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

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 Overview

Study Type

Observational

Enrollment (Anticipated)

30000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mexico City, Mexico, 12000
        • Recruiting
        • Alcaldía Milpa Alta. Ciudad de México
        • Contact:
        • Principal Investigator:
          • Enrique Baca-García, Dr
        • Principal Investigator:
          • Fuensanta Aroca, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 22 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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
Smartphone app with MeMind questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).

1 Day
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).
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

1 Day
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)

1 Day
Anxiety
Time Frame: 1 Day

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

GAD-7 (only screeni

1 Day
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.

1 Day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

August 22, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 26, 2019

Study Record Updates

Last Update Posted (Actual)

July 7, 2020

Last Update Submitted That Met QC Criteria

July 1, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available for researchers upon request

IPD Sharing Access Criteria

Upon request to Enrique Baca Garcia (enrique.baca@uam.es)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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