Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000996369
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
29/03/2026
Date registered
Help: Date registered
13/08/2026
Date last updated
Help: Date last updated
13/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
13/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of school-based poetry mutual-aid groups plus usual care versus supportive group sessions plus usual care on suicide risk in adolescents with a recent suicide attempt in Caldas, Colombia
Scientific title
A randomised controlled trial of a 16-week school-based poetry mutual-aid intervention plus usual care versus an attention-matched supportive psychoeducational group plus usual care for suicide risk in adolescents aged 12-17 years with a recent suicide attempt in Caldas, Colombia
Additional trial identifiers [1] 316899 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MART
Related trial records

Health condition
Health condition(s) studied:
Recent suicide attempt 341313 0
Suicide risk in adolescents 341314 0
Depressive symptoms in adolescents 341315 0
Condition category
Condition code
Mental Health 337387 337387 0 0
Suicide
Mental Health 338437 338437 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Arm 1: School-based poetry mutual-aid groups plus usual care.
Participants allocated to the intervention arm will receive a manualised 16-week school-based group intervention in addition to usual care. The intervention will be delivered in participating schools by a psychologist, with support from a family development professional and clinical oversight by a general practitioner and child psychiatrist. The programme will include 12 structured group sessions delivered over 16 weeks (8 weekly sessions followed by 4 fortnightly sessions), with approximately 90 minutes per session. Groups will be closed and will ideally include 8 to 10 adolescents.
The intervention is based on peer support and expressive writing/poetry activities. Core components include:
1. a brief opening and emotional check-in ritual;
2. guided reading of short poems or written texts related to emotions, identity, belonging, hopelessness, help-seeking, and future orientation;
3. brief structured poetry writing activities using accessible formats such as short verses, metaphors, lists, letters, and collective poems;
4. facilitated peer reflection and mutual aid;
5. explicit links between written material and coping, emotional regulation, problem-solving, help-seeking, and safety planning;
6. a brief closing ritual and session debrief.
The intervention also includes three brief structured caregiver contacts during the programme to review attendance, safety, warning signs, and practical support. All participants remain linked to usual mental health care and school support services.
For the purposes of this study, usual mental health care refers to the routine care and support available to adolescents after a suicide attempt through their health insurer/EPS (Entidad Promotora de Salud, in Spanish) , local mental health services, emergency services when required, school counselling/orientation services, and existing referral pathways. Usual care may include clinical assessment, outpatient psychological or psychiatric care, pharmacological treatment when indicated, crisis intervention, safety planning, emergency referral, and school-based support. The trial intervention will not replace or restrict usual care
Intervention code [1] 333606 0
Behaviour
Intervention code [2] 333607 0
Treatment: Other
Intervention code [3] 333608 0
Rehabilitation
Description of the comparator or control
Arm 2: Attention-matched supportive psychoeducational group plus usual care.
Participants allocated to the control arm will receive a manualised school-based supportive psychoeducational group in addition to usual care. The control condition will match the intervention arm in group format, number of sessions, duration, group size, caregiver contacts, and clinical monitoring, but it will not include poetry reading, poetry writing, or other expressive writing components.
The control programme will include 12 structured group sessions delivered over 16 weeks: 8 weekly sessions followed by 4 fortnightly sessions. Each session will last approximately 90 minutes. Groups will be closed and will ideally include 8 to 10 adolescents. Sessions will focus on emotional awareness, stress management, problem-solving, help-seeking, school-related stress, social support, safety planning, and relapse prevention.
The control programme will also include three brief structured caregiver contacts during the programme to review attendance, safety, warning signs, crisis-response procedures, referral needs, and practical support for the adolescent.
For the purposes of this study, usual mental health care refers to the routine care and support available to adolescents after a suicide attempt through their health insurer/EPS, local mental health services, emergency services when required, school counselling/orientation services, and existing referral pathways. Usual care may include clinical assessment, outpatient psychological or psychiatric care, pharmacological treatment when indicated, crisis intervention, safety planning, emergency referral, and school-based support. The control group will not replace or restrict usual care.
Control group
Active

Outcomes
Primary outcome [1] 344911 0
Suicide risk severity
Timepoint [1] 344911 0
Baseline, week 8, week 16, and week 24 post commencement of intervention
Secondary outcome [1] 459729 0
Depressive symptoms
Timepoint [1] 459729 0
Baseline, week 8, week 16, and week 24 post commencement of intervention
Secondary outcome [2] 459730 0
Subjective well-being
Timepoint [2] 459730 0
Baseline, week 16, and week 24 post commencement of intervention
Secondary outcome [3] 459731 0
Composite secondary/safety outcome: suicidal ideation and suicidal behaviour severity
Timepoint [3] 459731 0
Baseline, week 16 and week 24 post commencement of intervention, and whenever clinically indicated from baseline to week 24 post commencement of intervention following a positive safety screen or change in risk status
Secondary outcome [4] 459735 0
Organisational readiness for implementation
Timepoint [4] 459735 0
Pre-implementation and week 16 post commencement of intervention
Secondary outcome [5] 459736 0
Implementation fidelity
Timepoint [5] 459736 0
After each of the 12 group sessions across the 16-week intervention period (weekly during weeks 1-8 and fortnightly thereafter), with external fidelity rating for a pre-specified subsample of sessions
Secondary outcome [6] 459737 0
Reach
Timepoint [6] 459737 0
Recorded weekly during recruitment and summarised at week 16 post commencement of intervention
Secondary outcome [7] 459738 0
Adoption
Timepoint [7] 459738 0
Recorded at site initiation and summarised at week 16 post commencement of intervention
Secondary outcome [8] 463091 0
Penetration
Timepoint [8] 463091 0
Recorded weekly during the 16-week intervention period and summarised at week 16 post commencement of intervention
Secondary outcome [9] 463092 0
Dose delivered
Timepoint [9] 463092 0
Completed after each scheduled session and caregiver contact, and summarised at week 16 post commencement of intervention
Secondary outcome [10] 463093 0
Dose received
Timepoint [10] 463093 0
Completed after each scheduled session and caregiver contact, and summarised at week 16 post commencement of intervention
Secondary outcome [11] 463094 0
Implementation cost
Timepoint [11] 463094 0
Updated weekly throughout the study and summarised at week 16 post commencement of intervention
Secondary outcome [12] 463095 0
Initial sustainability
Timepoint [12] 463095 0
Week 16 post commencement of intervention.
Secondary outcome [13] 466187 0
Acceptability of the intervention: staff
Timepoint [13] 466187 0
Week 4 and week 16 post commencement of intervention
Secondary outcome [14] 466188 0
Acceptability of the intervention: caregivers
Timepoint [14] 466188 0
Week 4 and week 16 post commencement of intervention
Secondary outcome [15] 466189 0
Acceptability of the intervention: adolescents
Timepoint [15] 466189 0
Week 4 and week 16 post commencement of intervention
Secondary outcome [16] 466190 0
Intervention Appropriateness Measure (IAM): staff
Timepoint [16] 466190 0
Week 4 and week 16 post commencement of intervention
Secondary outcome [17] 466191 0
Intervention Appropriateness Measure (IAM): caregivers
Timepoint [17] 466191 0
Week 4 and week 16 post commencement of intervention
Secondary outcome [18] 466192 0
Intervention Appropriateness Measure (IAM): adolescents
Timepoint [18] 466192 0
Week 4 and week 16 post commencement of intervention
Secondary outcome [19] 466193 0
Intervention feasibility: staff
Timepoint [19] 466193 0
Week 4 and week 16 post commencement of intervention
Secondary outcome [20] 466194 0
Intervention feasibility: caregivers
Timepoint [20] 466194 0
Week 4 and week 16 post commencement of intervention
Secondary outcome [21] 466195 0
Intervention feasibility: adolescents
Timepoint [21] 466195 0
Week 4 and week 16 post commencement of intervention

Eligibility
Key inclusion criteria
Adolescents aged 12 to 17 years; currently enrolled in a participating secondary school in Caldas, Colombia; documented suicide attempt within the previous 12 months; clinically stable for outpatient and group-based participation at enrolment; written informed consent from a parent or legal guardian and assent from the adolescent; linked to usual care or willing to receive referral to usual mental health care; able to attend school-based group sessions during the study period.
Minimum age
12 Years
Maximum age
17 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Acute suicide risk requiring immediate intensive intervention or inpatient care at the time of enrolment; current psychotic episode, acute mania, severe intoxication, or another acute mental state preventing meaningful participation; severe cognitive impairment or developmental condition requiring a substantially different intervention format; lack of a parent/legal guardian able to provide consent and participate in minimum safety contacts; planned withdrawal from school or relocation outside the study area during the intervention period.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central allocation or sealed opaque sequentially numbered envelopes prepared by a person independent of recruitment and baseline assessment.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random allocation sequence using permuted blocks of variable size, stratified by school, sex, and baseline suicide risk severity. The sequence will be prepared by an independent statistician not involved in recruitment or intervention delivery.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
The primary analysis will follow the intention-to-treat principle. The primary outcome will be analysed using mixed-effects models for repeated measures including group, time, and group-by-time interaction, adjusted for baseline value and stratification variables where appropriate. Secondary continuous outcomes will be analysed using similar mixed-effects models. Safety events, including self-harm episodes, suicide attempts, emergency referrals, and hospitalisations, will be described by study arm and analysed exploratorily. Implementation outcomes will be summarised descriptively and, where appropriate, compared between arms.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
31/01/2027
Actual
Date of last data collection
Anticipated
30/05/2027
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 27988 0
Colombia
State/province [1] 27988 0
Caldas

Funding & Sponsors
Funding source category [1] 321495 0
Other Collaborative groups
Name [1] 321495 0
Universidad de Manizales
Country [1] 321495 0
Colombia
Primary sponsor type
Government body
Name
Alcaldía de Manizales
Address
Country
Colombia
Secondary sponsor category [1] 324257 0
None
Name [1] 324257 0
Address [1] 324257 0
Country [1] 324257 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320029 0
Comité de Bioética de la Universidad de Manizales
Ethics committee address [1] 320029 0
Ethics committee country [1] 320029 0
Colombia
Date submitted for ethics approval [1] 320029 0
31/10/2025
Approval date [1] 320029 0
12/11/2025
Ethics approval number [1] 320029 0
CBE11_2025

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 149194 0
Prof Felipe Agudelo-Hernández
Address 149194 0
Universidad de Manizales, Cra 9 a # 19-03, Campo Hermoso, Manizales, Caldas, Colombia. Email: [email protected]. COD: 170001
Country 149194 0
Colombia
Phone 149194 0
+57 314 6108744
Fax 149194 0
Email 149194 0
[email protected]
Contact person for public queries
Name 149195 0
Angela Aguirre Zuluaga
Address 149195 0
Universidad de Manizales, Cra 9 a # 19-03, Campo Hermoso, Manizales, Caldas, Colombia. Email: [email protected]. COD: 170001
Country 149195 0
Colombia
Phone 149195 0
+57 316 2235165
Fax 149195 0
Email 149195 0
[email protected]
Contact person for scientific queries
Name 149196 0
Felipe Agudelo-Hernández
Address 149196 0
Universidad de Manizales, Cra 9 a # 19-03, Campo Hermoso, Manizales, Caldas, Colombia. COD: 170001
Country 149196 0
Colombia
Phone 149196 0
+57 314 6108744
Fax 149196 0
Email 149196 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: Individual participant data will not be publicly shared because the study includes highly sensitive suicide-related mental health information from minors in a potentially identifiable school-based Colombian population, and the current consent and governance framework does not support open IPD release.



What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    _Aval_Bioetica_11_Andrés Felipe Agudelo.pdf


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.