Suicidal IdeationTEDUCANCT04067076
Massive Mental Health Screening Using Smartphones in 24 Pre-graduate Education Centers in Mexico City: TEDUCA Survey Protocol
An observational study of Suicidal Ideation and Social Behavior, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Mexico.
Trial summary
The objective of this study is to make a massive suicide risk and social behavior assessment in 24 pre-graduate education centers in Mexico City (approximately 30,000 students aged between 15 and 22 years), taking also into account other outcomes such as depression, anxiety, alcohol and drugs. Read more about this study
- Who is it for?
- Ages 15 to 22 years
- Conditions the study is for
- Suicidal Ideation, Social Behavior, Depression
- What is being tested?
- Self-administered evaluation questionnaire
- How many people
- 30,000 participants
- Where
- 1 siteMexico
- Study dates
- 26 Aug 2019to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 15 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Community composed of students between 15 and 22 years of the 24 educational institutions IEMS of Mexico City, enrolled at the scholar year 2019-2020
Who may be able to join
- Use a smartphone as personal or computer terminals enabled by the municipality of Milpa Alta or educational services.
- Be able to understand the nature, purpose and methodology of the study.
- Accept participation in the study and check the corresponding box in the app to verify that the informed consent has been expressly given.
Who cannot join
- Subject deprived of liberty (by judicial or administrative decision)
- Subject protected by law (guardianship or conservatorship)
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Alcaldía Milpa Alta. Ciudad de México
Mexico City, 12000
Pavel Arenas Castañeda, +52-5586148610, arenaspavel@gmail.com
Enrique Baca-García, Dr
About this study
The objective of this study is to make a massive suicide risk and social behavior assessment in 24 pre-graduate education centers in Mexico City (approximately 30,000 students aged between 15 and 22 years), taking also into account other outcomes such as depression, anxiety, alcohol and drugs. For this, an app for Smartphone (MeMind) or a web platform (www.MeMind.net) will be used in which the participants will take a self-administered questionnaire, composed of several psychometric instruments.
Our main hypothesis is that identification of suicide risk in the Mexico City's student community is feasible using their own smartphones and can serve as both a population screening tool for early specialist referral, as well as a tool for evaluating social behavior strategies and their relation to suicide behavior.
- Conditions
- Suicidal Ideation, Social Behavior, Depression, Depressive Disorder, Anxiety, Alcohol Drinking
- Being tested
- Self-administered evaluation questionnaire
- Keywords
- Mass Screening, Health Surveys, Mental Health, Suicidal Ideation, Young Adult, Interpersonal Relations, Smartphone
- Medical subject headings
- Suicidal Ideation, Social Behavior, Depression, Depressive Disorder, Anxiety Disorders, Alcohol Drinking, Substance-Related Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-administered evaluation questionnaireOther
Smartphone app with MeMind questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Students of IEMS of Mexico City | Students currently enrolled in the academic year 2019-2020 from the 24 IEMS centers of Mexico City Receives: Other: Self-administered evaluation questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal ideation
Columbia-Suicide Severity Rating Scale (C-SSRS) is encompassed into MeMind for this purpose.
In C-SSRS, four constructs are measured. The first is the severity of ideation, which is rated on a 5-point ordinal scale from 1="wish to be dead" to 5="suicidal intent with plan".
The second is the intensity of ideation, which comprises 5 items, each rated on a 5-point ordinal scale: frequency, duration, controllability, deterrents, and reason for ideation.
The third is the behavior, which is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
And the fourth is the lethality, which assesses actual attempts; actual lethality is rated on a 6-point ordinal scale.
Results are coded in the instrument itself with colored labels that indicates definitions of suicidal ideation and behavior, quantify both of them and gauge their severity.
Definitions are available elsewhere (http://cssrs.columbia.edu).
Measured: 1 Day
Social Behavior
The assessment of social interaction will be carried out through six games that expose the participant to decision-making in preset environments with very simple and easily understandable rules (Dictator's Game, Prisoner's Dilemma, Loss Aversion, Risk Aversion, Trust Game or The Investment Game, and Ambiguity Aversion).
Measured: 1 Day
Secondary outcomes (4)
Depression
Participants will be asked to complete a questionnaire regarding possible symptoms related to depression.
PHQ-9 questionnaire is emcompassed into Memind for this purpose.
Measured: 1 Day
Anxiety
Participants will be asked to complete a questionnaire regarding possible symptoms related to anxiety.
GAD-7 (only screeni
Measured: 1 Day
Drug Utilization
Participants will be asked to complete a questionnaire regarding possible symptoms related to drug abuse.
DAST (only questions 1,6,7) is emcompassed into Memind for this purpose.
Measured: 1 Day
Alcohol Drinking
Participants will be asked to complete a questionnaire regarding possible symptoms related to alcohol abuse.
Alcohol Use Disorders Identification Test (AUDIT-C)
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2019
- Study start26 Aug 2019
- Primary completionJul 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, Instituciones Educativas de nivel Medio Superior (IEMS) de Ciudad de México, Gobierno de la Ciudad de Mexico
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04067076
- Sponsor's protocol ID
- SmartMexSurvey2
- Acronym
- TEDUCA
- Status last verified
- Jul 2020
- First submitted
- 22 Aug 2019
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available for researchers upon request
Publications
Martinez-Nicolas I, Arenas Castaneda PE, Molina-Pizarro CA, Rosado Franco A, Maya-Hernandez C, Barahona I, Martinez-Ales G, Aroca Bisquert F, Baca-Garcia E, Barrigon ML. Impact of Depression on Anxiety, Well-being, and Suicidality in Mexican Adolescent and Young Adult Students From Mexico City: A Mental Health Screening Using Smartphones. J Clin Psychiatry. 2022 Apr 6;83(3):20m13806. doi: 10.4088/JCP.20m13806.
PubMed 35390233
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Massive Mental Health Screening Using Smartphones in 24 Pre-graduate Education Centers in Mexico City: TEDUCA Survey Protocol
- ClinicalTrials.gov ID
- NCT04067076
- Acronym / sponsor ID
- TEDUCA / SmartMexSurvey2
- Conditions
- Suicidal Ideation, Social Behavior, Depression, Depressive Disorder, Anxiety, Alcohol Drinking
- Keywords
- Mass Screening, Health Surveys, Mental Health, Suicidal Ideation, Young Adult, Interpersonal Relations, Smartphone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Universidad Nacional Autonoma de Mexico, Instituciones Educativas de nivel Medio Superior (IEMS) de Ciudad de México, Gobierno de la Ciudad de Mexico
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 26 Aug 2019 (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 objective of this study is to make a massive suicide risk and social behavior assessment in 24 pre-graduate education centers in Mexico City (approximately 30,000 students aged between 15 and 22 years), taking also into account other outcomes such as depression, anxiety, alcohol and drugs. For this, an app for Smartphone (MeMind) or a web platform (www.MeMind.net) will be used in which the participants will take a self-administered questionnaire, composed of several psychometric instruments.
Our main hypothesis is that identification of suicide risk in the Mexico City's student community is feasible using their own smartphones and can serve as both a population screening tool for early specialist referral, as well as a tool for evaluating social behavior strategies and their relation to suicide behavior.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Students of IEMS of Mexico City | – | Other: Self-administered evaluation questionnaireStudents currently enrolled in the academic year 2019-2020 from the 24 IEMS centers of Mexico City |
Who may qualify
- Ages
- 15 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Community composed of students between 15 and 22 years of the 24 educational institutions IEMS of Mexico City, enrolled at the scholar year 2019-2020
Key inclusion criteria (3 listed)
- Use a smartphone as personal or computer terminals enabled by the municipality of Milpa Alta or educational services.
- Be able to understand the nature, purpose and methodology of the study.
- Accept participation in the study and check the corresponding box in the app to verify that the informed consent has been expressly given.
Key exclusion criteria (2 listed)
- Subject deprived of liberty (by judicial or administrative decision)
- Subject protected by law (guardianship or conservatorship)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-administered evaluation questionnaireSmartphone app with MeMind questionnaires | Other | Students of IEMS of Mexico City |
Primary outcome
Suicidal ideation
Time frame: 1 Day
Columbia-Suicide Severity Rating Scale (C-SSRS) is encompassed into MeMind for this purpose. In C-SSRS, four constructs are measured. The first is the severity of ideation, which is rated on a 5-point ordinal scale from 1="wish to be dead" to 5="suicidal intent with plan". The second is the intensity of ideation, which comprises 5 items, each rated on a 5-point ordinal scale: frequency, duration, controllability, deterrents, and reason for ideation. The third is the behavior, which is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior. And the fourth is the lethality, which assesses actual attempts; actual lethality is rated on a 6-point ordinal scale. Results are coded in the instrument itself with colored labels that indicates definitions of suicidal ideation and behavior, quantify both of them and gauge their severity. Definitions are available elsewhere (http://cssrs.columbia.edu).
Social Behavior
Time frame: 1 Day
The assessment of social interaction will be carried out through six games that expose the participant to decision-making in preset environments with very simple and easily understandable rules (Dictator's Game, Prisoner's Dilemma, Loss Aversion, Risk Aversion, Trust Game or The Investment Game, and Ambiguity Aversion).
4 secondary outcomes
Depression
Time frame: 1 Day
Anxiety
Time frame: 1 Day
Drug Utilization
Time frame: 1 Day
Alcohol Drinking
Time frame: 1 Day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Derived from this study: PubMed 35390233Martinez-Nicolas I, Arenas Castaneda PE, Molina-Pizarro CA, Rosado Franco A, Maya-Hernandez C, Barahona I, Martinez-Ales G, Aroca Bisquert F, Baca-Garcia E, Barrigon ML. Impact of Depression on Anxiety, Well-being, and Suicidality in Mexican Adolescent and Young Adult Students From Mexico City: A Mental Health Screening Using Smartphones. J Clin Psychiatry. 2022 Apr 6;83(3):20m13806. doi: 10.4088/JCP.20m13806.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be available for researchers upon request
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicidal Ideation and Social Behavior, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Mexico.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal ideation (time frame: 1 Day). The study lists 2 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 NCT04067076, which also lists 1 linked publication.
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 7 Jul 2020.