AzTrials
AzTrials

Suicidal IdeationReframe-It+NCT06759441

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

A study testing Reframe-It+ in people with Suicidal Ideation and Depression, run by Universidad de los Andes, Chile at 1 site in Chile.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 14 to 17 years
Conditions the study is for
Suicidal Ideation, Depression, Anxiety
What is being tested?
Reframe-It+
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteChile
Study dates
3 Jun 2024to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Chile1 site

  • Universidad de los Andes

    Santiago, Santiago Metropolitan, 7620086

Other trials in Chile

About this study

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.

Read more

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.

Read the 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.

Being tested
Reframe-It+
Keywords
Suicidal Ideation, Children
Medical subject headings
Suicidal Ideation, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reframe-It+Behavioural

    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.

Study groups in NCT06759441
Study groupRoleWhat they receive
Intervention groupExperimentalParticipants 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.
Receives: Behavioral: Reframe-It+

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: through study completion, an average of 1 year

  2. 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.

    Measured: through study completion, an average of 1 year

  3. 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.

    Measured: through study completion, an average of 1 year

  4. 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

    Measured: through study completion, an average of 1 year

  5. 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.

    Measured: through study completion, an average of 1 year

  6. 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.

    Measured: through study completion, an average of 1 year

  7. 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.

    Measured: through study completion, an average of 1 year

  8. 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.

    Measured: through study completion, an average of 1 year

  9. 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.

    Measured: through study completion, an average of 1 year

  10. 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).

    Measured: through study completion, an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start3 Jun 2024
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06759441
Sponsor's protocol ID
FCS 202401
Acronym
Reframe-It+
Status last verified
Jun 2025
First submitted
26 Dec 2024
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data about primary and secondary outcomes without identifiable variables such as name, date of birth, or others.

Publications

  • World Health Organization. Suicide worldwide in 2019: global health estimates. Geneva: World Health Organization; 2021. Contract No.: CC BY-NC-SA 3.0 IGO.

  • Van Meter AR, Knowles EA, Mintz EH. Systematic Review and Meta-analysis: International Prevalence of Suicidal Ideation and Attempt in Youth. J Am Acad Child Adolesc Psychiatry. 2023 Sep;62(9):973-986. doi: 10.1016/j.jaac.2022.07.867. Epub 2022 Dec 20.

    PubMed 36563876

  • Pitman A, Osborn D, King M, Erlangsen A. Effects of suicide bereavement on mental health and suicide risk. Lancet Psychiatry. 2014 Jun;1(1):86-94. doi: 10.1016/S2215-0366(14)70224-X. Epub 2014 Jun 4.

    PubMed 26360405

  • Hawton K, Hill NTM, Gould M, John A, Lascelles K, Robinson J. Clustering of suicides in children and adolescents. Lancet Child Adolesc Health. 2020 Jan;4(1):58-67. doi: 10.1016/S2352-4642(19)30335-9. Epub 2019 Oct 9.

    PubMed 31606323

  • Hill NTM, Robinson J, Pirkis J, Andriessen K, Krysinska K, Payne A, Boland A, Clarke A, Milner A, Witt K, Krohn S, Lampit A. Association of suicidal behavior with exposure to suicide and suicide attempt: A systematic review and multilevel meta-analysis. PLoS Med. 2020 Mar 31;17(3):e1003074. doi: 10.1371/journal.pmed.1003074. eCollection 2020 Mar.

    PubMed 32231381

  • Hill NTM, Too LS, Spittal MJ, Robinson J. Understanding the characteristics and mechanisms underlying suicide clusters in Australian youth: a comparison of cluster detection methods. Epidemiol Psychiatr Sci. 2020 Aug 6;29:e151. doi: 10.1017/S2045796020000645.

    PubMed 32758330

  • Teti GL, Rebok F, Rojas SM, Grendas L, Daray FM. Systematic review of risk factors for suicide and suicide attempt among psychiatric patients in Latin America and Caribbean. Rev Panam Salud Publica. 2014 Aug;36(2):124-33.

    PubMed 25345534

  • Ministerio de Salud. Chile. Informe de la década de mortalidad por suicidio. Santiago, Chile: Oficina de Vigilancia de Enfermedades No Transmisibles y Encuestas Poblacionales, Departamento de Epidemiología, Ministerio de Salud; 2022.

  • Schilling SH, Carreno A, Tapia E, Mascayano F, Pitronello R, Santander F, Jorquera MJ, Burrone MS, Alvarado RV. Experts by Experience: Qualitative Evaluation of Adolescent Participation in the Development of a Technological Intervention to Prevent Youth Suicide in Chile. Front Psychiatry. 2021 Jan 25;11:522057. doi: 10.3389/fpsyt.2020.522057. eCollection 2020.

    PubMed 33603681

  • Robinson J, Cox G, Malone A, Williamson M, Baldwin G, Fletcher K, O'Brien M. A systematic review of school-based interventions aimed at preventing, treating, and responding to suicide- related behavior in young people. Crisis. 2013;34(3):164-82. doi: 10.1027/0227-5910/a000168.

    PubMed 23195455

  • World Health Organization. Live life: an implementation guide for suicide prevention in countries. Geneva: World Health Organization; 2021. Contract No.: CC BY-NC-SA 3.0 IGO.

  • Calear AL, Christensen H, Freeman A, Fenton K, Busby Grant J, van Spijker B, Donker T. A systematic review of psychosocial suicide prevention interventions for youth. Eur Child Adolesc Psychiatry. 2016 May;25(5):467-82. doi: 10.1007/s00787-015-0783-4. Epub 2015 Oct 15.

    PubMed 26472117

  • Brann KL, Baker D, Smith-Millman MK, Watt SJ, DiOrio C. A meta-analysis of suicide prevention programs for school-aged youth. Children and Youth Services Review. 2021;121:105826.

  • Wasserman D, Hoven CW, Wasserman C, Wall M, Eisenberg R, Hadlaczky G, Kelleher I, Sarchiapone M, Apter A, Balazs J, Bobes J, Brunner R, Corcoran P, Cosman D, Guillemin F, Haring C, Iosue M, Kaess M, Kahn JP, Keeley H, Musa GJ, Nemes B, Postuvan V, Saiz P, Reiter-Theil S, Varnik A, Varnik P, Carli V. School-based suicide prevention programmes: the SEYLE cluster-randomised, controlled trial. Lancet. 2015 Apr 18;385(9977):1536-44. doi: 10.1016/S0140-6736(14)61213-7. Epub 2015 Jan 9.

    PubMed 25579833

  • Singer JB, Erbacher TA, Rosen P. School-Based Suicide Prevention: A Framework for Evidence-Based Practice. School Mental Health. 2019;11(1):54-71.

Questions about this trial

What is this clinical trial studying?

A study testing Reframe-It+ in people with Suicidal Ideation and Depression, run by Universidad de los Andes, Chile at 1 site in Chile.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Suicidal Ideation Questionnaire (SIQ) (time frame: through study completion, an average of 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06759441, which also lists 56 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in