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

August 10, 2021 updated by: University Hospital, Montpellier

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 :

  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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Acceptability
Time Frame: at 6 months
Rate of completion of the ecological momentary assessment questionnaires.
at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Prevention modules use
Time Frame: 6 months
The number of times the patient uses prevention modules
6 months
Call module use
Time Frame: 6 months
The number of calls made through the application to relatives/psychiatry/samu services
6 months
Satisfation
Time Frame: 1, 2, 3, 4, 5 and 6 months
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
Time Frame: 6 months
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
Time Frame: 6 months
The occurrence of a suicidal event will be assessed by The Columbia-Suicide Severity Rating Scale
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Lille
University Hospital, Nīmes
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 22, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 28, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 10, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Suicidal Ideation

Clinical Trials on bae application

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings