Stratified Care Intervention for Suicidal Ideation, Depression, and Non-Suicidal Self-Injury in Adolescents (Reframe-IT+ & CARIBOU)

N/AActive Not RecruitingNCT07780084

Universidad de los Andes, Chile90 enrolled

Overview

The aim of this study is to evaluate the acceptability, feasibility, and fidelity of implementing a stratified care intervention for adolescents with suicidal ideation and depressive symptoms, and to preliminarily explore its effectiveness in reducing suicidal ideation and depression in educational institutions with high socioeconomic vulnerability in the Metropolitan Region. Specific Objectives 1. To determine the feasibility of implementing a stratified care plan tailored to the needs of adolescents with suicidal ideation. 2. To determine the fidelity of the implementation of Reframe-IT+ and CARIBOU-CBT, with the addition of the initial CARIBOU-SITB component, among participating facilitators following the intervention. 3. To determine the acceptability of the initial CARIBOU-SITB component among participating students and facilitators, as measured after the intervention. 4. To explore the efficacy of Reframe-IT+ and CARIBOU-CBT, with the addition of the initial CARIBOU-SITB component, in reducing suicidal ideation, depressive symptoms, anxiety, hopelessness, and non-suicidal self-injury (NSSI) immediately following the intervention, and at 3, 6, 9, and 12 months post-intervention. 5. To explore the efficacy of Reframe-IT+ and CARIBOU-CBT, with the addition of the initial CARIBOU-SITB component, in improving general functioning, quality of life, cognitive-behavioral skills related to behavioral activation, emotional regulation, and problem-solving immediately after the intervention, and at 3, 6, 9, and 12 months post-intervention. Participants will: 1. Complete a battery of self-report questionnaires before the intervention, immediately after, and at 3, 6, 9, and 12 months of follow-up. 2. Receive CARIBOU-SITB, a four-session intervention focused on safety planning and reducing the risk of self-harm. 3. Then receive either Reframe-IT+ (13 sessions) or CARIBOU-CBT (16 sessions), individual cognitive-behavioral interventions delivered at their school by a trained psychologist, depending on the severity of their depressive symptoms. Hypotheses or research assumptions This study proposes the following hypotheses regarding the feasibility of the study using Reframe-IT+ and CARIBOU-CBT with the addition of the initial CARIBOU-SITB component (H1), the fidelity of the intervention (H2), the acceptability of the initial CARIBOU-SITB component (H3)and the expected effects of the intervention (H4 and H5): H1: We will be able to recruit 21 educational institutions, screen 70% of the students who consent to participate in this project, and ensure the participation of 100 students, all of whom will be offered CARIBOU-SITB and then, based on depressive symptoms, will be assigned to Reframe-IT+ (47 students) or CARIBOU-CBT (53 students). H2: Facilitators of the Reframe-IT+ and CARIBOU-CBT programs, incorporating the initial CARIBOU-SITB component, will demonstrate 80% adherence to the manual-as a measure of fidelity-based on self-reports regarding the implementation of each session. H3: After adapting the material for the initial CARIBOU-SITB component to Chilean culture, a high level of acceptability (over 70% positive ratings) is expected from participating students and facilitators following the intervention. H4: Reframe-IT+ and CARIBOU-CBT, with the addition of the initial CARIBOU-SITB component, will reduce suicidal ideation, depressive and anxiety symptoms, hopelessness, and non-suicidal self-injury (NSSI) among participating students at the end of the intervention and at 3, 6, 9, and 12 months post-intervention. H5: Reframe-IT+ and CARIBOU-CBT, with the addition of the initial CARIBOU-SITB component, will improve overall functioning, quality of life, cognitive-behavioral skills, behavioral activation, emotional regulation, and problem-solving skills in participating students at the end of the intervention and at 3, 6, 9, and 12 months post-intervention.

This is a quasi-experimental study without a control group, using a pre-post design with follow-up assessments at 3, 6, 9, and 12 months post-intervention. The study targets 10th, 11th, and 12th-grade students attending secondary schools with high socioeconomic vulnerability (≥50% on the School Vulnerability Index, IVE-SINAE) in the Metropolitan Region of Chile. The intervention comprises two sequential components. First, all eligible students with suicidal ideation (C-SSRS score ≥3) receive CARIBOU-SITB, a four-session individual intervention based on dialectical behavior therapy and motivational interviewing, focused on safety planning and reducing the risk of self-harm. Following this component, students are stratified according to their depressive symptom severity on the PHQ-9: those with mild or moderate symptoms (PHQ-9 \<20) are offered Reframe-IT+, a 13-session individual cognitive-behavioral intervention combining in-person and digital delivery; those with severe symptoms (PHQ-9 ≥20) are offered CARIBOU-CBT, a 16-session individual cognitive-behavioral intervention. Both programs are delivered at the schools by trained psychologists and target behavioral activation, cognitive restructuring, emotional regulation, and problem-solving skills, with CARIBOU-CBT additionally addressing communication skills. The study is conducted in two phases. A preparatory phase includes translation and cultural adaptation of the CARIBOU-SITB manual, preparation of intervention and assessment materials, facilitator training, and development of protocols for managing critical risk situations. An implementation phase follows, encompassing school recruitment, parental informed consent, student screening and informed consent/assent, invitation interviews to confirm eligibility, program delivery, and post-intervention and follow-up assessments. Primary outcomes includes the feasibility of implementing the stratified care plan (recruitment, attendance, response, and retention rates), the fidelity of implementation by facilitators (self-reported adherence to session protocols), and the acceptability of the CARIBOU-SITB component (assessed via acceptability questionnaires and the Client Satisfaction Questionnaire, CSQ-8). Secondary outcomes explore the preliminary efficacy of the interventions in reducing suicidal ideation (C-SSRS, SIQ-JR), non-suicidal self-injury, depressive symptoms (PHQ-9), anxiety (GAD-7), and hopelessness (BHS), as well as their efficacy in improving general functioning, quality of life, and cognitive-behavioral skills related to behavioral activation, emotional regulation, and problem-solving, assessed immediately post-intervention and at 3, 6, 9, and 12 months.

Interventions

Reframe-IT and CARIBOUBEHAVIORAL

All participants first will receive the CARIBOU-SITB component (4 weekly sessions, 45 minutes each). Then students with severe depressive symptoms (PHQ-9 score ≥ 20) will receive CARIBOU-CBT: a cognitive-behavioral therapy intervention consisting of 16 weekly sessions of 45 minutes each, targeting behavioral activation, cognitive restructuring, problem-solving, and communication skills. Students with mild or moderate depressive symptoms (PHQ-9 score \< 20) will receive Reframe-IT+: a cognitive-behavioral therapy intervention consisting of 13 weekly sessions of 45 minutes each (5 in-person and 8 combining in-person and digital delivery), targeting behavioral activation, cognitive restructuring, emotional regulation, stress tolerance, and problem-solving. All interventions will be delivered individually at the educational institution by a trained psychologist.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Schools * Located in Santiago, Chile * Secondary school (1st through 4th year of secondary school) * At least two classes per grade level * At least 30 students per class * High vulnerability index (≥50%) as measured by the School Vulnerability Index - National Allocation System for Equality (IVE-SINAE) 2. Students * Students in grades 9, 10, and 11 * Suicidal ideation reported in 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 score \<20 on the PHQ-9 * For the CARIBOU-CBT Program: severe depressive symptoms, defined as a score ≥20 on the PHQ-9 Exclusion Criteria: * Participation in a manualized suicide prevention program (Reframe-IT+/CARIBOU) in 2025 * Severe psychotic symptoms, defined as clear perceptual disturbances and delusions identified during the invitation interview * Suicide attempt(s) in the past 3 months, or active suicidal ideation requiring hospitalization, as determined during the screening interview * History of a prior medical diagnosis of Bipolar Disorder I or II * History of a prior medical diagnosis of a Severe Eating Disorder (e.g., Anorexia Nervosa or Bulimia) * Severe substance use disorder, meeting any of the following patterns: daily cannabis use throughout the day; excessive alcohol or benzodiazepine use ≥3 times per week; cocaine or opioid use several days per month or more, as determined during the screening interview * Intellectual disability * Inability to speak, read, or write in Spanish

Outcomes

Primary Outcomes

Feasibility of Implementing the Stratified Care Plan

Feasibility will be assessed through recruitment and sample characteristics, attendance at invitation interviews, questionnaire response rates, participant attendance and progress in sessions, and retention/dropout rates, reported as percentages with 95% confidence intervals.

Time frame: Throughout the implementation phase (approximately 5 months)

Fidelity of Implementation of Reframe-IT+ and CARIBOU-CBT

Fidelity will be assessed via facilitator self-report session-monitoring questionnaires completed after each session with each participating student, measuring adherence to the intervention manuals. Adequate fidelity is defined as ≥80% adherence.

Time frame: After each session, throughout the implementation phase (approximately 5 months)

Acceptability of the CARIBOU-SITB Component - CSQ-8

Acceptability will be assessed among using the Client Satisfaction Questionnaire (CSQ-8), an 8-item instrument measuring overall satisfaction with the intervention received (score range 8-32). A high level of acceptability is defined over 70% of participant with score ≥ 24

Time frame: Immediately after completion of the CARIBOU-SITB component (approximately 4 weeks)

Acceptability of the CARIBOU-SITB Component - Students

Acceptability will be assessed among students using in-house general and module-specific acceptability questionnaires.

Time frame: Immediately after completion of the CARIBOU-SITB component (approximately 4 weeks)

Acceptability of the CARIBOU-SITB Component - Facilitators

Acceptability will be assessed among facilitators using in-house general and module-specific acceptability questionnaires.

Time frame: Immediately after completion of the CARIBOU-SITB component (approximately 4 weeks)

Secondary Outcomes

Change in Suicidal Ideation Severity

Measured using the Columbia Suicide Severity Rating Scale (C-SSRS), a 6-item self-report instrument assessing the severity of suicidal ideation and behavior (score range 0-6).