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Massive Mental Health Screening Using Smartphones in 24 Pre-graduate Education Centers in Mexico City: TEDUCA Survey Protocol (TEDUCA)

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ClinicalTrials.gov Identifier: NCT04067076
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : July 7, 2020
Sponsor:
Collaborators:
Universidad Nacional Autonoma de Mexico
Instituciones Educativas de nivel Medio Superior (IEMS) de Ciudad de México
Gobierno de la Ciudad de Mexico
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Brief 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. 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.


Condition or disease Intervention/treatment
Suicidal Ideation Social Behavior Depression Depressive Disorder Anxiety Alcohol Drinking Drug Abuse Other: Self-administered evaluation questionnaire

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Study Type : Observational
Estimated Enrollment : 30000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Massive Mental Health Screening Using Smartphones in 24 Pre-graduate Education Centers in Mexico City: TEDUCA Survey Protocol
Actual Study Start Date : August 26, 2019
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Students of IEMS of Mexico City
Students currently enrolled in the academic year 2019-2020 from the 24 IEMS centers of Mexico City
Other: Self-administered evaluation questionnaire
Smartphone app with MeMind questionnaires




Primary Outcome Measures :
  1. 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).


  2. 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).


Secondary Outcome Measures :
  1. Depression [ Time Frame: 1 Day ]

    Participants will be asked to complete a questionnaire regarding possible symptoms related to depression.

    PHQ-9 questionnaire is emcompassed into Memind for this purpose.


  2. Anxiety [ Time Frame: 1 Day ]

    Participants will be asked to complete a questionnaire regarding possible symptoms related to anxiety.

    GAD-7 (only screeni


  3. Drug Utilization [ Time Frame: 1 Day ]

    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.


  4. Alcohol Drinking [ Time Frame: 1 Day ]

    Participants will be asked to complete a questionnaire regarding possible symptoms related to alcohol abuse.

    Alcohol Use Disorders Identification Test (AUDIT-C)




Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 22 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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
Criteria

Inclusion Criteria:

  1. Use a smartphone as personal or computer terminals enabled by the municipality of Milpa Alta or educational services.
  2. Be able to understand the nature, purpose and methodology of the study.
  3. Accept participation in the study and check the corresponding box in the app to verify that the informed consent has been expressly given.

Exclusion Criteria:

  1. Subject deprived of liberty (by judicial or administrative decision)
  2. Subject protected by law (guardianship or conservatorship)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04067076


Locations
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Mexico
Alcaldía Milpa Alta. Ciudad de México Recruiting
Mexico City, Mexico, 12000
Contact: Pavel Arenas Castañeda    +52-5586148610    arenaspavel@gmail.com   
Principal Investigator: Enrique Baca-García, Dr         
Principal Investigator: Fuensanta Aroca, Dr         
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Universidad Nacional Autonoma de Mexico
Instituciones Educativas de nivel Medio Superior (IEMS) de Ciudad de México
Gobierno de la Ciudad de Mexico
Additional Information:
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Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT04067076    
Other Study ID Numbers: SmartMexSurvey2
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available for researchers upon request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Access Criteria: Upon request to Enrique Baca Garcia (enrique.baca@uam.es)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz:
Mass Screening
Health Surveys
Mental Health
Suicidal Ideation
Young Adult
Interpersonal Relations
Smartphone
Additional relevant MeSH terms:
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Substance-Related Disorders
Depressive Disorder
Suicidal Ideation
Alcohol Drinking
Behavioral Symptoms
Mood Disorders
Mental Disorders
Chemically-Induced Disorders
Suicide
Self-Injurious Behavior
Drinking Behavior