Online Referral and Intervention to Prevent Adolescent and Young Adult Suicide (ORIAS)
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|ClinicalTrials.gov Identifier: NCT04642157|
Recruitment Status : Not yet recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Suicide||Other: ELIOS Other: other resources contacts||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||396 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Online Referral and Intervention to Prevent Adolescent and Young Adult Suicide|
|Estimated Study Start Date :||December 2020|
|Estimated Primary Completion Date :||March 2023|
|Estimated Study Completion Date :||March 2023|
Experimental: ELIOS group
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.
ELIOS is a suicide prevention system worldwide entirely tailored to the AYA contemporaneous modes of interaction on social media.
Participants of the control arm will receive generic professional help contacts.
Other: other resources contacts
Three types of resources will be suggested via the ELIOS website:
- 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)
- Access to care after a suicide attempt [ 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
- Suicide attempt [ Time Frame: within the 3-months follow-up period ]Rate of participants with at least one suicide attempt
- Mortality [ Time Frame: at 3 months ]All-cause mortality rate
- psychological pain [ 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).
- Score at the Attitudes Toward Seeking Professional Psychological Help Scale - Short Form (ATSPPH-SF) care [ 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.
- Score at the French version of the Client Satisfaction Questionnaire-8 (CSQ-8) [ 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.
- Rate of successful recontacts (recontacts with a response) [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642157
|Contact: Charles-Edouard Notredame, MD||3 20 44 67 47 ext +firstname.lastname@example.org|
|Contact: Anne-Laure Demartyemail@example.com|
|Principal Investigator:||Charles-Edouard Notredame, MD||CHU Lille|