protocolSection identificationModule nctId: NCT06341634, orgStudyIdInfo id: VISIA, secondaryIdInfos id: TED2021-130747B-C22, type: OTHER_GRANT, domain: European Union, secondaryIdInfos id: 3494130747-130747-28-521, type: OTHER, domain: Ministry of Science and Innovation, briefTitle: Surveillance of Suicide Ideation in Adolescents (VISIA), acronym: VISIA, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-11-24, completionDateStruct date: 2024-11-24, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Servicio Gallego de Salud, class: OTHER_GOV, collaborators name: University of Vigo, collaborators name: Complejo Hospitalario Universitario de Vigo, collaborators name: Complexo Hospitalario de Ourense, collaborators name: Fundacin Biomedica Galicia Sur, descriptionModule briefSummary: The goal of this observational study is to validate an AI algorithm's capability to differentiate the population with suicidal ideation from a control population using various multimodal variables, including voice analysis, facial emotions, natural language, and proteomics data.The primary research question it aims to answer is:Is it possible to identify suicidal ideation and suicide risk in adolescents early and non-intrusively using multimodal data analysis through digital instruments equipped with artificial intelligence?Participants in this study will be asked to:Complete psychometric instruments to establish a gold standard for detecting suicide risk and suicidal ideation.Provide voice recordings, facial emotion data, and linguistic content in natural and specific contexts.Participate in salivary proteomics data collection.This study compares three distinct groups:Ideation: Adolescent patients with current suicidal ideation. Clinical Population: Psychological or psychiatric patients of the same age and gender without suicidal ideation.General Population: Adolescents without known psychological or psychiatric pathology of the same age and gender, without suicidal ideation.Researchers will compare these groups to determine if the AI algorithm is effective in differentiating individuals with suicidal ideation (Group 1) from both a clinical control group (Group 2) and a general population control group (Group 3) using the collected multimodal data. The study aims to assess the algorithm's ability to identify early signs of suicide risk in these distinct participant populations., conditionsModule conditions: Suicide, conditions: Distress, Emotional, conditions: Adolescent Behavior, conditions: Healthy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 339, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Strengths and Difficulties Questionnaire (SDQ), primaryOutcomes measure: Mood and Feelings Questionnaire (MFQ), primaryOutcomes measure: Paykel Suicide Scale (PSS), primaryOutcomes measure: Facial microexpressions, voice and linguistic content analysis, primaryOutcomes measure: Proteomic and stress level analysis, secondaryOutcomes measure: Millon Adolescent Clinical Inventory - II (MACI-II), secondaryOutcomes measure: Problematic Internet Use Scale in Adolescents (EUPI-A), secondaryOutcomes measure: European Bullying Intervention Project Questionnaire (EBIP-Q) and European Ciberbullying Intervention Project Questionnaire (ECIP-Q), otherOutcomes measure: Oviedo Response Infrequency Scale-Revised (INF-OV-R), eligibilityModule sex: ALL, minimumAge: 11 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Servizo Galego de Saúde, city: Santiago De Compostela, state: A Coruña, zip: 15703, country: Spain, geoPoint lat: 42.88052, lon: -8.54569, locations facility: Hospital Álvaro Cunqueiro, city: Vigo, state: Pontevedra, zip: 36211, country: Spain, geoPoint lat: 42.23282, lon: -8.72264, locations facility: University of Vigo, city: Vigo, state: Pontevedra, zip: 36310, country: Spain, geoPoint lat: 42.23282, lon: -8.72264, locations facility: University Hospital Complex of Ourense, city: Ourense, zip: 36002, country: Spain, geoPoint lat: 42.33669, lon: -7.86407, hasResults: False