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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04067076
Other study ID # SmartMexSurvey2
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date August 26, 2019
Est. completion date August 2020

Study information

Verified date July 2020
Source Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30000
Est. completion date August 2020
Est. primary completion date July 2020
Accepts healthy volunteers No
Gender All
Age group 15 Years to 22 Years
Eligibility 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 Design


Intervention

Other:
Self-administered evaluation questionnaire
Smartphone app with MeMind questionnaires

Locations

Country Name City State
Mexico Alcaldía Milpa Alta. Ciudad de México Mexico City

Sponsors (4)

Lead Sponsor Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Gobierno de la Ciudad de Mexico, Instituciones Educativas de nivel Medio Superior (IEMS) de Ciudad de México, Universidad Nacional Autonoma de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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).
1 Day
Primary 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). 1 Day
Secondary 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.
1 Day
Secondary Anxiety Participants will be asked to complete a questionnaire regarding possible symptoms related to anxiety.
GAD-7 (only screeni
1 Day
Secondary 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.
1 Day
Secondary Alcohol Drinking Participants will be asked to complete a questionnaire regarding possible symptoms related to alcohol abuse.
Alcohol Use Disorders Identification Test (AUDIT-C)
1 Day
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