Stratified-Care School-Based Intervention for Adolescent Suicidal Ideation
ConditionSuicidal Ideation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-18
SponsorUniversidad de los Andes, Chile
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inclusion Criteria for Educational Institutions
Located in Santiago, Chile.
Secondary education level (grades I-IV Medio).
Coeducational schools.
Disqualifiers
Exclusion Criteria for Students
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 design
Design model
Single group
Treatments tested in this trial
Reframe-IT and CARIBOU
BehavioralReframe-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.
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Single arm with the stratified-care intervention Reframe-IT and CARIBOUOther 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
immediately post-intervention2
Feasibility Recruitment
We will record the recruitment and characteristics of the sample
Time frame
through study completion, an average of 1 year3
Feasibility Attendance to eligibility interviews
We will record the number of adolescents and families who attend eligibility interviews.
Time frame
through study completion, an average of 1 year4
Feasibility Response rates to questionnaires
Response rates to questionnaires.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
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
Time frame
pre-post assessments and follow-ups at 3, 6, 9, and 12 months.2
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).
Time frame
pre-post assessments and follow-ups at 3, 6, 9, and 12 months.3
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).
Time frame
pre-post assessments and follow-ups at 3, 6, 9, and 12 months.4
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).
Time frame
pre-post assessments and follow-ups at 3, 6, 9, and 12 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Universidad de los Andes, Chile
Lead sponsor
University of Talca
Collaborator
Fundación Crecer y Sanar
Collaborator
Source ClinicalTrials.gov