Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-28 @ 2:01 AM
Study NCT ID:
NCT06341634
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-13
First Post:
2023-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance of Suicide Ideation in Adolescents (VISIA)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D000294', 'term': 'Adolescent Behavior'}, {'id': 'D000092864', 'term': 'Suicide Prevention'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 339}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2023-11-20', 'studyFirstSubmitQcDate': '2024-03-26', 'lastUpdatePostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Oviedo Response Infrequency Scale-Revised (INF-OV-R)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Is a 10 items self-report measurement with a dichotomous response format (Yes/No) developed to detect those participants who respond randomly, pseudo-randomly, or dishonestly to the administered measuring instruments. The items on this scale are typically intermixed with questions and statements from other self-report measures that are administered together to o enable better detection. Higher values are indicative of random, pseudo-random, or dishonest answers.'}], 'primaryOutcomes': [{'measure': 'Strengths and Difficulties Questionnaire (SDQ)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'This questionnaire detects probable cases of mental and behavioral disorders in children and adolescents aged 4 to 17. A score \\>19 points is considered positive in screening.'}, {'measure': 'Mood and Feelings Questionnaire (MFQ)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'This questionnaire assesses symptoms of depression/suicide risk. Scores above 27 points are considered positive for screening. Higher values are indicative of worse outcomes.'}, {'measure': 'Paykel Suicide Scale (PSS)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'This questionnaire asks about suicidal ideation over the past year. Scores equal to or greater than 4 are suggestive of suicidal ideation. Higher values are indicative of worse outcomes.'}, {'measure': 'Facial microexpressions, voice and linguistic content analysis', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Participants will be asked to speak in front of a camera about their emotional state over the past week. The recording will have a minimum duration of 2 minutes and will be used for voice analysis, facial microexpressions, and natural language processing (NLP) for linguistic content analysis.\n\nParticipants will also be asked to write a brief text on the computer in response to questions about how they perceive themselves and how they think others perceive them. The maximum duration for this exercise is 10 minutes.'}, {'measure': 'Proteomic and stress level analysis', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The collection of saliva is performed in a simple, non-invasive, and painless manner, allowing for the subsequent retrieval of high-quality proteins for further analysis and studies.'}], 'secondaryOutcomes': [{'measure': 'Millon Adolescent Clinical Inventory - II (MACI-II)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'A self-report questionnaire developed to evaluate the psychological functioning of adolescents. It assesses three domains in adolescent development. The average completion time is 30 minutes and can be conducted in groups.'}, {'measure': 'Problematic Internet Use Scale in Adolescents (EUPI-A)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'This 11-item questionnaire screens for problematic use of Internet among teenagers, ranginf fromm 0 to 44, with a cut-off for problematic use of 16 points. Higher values are indicative of worse outcomes.'}, {'measure': 'European Bullying Intervention Project Questionnaire (EBIP-Q) and European Ciberbullying Intervention Project Questionnaire (ECIP-Q)', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'This tool for jointly assessing bullying and cyberbullying cointains The European Bullying Intervention Project Questionnaire (14-items) and the European Cyberbullying Intervention Project Questionnaire (22-items), both of Likert nature that respectively evaluate behaviors related to bullying and cyber-bullying. Higher values are indicative of worse outcomes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Suicide Prevention', 'Distress, Emotional', 'Adolescent Behavior', 'Artificial Intelligence', 'Proteomics'], 'conditions': ['Suicide', 'Distress, Emotional', 'Adolescent Behavior', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '31622850', 'type': 'BACKGROUND', 'citation': 'Abd-Alrazaq AA, Alajlani M, Alalwan AA, Bewick BM, Gardner P, Househ M. An overview of the features of chatbots in mental health: A scoping review. Int J Med Inform. 2019 Dec;132:103978. doi: 10.1016/j.ijmedinf.2019.103978. Epub 2019 Sep 25.'}, {'pmid': '30474411', 'type': 'BACKGROUND', 'citation': 'Adamou M, Antoniou G, Greasidou E, Lagani V, Charonyktakis P, Tsamardinos I, Doyle M. Toward Automatic Risk Assessment to Support Suicide Prevention. Crisis. 2019 Jul;40(4):249-256. doi: 10.1027/0227-5910/a000561. Epub 2018 Nov 26.'}, {'pmid': '29986446', 'type': 'BACKGROUND', 'citation': 'Bachmann S. Epidemiology of Suicide and the Psychiatric Perspective. Int J Environ Res Public Health. 2018 Jul 6;15(7):1425. doi: 10.3390/ijerph15071425.'}, {'pmid': '9809120', 'type': 'BACKGROUND', 'citation': 'Briere J, Gil E. Self-mutilation in clinical and general population samples: prevalence, correlates, and functions. Am J Orthopsychiatry. 1998 Oct;68(4):609-20. doi: 10.1037/h0080369.'}, {'pmid': '24215434', 'type': 'BACKGROUND', 'citation': 'Brunner R, Kaess M, Parzer P, Fischer G, Carli V, Hoven CW, Wasserman C, Sarchiapone M, Resch F, Apter A, Balazs J, Barzilay S, Bobes J, Corcoran P, Cosmanm D, Haring C, Iosuec M, Kahn JP, Keeley H, Meszaros G, Nemes B, Podlogar T, Postuvan V, Saiz PA, Sisask M, Tubiana A, Varnik A, Wasserman D. Life-time prevalence and psychosocial correlates of adolescent direct self-injurious behavior: a comparative study of findings in 11 European countries. J Child Psychol Psychiatry. 2014 Apr;55(4):337-48. doi: 10.1111/jcpp.12166. Epub 2013 Nov 12.'}, {'pmid': '33355678', 'type': 'BACKGROUND', 'citation': 'Choi D, Sumner SA, Holland KM, Draper J, Murphy S, Bowen DA, Zwald M, Wang J, Law R, Taylor J, Konjeti C, De Choudhury M. Development of a Machine Learning Model Using Multiple, Heterogeneous Data Sources to Estimate Weekly US Suicide Fatalities. JAMA Netw Open. 2020 Dec 1;3(12):e2030932. doi: 10.1001/jamanetworkopen.2020.30932.'}, {'pmid': '25727110', 'type': 'BACKGROUND', 'citation': 'Krageloh CU, Czuba KJ, Billington DR, Kersten P, Siegert RJ. Using feedback from patient-reported outcome measures in mental health services: a scoping study and typology. Psychiatr Serv. 2015 Mar 1;66(3):224-41. doi: 10.1176/appi.ps.201400141. Epub 2014 Dec 1.'}, {'pmid': '30274648', 'type': 'BACKGROUND', 'citation': 'Gillies D, Christou MA, Dixon AC, Featherston OJ, Rapti I, Garcia-Anguita A, Villasis-Keever M, Reebye P, Christou E, Al Kabir N, Christou PA. Prevalence and Characteristics of Self-Harm in Adolescents: Meta-Analyses of Community-Based Studies 1990-2015. J Am Acad Child Adolesc Psychiatry. 2018 Oct;57(10):733-741. doi: 10.1016/j.jaac.2018.06.018. Epub 2018 Aug 21.'}, {'pmid': '30158822', 'type': 'BACKGROUND', 'citation': 'Coppersmith G, Leary R, Crutchley P, Fine A. Natural Language Processing of Social Media as Screening for Suicide Risk. Biomed Inform Insights. 2018 Aug 27;10:1178222618792860. doi: 10.1177/1178222618792860. eCollection 2018.'}, {'pmid': '32790653', 'type': 'BACKGROUND', 'citation': 'Czeisler ME, Lane RI, Petrosky E, Wiley JF, Christensen A, Njai R, Weaver MD, Robbins R, Facer-Childs ER, Barger LK, Czeisler CA, Howard ME, Rajaratnam SMW. Mental Health, Substance Use, and Suicidal Ideation During the COVID-19 Pandemic - United States, June 24-30, 2020. MMWR Morb Mortal Wkly Rep. 2020 Aug 14;69(32):1049-1057. doi: 10.15585/mmwr.mm6932a1.'}, {'pmid': '18037819', 'type': 'BACKGROUND', 'citation': 'Deveci A, Aydemir O, Taskin O, Taneli F, Esen-Danaci A. Serum BDNF levels in suicide attempters related to psychosocial stressors: a comparative study with depression. Neuropsychobiology. 2007;56(2-3):93-7. doi: 10.1159/000111539. Epub 2007 Nov 23.'}, {'pmid': '33148355', 'type': 'BACKGROUND', 'citation': 'Fernandez-Martinez I, Morales A, Mendez FX, Espada JP, Orgiles M. Spanish Adaptation and Psychometric Properties of the Parent Version of the Short Mood and Feelings Questionnaire (SMFQ-P) in a Non-Clinical Sample of Young School-Aged Children. Span J Psychol. 2020 Nov 5;23:e45. doi: 10.1017/SJP.2020.47.'}, {'pmid': '33404590', 'type': 'BACKGROUND', 'citation': 'Garcia de la Garza A, Blanco C, Olfson M, Wall MM. Identification of Suicide Attempt Risk Factors in a National US Survey Using Machine Learning. JAMA Psychiatry. 2021 Apr 1;78(4):398-406. doi: 10.1001/jamapsychiatry.2020.4165.'}, {'pmid': '16477515', 'type': 'BACKGROUND', 'citation': 'Golan O, Baron-Cohen S, Hill J. The Cambridge Mindreading (CAM) Face-Voice Battery: Testing complex emotion recognition in adults with and without Asperger syndrome. J Autism Dev Disord. 2006 Feb;36(2):169-83. doi: 10.1007/s10803-005-0057-y.'}, {'pmid': '27809591', 'type': 'BACKGROUND', 'citation': 'Hawgood J, De Leo D. Suicide Prediction - A Shift in Paradigm Is Needed. Crisis. 2016 Jul;37(4):251-255. doi: 10.1027/0227-5910/a000440. No abstract available.'}, {'pmid': '17453692', 'type': 'BACKGROUND', 'citation': 'Jacobson CM, Gould M. The epidemiology and phenomenology of non-suicidal self-injurious behavior among adolescents: a critical review of the literature. Arch Suicide Res. 2007;11(2):129-47. doi: 10.1080/13811110701247602.'}, {'pmid': '34865007', 'type': 'BACKGROUND', 'citation': 'Johnston JN, Campbell D, Caruncho HJ, Henter ID, Ballard ED, Zarate CA. Suicide Biomarkers to Predict Risk, Classify Diagnostic Subtypes, and Identify Novel Therapeutic Targets: 5 Years of Promising Research. Int J Neuropsychopharmacol. 2022 Mar 17;25(3):197-214. doi: 10.1093/ijnp/pyab083.'}, {'pmid': '21794184', 'type': 'BACKGROUND', 'citation': 'Kaess M, Parzer P, Haffner J, Steen R, Roos J, Klett M, Brunner R, Resch F. Explaining gender differences in non-fatal suicidal behaviour among adolescents: a population-based study. BMC Public Health. 2011 Jul 28;11:597. doi: 10.1186/1471-2458-11-597.'}, {'pmid': '22154566', 'type': 'BACKGROUND', 'citation': 'Kamali M, Saunders EF, Prossin AR, Brucksch CB, Harrington GJ, Langenecker SA, McInnis MG. Associations between suicide attempts and elevated bedtime salivary cortisol levels in bipolar disorder. J Affect Disord. 2012 Feb;136(3):350-8. doi: 10.1016/j.jad.2011.11.027. Epub 2011 Dec 10.'}, {'pmid': '11927139', 'type': 'BACKGROUND', 'citation': 'Karege F, Perret G, Bondolfi G, Schwald M, Bertschy G, Aubry JM. Decreased serum brain-derived neurotrophic factor levels in major depressed patients. Psychiatry Res. 2002 Mar 15;109(2):143-8. doi: 10.1016/s0165-1781(02)00005-7.'}, {'pmid': '34733641', 'type': 'BACKGROUND', 'citation': "Kouter K, Videtic Paska A. 'Omics' of suicidal behaviour: A path to personalised psychiatry. World J Psychiatry. 2021 Oct 19;11(10):774-790. doi: 10.5498/wjp.v11.i10.774. eCollection 2021 Oct 19."}, {'pmid': '33339317', 'type': 'BACKGROUND', 'citation': 'Lo Moro G, Soneson E, Jones PB, Galante J. Establishing a Theory-Based Multi-Level Approach for Primary Prevention of Mental Disorders in Young People. Int J Environ Res Public Health. 2020 Dec 16;17(24):9445. doi: 10.3390/ijerph17249445.'}, {'pmid': '33282335', 'type': 'BACKGROUND', 'citation': 'Meadows R, Hine C, Suddaby E. Conversational agents and the making of mental health recovery. Digit Health. 2020 Nov 20;6:2055207620966170. doi: 10.1177/2055207620966170. eCollection 2020 Jan-Dec.'}, {'pmid': '30635683', 'type': 'BACKGROUND', 'citation': 'Miranda-Mendizabal A, Castellvi P, Pares-Badell O, Alayo I, Almenara J, Alonso I, Blasco MJ, Cebria A, Gabilondo A, Gili M, Lagares C, Piqueras JA, Rodriguez-Jimenez T, Rodriguez-Marin J, Roca M, Soto-Sanz V, Vilagut G, Alonso J. Gender differences in suicidal behavior in adolescents and young adults: systematic review and meta-analysis of longitudinal studies. Int J Public Health. 2019 Mar;64(2):265-283. doi: 10.1007/s00038-018-1196-1. Epub 2019 Jan 12.'}, {'pmid': '33710292', 'type': 'BACKGROUND', 'citation': 'Navarro MC, Ouellet-Morin I, Geoffroy MC, Boivin M, Tremblay RE, Cote SM, Orri M. Machine Learning Assessment of Early Life Factors Predicting Suicide Attempt in Adolescence or Young Adulthood. JAMA Netw Open. 2021 Mar 1;4(3):e211450. doi: 10.1001/jamanetworkopen.2021.1450.'}, {'pmid': '11845650', 'type': 'BACKGROUND', 'citation': 'Nock MK, Kazdin AE. Examination of affective, cognitive, and behavioral factors and suicide-related outcomes in children and young adolescents. J Clin Child Adolesc Psychol. 2002 Mar;31(1):48-58. doi: 10.1207/S15374424JCCP3101_07.'}, {'pmid': '33276112', 'type': 'BACKGROUND', 'citation': 'Pacheco-Lorenzo MR, Valladares-Rodriguez SM, Anido-Rifon LE, Fernandez-Iglesias MJ. Smart conversational agents for the detection of neuropsychiatric disorders: A systematic review. J Biomed Inform. 2021 Jan;113:103632. doi: 10.1016/j.jbi.2020.103632. Epub 2020 Dec 2.'}, {'pmid': '20227453', 'type': 'BACKGROUND', 'citation': 'Pandey GN, Dwivedi Y, Rizavi HS, Ren X, Zhang H, Pavuluri MN. Brain-derived neurotrophic factor gene and protein expression in pediatric and adult depressed subjects. Prog Neuropsychopharmacol Biol Psychiatry. 2010 May 30;34(4):645-51. doi: 10.1016/j.pnpbp.2010.03.003. Epub 2010 Mar 20.'}, {'pmid': '33210279', 'type': 'BACKGROUND', 'citation': 'Pinon-Blanco A, Vergara-Moragues E, Fernandez-Martinez R, Gutierrez-Martinez O, Alvarez-Counago M, Martinez-Reglero C, Rivera-Baltanas T, Otero-Lamas F, Olivares-Diez J, Spuch-Calvar C. Effectiveness of the “Trisquel” board game intervention program for patients with schizophrenia spectrum disorders. Actas Esp Psiquiatr. 2020 Sep;48(5):209-219. Epub 2020 Sep 1.'}, {'pmid': '32673256', 'type': 'BACKGROUND', 'citation': 'Ramirez-Cifuentes D, Freire A, Baeza-Yates R, Punti J, Medina-Bravo P, Velazquez DA, Gonfaus JM, Gonzalez J. 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Adicciones. 2015 Mar 1;27(1):47-63.'}, {'type': 'BACKGROUND', 'citation': 'Parkhi O., Vedaldi A., and Zisserman A.. 2015. Deep Face Recognition. In Proceedings of the British Machine Vision Conference (BMVC). 41.1-41.12.'}, {'type': 'BACKGROUND', 'citation': 'De Quiroga S, Riesgo M, Martín del Campo E, Pulido S, Rodrigo S. (2019) Impacto Socioeconómico de la depresión y el suicidio en España [Internet]. Rev Esp Econ Salud: 2019; 4(15).'}, {'type': 'BACKGROUND', 'citation': 'Stappen, L., Baird, A., Christ, L., Schumann, L., Sertolli, B., Messner, E., Cambria, E., Zhao, G., Schuller, Björn. (2021). The MuSe 2021 Multimodal Sentiment Analysis Challenge: Sentiment, Emotion, Physiological-Emotion, and Stress.'}, {'type': 'BACKGROUND', 'citation': 'Vekiri I. and Chronaki A. (2008) "Gender issues in technology use: Perceived social support, computer self-efficacy and value beliefs, and computer use beyond school," Comput. Educ., vol. 51, no. 3, pp. 1392-1404, 2008.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organization (2014) Preventing suicide. A global imperative. Geneva: 2014.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organisation (2021a) Comprehensive mental health action plan 2013-2030. Geneva: World Health Organization; 2021. Licence: CC BY-NC-SA 3.0 IGO.'}, {'type': 'BACKGROUND', 'citation': 'World Health Organisation (2021b) Suicide in the world: global health estimates. 2019, 32 p., World Health Organization, Technical documents. WHO/MSD/MER/19.3.'}], 'seeAlsoLinks': [{'url': 'https://www.edu.xunta.gal/portal/sites/web/files/protocolo_risco_suicida-v.12.pdf', 'label': 'Suicide Risk Protocol'}]}, '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.\n\nThe primary research question it aims to answer is:\n\nIs 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?\n\nParticipants in this study will be asked to:\n\nComplete psychometric instruments to establish a gold standard for detecting suicide risk and suicidal ideation.\n\nProvide voice recordings, facial emotion data, and linguistic content in natural and specific contexts.\n\nParticipate in salivary proteomics data collection.\n\nThis study compares three distinct groups:\n\nIdeation: Adolescent patients with current suicidal ideation. Clinical Population: Psychological or psychiatric patients of the same age and gender without suicidal ideation.\n\nGeneral Population: Adolescents without known psychological or psychiatric pathology of the same age and gender, without suicidal ideation.\n\nResearchers 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.", 'detailedDescription': "Introduction:\n\nThe Surveillance of Suicide Ideation in Adolescents (VISIA) project is a collaborative effort involving a diverse research team encompassing experts in mental disorders and seasoned researchers in data science, specializing in intelligent services and applications across various domains. The project aims to address the shortcomings identified in existing research. The initial phase of this endeavor seeks to validate an artificial intelligence (AI) algorithm capable of distinguishing individuals with suicidal ideation from a control group by analyzing multimodal variables. These variables include voice analysis, facial emotions, natural language, and proteomics. The cases will be labeled following established protocols.\n\nHypothesis:\n\nThe primary research question driving this project is: Can early and non-intrusive identification of suicidal ideation and suicide risk in young adults be achieved using multimodal data analysis through digital instruments equipped with artificial intelligence?\n\nObjectives:\n\nThe overarching objective of this proposal is to design and implement an automated system for detecting emotional distress and suicide risk in adolescents aged between 11 and 16 using AI. This detection relies on molecular profiles derived from salivary proteomics, video and audio recordings in diverse contexts, and the linguistic content generated by the study participants. The integration of molecular profiles with data from video and audio recordings promises enhanced detection capabilities, providing a competitive edge in the development of future diagnostic tools.\n\nSpecific Objectives:\n\nTo realize the goals outlined above and tackle the scientific and technological challenges, the following specific objectives are established:\n\nDevelopment of a gold standard for detecting suicide risk and suicidal ideation in adolescents.\n\nIdentification of biomarkers (e.g., voice, facial expressions, salivary molecular fingerprint) relevant to characterizing adolescents with regard to suicide risk.\n\nIdentification of pertinent multimodal features for characterizing adolescents in relation to suicide risk.\n\nLabeling of samples and AI model training.\n\nMethodology:\n\nDesign and Study Subjects:\n\nThe study adopts a non-interventionist, analytical, observational, and prospective approach. It encompasses three distinct groups for comparison:\n\nIdeation: Comprising individuals with current suicidal ideation. Clinical Population: Consisting of psychological or psychiatric patients of the same age and gender, devoid of suicidal ideation.\n\nGeneral Population: Encompassing adolescents with no known psychological or psychiatric issues, matched in age and gender, and free of suicidal ideation.\n\nAll three groups will undergo assessments using psychometric instruments, serving as a gold standard for AI system training and validation.\n\nIn summary, the VISIA project endeavors to leverage artificial intelligence and multimodal data analysis to detect suicidal ideation and suicide risk in adolescents, offering the potential for early and non-intrusive identification. The study's comprehensive methodology, involving diverse subject groups and rigorous data collection, is poised to contribute significantly to the field of mental health research and diagnostic tool development."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adolescents aged between 11 and 16 years old from clinical and and general population.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIdeation Group\n\n* Participants must be between 11 and 16 years old.\n* Patients who do not meet any of the exclusion criteria and whose parents (both), guardians, or legal representatives accept their voluntary participation in the study. In case of divorce, authorization from both parents will be required.\n* Patients receive care in child and adolescent psychiatry or psychology services and currently have suicidal ideation.\n* Patients may have a previous follow-up, as long as they have suicidal ideation at the present moment, or they may be new consultations and may be receiving pharmacological treatment (which will be documented in the study).\n\nClinical Population Group\n\n* Participants must be between 11 and 16 years old.\n* Patients who do not meet any of the exclusion criteria and whose parents (both), guardians, or legal representatives accept their voluntary participation in the study. In case of divorce, authorization from both parents will be required.\n* Patients receive care in child and adolescent psychiatry or psychology services for any reason other than those listed as exclusion criteria.\n* Patients have not had suicidal ideation in the past year. Patients may have a previous follow-up or may be new consultations, and they may be receiving pharmacological treatment (which will be documented in the study).\n\nGeneral Population Group\n\n* Participants must be between 11 and 16 years old.\n* Students who do not meet any of the exclusion criteria and whose parents (both), guardians, or legal representatives accept their voluntary participation in the study. In case of divorce, authorization from both parents will be required.\n* Students must declare that they have not received psychiatric or psychological follow-up before, nor have they had suicidal ideation in the past year.\n\nExclusion Criteria (applicable to all groups):\n\n* Neurodevelopmental disorders or speech disorders affecting verbal communication capacity, specifically including:\n* Autism Spectrum Disorder grades 2 and 3.\n* Communication disorders (selective mutism, language disorder, phonological disorder, childhood-onset fluency disorder, social communication disorder).\n* Individuals with hearing impairment and verbal language impairment.\n* Individuals with moderate and severe intellectual disabilities.\n* Individuals with psychotic disorders.'}, 'identificationModule': {'nctId': 'NCT06341634', 'acronym': 'VISIA', 'briefTitle': 'Surveillance of Suicide Ideation in Adolescents (VISIA)', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Servicio Gallego de Salud'}, 'officialTitle': 'Surveillance of Suicide Ideation in Adolescents (VISIA)', 'orgStudyIdInfo': {'id': 'VISIA'}, 'secondaryIdInfos': [{'id': 'TED2021-130747B-C22', 'type': 'OTHER_GRANT', 'domain': 'European Union'}, {'id': '3494130747-130747-28-521', 'type': 'OTHER', 'domain': 'Ministry of Science and Innovation'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Ideation', 'description': 'Patients with current suicidal ideation, recruited by staff doctors and psychologists from the child and adolescent psychiatry units of the Álvaro Cunqueiro Hospital in Vigo and the University Hospital Complex in Ourense, who have been deemed suitable for participation and have had the participation conditions explained to them and their parents, will undergo the following assessment protocol:\n\nPaykel scale Mini International Neuropsychiatric Interview (MINI) Strengths and Difficulties Questionnaire (SDQ) Mood and Feelings Questionnaire (MFQ) European Bullying Intervention Project Questionnaire (EBIP-Q) Problematic Internet Use Scale in Adolescents (EUPI-A) Millon Adolescent Clinical Inventory (MACI)\n\nMultimodal experimental battery:\n\nRecording of voice features Video recording of facial microexpression Registering of autobiographical texts Collecting of saliva samples'}, {'label': 'Clinical Population', 'description': 'Psychological or psychiatric patients, devoid of suicidal ideation, recruited by staff doctors and psychologists from the child and adolescent psychiatry units of the Álvaro Cunqueiro Hospital in Vigo and the University Hospital Complex in Ourense, who have been deemed suitable for participation and have had the participation conditions explained to them and their parents, will undergo the following assessment protocol:\n\nPaykel scale Mini International Neuropsychiatric Interview (MINI) Strengths and Difficulties Questionnaire (SDQ) Mood and Feelings Questionnaire (MFQ) European Bullying Intervention Project Questionnaire (EBIP-Q) Problematic Internet Use Scale in Adolescents (EUPI-A) Millon Adolescent Clinical Inventory (MACI)\n\nMultimodal experimental battery:\n\nRecording of voice features Video recording of facial microexpression Registering of autobiographical texts Collecting of saliva samples'}, {'label': 'General Population', 'description': 'Students with no known psychological or psychiatric issues, and free of suicidal ideation in the past year, recruited from schools among students who voluntarily agree to participate, and who have been deemed suitable for participation and have had the participation conditions explained to them and their parents, will undergo the following assessment protocol:\n\nPaykel scale Mini International Neuropsychiatric Interview (MINI) Strengths and Difficulties Questionnaire (SDQ) Mood and Feelings Questionnaire (MFQ) European Bullying Intervention Project Questionnaire (EBIP-Q) Problematic Internet Use Scale in Adolescents (EUPI-A) Millon Adolescent Clinical Inventory (MACI)\n\nMultimodal experimental battery:\n\nRecording of voice features Video recording of facial microexpression Registering of autobiographical texts Collecting of saliva samples'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15703', 'city': 'Santiago de Compostela', 'state': 'A Coruña', 'country': 'Spain', 'facility': 'Servizo Galego de Saúde', 'geoPoint': {'lat': 42.88052, 'lon': -8.54569}}, {'zip': '36211', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'Hospital Álvaro Cunqueiro', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '36310', 'city': 'Vigo', 'state': 'Pontevedra', 'country': 'Spain', 'facility': 'University of Vigo', 'geoPoint': {'lat': 42.23282, 'lon': -8.72264}}, {'zip': '36002', 'city': 'Ourense', 'country': 'Spain', 'facility': 'University Hospital Complex of Ourense', 'geoPoint': {'lat': 42.33669, 'lon': -7.86407}}], 'overallOfficials': [{'name': 'Alejandro García Caballero', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Complex of Ourense'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Servicio Gallego de Salud', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University of Vigo', 'class': 'OTHER'}, {'name': 'Complejo Hospitalario Universitario de Vigo', 'class': 'OTHER'}, {'name': 'Complexo Hospitalario de Ourense', 'class': 'OTHER'}, {'name': 'Fundacin Biomedica Galicia Sur', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Coordinator of Mental Health Prevention/Promotion Programs', 'investigatorFullName': 'Alejandro Alberto García Caballero', 'investigatorAffiliation': 'Servicio Gallego de Salud'}}}}