)
    Study Completion Date
    July 11, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the 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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Suicide Attempt, Suicidal Ideation
    Keywords
    suicide attempt, suicidal ideation, e-Health, smartphone application, ecological momentary assessment, adolescents

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group using the smartphone application bae
    Arm Type
    Experimental
    Arm Description
    Patients with personal history of suicide attempt or with suicidal ideation, will use the application during 6 months.
    Intervention Type
    Other
    Intervention Name(s)
    bae application
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Acceptability
    Description
    Rate of completion of the ecological momentary assessment questionnaires.
    Time Frame
    at 6 months
    Secondary Outcome Measure Information:
    Title
    Prevention modules use
    Description
    The number of times the patient uses prevention modules
    Time Frame
    6 months
    Title
    Call module use
    Description
    The number of calls made through the application to relatives/psychiatry/samu services
    Time Frame
    6 months
    Title
    Satisfation
    Description
    Satisfaction is assessed by monthly questionnaires in the application (Likert scales from 0 to 10, 0 is the worst and 10 the best)
    Time Frame
    1, 2, 3, 4, 5 and 6 months
    Title
    Satisfaction
    Description
    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)
    Time Frame
    6 months
    Title
    Occurrence of a suicidal event
    Description
    The occurrence of a suicidal event will be assessed by The Columbia-Suicide Severity Rating Scale
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    17 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Philippe Courtet, MD PhD
    Phone
    467338581
    Ext
    +33
    Email
    p-courtet@chu-montpellier.fr

    12. IPD Sharing Statement

    Learn more about this trial

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

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