NCT07063914 Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation
| NCT ID | NCT07063914 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universidad de los Andes, Chile |
| Condition | Suicidal Ideation |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-06-25 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Inclusion Criteria for Educational Institutions * Located in Santiago, Chile. * Secondary education level (grades I-IV Medio). * Coeducational schools. * At least two classes per grade level in secondary education. * A minimum of 30 students per class. * Socioeconomic vulnerability level of ≥ 50%, as measured by the School Vulnerability Index (Índice de Vulnerabilidad Escolar - IVE-SINAE), which includes factors such as parental education and total household income. Inclusion Criteria for Students * Enrolled in grades I, II, or III Medio. * Suicidal ideation within the past month, defined as a score ≥ 3 on the Columbia-Suicide Severity Rating Scale (C-SSRS). * For the Reframe-IT+ program: mild or moderate depressive symptoms, defined as a PHQ-9 score \< 20. * For the CARIBOU program: severe depressive symptoms, defined as a PHQ-9 score ≥ 20. Exclusion Criteria: * Exclusion Criteria for Students * Participation in a structured suicide prevention program (Reframe-IT+) during 2024. * Severe psychotic symptoms, such as perceptual disturbances or delusional ideas, assessed during the eligibility interview. * Suicide attempt(s) in the past three months, assessed during the eligibility interview.
Contact & Investigator
Jorge E Gaete, MD. PhD.
STUDY DIRECTOR
Universidad de los Andes, Chile
Frequently Asked Questions
Who can join the NCT07063914 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 18 Years, studying Suicidal Ideation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07063914 currently recruiting?
Yes, NCT07063914 is actively recruiting participants. Contact the research team at jgaete@uandes.cl for enrollment information.
Where is the NCT07063914 trial being conducted?
This trial is being conducted at Santiago, Chile.
Who is sponsoring the NCT07063914 clinical trial?
NCT07063914 is sponsored by Universidad de los Andes, Chile. The principal investigator is Jorge E Gaete, MD. PhD. at Universidad de los Andes, Chile. The trial plans to enroll 60 participants.