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

18 augustus 2026 bijgewerkt door: Jorge Gaete, Universidad de los Andes, Chile

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

  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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

90

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Chili
      • Santiago, Chili
        • Universidad De Los Andes

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: NVT
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Reframe-IT+ and CARIBOU

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.
Gedragsmatig: Reframe-IT and CARIBOU
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Feasibility of Implementing the Stratified Care Plan
Tijdsspanne: 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.
Throughout the implementation phase (approximately 5 months)
Fidelity of Implementation of Reframe-IT+ and CARIBOU-CBT
Tijdsspanne: 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.
After each session, throughout the implementation phase (approximately 5 months)
Acceptability of the CARIBOU-SITB Component - CSQ-8
Tijdsspanne: 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
Immediately after completion of the CARIBOU-SITB component (approximately 4 weeks)
Acceptability of the CARIBOU-SITB Component - Students
Tijdsspanne: 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.
Immediately after completion of the CARIBOU-SITB component (approximately 4 weeks)
Acceptability of the CARIBOU-SITB Component - Facilitators
Tijdsspanne: 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.
Immediately after completion of the CARIBOU-SITB component (approximately 4 weeks)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Suicidal Ideation Severity
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
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).
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the Suicidal Ideation Questionnaire-Junior (SIQ-JR), a 15-item self-report instrument (score range 0-90).
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)
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using a self-report assessment of non-suicidal self-injurious behavior frequency and severity.
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the Patient Health Questionnaire (PHQ-9), a 9-item self-report instrument (score range 0-27).
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the Generalized Anxiety Disorder scale (GAD-7), a 7-item self-report instrument (score range 0-21).
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the Beck Hopelessness Scale (BHS), a 20-item self-report instrument (score range 0-20).
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the Community Assessment of Psychic Experiences-Positive (CAPE-P15), a 15-item self-report instrument (score range 15-60).
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the Mood and Feelings Questionnaire-Short Form (MFQ), a 13-item self-report instrument (score range 0-26).
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the Columbia Impairment Scale (CIS), Youth Version, a 13-item self-report instrument assessing functional impairment.
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the Behavioral Activation for Depression Scale (BADS).
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the Social Problem-Solving Inventory-Revised (SPSI-R).
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA).
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
Tijdsspanne: Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.
Measured using the KIDSCREEN instrument, assessing health-related quality of life.
Baseline, Immediately after completion of the intervention (approximately 20 weeks), and 3, 6, 9, and 12 months after completion of the intervention.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Universidad de los Andes, Chile

Medewerkers

Fundación Crecer y Sanar

Onderzoekers

  • Hoofdonderzoeker: Jorge Gaete, PhD, Centro de Investigación de Salud Mental Estudiantil (ISME)

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

9 juni 2026

Primaire voltooiing (Geschat)

30 november 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

5 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

18 augustus 2026

Eerst geplaatst (Werkelijk)

21 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

21 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

18 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FCS2026

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

The datasets used and/or analysed during the current study will be available from the corresponding author on reasonable request.

IPD-tijdsbestek voor delen

It is planned to submit the study protocol to a journal around September 2026

IPD-toegangscriteria voor delen

It is planned to submit the study protocol a journal around September 2026

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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