Clinical Trial

Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation

Recruiting
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Record status
This record was last updated August 1, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
Background. Suicidal ideation and depressive symptoms are highly prevalent among adolescents, with suicide representing a leading cause of death in this age group worldwide. School-based indicated prevention programs using cognitive behavioral therapy (CBT) have shown promise in addressing these mental health challenges. The Reframe-IT+ (Chile) and CARIBOU (Canada) programs are CBT-based, individually delivered interventions targeting adolescents at risk of suicide. This study aims to evaluate a culturally adapted stratified-care model using these two interventions, matched to depressive symptom severity. Methods. This is a quasi-experimental, single-arm study with pre-post assessments and follow-ups at 3, 6, 9, and 12 months. Six secondary schools with high socioeconomic vulnerability in Santiago, Chile, will participate. Students with suicidal ideation and mild/moderate depressive symptoms (PHQ-9 \< 20) will be offered Reframe-IT+, while those with severe symptoms (PHQ-9 ≥ 20) will be offered CARIBOU. Primary outcomes include the acceptability of CARIBOU, feasibility of the stratified-care model, and implementation fidelity. Secondary outcomes include reductions in suicidal ideation, depression, anxiety, hopelessness, and improvements in functioning, quality of life, behavioral activation, emotional regulation, and problem-solving skills. Discussion. This protocol addresses the need for scalable, culturally sensitive interventions for adolescent suicide prevention in school settings. By evaluating both the process and early outcomes of a stratified-care approach, this study will generate valuable evidence to inform future large-scale effectiveness trials and policy development in adolescent mental health.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-02.
Trial Details
NCT Number NCT07063914
Lead Sponsor Universidad de los Andes, Chile
Collaborators: University of Talca, Fundación Crecer y Sanar
Conditions Suicidal Ideation
Enrollment 60 participants
Start Date 2025-06-25
Primary Completion 2025-12-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-08-01