Suicidal IdeationNCT07063914
Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation
A study testing Reframe-IT and CARIBOU in people with Suicidal Ideation, run by Universidad de los Andes, Chile at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 to 18 years
- Conditions the study is for
- Suicidal Ideation
- 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
- 60 participants
- Where
- 1 siteChile
- Study dates
- 25 Jun 2025to 31 Dec 2025
- 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
- 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.
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Universidad de los Andes
Santiago, Las Condes
Saray A Ramírez, MsC., +56988191548, saramirez1@miuandes.cl
Valentina R Romo, MsC, +56984038329, vromo@miuandes.cl
About this study
Official title: Acceptability and Feasibility of a Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation in Chile: A Study Protocol
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.
Read the 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
- Being tested
- Reframe-IT and CARIBOU
- Keywords
- suicide, adolescents, depression, schools, prevention
- Medical subject headings
- Suicidal Ideation, Suicide, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reframe-IT and CARIBOUBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Single arm with the stratified-care intervention Reframe-IT and CARIBOU | Other | single arm Receives: Behavioral: Reframe-IT and CARIBOU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: immediately post-intervention
Feasibility Recruitment
We will record the recruitment and characteristics of the sample
Measured: 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.
Measured: through study completion, an average of 1 year
Feasibility Response rates to questionnaires
Response rates to questionnaires.
Measured: through study completion, an average of 1 year
Feasibility Session attendance
Session attendance and progress through the program.
Measured: through study completion, an average of 1 year
Feasibility Attrition
Participant retention and dropout rates.
Measured: 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (12)
Suicidal ideation
Columbia Suicide Severity Rating Scale (C-SSRS): A six-item self-report instrument designed to assess the severity of suicidal ideation (21). The first 5 items explore the presence of suicidal ideation, intent, and planning during the past month. The sixth item explores suicidal behavior either as preparation, initiation of a suicide attempt, or a suicide attempt itself during the past three months. Each item is scored 0= "No" or 1= "Yes". The total score can range from 0 to 6 points. According to the answers given to the different items, categories of severity of suicidal ideation are established: If you answer "Yes" to item 1 and/or item 2, and "No" to all other items, a slight risk is indicated. If one answers "Yes" to item 3 and 'No' to all other items, a moderate risk is indicated, and finally, if one answers "Yes" to any of items 4, 5 and 6, a severe risk is indicated (21). It has high levels of internal consistency (α=0.73) (21). We will use a Spanish version previously validat
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Suicidal ideation frecuency
Suicidal Ideation Questionnaire-Junior (SIQ-JR). It is a 15-item self-report instrument designed to assess the frequency of suicidal ideation in children and adolescents during the past month (23). Each item is scored by Likert scale from 0="Never" to 6="Almost every day". The total score can range from 0 to 90 points. It is considered that a score > 30 points could imply a potential risk of suicide (23). It has high levels of internal consistency (α=0.91) and test-retest reliability (K=0.89) (23). We will use a Spanish version previously validated in adolescents in Chile, which showed high levels of reliability (ω =0.97) (24).
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Depressive symptoms
The Patient Health Questionnaire (PHQ-9). It is a nine-item self-report instrument designed to assess the frequency of depressive symptomatology (25). Each item is scored by Likert scale from 0="Never" to 3="Almost every day". The total score can range from 0 to 27 points. The interpretation is made by adding the total of the 9 questions as follows: 0-4 points, no depression; 5-9, mild depression; 10-14, moderate depression; 15-19, moderately severe depression; 20-27, severe depression (25). It has high levels of internal consistency (α=0.89) (25). We will use a Spanish version previously validated in adolescents in Chile, which showed high levels of reliability (α =0.78) (26).
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Anxiety symptoms
The Generalized Anxiety Disorder Questionnaire (GAD-7). It is a seven-item self-report instrument designed to assess the frequency of anxious symptomatology (27). Each item is scored by Likert scale from 0="Never" to 3="Almost every day". The total score can range from 0 to 21 points. The interpretation is made by adding the total of the 9 questions as follows: 0-4 points, no anxiety; 5-9, mild anxiety; 10-14, moderate anxiety; 15-21, severe anxiety (27). It has high levels of internal consistency (α=0.92) (27). We will use a Spanish version previously validated in adolescents in Chile, which showed high levels of reliability (α =0.86) (28).
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Hopelessness
Beck Hopelessness Scale (BHS): It is a 20-item self-report instrument designed to assess hopelessness (29). Each item is scored from 0="False" to 1="True". The total score can range from 0 to 20 points. Interpretation is done by summing the total of the 20 questions as follows: 0-3 points, asymptomatic; 4-8, mild hopelessness; 9-14, moderate hopelessness; 15-20, severe hopelessness. It has high levels of internal consistency (α=0.93) (29). We will use a Spanish version previously validated in young people in Chile, which showed high levels of reliability (α =0.86) (30).
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Mood
Mood and Feelings Questionnaire (Short version)(33). It is a self-report instrument designed to assess mood. It consists of 13 items that are answered on a Likert scale of 0= "Not true" and 2= "True". The total score can range from 0 to 26 points. Different studies have shown that it is a unidimensional scale in populations aged 6 to 18 years in girls and boys (34, 35). It has high levels of internal reliability (α = 0.80 to 0.91) and validity in cohorts of children aged 8-16 (33).
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Psychotic symptomatology
Community Assessment of Psychotic Experiences Scale (CAPE-P15) (31). It is a self-report instrument designed to assess psychotic symptomatology. It consists of 15 items that are answered on a Likert scale from 1 = "Never" to 4 = "Very often". Scores can range from 15 to 60 points. The scale assesses three domains: paranoid ideation (PI, 5 items), bizarre experiences (EB, 7 items), and perceptual abnormalities (PA, 3 items) (35). The questionnaire can be evaluated through critical item review, where for example perceptual disturbances with psychotic features can be considered with scores ≥ 3 on item 13, 14 or 15. In a validation study of a Chilean population of adolescents between 13 and 18 years of age, the trifactorial nature of the scale was confirmed. The internal reliability for these factors was 0.78 for IP; 0.84 for EB; and 0.88 for AP (32).
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Impairment
Columbia Functional Impairment Scale (Youth Version)(36). It is a 13-item self-report instrument designed to assess the level of impairment in functioning in children and adolescents. Each item is scored on a scale from 0 = "No problem" to 4 = "Very big problem." The total score can range from 0 to 52 points. It has high levels of internal consistency, and the original study reported values of α = 0.70 to 0.78 across multiple assessment items (36). We have authorization from the authors of the scale to use the Spanish version.
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months
Behavioral Activation
Behavioral Activation Scale for Depression (BADS) (37). It is a self-report instrument that explores different coping mechanisms in adolescents and adults. It has 25 items distributed in 4 subscales: Behavioral Activation, Avoidance/Rumination, Impaired Work/School functioning, and Impaired Social functioning. Each item is scored on a scale from 0 = "Strongly Disagree" to 6 = "Strongly Agree". The total score can range from 0 to 150 points. It has good levels of internal consistency, both for the total scale (α= 0.79), and for the subscales: Behavioral Activation (α = 0.87), Avoidance/Rumination (α = 0.83), Work/Ecological Impairment (α = 0.78) and Social Impairment (α = 0.83). It has been used in other Latin American countries (38), and we will use the Chilean version, which has been validated and shows good internal reliability indices (Behavioral Activation, α = 0.81; Avoidance/Rumination, α = 0.85; Work/Ecological Impairment, α = 0.81; and Social Impairment, α = 0.87)(39).
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months
Problem-solving
Brief Problem Solving Inventory (SPSI-R). This 25-item self-report instrument was designed to assess problem solving in children and adolescents (40). It has two adaptive dimensions of problem solving (positive problem orientation and rational problem solving) and three dysfunctional dimensions (negative problem orientation, impulsivity/neglect style, and avoidance style). Each item is scored by Likert scale from 0="Not at all true for me" to 4="Extremely true for me". The total score can range from 0 to 100 points. It has high levels of internal consistency in all its scales (α=0.76 to 0.92) (40). It has been previously used in young people in Chile, which showed high levels of reliability (α =0.90) (41).
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months
Emotion regulation
Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA). This 10-item self-report instrument was designed to assess problem solving in children and adolescents (42). It has an adaptive dimension of emotional regulation (cognitive reappraisal, 6 items) and a dysfunctional dimension (emotional suppression, 4 items). Each item is scored by Likert scale from 1="Strongly disagree" to 5="Strongly agree". The score for the cognitive reappraisal scale can range from 6 to 30 points and the score for the emotional suppression scale can range from 4 to 20 points. It has high levels of internal consistency the cognitive reappraisal (α=0.75) and emotional suppression subscales 0.82) (42). We will use a Spanish version previously validated in adolescents in Chile, which showed acceptable levels of reliability in the cognitive reappraisal (ω=0.76; α=0.76) and emotional suppression (ω=0.71; α=0.71) subscales (43).
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months
Wellbeing and quality of life
KIDSCREEN-10 Index, Child and Adolescent Version (Kidscreen-10 Index). This 10-item self-report instrument was designed to assess well-being and health-related quality of life (44). It is a brief version of the Kidscreen-52 and the Kidscreen-27 (44). Each item is scored by Likert scale from 1="Never" to 5="Always". The total score can range from 10 to 50 points (44).It has high levels of internal consistency (α=0.82) (44). We will use a brief Spanish version previously validated in adolescents in Chile, which showed high levels of reliability (α =0.89) (45).
Measured: pre-post assessments and follow-ups at 3, 6, 9, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start25 Jun 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies 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
- Single group
- Model description
- This is an initial feasibility and a single-arm study with pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de los Andes, Chile
- Sponsor type
- University, hospital or other
- Collaborators
- University of Talca, Fundación Crecer y Sanar
- Responsible party
- Principal investigator, Jorge Gaete, Universidad de los Andes, Chile
- Investigators
- Jorge E Gaete, MD. PhD., Study director, Universidad de los Andes, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07063914
- Sponsor's protocol ID
- FCS2025
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: the data will have personal information of minors
Publications
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.
PubMed 31752375
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Feasibility of a Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation in Chile: A Study Protocol
- ClinicalTrials.gov ID
- NCT07063914
- Acronym / sponsor ID
- FCS2025
- Conditions
- Suicidal Ideation
- Keywords
- suicide, adolescents, depression, schools, prevention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Universidad de los Andes, ChileUniversity, hospital or other
- Collaborators
- University of Talca, Fundación Crecer y Sanar
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 14 Jul 2025 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an initial feasibility and a single-arm study with pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
| Arm | Type | Receives |
|---|---|---|
| Single arm with the stratified-care intervention Reframe-IT and CARIBOU | Other | Behavioral: Reframe-IT and CARIBOUsingle arm |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (3 listed)
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 CARIBOUReframe-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. | Behavioural | Single arm with the stratified-care intervention Reframe-IT and CARIBOU |
Primary outcome
Acceptability of the CARIBOU Program
Time frame: immediately post-intervention
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.
Feasibility Recruitment
Time frame: through study completion, an average of 1 year
We will record the recruitment and characteristics of the sample
Feasibility Attendance to eligibility interviews
Time frame: through study completion, an average of 1 year
We will record the number of adolescents and families who attend eligibility interviews.
Feasibility Response rates to questionnaires
Time frame: through study completion, an average of 1 year
Response rates to questionnaires.
Feasibility Session attendance
Time frame: through study completion, an average of 1 year
Session attendance and progress through the program.
Feasibility Attrition
Time frame: through study completion, an average of 1 year
Participant retention and dropout rates.
Implementation Fidelity
Time frame: through study completion, an average of 1 year
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.
12 secondary outcomes
Suicidal ideation
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Suicidal ideation frecuency
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Depressive symptoms
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Anxiety symptoms
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Hopelessness
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Mood
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Psychotic symptomatology
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months.
Impairment
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months
Behavioral Activation
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months
Problem-solving
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months
Emotion regulation
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months
Wellbeing and quality of life
Time frame: pre-post assessments and follow-ups at 3, 6, 9, and 12 months
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 1 Aug 2025.
- Background: PubMed 31752375Lim 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.
- Individual participant dataSharing planned: No. the data will have personal information of minors
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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.
Jorge E Gaete, MD. PhD. study director
Universidad de los Andes, Chile
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 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 10 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 1 Aug 2025. 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?
Contact Jorge E Gaete, MD, PhD (+56940245650, jgaete@uandes.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the CARIBOU Program (time frame: immediately post-intervention). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07063914, which also lists 1 linked publication.
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 1 Aug 2025.