NCT06551038

Brief Summary

Suicide is one of the main causes of death among teenagers. Because it is preventable, primary prevention of suicide has become a public health priority, with encouraging results in promoting suicide awareness and reducing suicidal thoughts among adolescents. However, the lack of studies conducted among vulnerable populations (i.e., marginalised, disengaged and disadvantaged) is a major gap, even though these populations present an increased risk of suicidal behaviour. The aim of this project is to test the effectiveness of a brief primary suicide prevention intervention for vulnerable adolescents, using a randomised controlled trial. Vulnerable adolescents include those 1) detained in juvenile detention centres, 2) at risk of dropping out of school, 3) undergoing treatment for psychiatric disorders, 4) belonging to a sexual or gender diversity, 5) affected by chronic conditions, or 6) with relational/familial problems. The main aim is to test the effectiveness of the intervention on a composite measure of suicide awareness, psychological distress and suicidal thoughts. The project will also explore other issues that present challenges for vulnerable populations: access to primary suicide prevention and non-response bias. The study will provide relevant results to address the current lack of high-quality evidence for primary suicide prevention in adolescents.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for not_applicable

Timeline
29mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

19 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Mar 2025Sep 2028

First Submitted

Initial submission to the registry

August 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

March 11, 2025

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2027

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

2.2 years

First QC Date

August 8, 2024

Last Update Submit

December 11, 2025

Conditions

Keywords

SuicidePrimary preventionVulnerable adolescentsPsychological distress

Outcome Measures

Primary Outcomes (1)

  • Composite measure of suicide awareness

    Nine-item perceived suicide awareness scale (PSAS-9), assessed on a 5-point scale, score ranging from 0 to 36, with a higher score indicating a higher suicide awareness

    One-week post-baseline

Secondary Outcomes (7)

  • Composite measure of suicide awareness

    Three-month post-baseline

  • Knowledge on suicide

    One-week post-baseline; three-month post-baseline

  • Knowledge of local resources

    One-week post-baseline; three-month post-baseline

  • Suicidal thoughts

    One-week post-baseline; three-month post-baseline

  • Psychological distress

    One-week post-baseline; three-month post-baseline

  • +2 more secondary outcomes

Other Outcomes (3)

  • Number of participants with serious adverse events (safety outcome)

    One-month post baseline

  • Number of participants with adverse events (safety outcome)

    One-month post baseline

  • Self-reported distress (safety outcome)

    One-week post-baseline

Study Arms (2)

Primary suicide prevention intervention

EXPERIMENTAL

The framework of the primary suicide prevention intervention is psychoeducation. The intervention lasts for 90 minutes and is conducted in groups of 5 to 15 (on average 10) participants. It provides general information on suicidal behaviors, information about facts and myths about suicide, identification of risk factors and warning signs of suicidal behaviors, and information on ways to seek for help and get support for themselves and others in the canton. The intervention includes a lecture, group discussions based on case examples, and a quiz on facts and myths about suicide. It is conducted by a trained staff member with the support of a psychologist trained in suicide prevention for children and adolescents. It follows a standardized format.

Behavioral: Primary suicide prevention intervention

Art-based control intervention

ACTIVE COMPARATOR

The control intervention will be an art-based activity, a workshop on slam poetry. At the end of the study, participants will get a flyer containing information on suicide prevention with the participants of the control group. Therefore, they will have a low-threshold intervention.

Behavioral: Art-based control intervention

Interventions

Psychoeducation workshop

Primary suicide prevention intervention

Slam poetry workshop

Art-based control intervention

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Vulnerable adolescents defined as being: 1) detained in juvenile detention centers, 2) disconnected from school, 3) in treatment for psychiatric disorders, 4) belonging to a sexual or gender minority, 5) affected by chronic conditions, or 6) with relational/familial problems.
  • Age 14 to 25 years old.
  • Good knowledge of French.
  • Accepting to sign the informed consent.

You may not qualify if:

  • The medical/educational staff considers that the intervention will interfere with appropriate management of acute psychiatric disorder or may cause harm to self or other.
  • Being enrolled in another suicide prevention intervention during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Dialogai et Totem

Geneva, Canton of Geneva, 1201, Switzerland

RECRUITING

Programme ForMe (anciennement SEMO) et dispositif ProPULSE

Plan-les-Ouates, Canton of Geneva, 1228, Switzerland

RECRUITING

Centre de Détention et d'Observation La Clairière

Vernier, Canton of Geneva, 1214, Switzerland

RECRUITING

Programme Intégration et Formation Professionnelle

Vernier, Canton of Geneva, 1214, Switzerland

RECRUITING

Agnodice

Lausanne, Canton of Vaud, 1003, Switzerland

RECRUITING

Vogay

Lausanne, Canton of Vaud, 1003, Switzerland

RECRUITING

Centre Thérapeutique de Jour pour Adolescents

Lausanne, Canton of Vaud, 1005, Switzerland

RECRUITING

Unité de Soins Psychiatriques Fermée pour Mineurs

Lausanne, Canton of Vaud, 1008, Switzerland

RECRUITING

Établissement de Détention pour mineurs et jeunes adultes Les Léchaires

Palézieux, Canton of Vaud, 1607, Switzerland

RECRUITING

Centre éducatif fermé de Pramont

Sierre, Valais, 3977, Switzerland

RECRUITING

CAP Formations, Cité des Métiers

Geneva, 1205, Switzerland

RECRUITING

Unité de Liaison Ambulatoire et Hospitalière, Service de psychiatrie de l'enfant et de l'adolescent, HUG

Geneva, 1205, Switzerland

RECRUITING

Foyers de Gilly

Grand-Lancy, 1212, Switzerland

RECRUITING

Foyer de Chailly

Lausanne, 1012, Switzerland

RECRUITING

Ren'Fort

Lausanne, 1018, Switzerland

RECRUITING

Foyer La Pommeraie

Lonay, 1027, Switzerland

RECRUITING

Service des Parcours Individualisé

Onex, 1213, Switzerland

RECRUITING

Le Repuis

Petit Lancy, 1213, Switzerland

RECRUITING

Astural, Parcours A2mains

Thônex, 1226, Switzerland

RECRUITING

Related Publications (1)

  • Baggio S, Bailey E, Edan A, Heller P, Kapp C, Lambert N, Michaud L, Mundt AP, Nsingi N, Perez S, Peregalli S, Piguet C, Piotrowski C, Prutyanova Y, Rumley M, Sapin M, Urben S, Iglesias K. Evaluating primary suicide prevention in adolescents with risk factors (ESPAIR): study protocol for a cluster-randomized controlled trial. Trials. 2025 Nov 24;26(1):537. doi: 10.1186/s13063-025-09266-y.

MeSH Terms

Conditions

Suicide PreventionSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Stéphanie Baggio, Prof.

    Institute of Primary Health Care (BIHAM), University of Bern

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stéphanie Baggio, Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 8, 2024

First Posted

August 13, 2024

Study Start

March 11, 2025

Primary Completion (Estimated)

May 30, 2027

Study Completion (Estimated)

September 30, 2028

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

Data will be shared on https://www.swissubase.ch.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
After the publication of the main results of the study
Access Criteria
Upon approval from the principal investigator

Locations