- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06551038
Evaluating Primary Suicide Prevention in Adolescents With Risk Factors (ESPAIR)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Stéphanie Baggio, Prof.
- Phone Number: +41316846774
- Email: stephanie.baggio@unibe.ch
Study Locations
-
-
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Geneva, Switzerland, 1205
- Recruiting
- CAP Formations, Cité des Métiers
-
Contact:
- Nadejda Lambert
- Phone Number: +41223205567
- Email: nadejda@stopsuicide.ch
-
Geneva, Switzerland, 1205
- Recruiting
- Unité de Liaison Ambulatoire et Hospitalière, Service de psychiatrie de l'enfant et de l'adolescent, HUG
-
Contact:
- Santiago Peregalli
- Phone Number: +41223724800
- Email: santiago.peregalli@hug.ch
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Grand-Lancy, Switzerland, 1212
- Recruiting
- Foyers de Gilly
-
Contact:
- Patrick Heller, MD
- Phone Number: +41223055218
- Email: patrick.heller@hug.ch
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Lausanne, Switzerland, 1012
- Recruiting
- Foyer de Chailly
-
Contact:
- Patrick Heller, MD
- Phone Number: +41223055218
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Lausanne, Switzerland, 1018
- Recruiting
- Ren'Fort
-
Contact:
- Nadejda Lambert
- Phone Number: +41223205567
- Email: nadejda@stopsuicide.ch
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Lonay, Switzerland, 1027
- Recruiting
- Foyer La Pommeraie
-
Contact:
- Patrick Heller, MD
- Phone Number: +41223055218
- Email: patrick.heller@hug.ch
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Onex, Switzerland, 1213
- Recruiting
- Service des Parcours Individualisé
-
Contact:
- Nadejda Lambert
- Phone Number: +41223205567
- Email: nadejda@stopsuicide.ch
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Petit Lancy, Switzerland, 1213
- Recruiting
- Le Repuis
-
Contact:
- Nadejda Lambert
- Phone Number: +41223205567
- Email: nadejda@stopsuicide.ch
-
Thônex, Switzerland, 1226
- Recruiting
- Astural, Parcours A2mains
-
Contact:
- Nadejda Lambert
- Phone Number: +41223205567
- Email: nadejda@stopsuicide.ch
-
-
Canton of Geneva
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Geneva, Canton of Geneva, Switzerland, 1201
- Recruiting
- Dialogai et Totem
-
Contact:
- Nadjeda Lambert
- Phone Number: +41223205567
- Email: nadejda@stopsuicide.ch
-
Plan-les-Ouates, Canton of Geneva, Switzerland, 1228
- Recruiting
- Programme ForMe (anciennement SEMO) et dispositif ProPULSE
-
Contact:
- Nadejda Lambert
- Phone Number: +41223205567
- Email: nadejda@stopsuicide.ch
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Vernier, Canton of Geneva, Switzerland, 1214
- Recruiting
- Programme Intégration et Formation Professionnelle
-
Contact:
- Nadejda Lambert
- Phone Number: +41223205567
- Email: nadejda@stopsuicide.ch
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Vernier, Canton of Geneva, Switzerland, 1214
- Recruiting
- Centre de Détention et d'Observation La Clairière
-
Contact:
- Patrick Heller, MD
- Phone Number: +41223055218
- Email: patrick.heller@hug.ch
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-
Canton of Vaud
-
Lausanne, Canton of Vaud, Switzerland, 1003
- Recruiting
- Agnodice
-
Contact:
- Nadejda Lambert
- Phone Number: +41223205567
- Email: nadejda@stopsuicide.ch
-
Lausanne, Canton of Vaud, Switzerland, 1003
- Recruiting
- Vogay
-
Contact:
- Nadejda Lambert
- Phone Number: +41223205567
- Email: nadejda@stopsuicide.ch
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Lausanne, Canton of Vaud, Switzerland, 1005
- Recruiting
- Centre Thérapeutique de Jour pour Adolescents
-
Contact:
- Sébastien Urben, Dr.
- Phone Number: +41213147492
- Email: Sebastien.Urben@chuv.ch
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Lausanne, Canton of Vaud, Switzerland, 1008
- Recruiting
- Unité de Soins Psychiatriques Fermée pour Mineurs
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Contact:
- Sébastien Urben, Dr.
- Phone Number: +41213147492
- Email: Sebastien.Urben@chuv.ch
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Palézieux, Canton of Vaud, Switzerland, 1607
- Recruiting
- Établissement de Détention pour mineurs et jeunes adultes Les Léchaires
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Contact:
- Patrick Heller, MD
- Phone Number: +41223055218
- Email: patrick.heller@hug.ch
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-
Valais
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Sierre, Valais, Switzerland, 3977
- Recruiting
- Centre éducatif fermé de Pramont
-
Contact:
- Patrick Heller, MD
- Phone Number: +41223055218
- Email: patrick.heller@hug.ch
-
Contact:
- Stéphanie Baggio, PhD
- Phone Number: +41316846774
- Email: stephanie.baggio@unibe.ch
-
Sub-Investigator:
- Patrick Heller, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Primary suicide prevention intervention
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.
|
Psychoeducation workshop
|
|
Active Comparator: Art-based control intervention
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.
|
Slam poetry workshop
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Composite measure of suicide awareness
Time Frame: One-week post-baseline
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Access to primary suicide prevention
Time Frame: Baseline
|
Self-developed scale on primary suicide prevention training, 3 questions combined in a binary indicator (yes/no)
|
Baseline
|
|
Composite measure of suicide awareness
Time Frame: Three-month post-baseline
|
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
|
Three-month post-baseline
|
|
Knowledge on suicide
Time Frame: One-week post-baseline; three-month post-baseline
|
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; three-month post-baseline
|
|
Knowledge of local resources
Time Frame: One-week post-baseline; three-month post-baseline
|
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; three-month post-baseline
|
|
Suicidal thoughts
Time Frame: One-week post-baseline; three-month post-baseline
|
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; three-month post-baseline
|
|
Psychological distress
Time Frame: One-week post-baseline; three-month post-baseline
|
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; three-month post-baseline
|
|
Attrition
Time Frame: Three-month post-baseline
|
Percentage of participants who drop out, continuous variable (0-100), with a higher percentage indicating a higher level of attrition
|
Three-month post-baseline
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants with serious adverse events (safety outcome)
Time Frame: One-month post baseline
|
Death, life-threatening event, and hospitalisation
|
One-month post baseline
|
|
Number of participants with adverse events (safety outcome)
Time Frame: One-month post baseline
|
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)
Time Frame: One-week post-baseline
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Stéphanie Baggio, Prof., Institute of Primary Health Care (BIHAM), University of Bern
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-01208
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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