Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation

NCT07063914 | Recruiting

• 1 other identifier: FCS2025
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicidal Ideation

Keywords

suicide; adolescents; depression; schools; prevention

Outcome Measures

Primary Outcomes (7)

• Acceptability of the CARIBOU Program

  Acceptability will be assessed by examining how well the intervention is received by student participants and facilitators, and how well it addresses the needs of the target population. Upon completion of the program, participants will complete a general acceptability questionnaire and a module-specific acceptability questionnaire. Facilitators will complete a general acceptability questionnaire as well. All instruments were developed by the research team and are designed to measure the program's content in detail. Additionally, the Client Satisfaction Questionnaire (CSQ-8) will be used to assess overall satisfaction with the intervention (19). The CSQ-8 consists of 8 Likert-scale items with four response options, and includes open fields for comments and suggestions. It has demonstrated high internal consistency (α = 0.83-0.93) (20) and will be slightly adapted to reflect the context of this study.

  immediately post-intervention

• Feasibility Recruitment

  We will record the recruitment and characteristics of the sample

  through study completion, an average of 1 year

• Feasibility Attendance to eligibility interviews

  We will record the number of adolescents and families who attend eligibility interviews.

  through study completion, an average of 1 year

• Feasibility Response rates to questionnaires

  Response rates to questionnaires.

  through study completion, an average of 1 year

• Feasibility Session attendance

  Session attendance and progress through the program.

  through study completion, an average of 1 year

• Feasibility Attrition

  Participant retention and dropout rates.

  through study completion, an average of 1 year

• Implementation Fidelity

  Fidelity will be assessed by determining facilitator adherence to program protocols (Reframe-IT+ and CARIBOU). After each session, facilitators will complete a self-report monitoring form to record implementation fidelity. These forms were developed by the research team and assess the delivery of each session's content.

  through study completion, an average of 1 year

Secondary Outcomes (12)

• Suicidal ideation

  pre-post assessments and follow-ups at 3, 6, 9, and 12 months.

• Suicidal ideation frecuency

  pre-post assessments and follow-ups at 3, 6, 9, and 12 months.

• Depressive symptoms

  pre-post assessments and follow-ups at 3, 6, 9, and 12 months.

• Anxiety symptoms

  pre-post assessments and follow-ups at 3, 6, 9, and 12 months.

• Hopelessness

  pre-post assessments and follow-ups at 3, 6, 9, and 12 months.

Study Arms (1)

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

OTHER

single arm

Behavioral: Reframe-IT and CARIBOU

Interventions

Reframe-IT and CARIBOU 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.

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

Eligibility Criteria

• Age: 14 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• University of Talca: collaborator
• Fundación Crecer y Sanar: collaborator

Study Sites (1)

Universidad de los Andes

Santiago, Las Condes, Chile

RECRUITING

Related Publications (1)

• 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.

  PMID: 31752375 BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation; Suicide; Depression

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Jorge E Gaete, MD. PhD.

  Universidad de Los Andes

  STUDY DIRECTOR

Central Study Contacts

Jorge E Gaete, MD, PhD

CONTACT

+56940245650; jgaete@uandes.cl

Saray A Ramírez, MsC

CONTACT

+56988191548; saramirez1@miuandes.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: This is an initial feasibility and a single-arm study with pre-post assessments and follow-ups at 3, 6, 9, and 12 months.

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 14, 2025
• Study Start: June 25, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)