NCT04067076

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 26, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

August 26, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

July 7, 2020

Status Verified

July 1, 2020

Enrollment Period

10 months

First QC Date

August 22, 2019

Last Update Submit

July 1, 2020

Conditions

Keywords

Mass ScreeningHealth SurveysMental HealthSuicidal IdeationYoung AdultInterpersonal RelationsSmartphone

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Depression

    1 Day

  • Anxiety

    1 Day

  • Drug Utilization

    1 Day

  • Alcohol Drinking

    1 Day

Study Arms (1)

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

Interventions

Smartphone app with MeMind questionnaires

Students of IEMS of Mexico City

Eligibility Criteria

Age15 Years - 22 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • Subject deprived of liberty (by judicial or administrative decision)
  • Subject protected by law (guardianship or conservatorship)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alcaldía Milpa Alta. Ciudad de México

Mexico City, 12000, Mexico

RECRUITING

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Suicidal IdeationSocial BehaviorDepressionDepressive DisorderAnxiety DisordersAlcohol DrinkingSubstance-Related DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorMood DisordersMental DisordersDrinking BehaviorChemically-Induced DisordersPersonal Satisfaction

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2019

First Posted

August 26, 2019

Study Start

August 26, 2019

Primary Completion

July 1, 2020

Study Completion

August 1, 2020

Last Updated

July 7, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will share

Data will be available for researchers upon request

Shared Documents
STUDY PROTOCOL, SAP, ICF
Access Criteria
Upon request to Enrique Baca Garcia (enrique.baca@uam.es)

Locations