Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation

NCT ID: NCT07063914

Last Updated: 2025-08-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2025-12-31

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.

Detailed Description

Suicide among adolescents and young people is a highly prevalent global issue, with suicidal ideation reaching rates of approximately 18% and suicide attempts around 6% (1). According to the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD), suicide ranks as the fifth leading cause of death among individuals aged 10 to 24 (2), with a mortality rate of 6.0 per 100,000 in this age group (3). Suicide mortality increases with age: 1.2 per 100,000 among those aged 10-14; 6.7 among those aged 15-19; and 10.6 among those aged 20-24 (3). In Latin America, suicide mortality rates surpass global averages, reaching 9.8 per 100,000, and in Chile, the rate is 7.2 per 100,000 (3).

Numerous risk factors are associated with suicide, including genetic, biological, psychological, and social factors (4,5). Each case of suicide is caused by a unique, dynamic, and complex interaction of these elements (4,5). However, depression remains the most frequently reported common factor (4). A recent literature review found that between 50-65% of suicide cases met criteria for depression (4). Regarding its broader impact, depressive symptoms are even more prevalent than suicidal ideation, with global rates of 43.9%, including mild, moderate, and severe cases (6). Moreover, the number of depression cases among adolescents has grown exponentially, with a 21.6% increase in total cases and a 19% increase in incidence compared to the 1990s (7). In Chile, adolescent depression is estimated to affect 8.3% of the population, yet fewer than half receive mental health care (8).

Secondary schools are recognized as appropriate, accessible, and effective settings for suicide (9) and depression prevention programs (10) for adolescents. School-based interventions offer broad reach and enable large-scale prevention efforts (9,10). Evidence shows that such programs improve suicide awareness and coping skills to reduce suicidal thoughts and attempts (9,11,12). However, indicated interventions-those targeting at-risk individuals with clinical or psychosocial approaches such as cognitive-behavioral therapy (CBT)-remain less common in school settings (13), despite their established efficacy in other contexts (13), underscoring the need for further research on their implementation in schools.

Two CBT-based programs have demonstrated effectiveness and safety in reducing suicidal ideation and depressive symptoms. Both are indicated interventions, meaning they target individuals already at risk and are delivered individually.

The Reframe-IT program, developed in Australia, targets behavioral activation, cognitive restructuring, emotion regulation, stress tolerance, and problem-solving skills (14). It includes eight digital sessions designed for delivery by school well-being staff (14). A pilot randomized controlled trial in Australia showed greater reductions in suicidal ideation, depression, and hopelessness among the intervention group than controls, although differences were not statistically significant due to insufficient statistical power (14). In Chile, the research team collaborated with the University of Talca for over four years to culturally adapt Reframe-IT, developing Reframe-IT+ by adding five face-to-face sessions to the original eight. An initial pilot study with 52 participants showed high acceptability and reductions of 15.2 points in suicidal ideation and 3.5 in depressive symptoms (15). A subsequent RCT with 1,546 screened students and 100 randomized participants demonstrated significant decreases of 6.7 points in suicidal ideation and 3.1 in depressive symptoms (16). Following these positive results, a scaled-up quasi-experimental study in Santiago (CEC2024061) included 75 students and showed preliminary reductions of 2.5 points in suicidal ideation and 3.2 in depressive symptoms.

The CARIBOU program, developed in Canada, targets behavioral activation, cognitive restructuring, problem-solving, and communication skills (17). It consists of 16 sessions facilitated by trained professionals from diverse backgrounds. A non-randomized pilot study showed a 2-point reduction in depressive symptoms (17). Moreover, 80% of participants reported program engagement, and facilitators achieved 95% fidelity in implementation (17). The research team has initiated contact with Dr. Darren Courtney, CARIBOU's lead developer, to begin its cultural adaptation in Chile as part of the present study.

This study proposes a stratified-care intervention model in which treatment intensity is matched to individual needs, ensuring appropriate levels of care. Adolescents with suicidal ideation will be offered Reframe-IT+ if they present with mild or moderate depressive symptoms, and CARIBOU if they present with severe symptoms.

METHODOLOGY General Objective The general objective of this study is to examine the acceptability of the CARIBOU program and the feasibility and fidelity of implementing a stratified-care approach tailored to the needs of adolescents with suicidal ideation. Under this model, students with mild or moderate depressive symptoms (PHQ-9 < 20) will be offered the Reframe-IT+ program, and those with severe depressive symptoms (PHQ-9 ≥ 20) will be offered the CARIBOU program. Additionally, this study aims to explore the efficacy of a stratified-care intervention in adolescents at risk for suicide and with depressive symptomatology.

Conditions

Suicidal Ideation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Single arm with the stratified-care intervention Reframe-IT and CARIBOU

single arm

Group Type: OTHER

Reframe-IT and CARIBOU

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Talca

OTHER

Sponsor Role: collaborator

Fundación Crecer y Sanar

UNKNOWN

Sponsor Role: collaborator

Universidad de los Andes, Chile

OTHER

Sponsor Role: lead

Responsible Party

Jorge Gaete

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jorge E Gaete, MD. PhD.

Role: STUDY_DIRECTOR

Universidad de Los Andes

Locations

Universidad de los Andes

Santiago, Las Condes, Chile

Site Status: RECRUITING

Countries

Chile

Central Contacts

Jorge E Gaete, MD, PhD

Role: CONTACT

jgaete@uandes.cl

+56940245650

Saray A Ramírez, MsC

Role: CONTACT

saramirez1@miuandes.cl

+56988191548

Facility Contacts

Saray A Ramírez, MsC.

Role: primary

saramirez1@miuandes.cl

+56988191548

Valentina R Romo, MsC

Role: backup

vromo@miuandes.cl

+56984038329

References

Lim KS, Wong CH, McIntyre RS, Wang J, Zhang Z, Tran BX, Tan W, Ho CS, Ho RC. Global Lifetime and 12-Month Prevalence of Suicidal Behavior, Deliberate Self-Harm and Non-Suicidal Self-Injury in Children and Adolescents between 1989 and 2018: A Meta-Analysis. Int J Environ Res Public Health. 2019 Nov 19;16(22):4581. doi: 10.3390/ijerph16224581.

Reference Type: BACKGROUND

PMID: 31752375 (View on PubMed)

Other Identifiers

FCS2025

Identifier Type: -

Identifier Source: org_study_id