Surveillance of Suicide Ideation in Adolescents (VISIA)

NCT06341634 | Enrolling By Invitation

• 3 other identifiers: VISIATED2021-130747B-C223494130747-130747-28-521
• Study Type: observational
• Target: 339
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Suicide; Distress, Emotional; Adolescent Behavior; Healthy

Keywords

Suicide Prevention; Distress, Emotional; Adolescent Behavior; Artificial Intelligence; Proteomics

Outcome Measures

Primary Outcomes (5)

• Strengths and Difficulties Questionnaire (SDQ)

  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.

  through study completion, an average of 1 year

• Mood and Feelings Questionnaire (MFQ)

  This questionnaire assesses symptoms of depression/suicide risk. Scores above 27 points are considered positive for screening. Higher values are indicative of worse outcomes.

  through study completion, an average of 1 year

• Paykel Suicide Scale (PSS)

  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.

  through study completion, an average of 1 year

• Facial microexpressions, voice and linguistic content analysis

  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. Participants 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.

  through study completion, an average of 1 year

• Proteomic and stress level analysis

  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.

  through study completion, an average of 1 year

Secondary Outcomes (3)

• Millon Adolescent Clinical Inventory - II (MACI-II)

  through study completion, an average of 1 year

• Problematic Internet Use Scale in Adolescents (EUPI-A)

  through study completion, an average of 1 year

• European Bullying Intervention Project Questionnaire (EBIP-Q) and European Ciberbullying Intervention Project Questionnaire (ECIP-Q)

  through study completion, an average of 1 year

Other Outcomes (1)

• Oviedo Response Infrequency Scale-Revised (INF-OV-R)

  through study completion, an average of 1 year

Study Arms (3)

Ideation

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: Paykel 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) Multimodal experimental battery: Recording of voice features Video recording of facial microexpression Registering of autobiographical texts Collecting of saliva samples

Clinical Population

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: Paykel 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) Multimodal experimental battery: Recording of voice features Video recording of facial microexpression Registering of autobiographical texts Collecting of saliva samples

General Population

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: Paykel 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) Multimodal experimental battery: Recording of voice features Video recording of facial microexpression Registering of autobiographical texts Collecting of saliva samples

Eligibility Criteria

• Age: 11 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Adolescents aged between 11 and 16 years old from clinical and and general population.

You may qualify if:

• Ideation Group
• Participants must be between 11 and 16 years old.

You may not qualify if:

• 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 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 must declare that they have not received psychiatric or psychological follow-up before, nor have they had suicidal ideation in the past year.
• 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.

Sponsors & Collaborators

• Servicio Gallego de Salud: lead
• University of Vigo: collaborator
• Complejo Hospitalario Universitario de Vigo: collaborator
• Complexo Hospitalario de Ourense: collaborator
• Fundacin Biomedica Galicia Sur: collaborator

Study Sites (4)

Servizo Galego de Saúde

Santiago de Compostela, A Coruña, 15703, Spain

Location

Hospital Álvaro Cunqueiro

Vigo, Pontevedra, 36211, Spain

Location

University of Vigo

Vigo, Pontevedra, 36310, Spain

Location

University Hospital Complex of Ourense

Ourense, 36002, Spain

Location

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Related Links

• Suicide Risk Protocol

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples

MeSH Terms

Conditions

Suicide; Adolescent Behavior; Suicide Prevention

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Alejandro García Caballero

  University Hospital Complex of Ourense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Coordinator of Mental Health Prevention/Promotion Programs

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: April 2, 2024
• Study Start: February 6, 2024
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: March 13, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)