Evaluating Primary Suicide Prevention in Adolescents With Risk Factors
NCT Number: NCT06551038
Acronym: ESPAIR
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Suicide Prevention
Interventions: BEHAVIORAL: Primary suicide prevention intervention|BEHAVIORAL: Art-based control intervention
Sponsor: University of Bern
Sex: ALL
Age: CHILD, ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2025-01-01
Completion Date: 2028-09-30
Locations: Programme ForMe (anciennement SEMO) et dispositif ProPULSE, Plan-les-Ouates, Geneva, 1228, Switzerland|Centre de Détention et d'Observation La Clairière, Vernier, Geneva, 1214, Switzerland|Programme Intégration et Formation Professionnelle, Vernier, Geneva, 1214, Switzerland|Agnodice, Lausanne, Vaud, 1003, Switzerland|Vogay, Lausanne, Vaud, 1003, Switzerland|Centre Thérapeutique de Jour pour Adolescents, Lausanne, Vaud, 1005, Switzerland|Unité de Soins Psychiatriques Fermée pour Mineurs, Lausanne, Vaud, 1008, Switzerland|Établissement de Détention pour mineurs et jeunes adultes Les Léchaires, Palézieux, Vaud, 1607, Switzerland|Dialogai et Totem, Geneva, 1201, Switzerland

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.

Primary Outcome Measures: 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 Outcome Measures: 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, Six-month post-baseline|Knowledge on suicide, Literacy of Suicide Scale (LOSS), 12 binary (true/false) questions, score ranging from 0 to 12, with a higher score indicating higher knowledge on suicide, One-week post-baseline; six-month post-baseline|Knowledge of local resources, Self-developed scale on local resources, 6 binary (true/false) questions, score ranging from 0 to 6, with a higher score indicating higher knowledge of local resources, One-week post-baseline; six-month post-baseline|Suicidal thoughts, Suicidal Ideation Attributes Scale (SIDAS), 10 questions assessed on a 5-point scale, with a score ranging from 0 to 50. A higher score indicates a higher level of suicidal thoughts., One-week post-baseline; six-month post-baseline|Psychological distress, Kessler Psychological Distress scale (K-6), 6-item scale is assessed on a 5-point scale, with a score ranging from 0 to 24. A higher score indicates a higher level of psychological distress., One-week post-baseline; six-month post-baseline|Access to primary suicide prevention, Self-developed scale on primary suicide prevention training, 3 questions combined in a binary indicator (yes/no), Baseline|Attrition, Percentage of participants who drop out, continuous variable (0-100), with a higher percentage indicating a higher level of attrition, Six-month post-baseline
Other Outcome Measures: Number of participants with serious adverse events (safety outcome), Death, life-threatening event, and hospitalisation, One-month post baseline|Number of participants with adverse events (safety outcome), Scarification, insomnia, appetite problems, substance use, and para-suicidal endangerment behaviors identified and reported by the local team, One-month post baseline|Self-reported distress (safety outcome), Composite outcome with two questions from Bailey et al. (2017, https://https://doi.org/10.1027/0227-5910/a000465) related to the distressing and pleasurable nature of the intervention, assessed on a 5-point scale, score ranging from 0 to 8, a higher score indicating higher self-reported distress, One-week post-baseline