Surveillance of Suicide Ideation in Adolescents (VISIA)
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 339
- 试验地点
- 4
- 主要终点
- Strengths and Difficulties Questionnaire (SDQ)
研究概览
简要总结
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.
详细描述
Introduction:
The 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.
Hypothesis:
The 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?
Objectives:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- 未提供
结局指标
主要结局
Strengths and Difficulties Questionnaire (SDQ)
时间窗: through study completion, an average of 1 year
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.
Paykel Suicide Scale (PSS)
时间窗: through study completion, an average of 1 year
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.
Mood and Feelings Questionnaire (MFQ)
时间窗: through study completion, an average of 1 year
This questionnaire assesses symptoms of depression/suicide risk. Scores above 27 points are considered positive for screening. Higher values are indicative of worse outcomes.
Facial microexpressions, voice and linguistic content analysis
时间窗: through study completion, an average of 1 year
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.
Proteomic and stress level analysis
时间窗: through study completion, an average of 1 year
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.
次要结局
- Millon Adolescent Clinical Inventory - II (MACI-II)(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)
- Problematic Internet Use Scale in Adolescents (EUPI-A)(through study completion, an average of 1 year)
研究者
Alejandro Alberto García Caballero
Coordinator of Mental Health Prevention/Promotion Programs
Servicio Gallego de Salud