SuicideORIASNCT04642157
Online Referral and Intervention to Prevent Adolescent and Young Adult Suicide
A study testing ELIOS and other resources contacts in people with Suicide, run by University Hospital, Lille at 1 site in France.
Trial summary
ORIAS is a randomized controlled trial designed to study the efficacy of the ELIOS system in reducing suicidality in the AYA, reinforcing their motivation to seek help and making them access to care. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Suicide
- What is being tested?
- ELIOS and other resources contacts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 396 participants
- Where
- 1 siteFrance
- Study dates
- 13 Oct 2022to 13 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- To spontaneously contact the ELIOS online system
- To have been experiencing suicidal ideations in the week prior the contact
- To live in France and speak French
- To provide informed consent
- For ethical reasons, we decided not to include minors, due to impossibility of getting the parental authorizations without compromising the facilitation role of the system. However, most recent expert consensus consider that adolescence extends to 25 years old.
Who cannot join
- To contact the ELIOS online system for a relative or an acquaintance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Anne-Laure Demarty contact
France1 site, 1 recruiting
- Recruiting
CHU de Lille
Lille, 59000
CHARLES-EDOUARD NOTRE-DAME, DR, 0320446747 ext. +33, charles-edouard.notredame@chru-lille.fr
About this study
ORIAS is a randomized controlled trial designed to study the efficacy of the ELIOS system in reducing suicidality in the AYA, reinforcing their motivation to seek help and making them access to care.
As ELIOS would be the first suicide prevention system worldwide entirely tailored to the AYA contemporaneous modes of interaction on social media, ORIAS was designed to address the challenge of deciding whether this innovation is worth adding to the current national and international prevention arsenal. While randomized control trials are crucially lacking in the field of suicide prevention, especially on the Internet, the high-level evidence that ORIAS is expected to bring could have a decisive influence on how the French prevention strategies will seize the social media.
Read the detailed description
ELIOS will consist in a digital system that distressed users can contact via different social media or traditional communication channels. Participants randomized to the ELIOS group will be offered to interact online with a web-clinician who will deliver adapted interventions to alleviate their distress and refer them to appropriate care.The ELIOS web-clinicians will be psychologists and nurses supervised by a psychiatrist, specially trained to carry out crisis, counselling and motivational at distance interventions with AYA. In addition, they will receive a special training module dedicated to the interaction constraints and possibilities that the social media imply, but also to the textual and iconographic communication modalities. Human resources of ELIOS will be shared with those of the VigilanS program.
The ORIAS study primarily aims at showing the superiority of the ELIOS system in decreasing suicidality at 3 months in comparison to simple professional contact delivery among the AYA who seek help online for suicidal ideations.
With that purpose, participants will be randomly allocated to 2 parallel arms
- In addition to receiving the same generic mental health resources as in the control group, the participants of the ELIOS arm will benefit from the intervention of the ELIOS team. This includes an initial systematic contact with an ELIOS web-clinician, systematic recontacts by the ELIOS web-clinicians, scheduled at 24h, 72h and/or 7 days, depending on the participants' level of suicide risk and the opportunity to spontaneously contact the ELIOS system and get in contact with a web-clinician. All the ELIOS interventions will be subordinated to the two main goals of reducing the users' distress and suicidality and achieving an effective referral to the mental health care services. To do so, the web-clinicians will variably combine three complementary psychotherapeutic techniques: crisis intervention, counselling and motivational guidance. The interventions will be constrained by the imperative of rapidly bringing the participants from social media channels to more engaging channels (phone call or video-conference) in order to gain degrees of freedom in the interaction.
- Participants of the control arm will receive generic professional help contacts. Three types of resources will be suggested via the ELIOS website: the General Practitioner (GP), the closest Medical and Psychological Center, the emergency services. The order of presentation of the resource contacts will depend on the participants' intensity of suicidal ideation.
In both arms, data will be collected by means of online self-questionnaire before the intervention or provision of resource contacts (T0) and 3 months later (T1).
As primary efficacy analysis, the change in the Columbia Suicide Severity Rating Scale Intensity of Ideation-subscale score between baseline and M3 will be compared between the 2 arms using the constrained longitudinal data analysis (cLDA) model. To take into account the stratified factor considered in randomization, gender will be included as a covariate in the cLDA model. The treatment effect (mean between-arms difference in the 3-months change from baseline) will be estimated by the time-by-arm interaction. If normality of the model residuals is not satisfied (despite the log-transformation of the data), non-parametric analysis will be used; absolute changes between baseline and M3 will be calculated and compared between the 2 arms using non-parametric analysis of covariance adjusted for baseline values. Primary analysis will be conducted according to the ITT principle after handling missing values. A complete case-analysis will be performed as sensitivity analysis. In a second sensitivity analysis, the primary endpoint will be compared between the 2 arms by including in the cLDA model pre-specified covariates known for their association with suicidal behaviors, namely age, regular consumption of tobacco, regular consumption of alcohol, regular consumption of drugs, known pre-existing psychiatric disorder and personal history of suicide attempt. The necessary subjects number is 386 (193 per arm).
- Conditions
- Suicide
- Being tested
- ELIOS, other resources contacts
- Keywords
- Suicide, Prevention, Web, Social media, Adolescence, Youth
- Medical subject headings
- Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELIOSOther
ELIOS is a suicide prevention system worldwide entirely tailored to the AYA contemporaneous modes of interaction on social media.
This includes
- A systematic initial contact with an ELIOS web-clinician
- Systematic recontacts by the ELIOS web-clinicians scheduled at 24h, 72h and/or 7 days, depending on the participants' level of suicide risk
- The opportunity to spontaneously contact the ELIOS system and get in contact with a web-clinician
other resources contactsOther
Three types of resources will be suggested via the ELIOS website:
- The General Practitioner (GP)
- The closest medico-psychologic center (CMP)
- The emergency services The order of presentation of the resource contacts will depend on the participants' intensity of suicidal ideation.
| Study group | Role | What they receive |
|---|---|---|
| ELIOS group | Experimental | In addition to receiving the same generic mental health resources as in the control group, the participants of the ELIOS arm will benefit from the intervention of the ELIOS team. Receives: Other: ELIOS |
| control group | Other | Participants of the control arm will receive generic professional help contacts. Receives: Other: other resources contacts |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of the intensity of the severest suicidal ideation experienced in the past week by the participants.
The intensity of suicidal ideation will be measured by the total score on the Intensity of Ideation (IoI) subscale of the Columbia Suicide Severity Rating Scale (C-SSRS)
Measured: from baseline to the 3-months follow-up
Secondary outcomes (7)
Access to care after a suicide attempt
Rate of participants with at least one access to the conventional healthcare system, visit to the emergency room or admission to hospital immediately after a suicide attempt or conscious life-threatening behavior
Measured: within the 3-months follow-up period
Suicide attempt
Rate of participants with at least one suicide attempt
Measured: within the 3-months follow-up period
Mortality
All-cause mortality rate
Measured: at 3 months
psychological pain
The participants will be asked to self-estimate and report the intensity of their last week severest psychological pain via a Visual Analogous Scale (VAS) going from "No psychological pain" (score = 0) to "Maximal possible psychological pain" (score = 10).
Measured: at 3 months
Score at the Attitudes Toward Seeking Professional Psychological Help Scale - Short Form (ATSPPH-SF) care
The ATSPPH-SF is one of the most widely used tool to measure help-seeking related attitudes. Its 10 items consist in 4-points Likert scale questions, with answers possibly ranging from 0 (disagree) to 3 (agree). Five items are reverse-scored so that higher scores indicate more positive attitudes towards seeking professional psychological help.
Measured: at 3 months
Score at the French version of the Client Satisfaction Questionnaire-8 (CSQ-8)
The CSQ-8 is validated and frequently used in relation to mental health services (78-80). It consists in 8 items to which the participants respond via Likert scales ranging from 1 (low satisfaction) to 4 (high satisfaction). Higher scores indicate greater satisfaction with the services.
Measured: at 3 months
Rate of successful recontacts (recontacts with a response)
Develop a database of types of contact and corresponding metadata for collect data related to the way the platform is used.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start13 Oct 2022
- Primary completion13 Jul 2026 (estimated)
- Study completion13 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 396 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Charles-Edouard Notredame, MD, Principal investigator, CHU Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642157
- Sponsor's protocol ID
- 2018_93
- Other IDs
- 2020-A00252-37, PHRCN-18-0418
- Acronym
- ORIAS
- Status last verified
- Jun 2025
- First submitted
- 13 Jul 2020
- Last updated
- 27 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Morgieve M, Manon L, Lesniak AC, Rougegrez L, Rigbourg N, Jardon V, Wathelet M, Demarty AL, Dahache K, Duhamel A, Delbarre T, Grandgenevre P, Notredame CE. Social Media-Based Professional Intervention vs Resource Provision for Youth With Suicidal Ideation or Behavior: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Apr 24;15:e83303. doi: 10.2196/83303.
PubMed 42061852
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Referral and Intervention to Prevent Adolescent and Young Adult Suicide
- ClinicalTrials.gov ID
- NCT04642157
- Acronym / sponsor ID
- ORIAS / 2018_93
- Conditions
- Suicide
- Keywords
- Suicide, Prevention, Web, Social media, Adolescence, Youth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 396 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- 13 Jul 2026 (estimated)
- Study completion
- 13 Jul 2026 (estimated)
- First posted
- 24 Nov 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.
ORIAS is a randomized controlled trial designed to study the efficacy of the ELIOS system in reducing suicidality in the AYA, reinforcing their motivation to seek help and making them access to care.
As ELIOS would be the first suicide prevention system worldwide entirely tailored to the AYA contemporaneous modes of interaction on social media, ORIAS was designed to address the challenge of deciding whether this innovation is worth adding to the current national and international prevention arsenal. While randomized control trials are crucially lacking in the field of suicide prevention, especially on the Internet, the high-level evidence that ORIAS is expected to bring could have a decisive influence on how the French prevention strategies will seize the social media.
Detailed description
ELIOS will consist in a digital system that distressed users can contact via different social media or traditional communication channels. Participants randomized to the ELIOS group will be offered to interact online with a web-clinician who will deliver adapted interventions to alleviate their distress and refer them to appropriate care.The ELIOS web-clinicians will be psychologists and nurses supervised by a psychiatrist, specially trained to carry out crisis, counselling and motivational at distance interventions with AYA. In addition, they will receive a special training module dedicated to the interaction constraints and possibilities that the social media imply, but also to the textual and iconographic communication modalities. Human resources of ELIOS will be shared with those of the VigilanS program.
The ORIAS study primarily aims at showing the superiority of the ELIOS system in decreasing suicidality at 3 months in comparison to simple professional contact delivery among the AYA who seek help online for suicidal ideations.
With that purpose, participants will be randomly allocated to 2 parallel arms
- In addition to receiving the same generic mental health resources as in the control group, the participants of the ELIOS arm will benefit from the intervention of the ELIOS team. This includes an initial systematic contact with an ELIOS web-clinician, systematic recontacts by the ELIOS web-clinicians, scheduled at 24h, 72h and/or 7 days, depending on the participants' level of suicide risk and the opportunity to spontaneously contact the ELIOS system and get in contact with a web-clinician. All the ELIOS interventions will be subordinated to the two main goals of reducing the users' distress and suicidality and achieving an effective referral to the mental health care services. To do so, the web-clinicians will variably combine three complementary psychotherapeutic techniques: crisis intervention, counselling and motivational guidance. The interventions will be constrained by the imperative of rapidly bringing the participants from social media channels to more engaging channels (phone call or video-conference) in order to gain degrees of freedom in the interaction.
- Participants of the control arm will receive generic professional help contacts. Three types of resources will be suggested via the ELIOS website: the General Practitioner (GP), the closest Medical and Psychological Center, the emergency services. The order of presentation of the resource contacts will depend on the participants' intensity of suicidal ideation.
In both arms, data will be collected by means of online self-questionnaire before the intervention or provision of resource contacts (T0) and 3 months later (T1).
As primary efficacy analysis, the change in the Columbia Suicide Severity Rating Scale Intensity of Ideation-subscale score between baseline and M3 will be compared between the 2 arms using the constrained longitudinal data analysis (cLDA) model. To take into account the stratified factor considered in randomization, gender will be included as a covariate in the cLDA model. The treatment effect (mean between-arms difference in the 3-months change from baseline) will be estimated by the time-by-arm interaction. If normality of the model residuals is not satisfied (despite the log-transformation of the data), non-parametric analysis will be used; absolute changes between baseline and M3 will be calculated and compared between the 2 arms using non-parametric analysis of covariance adjusted for baseline values. Primary analysis will be conducted according to the ITT principle after handling missing values. A complete case-analysis will be performed as sensitivity analysis. In a second sensitivity analysis, the primary endpoint will be compared between the 2 arms by including in the cLDA model pre-specified covariates known for their association with suicidal behaviors, namely age, regular consumption of tobacco, regular consumption of alcohol, regular consumption of drugs, known pre-existing psychiatric disorder and personal history of suicide attempt. The necessary subjects number is 386 (193 per arm).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELIOS group | Experimental | Other: ELIOSIn addition to receiving the same generic mental health resources as in the control group, the participants of the ELIOS arm will benefit from the intervention of the ELIOS team. |
| control group | Other | Other: other resources contactsParticipants of the control arm will receive generic professional help contacts. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- To spontaneously contact the ELIOS online system
- To have been experiencing suicidal ideations in the week prior the contact
- To live in France and speak French
- To provide informed consent
- For ethical reasons, we decided not to include minors, due to impossibility of getting the parental authorizations without compromising the facilitation role of the system. However, most recent expert consensus consider that adolescence extends to 25 years old.
Key exclusion criteria (1 listed)
- To contact the ELIOS online system for a relative or an acquaintance
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 |
|---|---|---|
| ELIOSELIOS is a suicide prevention system worldwide entirely tailored to the AYA contemporaneous modes of interaction on social media. This includes * A systematic initial contact with an ELIOS web-clinician * Systematic recontacts by the ELIOS web-clinicians scheduled at 24h, 72h and/or 7 days, depending on the participants' level of suicide risk * The opportunity to spontaneously contact the ELIOS system and get in contact with a web-clinician | Other | ELIOS group |
| other resources contactsThree types of resources will be suggested via the ELIOS website: * The General Practitioner (GP) * The closest medico-psychologic center (CMP) * The emergency services The order of presentation of the resource contacts will depend on the participants' intensity of suicidal ideation. | Other | control group |
Primary outcome
the change of the intensity of the severest suicidal ideation experienced in the past week by the participants.
Time frame: from baseline to the 3-months follow-up
The intensity of suicidal ideation will be measured by the total score on the Intensity of Ideation (IoI) subscale of the Columbia Suicide Severity Rating Scale (C-SSRS)
7 secondary outcomes
Access to care after a suicide attempt
Time frame: within the 3-months follow-up period
Suicide attempt
Time frame: within the 3-months follow-up period
Mortality
Time frame: at 3 months
psychological pain
Time frame: at 3 months
Score at the Attitudes Toward Seeking Professional Psychological Help Scale - Short Form (ATSPPH-SF) care
Time frame: at 3 months
Score at the French version of the Client Satisfaction Questionnaire-8 (CSQ-8)
Time frame: at 3 months
Rate of successful recontacts (recontacts with a response)
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
- Derived from this study: PubMed 42061852Morgieve M, Manon L, Lesniak AC, Rougegrez L, Rigbourg N, Jardon V, Wathelet M, Demarty AL, Dahache K, Duhamel A, Delbarre T, Grandgenevre P, Notredame CE. Social Media-Based Professional Intervention vs Resource Provision for Youth With Suicidal Ideation or Behavior: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2026 Apr 24;15:e83303. doi: 10.2196/83303.
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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.
Anne-Laure Demarty contact
Charles-Edouard Notredame, MD principal investigator
CHU Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELIOS and other resources contacts in people with Suicide, run by University Hospital, Lille 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 5 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: looking for participants now, as of the sponsor's last update on 27 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles-Edouard Notredame, MD (3 20 44 67 47 ext. +33, charles-edouard.notredame@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of the intensity of the severest suicidal ideation experienced in the past week by the participants. (time frame: from baseline to the 3-months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642157, which also lists 1 linked publication.
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 27 Jun 2025.