Technology-assisted Methods to Advance Suicide Prevention Among Youth in Colombia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-19
SponsorBrown University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
aged 14-19
attending a secondary school in Bogota
willing to try the digital platform
Disqualifiers
not meeting inclusion criteria
Trial design
Design model
Sequential
Treatments tested in this trial
Digital Platform Intervention
BehavioralKey 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.
Treatment groups
228 Participants
are divided into 2 treatment groupsGroup A: Digital Platform InterventionExperimental treatment 1 intervention
Group B: waitlist controlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, immediately after the intervention, and 3-months after the intervention2
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.
Time frame
baseline, immediately after the intervention and 3-months after the intervention3
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.
Time frame
baseline, immediately after the intervention and 3-months after the interventionSecondary outcomes
1
WHO-5
The WHO-5 is a 5-item scale that measures current well-being over the past two weeks. The measure is scored on a 6-point Likert-scale: 0=at no time; 1=some of the time; 2=less than half of the time; 4=most of the time; 5=all of the time. Higher scores reflect a greater sense of well-being. The measure has been translated to Spanish and validated with populations of youth and adults.
Time frame
baseline, immediately after the intervention and 3-months after the interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Brown University
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator
Source ClinicalTrials.gov