Clinical trial NCT06759441: Exploring the Effectiveness of a Suicide Ideation Prevention Program: Reframe-IT+
Official title: Exploring the Effectiveness of a Suicide Ideation Prevention Program: Reframe-IT+
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Suicidal Ideation
Depression
Anxiety
Hopelessness
Keywords: Suicidal Ideation
Children
Lead sponsor: Universidad de los Andes, Chile
Sponsor class: OTHER
Collaborators: name: Fundación Crecer y Sanar
name: Daniel Nuñez (Universidad de Talca)
First posted: 2025-01-06
Enrollment: 52
Sex: ALL
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Detailed description: Suicide is a leading cause of death among young people and suicide-related behaviors (SRBs) are common. Worldwide, 12-month prevalence rates of suicidal ideation, suicidal ideation with a plan, and suicide attempts in youth aged 14-21 years are 15.4-18.4%, 7.9-10.9%, and 5.7-7.1%, respectively. Suicide and suicide-related behaviors have a significant negative impact on individuals' family, friends, and the broader community. It may also increase the risk of subsequent suicides in those exposed to death by suicide. In Latin America, suicide rates have increased over the past two decades, with Chile having one of the highest rates in the region (8.0/100,000 per year, 13.4 for men and 3.0 for women). Youth suicide prevention is a key public health priority in Chile, but limited high-quality, evidence-based interventions are available.

Secondary schools are an appropriate and accessible setting for youth suicide prevention programs and have been identified as a relevant prevention setting in national and international prevention strategies. Interventions implemented in school settings have a broad reach and facilitate prevention programs to support adolescents on a large scale. School-based prevention programs have been shown to increase suicide awareness and improve skills to reduce suicidal attempts and ideation. Indicated interventions focused on the application of clinical or psychosocial interventions (e.g., cognitive-behavioral therapy, CBT) for at-risk groups have been less common in school settings. However, evidence for these interventions is widely established in other contexts, and further school-based research on such programs is warranted.

Digital technologies are a potentially viable and efficient way to implement and scale up suicide prevention programs in schools. While digital suicide prevention programs have been shown to be safe and effective, only a small number of studies have relied on digital technologies in school settings. This is a missed opportunity, as research suggests that digital interventions for other mental health problems, such as depression and anxiety, are acceptable and minimize youth concerns regarding privacy, safety, stigma, and anonymity that may be associated with in-person programs. Digital programs may also reduce costs and increase accessibility to support when resource constraints may hinder access to services. This combination of factors has sparked significant international interest in finding technology-based solutions for suicide prevention.

The Reframe-IT program is an Internet-based cognitive behavioral therapy (CBT) program that aims to reduce suicidal ideation in youth. Reframe-IT's eight online modules have a unique focus on youth, and the program is distinguished by being designed to be facilitated and supported by school wellness staff. The staff support component is an important feature, as research suggests that digital programs delivered with support from clinicians have better treatment outcomes, lower dropout rates, and improved adherence. Reframe-IT was piloted in two phases in Australia. During the first phase, a case series study was conducted using pre- and post-tests, and results indicated that the program was associated with decreased suicidal thoughts, depression, and feelings of hopelessness. For the second phase, a pilot randomized controlled trial demonstrated that those who received the intervention had greater (although not statistically significant, due to being underpowered) reductions in suicidal ideation, depression, and hopelessness compared to the control group. Participants provided positive feedback on Reframe-IT in both studies, and it was not associated with any iatrogenic effects. Reframe-IT is currently part of a large randomized controlled trial in Australia.

Previous studies have shown that stand-alone digital interventions might have a lower impact than when combined with face-to-face sessions (26). One possible explanation suggests that face-to-face sessions may reinforce the therapeutic alliance, promoting adherence and efficacy in the digital intervention (27, 28). To our knowledge, no previous study has used combined interventions to reduce SRB delivered in school settings. The small body of evidence available suggests that school-based digital interventions targeting at-risk youth are a promising avenue for suicide prevention, primarily where mental health support is limited (29). It has been suggested that developing and testing this type of intervention is suitable in Latin American countries (30). The Reframe-IT program was adapted for Chilean youth to address this need. The current study examined the acceptability and feasibility of a combined intervention that included Reframe-IT plus four additional in-person sessions for adolescents.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Suicidal Ideation Questionnaire (SIQ)
timeFrame: through study completion, an average of 1 year
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: through study completion, an average of 1 year
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: through study completion, an average of 1 year
measure: The Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: through study completion, an average of 1 year
measure: Beck Hopelessness Scale (BHS)
timeFrame: through study completion, an average of 1 year
measure: Community Assessment of Psychotic Experiences Scale (CAPE-P15)
timeFrame: through study completion, an average of 1 year
measure: Quality of life questionnaire for Child and Adolescent Version (Kidscreen-10 Index)
timeFrame: through study completion, an average of 1 year
measure: Brief Problem Solving Inventory (SPSI-R)
timeFrame: through study completion, an average of 1 year
measure: The Cognitive-behavioural Therapy Skills Questionnaire (CBTSQ)
timeFrame: through study completion, an average of 1 year
measure: Emotional Regulation Questionnaire-CA (ERQ-CA)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Universidad de los Andes
state: Metropolitana
Study officials:
affiliation: Universidad de Los Andes
name: Jorge Gaete, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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