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
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
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
NCT ID
NCT04686162
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
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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