Harnessing Technology-assisted Methods to Advance Suicide Prevention Among Youth in Colombian School Settings
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- PHQ-9
研究概览
简要总结
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.
详细描述
This study uses a multi-level approach that leverages innovative, culturally appropriate mHealth technology to reduce SIB and promote mental health in Colombian youth: (a) digital platform for youth; (b) digital platform for teachers; and (c) hybrid mental health training program for teachers. Study investigators will conduct a hybrid-type 1 implementation-effectiveness stepped wedge pilot trial to evaluate the digital platform and hybrid mental health teacher training program implemented within secondary schools in Bogota, Colombia.
Prior to launching the pilot trial, study investigators will conduct an initial needs assessment with key stakeholders to identify barriers and facilitators to successful implementation of the digital platform. Investigators will use a mixed methods approach and conduct qualitative interviews with key stakeholders (teachers (N=10), youth (N=12), caregivers (N=5) and school administrators (N=3)). Quantitative measures will include school climate, leadership, and attitudes towards technology-assisted interventions. Qualitative data analysis will follow an iterative process of open coding for themes, followed by focused coding to determine frequency of themes. Mixed methods analysis will use joint displays to integrate qualitative and quantitative data and highlight key findings. Results will inform development of a formal implementation blueprint that will be reviewed with key stakeholders and used to guide implementation of the platform.
User-centered design methods will guide refinements of the youth interface and further development of the teacher interface in the digital platform. The process will include two co-design workshops with youth (N=10) and two with teachers (N=8). Ender-user feedback from the initial co-design process will be incorporated to further optimize the digital platform's functionality and features to build the alpha prototype. Three, iterative user-testing sessions of the alpha prototype will be held with youth and teachers using "think aloud protocols" to elicit end-user feedback on features that are user-friendly versus confusing or hard to use. Feedback from user-testing sessions will inform further refinements and development of the beta prototype. Study investigators will then conduct three additional user-testing sessions with teachers and youth, respectively, to test the beta prototype. User-testing participants will complete the System Usability Scale after the last UI/UX testing session to asses usability prior to launching the pilot trial.
Aim 1. (Exploration and Preparation) Explore barriers and facilitators to successful implementation of the digital platform in Colombian schools. A mixed-methods participatory process with key stakeholders will be used to identify implementation barriers and facilitators. Aim 1a. User-centered design principles will guide refinements of the digital platform.
Aim 2. (Implementation) Conduct a hybrid type 1 implementation-effectiveness stepped wedge pilot trial to assess the feasibility, acceptability, usability and preliminary effects of the digital platform implemented within 3 schools in reducing SIB and improving mood (e.g., anxiety/depression) among Colombian youth aged 14-19 (N=150). Study Hypotheses are that: (a) the digital platform will be feasible, acceptable, and usable among youth; and (b) youth who use the digital platform will exhibit greater reductions in SIB and mood symptoms during their school's intervention period compared with youth in the pre-intervention period (no digital platform use) at post-intervention and 3-month follow-up. Aim 2a. Explore safety planning skills (youth-level) and linkages to mental health services (service-level) as mechanisms of change. We hypothesize that: (a) use of the digital platform will be related to greater safety planning skills and service usage; and (b) safety planning skills and service usage will be related to reduced SIB and mood symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 19 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged 14-19
- •attending a secondary school in Bogota
- •willing to try the digital platform
排除标准
- •not meeting inclusion criteria
研究组 & 干预措施
waitlist control
No intervention will be administered to youth during their assigned waitlist control period.
Digital Platform Intervention
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.
干预措施: Digital Platform Intervention (Behavioral)
结局指标
主要结局
PHQ-9
时间窗: Baseline, immediately after the intervention, and 3-months after the intervention
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.
GAD-7
时间窗: baseline, immediately after the intervention and 3-months after the intervention
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.
Self-injurious Thoughts and Behaviors Interview-short form, adapted
时间窗: baseline, immediately after the intervention and 3-months after the intervention
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.
次要结局
- WHO-5(baseline, immediately after the intervention and 3-months after the intervention)
