Exploring the Effectiveness of a Suicide Ideation Prevention Program: Reframe-IT+

NCT06759441 | Completed

• 1 other identifier: FCS 202401
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Suicide is a leading cause of death among young people, with worldwide prevalence rates of suicidal ideation, suicidal ideation with a plan, and suicide attempts in youth aged 14-21 years. These behaviors have a significant negative impact on individuals, families, and the community at large. In Latin America, including Chile, suicide rates have increased in recent decades. Youth suicide prevention is a public health priority in Chile, although evidence-based interventions of high quality are lacking. Secondary schools are a suitable and accessible setting for youth suicide prevention programs, with interventions that raise awareness about suicide and improve skills to reduce suicide attempts and suicidal ideation. Despite the effectiveness of interventions such as cognitive-behavioral therapy (CBT), these are less common in school settings, although digital technologies offer a potentially efficient way to implement suicide prevention programs in schools. The Reframe-IT program is an Internet-based cognitive-behavioral therapy designed to reduce suicidal ideation in youth, supported by school wellness staff. Studies in Australia demonstrated the effectiveness and acceptability of Reframe-IT, although it is suggested that digital interventions may have a greater impact when combined with face-to-face sessions. This study examined the acceptability and feasibility of a combined intervention that included Reframe-IT and four additional in-person sessions for adolescents in Chile. It is suggested that these combined interventions could be a promising strategy for youth suicide prevention in school settings, especially in Latin American countries where mental health support is limited.

Conditions

Suicidal Ideation; Depression; Anxiety; Hopelessness

Keywords

Suicidal Ideation; Children

Outcome Measures

Primary Outcomes (10)

• Suicidal Ideation Questionnaire (SIQ)

  This is a 30-item self-report instrument designed to assess suicidal ideation in adolescents. It has high levels of internal consistency (α=.93) and test-retest reliability over four weeks (kappa=.72). We used a Spanish version previously validated in adolescents in Chile. In our sample, Cronbach's α at baseline was .90 and McDonald's ω was .91.

  through study completion, an average of 1 year

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  The first 5 items explore the presence of suicidal ideation, intention, and planning and are assessed over the past month. The sixth item explores suicidal behavior either as preparation, initiation of a suicide attempt, or a suicide attempt itself in the last three months. Each item is answered Yes or No. It has been validated in an English-speaking population (range of internal reliability goes from α=0.73 to α=0.93) and a Spanish-speaking population (α=0.53). The total score range is from 0 to 6 points. According to the answers provided To the different items, the categories of severity of suicidal ideation are established: If the answer is "Yes" to item 1 and/or item 2 and "No" to all the other items, a slight risk is indicated. If the answer is "Yes" to item 2 and answer "Yes" only to item 3, it suggests that the risk is moderate. If the answer si "Yes" to item 2 and the answer is "Yes" to any of items 4, 5, and 6, it indicates that the risk is severe.

  through study completion, an average of 1 year

• The Patient Health Questionnaire (PHQ-9)

  Is a self-administered version of the PRIME-MD diagnostic instrument for common mental disorders. The PHQ-9 is the depression module, which rates each of the 9 Diagnostic and Statistical Manual of Mental Disorders (DSM-V) criteria from "0" (Never) to "3" (Almost every day). In Chile, it has been validated for the detection of Chilean people aged 20 years and older, with a sensitivity of 92% and a specificity of 89%, compared to the Hamilton Depression Scale. In addition, it presents a construct validity and a predictive validity concurrent with the International Classification of Diseases (ICD-10) criteria for depression. The interpretation is made by adding the total of the first 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.

  through study completion, an average of 1 year

• The Generalized Anxiety Disorder 7 (GAD-7)

  Is an instrument developed from the PRIME-MD diagnostic instrument. Although designed primarily as a screening and severity measure for generalized anxiety disorder, also has moderately good performance characteristics for other common anxiety disorders: panic disorder, social anxiety disorder, and posttraumatic stress disorder. It consists of 7 questions. Its score is calculated by assigning scores from 0 to 3, to response categories from "Never" to "Almost every day." It has been validated into Spanish, where a cut-off score of 10 showed adequate values of sensitivity (86.8%) and specificity (93.4%). The scale correlated significantly with Hamilton Anxiety Rating Scale (HAM-A) (0.852, p \< 0.001), Hospital Anxiety and Depression Scale (HADS) (anxiety domain, 0.903, p \< 0.001) and World Health Organization Disability Assessment Questionnaire (WHO-DAS II) (0.696, p \< 0.001). The total GAD-7 score for the seven items ranges from 0 to 21. Scores of 5, 10, and 15 represent cutoff points

  through study completion, an average of 1 year

• Beck Hopelessness Scale (BHS)

  Hopelessness is measured using the Beck Hopelessness Scale, a self-report scale with 20 true-false items. Nine are keyed "false" and 11 are keyed "true." Each response is assigned a score of 0 or 1 for each statement, and the total "hopelessness score" is the sum of the individual item scores. A cutoff score of 9 on the scale has been found to predict eventual suicide in clinical samples. Good internal consistency (α= .86) was observed in Chilean youth. In our sample at baseline, Cronbach's α was .82 and McDonald's ω was .82.

  through study completion, an average of 1 year

• Community Assessment of Psychotic Experiences Scale (CAPE-P15)

  This is a 15-item self-report instrument. Item responses range from 1 (never) to 5 (very often). The scale assesses three domains: paranoid ideation (PI, 5 items), bizarre experiences (EB, 7 items), and perceptual anomalies (AP, 3 items). Scores can range from 15 to 75. Higher scores indicate greater severity of Psychotic Experiences. All items are averaged for an overall measure of the trait being assessed. 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. Internal reliability for these factors was 0.779 for PI; 0.839 for EB; and 0.884 for AP.

  through study completion, an average of 1 year

• Quality of life questionnaire for Child and Adolescent Version (Kidscreen-10 Index)

  This instrument measures well-being and health-related quality of life. The Kidscreen-10 is a short version of the Kidscreen-52 and Kidscreen-27, where a Rasch analysis was applied to identify those items that represented a latent, unidimensional and global construct of HRQoL. Results of studies indicate that the Kidscreen-10 provides a generally valid measure of HRQoL in children and adolescents. It has 10 items, of which 2 items are answered on a response scale from 1 = Not at all to 5 = Extremely; and the other 8 items are answered on a response scale from 1 = Never to 5 = Always. It has a version for parents and another for children and adolescents. It has demonstrated good psychometric properties, as well as good internal consistency (Cronbach's alpha = 0.82) and good test-retest stability (r = 0.73; Intraclass Correlation Coefficient (ICC) = 0.72). The self-report version for adolescents will be used.

  through study completion, an average of 1 year

• Brief Problem Solving Inventory (SPSI-R)

  This is a 25-item self-report instrument that measures two adaptive problem-solving dimensions (positive problem orientation and rational problem solving) and three dysfunctional dimensions (negative problem orientation, impulsive/careless style, and avoidant style). Each item is rated on a 5-point scale ranging from not at all true for me (0) to extremely true for me (4). The Spanish version has the same factor structure and appropriate alpha coefficients for the five subscales (from .62 to .99), and an overall internal consistency of .90 in Chilean adolescents. In our sample at baseline, Cronbach's α was .83 and McDonald's ω was .83 on an overall scale.

  through study completion, an average of 1 year

• The Cognitive-behavioural Therapy Skills Questionnaire (CBTSQ)

  The Cognitive-behavioural Therapy Skills Questionnaire is used to test which components of CBT seem to be most active. This scale originally has 16 items. Respondents rate each item on a 5-point Likert scale, from 1 (I don't do this) to 5 (I always do this). The instrument measures two skills: cognitive restructuring (CR) and behavioural activation (BA) (i.e. changes in behavioural avoidance/control and changes in cognitive style). Both scales have good reliability (CR: α=0.88; BA: α=0.85). Two items refer to the evaluation of aspects related to a disease or treatment and since in this study we want to evaluate cognitive-behavioural skills, we have chosen to exclude these two items from the questionnaire, leaving a 14-item instrument. In a study whose publication is under review with a sample of adolescents between 15 and 18 years old, using the 14-item instrument, we found that the reliability was α=0.77 and ω=0.78 for BA, and α=0.80 and ω=0.81 for CR.

  through study completion, an average of 1 year

• Emotional Regulation Questionnaire-CA (ERQ-CA)

  Emotional regulation (ER) was measured using the Emotion Regulation Questionnaire for Children and Adolescents (ERQ-CA); Spanish version, validated in adolescents in Chile. It is a self-report scale of 10 items, which are rated on a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5). It assesses two styles of emotional regulation: Cognitive Reappraisal (CR, six items), which consists of redefining a potential emotion-provoking situation in such a way as to change its emotional impact, and Expressive Suppression (ES, four items), which consists of inhibiting the behavioral expression of emotion. It has a high level of reliability for each of the subscales: cognitive reappraisal subscale (α=0.83 and ω=0.84); the expressive suppression subscale (α=0.42 and ω=0.50).

  through study completion, an average of 1 year

Study Arms (1)

Intervention group

EXPERIMENTAL

Participants will receive an individual intervention (Reframe-It+) based on cognitive behavioral therapy, with a focus on problem-solving and help-seeking, which is carried out at the Educational Establishment with a trained psychologist. It consists of 13 weekly sessions of 25 minutes each, of which 5 sessions have a face-to-face component and 8 sessions have a face-to-face-digital component where students use a computer always in the company of a psychologist facilitating the program.

Behavioral: Reframe-It+

Interventions

Reframe-It+ BEHAVIORAL

Reframe-IT+ is an individual intervention based on cognitive behavioral therapy, with a problem-solving and help-seeking approach, which is carried out at the Educational Establishment with a trained psychologist. It consists of 13 weekly sessions of 25 minutes each, of which 5 sessions have a face-to-face component and 8 sessions have a face-to-face-digital component where students use a computer always in the company of a psychologist facilitating the program.

Intervention group

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Students in first, second and third year of secondary school from educational establishments with high socioeconomic vulnerability.
• Students who attend educational establishments located in Santiago (Chile).
• Students who attend educational establishments with secondary education (first to fourth year of secondary school).
• Students who attend mixed educational establishments.
• Students who attend educational establishments with at least two courses in first, second and third year of secondary school.
• Students who attend educational establishments with at least 30 students per course.
• Students who attend educational establishments with vulnerability (≥55%), measured with the School Vulnerability Index - National Allocation System for Equality (IVE-SINAE). This index is the proportion of students in each school with high vulnerability. This index considers the following socioeconomic variables to group schools: mother's educational level, father's educational level, and total monthly household income, among others.
• Students who score high in suicidal ideation in the past month (score ≥ 3 on the Columbia-Suicide Severity Rating Scale (C-SSRS).

You may not qualify if:

• Students with severe depressive symptoms assessed by the PHQ-9 (\>19 points).
• Students with high severity of psychotic symptoms assessed by the Community Assessment of Psychic Experiences-Positive Scale (CAPE, P15) with score ≥ 3 on items n°13 and/or n°14 and/or n°15.
• Students with suicide attempt(s) in the past month.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead
• Fundación Crecer y Sanar: collaborator
• University of Talca: collaborator

Study Sites (1)

Universidad de los Andes

Santiago, Santiago Metropolitan, 7620086, Chile

Location

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  PMID: 8560308 BACKGROUND

MeSH Terms

Conditions

Suicidal Ideation; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Jorge Gaete, MD, PhD

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: This study has a quasi-experimental design, without a control group with pre-post intervention evaluation. This design is suitable to start the study of an intervention and its applicability to the target population, especially when it comes to interventions that have multiple components. This type of study allows determining changes in behavior before and after the intervention in the same subjects, which allows exploring possible effects of this intervention. This study hopes to generate evidence of the effectiveness of the intervention, taking into account the limitations of the generalization of these results as it is a quasi-experimental study.

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 6, 2025
• Study Start: June 3, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: At the end of the study and until five years after the end of the study.
• Access Criteria: Any researchers who ask the principal investigator fot secondary analysis, data anonymized.

Locations

CL (1)