NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Universidad de los Andes, Chile
Conditions: Depression in Adolescence, Suicidal Ideation, Non Suicidal Self Injury
Interventions: Reframe-IT and CARIBOU
Countries: Chile
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.
Sex: ALL
Age: 14 Years to 18 Years
Healthy volunteers: No
Study type: INTERVENTIONAL
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
- Santiago, Chile