Suicide AttemptBAENCT04686162
Bae: A Smartphone Application for a Better Following Adolescents at Risk of Suicidal Behavior: Study of Acceptability and Preliminary Results of Efficacy
A study testing bae application in people with Suicide Attempt and Suicidal Ideation, run by University Hospital, Montpellier.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicide Attempt, Suicidal Ideation
- What is being tested?
- bae application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2021to 11 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- Patient deprived of liberty (by judicial or administrative decision)
- Inability to understand, speak and write French
- Participation in another study with an exclusion period.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Suicide Attempt, Suicidal Ideation
- Being tested
- bae application
- Keywords
- suicide attempt, suicidal ideation, e-Health, smartphone application, ecological momentary assessment, adolescents
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bae applicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: bae application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability
Rate of completion of the ecological momentary assessment questionnaires.
Measured: at 6 months
Secondary outcomes (5)
Prevention modules use
The number of times the patient uses prevention modules
Measured: 6 months
Call module use
The number of calls made through the application to relatives/psychiatry/samu services
Measured: 6 months
Satisfation
Satisfaction is assessed by monthly questionnaires in the application (Likert scales from 0 to 10, 0 is the worst and 10 the best)
Measured: 1, 2, 3, 4, 5 and 6 months
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)
Measured: 6 months
Occurrence of a suicidal event
The occurrence of a suicidal event will be assessed by The Columbia-Suicide Severity Rating Scale
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start20 Sep 2021 (estimated)
- Primary completion11 Jul 2022 (estimated)
- Study completion11 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide AttemptStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Nîmes, La Timone Hospital, Marseille, Association "Mal être des adolescents", Marseille, Salvator Hospital, Marseille, Institut National de la Santé Et de la Recherche Médicale, France, Laboratoire d'Informatique, de Robotique et de Microélectronique de Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686162
- Sponsor's protocol ID
- RECHMPL20-0153
- Other IDs
- 2020-A03150-39
- Acronym
- BAE
- Status last verified
- Feb 2021
- First submitted
- 22 Dec 2020
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bae: A Smartphone Application for a Better Following Adolescents at Risk of Suicidal
- ClinicalTrials.gov ID
- NCT04686162
- Acronym / sponsor ID
- BAE / RECHMPL20-0153
- Conditions
- Suicide Attempt, Suicidal Ideation
- Keywords
- suicide attempt, suicidal ideation, e-Health, smartphone application, ecological momentary assessment, adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- University Hospital, Lille, University Hospital, Nîmes, La Timone Hospital, Marseille, Association "Mal être des adolescents", Marseille, Salvator Hospital, Marseille, Institut National de la Santé Et de la Recherche Médicale, France, Laboratoire d'Informatique, de Robotique et de Microélectronique de Montpellier
- Study start
- 20 Sep 2021 (estimated)
- Primary completion
- 11 Jul 2022 (estimated)
- Study completion
- 11 Jul 2022 (estimated)
- First posted
- 28 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group using the smartphone application bae | Experimental | Other: bae applicationPatients with personal history of suicide attempt or with suicidal ideation, will use the application during 6 months. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Patient deprived of liberty (by judicial or administrative decision)
- Inability to understand, speak and write French
- Participation in another study with an exclusion period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bae applicationPatients 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. | Other | Group using the smartphone application bae |
Primary outcome
Acceptability
Time frame: at 6 months
Rate of completion of the ecological momentary assessment questionnaires.
5 secondary outcomes
Prevention modules use
Time frame: 6 months
Call module use
Time frame: 6 months
Satisfation
Time frame: 1, 2, 3, 4, 5 and 6 months
Satisfaction
Time frame: 6 months
Occurrence of a suicidal event
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing bae application in people with Suicide Attempt and Suicidal Ideation, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Courtet, MD PhD (467338581 ext. +33, p-courtet@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.