Clinical trial NCT06551038: Evaluating Primary Suicide Prevention in Adolescents With Risk Factors
Official title: Evaluating Primary Suicide Prevention in Adolescents With Risk Factors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Suicide Prevention
Keywords: Suicide
Primary prevention
Vulnerable adolescents
Psychological distress
Lead sponsor: University of Bern
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 240
Sex: ALL
Minimum age (years): 14
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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, and 4) belonging to a sexual or gender minority. 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.


Eligibility criteria: Inclusion Criteria:

* Vulnerable adolescents defined as being: 1) detained in juvenile detention centers, 2) disconnected from school, 3) in treatment for psychiatric disorders, or 4) belonging to a sexual or gender minority.
* Age 14 to 18 years old.
* Good knowledge of French.
* Accepting to sign the informed consent.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Composite measure of suicide awareness
timeFrame: One-week post-baseline
Secondary outcomes:
measure: Composite measure of suicide awareness
timeFrame: Six-month post-baseline
measure: Knowledge on suicide
timeFrame: One-week post-baseline; six-month post-baseline
measure: Knowledge of local resources
timeFrame: One-week post-baseline; six-month post-baseline
measure: Suicidal thoughts
timeFrame: One-week post-baseline; six-month post-baseline
measure: Psychological distress
timeFrame: One-week post-baseline; six-month post-baseline
measure: Access to primary suicide prevention
timeFrame: Baseline
measure: Attrition
timeFrame: Six-month post-baseline
Other outcomes:
measure: Number of participants with serious adverse events (safety outcome)
timeFrame: One-month post baseline
measure: Number of participants with adverse events (safety outcome)
timeFrame: One-month post baseline
measure: Self-reported distress (safety outcome)
timeFrame: One-week post-baseline
Locations:
city: Plan-les-Ouates
country: Switzerland
facility: Programme ForMe (anciennement SEMO) et dispositif ProPULSE
state: Geneva
city: Vernier
country: Switzerland
facility: Centre de Détention et d'Observation La Clairière
state: Geneva
city: Vernier
country: Switzerland
facility: Programme Intégration et Formation Professionnelle
state: Geneva
city: Sierre
country: Switzerland
facility: Centre éducatif fermé de Pramont
state: Valais
city: Lausanne
country: Switzerland
facility: Agnodice
state: Vaud
city: Lausanne
country: Switzerland
facility: Vogay
state: Vaud
city: Lausanne
country: Switzerland
facility: Centre Thérapeutique de Jour pour Adolescents
state: Vaud
city: Lausanne
country: Switzerland
facility: Unité de Soins Psychiatriques Fermée pour Mineurs
state: Vaud
city: Palézieux
country: Switzerland
facility: Établissement de Détention pour mineurs et jeunes adultes Les Léchaires
state: Vaud
city: Geneva
country: Switzerland
facility: Dialogai et Totem
Study officials:
affiliation: Institute of Primary Health Care (BIHAM), University of Bern
name: Stéphanie Baggio, Prof.
role: PRINCIPAL_INVESTIGATOR
References: