SuicideVISIANCT06341634
Surveillance of Suicide Ideation in Adolescents (VISIA)
An observational study of Suicide and Distress, Emotional, run by Servicio Gallego de Salud at 4 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide, Distress, Emotional, Adolescent Behavior
- How many people
- 339 participants
- Where
- 4 sitesSpain
- Study dates
- 6 Feb 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Adolescents aged between 11 and 16 years old from clinical and and general population.
Who may be able to join
- 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
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain4 sites
University Hospital Complex of Ourense
Ourense, 36002
Servizo Galego de Saúde
Santiago de Compostela, A Coruña, 15703
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36211
University of Vigo
Vigo, Pontevedra, 36310
About this study
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:
Read more
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.
Read the detailed description
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:
The 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.
Specific Objectives:
To realize the goals outlined above and tackle the scientific and technological challenges, the following specific objectives are established:
Development of a gold standard for detecting suicide risk and suicidal ideation in adolescents.
Identification of biomarkers (e.g., voice, facial expressions, salivary molecular fingerprint) relevant to characterizing adolescents with regard to suicide risk.
Identification of pertinent multimodal features for characterizing adolescents in relation to suicide risk.
Labeling of samples and AI model training.
Methodology:
Design and Study Subjects:
The study adopts a non-interventionist, analytical, observational, and prospective approach. It encompasses three distinct groups for comparison:
Ideation: Comprising individuals with current suicidal ideation. Clinical Population: Consisting of psychological or psychiatric patients of the same age and gender, devoid of suicidal ideation.
General Population: Encompassing adolescents with no known psychological or psychiatric issues, matched in age and gender, and free of suicidal ideation.
All three groups will undergo assessments using psychometric instruments, serving as a gold standard for AI system training and validation.
In 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.
- Conditions
- Suicide, Distress, Emotional, Adolescent Behavior, Healthy
- Keywords
- Suicide Prevention, Distress, Emotional, Adolescent Behavior, Artificial Intelligence, Proteomics
- Medical subject headings
- Suicide, Adolescent Behavior, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (3)
Millon Adolescent Clinical Inventory - II (MACI-II)
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.
Measured: through study completion, an average of 1 year
Problematic Internet Use Scale in Adolescents (EUPI-A)
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.
Measured: through study completion, an average of 1 year
European Bullying Intervention Project Questionnaire (EBIP-Q) and European Ciberbullying Intervention Project Questionnaire (ECIP-Q)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start6 Feb 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (47)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 339 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Servicio Gallego de Salud
- Sponsor type
- Other government
- Collaborators
- University of Vigo, Complejo Hospitalario Universitario de Vigo, Complexo Hospitalario de Ourense, Fundacin Biomedica Galicia Sur
- Responsible party
- Principal investigator, Alejandro Alberto García Caballero, Servicio Gallego de Salud
- Investigators
- Alejandro García Caballero, Principal investigator, University Hospital Complex of Ourense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341634
- Sponsor's protocol ID
- VISIA
- Other IDs
- TED2021-130747B-C22, 3494130747-130747-28-521
- Acronym
- VISIA
- Status last verified
- Mar 2025
- First submitted
- 20 Nov 2023
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31622850Adamou 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.
PubMed 30474411Bachmann S. Epidemiology of Suicide and the Psychiatric Perspective. Int J Environ Res Public Health. 2018 Jul 6;15(7):1425. doi: 10.3390/ijerph15071425.
PubMed 29986446Briere 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.
PubMed 9809120Brunner 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.
PubMed 24215434Choi 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.
PubMed 33355678Krageloh 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.
PubMed 25727110Gillies 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.
PubMed 30274648Coppersmith 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.
PubMed 30158822Czeisler 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.
PubMed 32790653Deveci 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.
PubMed 18037819Fernandez-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.
PubMed 33148355Garcia 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.
PubMed 33404590Golan 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.
PubMed 16477515Hawgood 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.
PubMed 27809591
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Suicide Ideation in Adolescents (VISIA)
- ClinicalTrials.gov ID
- NCT06341634
- Acronym / sponsor ID
- VISIA / VISIA
- Conditions
- Suicide, Distress, Emotional, Adolescent Behavior, Healthy
- Keywords
- Suicide Prevention, Distress, Emotional, Adolescent Behavior, Artificial Intelligence, Proteomics
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 339 participants (estimated)
- Lead sponsor
- Servicio Gallego de SaludOther government
- Collaborators
- University of Vigo, Complejo Hospitalario Universitario de Vigo, Complexo Hospitalario de Ourense, Fundacin Biomedica Galicia Sur
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
The 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.
Specific Objectives:
To realize the goals outlined above and tackle the scientific and technological challenges, the following specific objectives are established:
Development of a gold standard for detecting suicide risk and suicidal ideation in adolescents.
Identification of biomarkers (e.g., voice, facial expressions, salivary molecular fingerprint) relevant to characterizing adolescents with regard to suicide risk.
Identification of pertinent multimodal features for characterizing adolescents in relation to suicide risk.
Labeling of samples and AI model training.
Methodology:
Design and Study Subjects:
The study adopts a non-interventionist, analytical, observational, and prospective approach. It encompasses three distinct groups for comparison:
Ideation: Comprising individuals with current suicidal ideation. Clinical Population: Consisting of psychological or psychiatric patients of the same age and gender, devoid of suicidal ideation.
General Population: Encompassing adolescents with no known psychological or psychiatric issues, matched in age and gender, and free of suicidal ideation.
All three groups will undergo assessments using psychometric instruments, serving as a gold standard for AI system training and validation.
In 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Adolescents aged between 11 and 16 years old from clinical and and general population.
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Strengths and Difficulties Questionnaire (SDQ)
Time frame: 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.
Mood and Feelings Questionnaire (MFQ)
Time frame: 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.
Paykel Suicide Scale (PSS)
Time frame: 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.
Facial microexpressions, voice and linguistic content analysis
Time frame: 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
Time frame: 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.
3 secondary outcomes
Millon Adolescent Clinical Inventory - II (MACI-II)
Time frame: through study completion, an average of 1 year
Problematic Internet Use Scale in Adolescents (EUPI-A)
Time frame: through study completion, an average of 1 year
European Bullying Intervention Project Questionnaire (EBIP-Q) and European Ciberbullying Intervention Project Questionnaire (ECIP-Q)
Time frame: through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Background: PubMed 31622850Abd-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.
- Background: PubMed 30474411Adamou 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.
- Background: PubMed 29986446Bachmann S. Epidemiology of Suicide and the Psychiatric Perspective. Int J Environ Res Public Health. 2018 Jul 6;15(7):1425. doi: 10.3390/ijerph15071425.
- Background: PubMed 9809120Briere 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.
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- Suicide Risk ProtocolLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alejandro García Caballero principal investigator
University Hospital Complex of Ourense
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicide and Distress, Emotional, run by Servicio Gallego de Salud at 4 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strengths and Difficulties Questionnaire (SDQ) (time frame: through study completion, an average of 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06341634, which also lists 47 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.