SuicideE-psYouthNCT04946955
Adaptation of a French E-health Tool for Suicide Prevention in Young Populations
A study testing Application and website with or without promotion in people with Suicide and Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
"France's suicide rate is among the highest in Europe, with the young among the more at risk. Several European projects have demonstrated the effectiveness of using e-tools in suicide prevention particularly for hard-to-reach populations. Read more about this study
- Who is it for?
- Ages 11 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Depression, Psychological Distress
- What is being tested?
- Application and website with or without promotion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,000,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2021to 31 Dec 2023
- 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 11 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- The inclusion criteria for users in the study were adolescents and young adults:
- between 11 and 25 years old
- living in France
- with a valid email account and internet access
- volunteers
- no objection from the legal representative for minors.
- The criterion for non-inclusion will be the refusal of the users and/or the legal representative for minors to participate."
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (URC Eco, Hôpital Hôtel-Dieu)
Paris, 75004
Karine Chevreul, MD, PhD, +33140274148, karine.chevreul@inserm.fr
Laure Daval, PharmD, +33140274575, laure.daval@aphp.fr
About this study
Official title: Intervention Research for Suicide Prevention Among Adolescents and Young Adults in the General Population Using E-health Tools and a Promotion System Involving the Civilian Population
"France's suicide rate is among the highest in Europe, with the young among the more at risk. Several European projects have demonstrated the effectiveness of using e-tools in suicide prevention particularly for hard-to-reach populations.
Lessons from StopBlues, an e-health tool (application/website) for suicide prevention in the general population developed in 2018 which was promoted by municipalities and general practitioners, show the necessity to adapt its content for young people.
Read more
The objective is to develop an e-health tool for suicide prevention targeting adolescents and young adults with psychological pain by adapting StopBlues and its promotional plan.
The detailed content of the e-health tool and its promotional plan will be determined via a literature review followed by individual and group interviews with experts and youth, with StopBlues as a starting part.
This adaptation of StopBlues will allow to reach a larger audience by offering a more suitable solution for this vulnerable population. A web-portal will serve as an entry point for both StopBlues and the new e-tool where users will be redirected to one of the tools/modules according to their profile and respective needs. "
Read the detailed description
"Context: France's suicide rate is among the highest in Europe, with the young among the more at risk. Several European projects have demonstrated the effectiveness of using e-tools in suicide prevention particularly for hard-to-reach populations.
Lessons from StopBlues, an e-health tool (application/website) for suicide prevention in the general population developed in 2018 which was promoted by municipalities and general practitioners, show the necessity to adapt its content for young people.
Research objectives:
Phase I: Development of the e-health tool The objective of this part is to set up a consultation to co-construct, on the one hand, an e-mental health tool including a smartphone application and its website with and for young people adapted to their age group and, on the other hand, the promotionnal plan.
Methodology: The detailed content of the e-health tool and the promotional tools will be determinated with a literature review and consultations of youth and experts. Then, the investigators will rely on different networks to invite young people to an online consultation according to their age group to participate from the start to this intervention. Several means will be mobilised to involve them. the investigators will discuss with them: their feelings about the existing StopBlues adult tool (www.stopblues.fr), their perception of the specific topics that need to be addressed regarding the causes of psychological suffering, the possible solutions, the identification of speakers who act out situations that young people can identify with, their opinion on the graphic charter and design, and finally the means of dissemination that we could use to promote this tool.
The investigators will use the data saturation method to stop recruiting. The data collection necessary for the co-construction will be realised on digital platforms through surveys including questionnaires with either open questions or multiple-choice questions. The data will then be analysed using qualitative and quantitative methods.
The investigators will also use the digital platforms mobilised for this consultation to present the results and validate with participating youth the final version of the content, structure and ergonomics of the tool to be developed.
Expected results: This consultation will allow the project team to co-construct with young people an e-health intervention involving a mobile application, a website and their promotion.
The investigators also expect it to provide more precise information on:
- youth feelings about the adult version of the tool (StopBlues): its content, its ergonomics and the means of communication used (videos of professionals and testimonies);
- youth perception of the specific topics that need to be addressed regarding the causes of psychological suffering and possible solutions;
- youth opinions concerning the graphic charter, the name and logo of the tool; - and identification of some witnesses or witnesses' relatives to interview.
Phase II: Implementation of the intervention
The main objective is to assess the effectiveness in reducing suicidal acts of a suicide prevention program for young adults in the general population, combining an e-health tool and its promotion by local authorities. The secondary objectives are to assess the effect of the programme on youth in terms of :
- efficiency of the programme and its total and sectoral budgetary impact.
- quality of life
- mental health status (anxiety and depressive symptoms, addictions, eating disorders, suicide risk)
- use of formal and informal help
- depression detected by a relative
- user satisfaction
- effectiveness of the promotion on the intensity of use of the e-health tool
- completion of the safety plan
- school or employment integration
- effectiveness of the tool according to the social status of users
- spillover effect of the programme on the youth suicide prevention policy: measures put in place secondarily by the communities involved
- the process of implementation of the promotion by the communities
- barriers and levers for studying transferability. Methodology: The trial will last 18 months from the moment the e-tool will be online. Data will be collected both from health data bases and at the individual user level.
Expected results: The intervention, which includes the development of an e-health tool for young people and its implementation with a promotion, will make it possible to confirm the applicability of the intervention model used for adults for suicide prevention in the general population (StopBlues), on a more restricted population (the E-psyjeunes tool), that of 11-25 year olds. This project will make it possible to address the question, mentioned many times when StopBlues was set up, of psychological suffering of young people. The malaise of adolescents and young adults is unique and requires specific development. Through this project, a response can be provided to the many actors (young people, associations, health professionals, local authorities, etc.) looking for help and solutions.
The investigators believe that this intervention will lead to a reduction in suicidal acts (suicides and attempted suicides) of young people. With the use of these tool, users should develop a better knowledge of mental health and suicide in general, but also of their own mental health status. They should also become more aware of the formal and informal ways of seeking help and their use of help should increase, as well as their actions increasing well-being/coping strategies implementation. A decrease in the stigma of mental disorders is also expected among young people."
- Conditions
- Suicide, Depression, Psychological Distress, Anxiety Disorders
- Being tested
- Application and website with or without promotion
- Keywords
- Primary care, Prevention, Suicide, Mental health, Young adults, Adolescents
- Medical subject headings
- Suicide, Depression, Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application and website with or without promotionOther
Development of an application and a website to de-stigmatise mental health and support the user in seeking help
| Study group | Role | What they receive |
|---|---|---|
| Application and website with promotion | Experimental | Development of an application and a website to de-stigmatise mental health and support the user in seeking help Receives: Other: Application and website with or without promotion |
| Application and website without promotion | Other | Not described Receives: Other: Application and website with or without promotion |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of suicidal acts (completed suicide and suicide attempts)
The number of completed suicides will be extracted from the database of the Epidemiology center on medical causes of deaths (CépiDc) for each local authority participating. The number of attempted suicides will be extracted from the national database of public and private hospital admissions (PMSI-MCO) and the national emergency database (Oscour).
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Within the framework of the project, the beneficiary public is the population of young adults and adolescents between 11 and 25 years old likely to connect to a mobile application and an associated website dedicated to the prevention of psychological suffering and suicide.
- Masking
- None (open label)
- Enrolment
- 12,000,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karine Chevreul, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946955
- Sponsor's protocol ID
- APHP180676
- Acronym
- E-psYouth
- Status last verified
- Jun 2021
- First submitted
- 23 Jun 2021
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Research for Suicide Prevention Among Adolescents and Young Adults in the General Population Using E-health Tools and a Promotion System Involving the Civilian Population
- ClinicalTrials.gov ID
- NCT04946955
- Acronym / sponsor ID
- E-psYouth / APHP180676
- Conditions
- Suicide, Depression, Psychological Distress, Anxiety Disorders
- Keywords
- Primary care, Prevention, Suicide, Mental health, Young adults, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12,000,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 1 Jul 2021 (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.
"France's suicide rate is among the highest in Europe, with the young among the more at risk. Several European projects have demonstrated the effectiveness of using e-tools in suicide prevention particularly for hard-to-reach populations.
Lessons from StopBlues, an e-health tool (application/website) for suicide prevention in the general population developed in 2018 which was promoted by municipalities and general practitioners, show the necessity to adapt its content for young people.
The objective is to develop an e-health tool for suicide prevention targeting adolescents and young adults with psychological pain by adapting StopBlues and its promotional plan.
The detailed content of the e-health tool and its promotional plan will be determined via a literature review followed by individual and group interviews with experts and youth, with StopBlues as a starting part.
This adaptation of StopBlues will allow to reach a larger audience by offering a more suitable solution for this vulnerable population. A web-portal will serve as an entry point for both StopBlues and the new e-tool where users will be redirected to one of the tools/modules according to their profile and respective needs. "
Detailed description
"Context: France's suicide rate is among the highest in Europe, with the young among the more at risk. Several European projects have demonstrated the effectiveness of using e-tools in suicide prevention particularly for hard-to-reach populations.
Lessons from StopBlues, an e-health tool (application/website) for suicide prevention in the general population developed in 2018 which was promoted by municipalities and general practitioners, show the necessity to adapt its content for young people.
Research objectives:
Phase I: Development of the e-health tool The objective of this part is to set up a consultation to co-construct, on the one hand, an e-mental health tool including a smartphone application and its website with and for young people adapted to their age group and, on the other hand, the promotionnal plan.
Methodology: The detailed content of the e-health tool and the promotional tools will be determinated with a literature review and consultations of youth and experts. Then, the investigators will rely on different networks to invite young people to an online consultation according to their age group to participate from the start to this intervention. Several means will be mobilised to involve them. the investigators will discuss with them: their feelings about the existing StopBlues adult tool (www.stopblues.fr), their perception of the specific topics that need to be addressed regarding the causes of psychological suffering, the possible solutions, the identification of speakers who act out situations that young people can identify with, their opinion on the graphic charter and design, and finally the means of dissemination that we could use to promote this tool.
The investigators will use the data saturation method to stop recruiting. The data collection necessary for the co-construction will be realised on digital platforms through surveys including questionnaires with either open questions or multiple-choice questions. The data will then be analysed using qualitative and quantitative methods.
The investigators will also use the digital platforms mobilised for this consultation to present the results and validate with participating youth the final version of the content, structure and ergonomics of the tool to be developed.
Expected results: This consultation will allow the project team to co-construct with young people an e-health intervention involving a mobile application, a website and their promotion.
The investigators also expect it to provide more precise information on:
- youth feelings about the adult version of the tool (StopBlues): its content, its ergonomics and the means of communication used (videos of professionals and testimonies);
- youth perception of the specific topics that need to be addressed regarding the causes of psychological suffering and possible solutions;
- youth opinions concerning the graphic charter, the name and logo of the tool; - and identification of some witnesses or witnesses' relatives to interview.
Phase II: Implementation of the intervention
The main objective is to assess the effectiveness in reducing suicidal acts of a suicide prevention program for young adults in the general population, combining an e-health tool and its promotion by local authorities. The secondary objectives are to assess the effect of the programme on youth in terms of :
- efficiency of the programme and its total and sectoral budgetary impact.
- quality of life
- mental health status (anxiety and depressive symptoms, addictions, eating disorders, suicide risk)
- use of formal and informal help
- depression detected by a relative
- user satisfaction
- effectiveness of the promotion on the intensity of use of the e-health tool
- completion of the safety plan
- school or employment integration
- effectiveness of the tool according to the social status of users
- spillover effect of the programme on the youth suicide prevention policy: measures put in place secondarily by the communities involved
- the process of implementation of the promotion by the communities
- barriers and levers for studying transferability. Methodology: The trial will last 18 months from the moment the e-tool will be online. Data will be collected both from health data bases and at the individual user level.
Expected results: The intervention, which includes the development of an e-health tool for young people and its implementation with a promotion, will make it possible to confirm the applicability of the intervention model used for adults for suicide prevention in the general population (StopBlues), on a more restricted population (the E-psyjeunes tool), that of 11-25 year olds. This project will make it possible to address the question, mentioned many times when StopBlues was set up, of psychological suffering of young people. The malaise of adolescents and young adults is unique and requires specific development. Through this project, a response can be provided to the many actors (young people, associations, health professionals, local authorities, etc.) looking for help and solutions.
The investigators believe that this intervention will lead to a reduction in suicidal acts (suicides and attempted suicides) of young people. With the use of these tool, users should develop a better knowledge of mental health and suicide in general, but also of their own mental health status. They should also become more aware of the formal and informal ways of seeking help and their use of help should increase, as well as their actions increasing well-being/coping strategies implementation. A decrease in the stigma of mental disorders is also expected among young people."
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Within the framework of the project, the beneficiary public is the population of young adults and adolescents between 11 and 25 years old likely to connect to a mobile application and an associated website dedicated to the prevention of psychological suffering and suicide.
| Arm | Type | Receives |
|---|---|---|
| Application and website with promotion | Experimental | Other: Application and website with or without promotionDevelopment of an application and a website to de-stigmatise mental health and support the user in seeking help |
| Application and website without promotion | Other | Other: Application and website with or without promotion |
Who may qualify
- Ages
- 11 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- between 11 and 25 years old
- living in France
- with a valid email account and internet access
- volunteers
- no objection from the legal representative for minors.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Application and website with or without promotionDevelopment of an application and a website to de-stigmatise mental health and support the user in seeking help | Other | Application and website with promotion, Application and website without promotion |
Primary outcome
number of suicidal acts (completed suicide and suicide attempts)
Time frame: 12 month
The number of completed suicides will be extracted from the database of the Epidemiology center on medical causes of deaths (CépiDc) for each local authority participating. The number of attempted suicides will be extracted from the national database of public and private hospital admissions (PMSI-MCO) and the national emergency database (Oscour).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Karine Chevreul, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application and website with or without promotion in people with Suicide and Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 1 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 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Karine Chevreul, MD, PhD (+33140274148, karine.chevreul@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of suicidal acts (completed suicide and suicide attempts) (time frame: 12 month). 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 20 Oct 2021.