CHU de Lille
Lille, 59000, France
Location status: Recruiting
NCT Number: NCT04642157
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.
Interested in participating?
Request Info18 year–25 year
All sexes
Interventional
Not applicable
Lille, 59000, France
Location status: Recruiting
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 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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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
ELIOS is a suicide prevention system worldwide entirely tailored to the AYA contemporaneous modes of interaction on social media.
This includes
Three types of resources will be suggested via the ELIOS website:
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)
Time frame: within the 3-months follow-up period
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
Rate of participants with at least one suicide attempt
Time frame: at 3 months
All-cause mortality rate
Time frame: at 3 months
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
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
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: Through study completion, an average of 3 months
Develop a database of types of contact and corresponding metadata for collect data related to the way the platform is used.
Contact information is provided by the study sponsor or research team.
University Hospital, Lille
Other
Acronym: ORIAS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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