- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04067076
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
Mexico City, Mexico, 12000
- Recruiting
- Alcaldía Milpa Alta. Ciudad de México
-
Contact:
- Pavel Arenas Castañeda
- Phone Number: +52-5586148610
- Email: arenaspavel@gmail.com
-
Principal Investigator:
- Enrique Baca-García, Dr
-
Principal Investigator:
- Fuensanta Aroca, Dr
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Subject deprived of liberty (by judicial or administrative decision)
- Subject protected by law (guardianship or conservatorship)
Study Plan
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
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SmartMexSurvey2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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