Depression in AdolescenceNCT07780084
Stratified Care Intervention for Suicidal Ideation, Depression, and Non-Suicidal Self-Injury in Adolescents (Reframe-IT+ & CARIBOU)
A study testing Reframe-IT and CARIBOU in people with Depression in Adolescence and Suicidal Ideation, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Depression in Adolescence, Suicidal Ideation, Non Suicidal Self Injury
- What is being tested?
- Reframe-IT and CARIBOU
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChile
- Study dates
- 9 Jun 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptability, Feasibility, Fidelity, and Exploration of the Efficacy of a Stratified Care Intervention for the Prevention of Suicidal Ideation, Depression, and Non-Suicidal Self-Injury: Reframe-IT+ & CARIBOU
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
Read more
- To determine the feasibility of implementing a stratified care plan tailored to the needs of adolescents with suicidal ideation.
- 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.
- To determine the acceptability of the initial CARIBOU-SITB component among participating students and facilitators, as measured after the intervention.
- 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.
- 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:
- Complete a battery of self-report questionnaires before the intervention, immediately after, and at 3, 6, 9, and 12 months of follow-up.
- Receive CARIBOU-SITB, a four-session intervention focused on safety planning and reducing the risk of self-harm.
- 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.
Read the detailed description
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.
- Being tested
- Reframe-IT and CARIBOU
- Keywords
- Adolescent Depression, Youth Mental Health, Suicidal Ideation, Suicide Prevention, Stratified Care, Cognitive Behavioral Therapy, Dialectical Behavior Therapy, Non Suicidal Self Injury
- Medical subject headings
- Suicidal Ideation, Self-Injurious Behavior, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reframe-IT and CARIBOUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Reframe-IT+ and CARIBOU | Experimental | All participants first will receive the CARIBOU-SITB component. Then students with severe depressive symptoms (PHQ-9 score ≥ 20) will receive CARIBOU-CBT: a cognitive-behavioral therapy intervention.
Students with mild or moderate depressive symptoms (PHQ-9 score < 20) will receive Reframe-IT+: a cognitive-behavioral therapy intervention. All interventions will be delivered individually at the educational institution by a trained psychologist. Receives: Behavioral: Reframe-IT and CARIBOU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: Immediately after completion of the CARIBOU-SITB component (approximately 4 weeks)
Secondary outcomes (13)
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).
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Frequency of Suicidal Ideation
Measured using the Suicidal Ideation Questionnaire-Junior (SIQ-JR), a 15-item self-report instrument (score range 0-90).
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Non-Suicidal Self-Injury (NSSI)
Measured using a self-report assessment of non-suicidal self-injurious behavior frequency and severity.
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Depressive Symptoms
Measured using the Patient Health Questionnaire (PHQ-9), a 9-item self-report instrument (score range 0-27).
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Anxiety Symptoms
Measured using the Generalized Anxiety Disorder scale (GAD-7), a 7-item self-report instrument (score range 0-21).
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Hopelessness
Measured using the Beck Hopelessness Scale (BHS), a 20-item self-report instrument (score range 0-20).
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Psychotic Symptoms
Measured using the Community Assessment of Psychic Experiences-Positive (CAPE-P15), a 15-item self-report instrument (score range 15-60).
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Mood Intensity
Measured using the Mood and Feelings Questionnaire-Short Form (MFQ), a 13-item self-report instrument (score range 0-26).
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in General Functional Impairment
Measured using the Columbia Impairment Scale (CIS), Youth Version, a 13-item self-report instrument assessing functional impairment.
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Behavioral Activation Skills
Measured using the Behavioral Activation for Depression Scale (BADS).
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Problem-Solving Skills
Measured using the Social Problem-Solving Inventory-Revised (SPSI-R).
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Emotional Regulation Skills
Measured using the Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA).
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Quality of Life
Measured using the KIDSCREEN instrument, assessing health-related quality of life.
Measured: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2026
- Study start9 Jun 2026
- Primary completion30 Nov 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Crecer y Sanar
- Responsible party
- Principal investigator, Jorge Gaete, Universidad de los Andes, Chile
- Investigators
- Jorge Gaete, PhD, Principal investigator, Centro de Investigación de Salud Mental Estudiantil (ISME)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07780084
- Sponsor's protocol ID
- FCS2026
- Status last verified
- Aug 2026
- First submitted
- 5 Aug 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability, Feasibility, Fidelity, and Exploration of the Efficacy of a Stratified Care Intervention for the Prevention of Suicidal Ideation, Depression, and Non-Suicidal Self-Injury: Reframe-IT+ & CARIBOU
- ClinicalTrials.gov ID
- NCT07780084
- Acronym / sponsor ID
- FCS2026
- Keywords
- Adolescent Depression, Youth Mental Health, Suicidal Ideation, Suicide Prevention, Stratified Care, Cognitive Behavioral Therapy, Dialectical Behavior Therapy, Non Suicidal Self Injury
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- Fundación Crecer y Sanar
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 21 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To determine the feasibility of implementing a stratified care plan tailored to the needs of adolescents with suicidal ideation.
- 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.
- To determine the acceptability of the initial CARIBOU-SITB component among participating students and facilitators, as measured after the intervention.
- 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.
- 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:
- Complete a battery of self-report questionnaires before the intervention, immediately after, and at 3, 6, 9, and 12 months of follow-up.
- Receive CARIBOU-SITB, a four-session intervention focused on safety planning and reducing the risk of self-harm.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Reframe-IT+ and CARIBOU | Experimental | Behavioral: Reframe-IT and CARIBOUAll participants first will receive the CARIBOU-SITB component. Then students with severe depressive symptoms (PHQ-9 score ≥ 20) will receive CARIBOU-CBT: a cognitive-behavioral therapy intervention. Students with mild or moderate depressive symptoms (PHQ-9 score < 20) will receive Reframe-IT+: a cognitive-behavioral therapy intervention. All interventions will be delivered individually at the educational institution by a trained psychologist. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Schools
- Students
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reframe-IT and CARIBOUAll 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. | Behavioural | Reframe-IT+ and CARIBOU |
Primary outcome
Feasibility of Implementing the Stratified Care Plan
Time frame: Throughout the implementation phase (approximately 5 months)
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.
Fidelity of Implementation of Reframe-IT+ and CARIBOU-CBT
Time frame: After each session, throughout the implementation phase (approximately 5 months)
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.
Acceptability of the CARIBOU-SITB Component - CSQ-8
Time frame: Immediately after completion of the CARIBOU-SITB component (approximately 4 weeks)
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
Acceptability of the CARIBOU-SITB Component - Students
Time frame: Immediately after completion of the CARIBOU-SITB component (approximately 4 weeks)
Acceptability will be assessed among students using in-house general and module-specific acceptability questionnaires.
Acceptability of the CARIBOU-SITB Component - Facilitators
Time frame: Immediately after completion of the CARIBOU-SITB component (approximately 4 weeks)
Acceptability will be assessed among facilitators using in-house general and module-specific acceptability questionnaires.
13 secondary outcomes
Change in Suicidal Ideation Severity
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Frequency of Suicidal Ideation
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Non-Suicidal Self-Injury (NSSI)
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Depressive Symptoms
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Anxiety Symptoms
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Hopelessness
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Psychotic Symptoms
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Mood Intensity
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in General Functional Impairment
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Behavioral Activation Skills
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Problem-Solving Skills
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Emotional Regulation Skills
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Change in Quality of Life
Time frame: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.
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Assessment of the Seasonality of Depressive Symptoms in Adolescents
Depressive Symptoms
Recruiting
The Mindful Smartphone Use Study
Depression and/or Anxiety Symptoms, Problematic Phone Use Behavior
Recruiting
CBT Enhanced With Social Cognitive Training vs. CBT Only With Depressed Youth
Depression
Recruiting
Rise & Thrive: Community-Engagement Intervention for Stress and Depression in Youth.
Depressive Symptoms, Allostatic Load
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Gaete, PhD principal investigator
Centro de Investigación de Salud Mental Estudiantil (ISME)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reframe-IT and CARIBOU in people with Depression in Adolescence and Suicidal Ideation, run by Universidad de los Andes, Chile at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Implementing the Stratified Care Plan (time frame: Throughout the implementation phase (approximately 5 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.