Online Referral and Intervention to Prevent Adolescent and Young Adult Suicide (ORIAS)
Primary Purpose
Suicide
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ELIOS
other resources contacts
Sponsored by
About this trial
This is an interventional prevention trial for Suicide focused on measuring Suicide, Prevention, Web, Social media, Adolescence, Youth
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- To contact the ELIOS online system for a relative or an acquaintance
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
ELIOS group
control group
Arm Description
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.
Participants of the control arm will receive generic professional help contacts.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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
Suicide attempt
Rate of participants with at least one suicide attempt
Mortality
All-cause mortality rate
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).
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.
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.
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.
Full Information
NCT ID
NCT04642157
First Posted
July 13, 2020
Last Updated
April 22, 2021
Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
1. Study Identification
Unique Protocol Identification Number
NCT04642157
Brief Title
Online Referral and Intervention to Prevent Adolescent and Young Adult Suicide
Acronym
ORIAS
Official Title
Online Referral and Intervention to Prevent Adolescent and Young Adult Suicide
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2021 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
Collaborators
Ministry of Health, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
Suicide, Prevention, Web, Social media, Adolescence, Youth
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
396 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ELIOS group
Arm Type
Experimental
Arm Description
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.
Arm Title
control group
Arm Type
Other
Arm Description
Participants of the control arm will receive generic professional help contacts.
Intervention Type
Other
Intervention Name(s)
ELIOS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
other resources contacts
Intervention Description
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.
Primary Outcome Measure Information:
Title
the change of the intensity of the severest suicidal ideation experienced in the past week by the participants.
Description
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)
Time Frame
from baseline to the 3-months follow-up
Secondary Outcome Measure Information:
Title
Access to care after a suicide attempt
Description
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
Time Frame
within the 3-months follow-up period
Title
Suicide attempt
Description
Rate of participants with at least one suicide attempt
Time Frame
within the 3-months follow-up period
Title
Mortality
Description
All-cause mortality rate
Time Frame
at 3 months
Title
psychological pain
Description
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).
Time Frame
at 3 months
Title
Score at the Attitudes Toward Seeking Professional Psychological Help Scale - Short Form (ATSPPH-SF) care
Description
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.
Time Frame
at 3 months
Title
Score at the French version of the Client Satisfaction Questionnaire-8 (CSQ-8)
Description
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.
Time Frame
at 3 months
Title
Rate of successful recontacts (recontacts with a response)
Description
Develop a database of types of contact and corresponding metadata for collect data related to the way the platform is used.
Time Frame
Through study completion, an average of 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
To contact the ELIOS online system for a relative or an acquaintance
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Charles-Edouard Notredame, MD
Phone
3 20 44 67 47
Ext
+33
Email
charles-edouard.notredame@chru-lille.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Anne-Laure Demarty
Email
annelaure.demarty@chru-lille.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles-Edouard Notredame, MD
Organizational Affiliation
CHU Lille
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Online Referral and Intervention to Prevent Adolescent and Young Adult Suicide
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