NCT04642157

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
396

participants targeted

Target at P75+ for not_applicable

Timeline
3mo left

Started Oct 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Oct 2022Jul 2026

First Submitted

Initial submission to the registry

July 13, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
1.9 years until next milestone

Study Start

First participant enrolled

October 13, 2022

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2026

Last Updated

June 27, 2025

Status Verified

June 1, 2025

Enrollment Period

3.8 years

First QC Date

July 13, 2020

Last Update Submit

June 23, 2025

Conditions

Suicide

Keywords

SuicidePreventionWebSocial mediaAdolescenceYouth

Outcome Measures

Primary Outcomes (1)

  • 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)

    from baseline to the 3-months follow-up

Secondary Outcomes (7)

  • Access to care after a suicide attempt

    within the 3-months follow-up period

  • Suicide attempt

    within the 3-months follow-up period

  • Mortality

    at 3 months

  • psychological pain

    at 3 months

  • Score at the Attitudes Toward Seeking Professional Psychological Help Scale - Short Form (ATSPPH-SF) care

    at 3 months

  • +2 more secondary outcomes

Study Arms (2)

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.

Other: ELIOS

control group

OTHER

Participants of the control arm will receive generic professional help contacts.

Other: other resources contacts

Interventions

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

ELIOS group
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.

control group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • To contact the ELIOS online system for a relative or an acquaintance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Lille

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Charles-Edouard Notredame, MD

    CHU Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charles-Edouard Notredame, MD

CONTACT

3 20 44 67 47charles-edouard.notredame@chru-lille.fr

Anne-Laure Demarty

CONTACT

annelaure.demarty@chru-lille.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

November 24, 2020

Study Start

October 13, 2022

Primary Completion (Estimated)

July 13, 2026

Study Completion (Estimated)

July 13, 2026

Last Updated

June 27, 2025

Record last verified: 2025-06

Locations

FR(1)