Recruiting

Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation

ClinicalTrials.gov IDNCT07063914

PhaseNA

Enrollment60

SponsorUniversidad de los Andes, Chile

Age14 Years

SexALL

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Conditions studied

Suicidal Ideation

About this study

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.

Interventions

Behavioral: Reframe-IT and CARIBOU — Reframe-IT+ An individual intervention based on cognitive-behavioral therapy (CBT) focused on developing skills in behavioral activation, cognitive restructuring, emotion regulation, stress tolerance, and problem-solving. It is delivered in the school setting by a trained psychologist from the research team. The program consists of 13 weekly sessions of 45 minutes each: 5 face-to-face sessions and 8 combined digital/in-person sessions where students use a computer under the supervision of a psychologist facilitator. CARIBOU An individual CBT-based intervention focused on behavioral activation, cognitive restructuring, problem-solving, and communication skills. It is conducted in the school setting by a trained psychologist and consists of 16 weekly sessions of 45 minutes each.

Primary outcomes

Acceptability of the CARIBOU Program (immediately post-intervention)
Feasibility Recruitment (through study completion, an average of 1 year)
Feasibility Attendance to eligibility interviews (through study completion, an average of 1 year)
Feasibility Response rates to questionnaires (through study completion, an average of 1 year)
Feasibility Session attendance (through study completion, an average of 1 year)
Feasibility Attrition (through study completion, an average of 1 year)
Implementation Fidelity (through study completion, an average of 1 year)

Eligibility information

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.

Study locations

Universidad de los Andes, Santiago, Las Condes Chile

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.