Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation

NCT07063914 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-08-01

No results posted yet for this study

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.

Conditions

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.

Sponsors & Collaborators

  • University of Talca

    collaborator OTHER
  • Fundación Crecer y Sanar

    collaborator UNKNOWN
  • Universidad de los Andes, Chile

    lead OTHER

Principal Investigators

  • Jorge E Gaete, MD. PhD. · Universidad de Los Andes

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
14 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-25
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Chile

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07063914 on ClinicalTrials.gov