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ENROLLING BY INVITATION

NCT06341634

Surveillance of Suicide Ideation in Adolescents (VISIA)

Sponsor: Servicio Gallego de Salud

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

11 Years - 16 Years

Study Type

OBSERVATIONAL

Enrollment

339

Start Date

2024-02-06

Completion Date

2025-09-30

Last Updated

2025-03-13

Healthy Volunteers

Yes

Conditions

Suicide Distress, Emotional Adolescent Behavior Healthy

Inclusion Criteria: Ideation Group * Participants must be between 11 and 16 years old. * 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. * Patients receive care in child and adolescent psychiatry or psychology services and currently have suicidal ideation. * 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). Clinical Population Group * Participants must be between 11 and 16 years old. * 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. * Patients receive care in child and adolescent psychiatry or psychology services for any reason other than those listed as exclusion criteria. * 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). General Population Group * Participants must be between 11 and 16 years old. * 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. * Students must declare that they have not received psychiatric or psychological follow-up before, nor have they had suicidal ideation in the past year. Exclusion Criteria (applicable to all groups): * Neurodevelopmental disorders or speech disorders affecting verbal communication capacity, specifically including: * Autism Spectrum Disorder grades 2 and 3. * Communication disorders (selective mutism, language disorder, phonological disorder, childhood-onset fluency disorder, social communication disorder). * Individuals with hearing impairment and verbal language impairment. * Individuals with moderate and severe intellectual disabilities. * Individuals with psychotic disorders.

Locations (4)

Servizo Galego de Saúde

Santiago de Compostela, A Coruña, Spain

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, Spain

University of Vigo