Technology-assisted Methods to Advance Suicide Prevention Among Youth in Colombia

NCT06651554 | Recruiting

• 2 other identifiers: STUDY00000508R34MH136232-01
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

Brief Summary

This study will investigate a multi-level approach that applies technology-assisted methods to reduce suicidal thoughts and behaviors (SIB) and promote mental health among Colombian youth: (a) digital platform for youth; (b) digital platform for teachers; and (c) hybrid mental health training diploma program for teachers. This approach will evaluate an open-access digital platform for suicide prevention among Colombian youth. Key features of the digital platform include mental health self-help tools, a customizable safety plan, links to online counseling services, and gamification elements. The digital platform's teacher interface will incorporate psychoeducation, brief suicide-risk screening and decision support tools to enhance teacher capacity to assess risk for suicide and refer youth to the appropriate level of services. Study investigators will conduct a hybrid-type 1 implementation-effectiveness stepped wedge pilot trial design to evaluate the digital platform and hybrid mental health teacher training program implemented within secondary schools in Bogota, Colombia. Study aims are to: Aim 1. An initial needs assessment will be conducted with key stakeholders (youth, teachers, caregivers, school administrators) to identify barriers and facilitators to successful implementation of the multi-level approach. User-centered design methods will be used to refine the digital platform and incorporate end-user feedback into the final prototype. Aim 2. Investigators will evaluate: (a) feasibility, acceptability, and usability of the digital platform across three schools in Colombia; and (b) the preliminary effects of the digital platform in reducing SIB and improving mood (e.g., anxiety/depression) among Colombian youth aged 14-19 attending the three schools. Safety planning skills acquisition (youth-level) and linkages to mental health services (service-level) will be assessed as potential mechanisms of change. Aim 3. The study will apply a multi-disciplinary capacity building model to strengthen behavioral health and implementation science research, healthcare delivery capacity, and mental health policy. In partnership with Pontificia Javeriana University, experts in suicide prevention, data science, and implementation science will be engaged to build in-country research capacity at the individual and institutional level.

Conditions

Suicidal Ideations; Suicidal Behaviors; Depression, Anxiety; Well-being

Keywords

suicide prevention; adolescent health; mHealth; Colombia; Implementation Science

Outcome Measures

Primary Outcomes (3)

• PHQ-9

  The PHQ-9 is a 9-item scale used as a brief assessment of depression symptoms during the past two weeks. The measure is scored on a 4-point Likert scale: 0=not at all; 1=several days; 2=more than half the days; 3=nearly every day. Higher scores indicate worse depression symptoms. Item 9 can be used to screen for suicidal ideation (e.g., thoughts that you would be better of dead or hurting yourself). The measure has been translated to Spanish and validated previously in Colombia with youth and adults.

  Baseline, immediately after the intervention, and 3-months after the intervention

• GAD-7

  The GAD-7 is a 7-item scale used as a brief assessment of anxiety symptoms. The measure is scored on a 4-point Likert scale: 0=not at all; 1=several days; 2=more than half the days; 3=nearly every day. Higher scores indicate worse anxiety. The measure has been translated to Spanish and validated previously in Colombia with youth and adults.

  baseline, immediately after the intervention and 3-months after the intervention

• Self-injurious Thoughts and Behaviors Interview-short form, adapted

  The SITBI short form is a structured interview designed to assess the presence, frequency, and characteristics of a broad array of self-injurious thoughts and behaviors. The measure has been translated to Spanish and validated in adolescent/young adult and Spanish speaking populations. Items are scored on a 5-point Likert-scale ranging from: 0=low/little to 4=very much/severe. Higher scores indicate greater frequency and/or severity of self-injurious thoughts and behaviors.

  baseline, immediately after the intervention and 3-months after the intervention

Secondary Outcomes (1)

• WHO-5

  baseline, immediately after the intervention and 3-months after the intervention

Study Arms (2)

Digital Platform Intervention

EXPERIMENTAL

Key features of the digital platform intervention include mental health self-help tools, a customizable safety plan, links to online counseling services, and gamification elements.

Behavioral: Digital Platform Intervention

waitlist control

NO INTERVENTION

No intervention will be administered to youth during their assigned waitlist control period.

Interventions

Digital Platform Intervention BEHAVIORAL

Key features of the digital platform include mental health self-help tools, a customizable safety plan, links to online counseling services, and gamification elements. Youth will be able to access the digital platform as often as they like during their assigned 3-month intervention period.

Digital Platform Intervention

Eligibility Criteria

• Age: 14 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 14-19
• attending a secondary school in Bogota
• willing to try the digital platform

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Pontificia Javeriana Universidad

Bogotá, Colombia, Colombia

RECRUITING

MeSH Terms

Conditions

Suicidal Ideation; Depression; Anxiety Disorders; Suicide Prevention

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Alethea Desrosiers

  Brown University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alethea Desrosiers

CONTACT

401-863-1000; alethea_desrosiers@brown.du

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 21, 2024
• Study Start: May 12, 2025
• Primary Completion (Estimated): December 15, 2027
• Study Completion (Estimated): May 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)