Suicide Re Attempts in Young Adults After First Suicide Attempt : Socio-demographic, Clinical and Biological Correlates (SURAYA)
Primary Purpose
Suicide
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
clinical and biological correlates
Sponsored by
About this trial
This is an interventional prevention trial for Suicide focused on measuring suicide attempt, suicide re attempt
Eligibility Criteria
Inclusion Criteria:
- between the ages of 18 and 25
- a first suicide attempt
- Master French sufficient
Exclusion Criteria:
- Majors protected: under curatorship or under guardianship
Sites / Locations
- Centre Hospitalier Le VinatierRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
SUICID ATTEMPT YOUNG PEOPLE
Arm Description
Suicide Re Attempts in Young Adults after first suicide attempt : socio-demographic, clinical and biological correlates
Outcomes
Primary Outcome Measures
Assessment of the prevalence of SR rate over a 3-months period after the first suicide attempt, among young adults aged 18 to 25.
Secondary Outcome Measures
mature and total BDNF
We will try to highlight correlations between the reiteration of the suicidal act and biological measures
level of urbanity
sociodemographic risk factor
socio-economic level
sociodemographic risk factor
social and family context
sociodemographic risk factor
date of birth
sociodemographic risk factor
place of birth
sociodemographic risk factor
BIS : Barratt Impulsive Scale
The Barratt Impulsiveness Scale (BIS) is a widely used measure of impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness).
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
C-SSRS : Colombia Suicide Severity Rating Scale
The Screener contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime and past 3 months. Each question addresses a different component of the respondent's suicide ideation severity and behavior.
Question 1: wish to be dead Question 2: non-specific suicidal thoughts Questions 3-5: more specific suicidal thoughts and intent to act Question 6: suicidal behavior over the respondent's lifetime and past 3 months If the respondent answers "yes" to Question 2, he/she is instructed to answer Questions 3-5. If the respondent answers "no" to Question 2, he/she may skip to Question 6.
An answer of "yes" to any of the six questions may indicate a need for referral to a trained mental health professional and an answer of "yes" to questions 4, 5 or 6 indicate high-risk.
hair cortisol and blood cortisol
We will try to highlight correlations between the reiteration of the suicidal act and biological measures
Analog visual scales
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Negative life events during the last 6 months
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
The reasons for living inventory
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
CTQ : childhood trauma questionnary
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
STAXI-2
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
PQB : psychosis risk screening
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
QIDS : Quick Inventory of Depressive Symptomatology
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
MDQ : Mood disorder questionnaire
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
CUDIT : Cannabis use Disorders Identification Test
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
CAST : Cannabis Abuse Screening Test
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Fagerstrom Questionary
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
AUDIT : Alcohol use disorders test
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03538197
Brief Title
Suicide Re Attempts in Young Adults After First Suicide Attempt : Socio-demographic, Clinical and Biological Correlates
Acronym
SURAYA
Official Title
SURAYA : Suicide Re Attempts in Young Adults After First Suicide Attempt : Socio-demographic, Clinical and Biological Correlates
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 22, 2018 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital le Vinatier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Suicide is the second leading cause of death among people aged 15 to 24 (WHO, 2014). After a first suicide attempt, the 18 to 25 years old would be very likely to repeat the act: 25 to 31% would make a new attempt in the following year (Christiansen et al, 2007).
Nevertheless the literature on this subject is not detailed. In this project, we hypothesize that young adults aged 18 to 25 who have made their first suicide attempt will repeat their act more frequently than younger or older populations. In addition, these young people would have identifiable risk factors (sociodemographic, clinical and biological) that differ from young people who do not enter this phenomenon.
Our main objective is to measure the rate of suicidal reiteration in a population of young adults aged 18 to 25 years.
Our secondary objectives are to identify sociodemographic, clinical and biological characteristics of a population of suicidal re attempt young people, to highlight potential risk factors
Detailed Description
Objectives:
Our main objective is to measure the rate of suicidal re attempt (SR) in a population of young adults aged 18 to 25 years.
Our secondary objectives are to identify sociodemographic, clinical and biological characteristics of a population of suicidal young people, in an attempt to highlight potential risk factors. We will try to highlight correlations between the reiteration of the suicidal act and:
socio-demographic criteria: level of urbanity, socio-economic level, social and family context, date and place of birth, religion, sexual orientation, name and contact details of the general practitioner, previous access to care
scores on the scales of various psychiatric pathologies, existing or in formation (eg depression, anxiety disorders, psychosis)
alterations at the peripheral level
on the stress response system: cortisolemia and capillary cortisol levels
on the total and mature serum BDNF
In addition, DNA and RNA genetic samples will be taken in order to constitute a biological collection for later research.
Type of study: This is an interventional research with minimal risks and constraints (2 ° study), multicenter prospective cohort.
Number of centers: 2 Suicide Prevention Center at the Le Vinatier Hospital Center and the Post Crisis Unit at the Edouard Herriot Hospital of the Hospices Civils de Lyon.
Description of the study / experimental plan:
This is a prospective cohort study that will be divided into two groups: "repeat suicide attempt" and "no repeat attempt"
Primary judgment criterion:
This is the occurrence of repeating a suicide attempt (over a period of 3 months after the initial attempt.
In this project, a suicide attempt is defined according to WHO criteria as "non-fatal suicidal behavior, self-inflicted injury with a desire to end one's life that does not lead to death".
Number of subjects:
Our study will include 200 patients at the Le Vinatier CH Suicide Prevention Center and the Post Crisis Unit at Edouard Herriot Hospital.
inclusion criteria: between the ages of 18 and 25
a first suicide attempt
Master French sufficient
Exclusion Criteria:
-Majors protected: under curatorship or under guardianship
Course of the study :
-Inclusion will take place immediately after the first suicide attempt at the Post Crisis Unit at Edouard Herriot Hospital and the Suicide Prevention Center.
An anamnestic collection of social and demographic data will be carried out: level of urbanity, professional activity, level of study, access to care, and previous care received, socio-economic level, social and family context (notably existing conflict with parents or love break-up). The patient's telephone number will be collected as well as the patient's psychiatric and addiction history, and the means used for the suicide attempt.
Different scales of assessments, by means of self-questionnaires, will be given to the patient and an investigator will provide the C-SSRS scale assessment for the suicidal risk severity. Finally a venous blood sample will be performed with a measure of total and mature serum BDNF and cortisolemia. Capillary cortisol will also be measured.
After obtaining the patient's consent, two blood samples (DNA and RNA) will be collected and stored at -80 degrees to create a biological collection for later research.
An orientation in the course of care will then be given to the subject who will receive the appropriate care as well as a phone call made by the Suicide Prevention Center.
-At 3 months: A phone call will be made to check the presence or absence of the main evaluation criterion: the repetition of a suicide attempt. In addition, the patient will be asked about life events during these three months and the care received since inclusion.
Benefits and risks of this study:
The expected benefits of this study are: a better understanding of the mechanisms underlying the recurrence of the suicidal act, which could allow an optimal patient management and an adapted orientation in the care network, this for a setting in place in the near future.
In addition, patients included in the study will benefit from follow-up.
The foreseeable risk is the SR that can lead to suicide. To minimize this risk, each patient included in this protocol will benefit from a clinical evaluation performed by a trained investigator. At the end of this evaluation, according to the observed suicidal risk, an orientation in the course of care will be proposed. Each patient will be informed of the different modalities of psychiatry consultations and how to challenge the network. In addition, all patients will receive a phone call from the Suicide Prevention Center.
No serious adverse effects that could be attributed to the project are expected as part of this research.
Indeed, the blood test is carried out systematically as part of a post-suicide treatment and no other invasive examination is scheduled. The only undesirable events that can occur after a venous blood collection are: a hematoma at the point of puncture, pain during the bite, vagal discomfort or rare cases of infectious risks. These risks are greatly minimized by means of sterile single-use equipment and qualified medical personnel, and can not be considered as a serious expected adverse effect.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide
Keywords
suicide attempt, suicide re attempt
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SUICID ATTEMPT YOUNG PEOPLE
Arm Type
Other
Arm Description
Suicide Re Attempts in Young Adults after first suicide attempt : socio-demographic, clinical and biological correlates
Intervention Type
Other
Intervention Name(s)
clinical and biological correlates
Intervention Description
To measure the rate of suicidal re attempt (SR) in a population of young adults aged 18 to 25 years.
To identify sociodemographic, clinical and biological characteristics of a population of suicidal young people, in an attempt to highlight potential risk factors
Primary Outcome Measure Information:
Title
Assessment of the prevalence of SR rate over a 3-months period after the first suicide attempt, among young adults aged 18 to 25.
Time Frame
Within the first 3 months following a first suicide attempt
Secondary Outcome Measure Information:
Title
mature and total BDNF
Description
We will try to highlight correlations between the reiteration of the suicidal act and biological measures
Time Frame
Within the first 3 months after the first suicide attempt
Title
level of urbanity
Description
sociodemographic risk factor
Time Frame
Within the first 3 month following a first suicide attempt
Title
socio-economic level
Description
sociodemographic risk factor
Time Frame
Within the first 3 month following a first suicide attempt
Title
social and family context
Description
sociodemographic risk factor
Time Frame
Within the first 3 months following a first suicide attempt
Title
date of birth
Description
sociodemographic risk factor
Time Frame
Within the first 3 months following a first suicide attempt
Title
place of birth
Description
sociodemographic risk factor
Time Frame
Within the first 3 months following a first suicide attempt
Title
BIS : Barratt Impulsive Scale
Description
The Barratt Impulsiveness Scale (BIS) is a widely used measure of impulsiveness. It includes 30 items that are scored to yield six first-order factors (attention, motor, self-control, cognitive complexity, perseverance, and cognitive instability impulsiveness) and three second-order factors (attentional, motor, and non-planning impulsiveness).
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
C-SSRS : Colombia Suicide Severity Rating Scale
Description
The Screener contains 6 "yes" or "no" questions in which respondents are asked to indicate whether they have experienced several thoughts or feelings relating to suicide over the past month and behaviors over their lifetime and past 3 months. Each question addresses a different component of the respondent's suicide ideation severity and behavior.
Question 1: wish to be dead Question 2: non-specific suicidal thoughts Questions 3-5: more specific suicidal thoughts and intent to act Question 6: suicidal behavior over the respondent's lifetime and past 3 months If the respondent answers "yes" to Question 2, he/she is instructed to answer Questions 3-5. If the respondent answers "no" to Question 2, he/she may skip to Question 6.
An answer of "yes" to any of the six questions may indicate a need for referral to a trained mental health professional and an answer of "yes" to questions 4, 5 or 6 indicate high-risk.
Time Frame
Within the first 3 months following a first suicide attempt
Title
hair cortisol and blood cortisol
Description
We will try to highlight correlations between the reiteration of the suicidal act and biological measures
Time Frame
Within the first 3 months following a first suicide attempt
Title
Analog visual scales
Description
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
Negative life events during the last 6 months
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
The reasons for living inventory
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
CTQ : childhood trauma questionnary
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
STAXI-2
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
PQB : psychosis risk screening
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
QIDS : Quick Inventory of Depressive Symptomatology
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
MDQ : Mood disorder questionnaire
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
CUDIT : Cannabis use Disorders Identification Test
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
CAST : Cannabis Abuse Screening Test
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
Fagerstrom Questionary
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
Title
AUDIT : Alcohol use disorders test
Description
Clinical risk factor : We aim to highlight correlations between the reiteration of the suicidal act and different scores on clinical scales
Time Frame
Within the first 3 months following a first suicide attempt
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
between the ages of 18 and 25
a first suicide attempt
Master French sufficient
Exclusion Criteria:
Majors protected: under curatorship or under guardianship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
POULET Emmanuel, Ph
Phone
04 72 11 00 09
Email
emmanuel.poulet@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
HERMAND MARIANNE
Phone
04 72 11 00 09
Email
emmanuel.poulet@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
POULET Emmanuel, Ph
Organizational Affiliation
CH LE VINATIER
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Le Vinatier
City
Bron
State/Province
Aura
ZIP/Postal Code
69678 CEDEX
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
POULET EMMANUEL, PUPH
Phone
0033437915120
Email
emmanuel.poulet@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
VIAL VERONIQUE
Phone
0033437915531
Email
veronique.vial@ch-le-vinatier.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35845461
Citation
Abrial E, Chalancon B, Leaune E, Brunelin J, Wallon M, Moll F, Barakat N, Hoestlandt B, Fourier A, Simon L, Magnin C, Hermand M, Poulet E. Investigating Predictive Factors of Suicidal Re-attempts in Adolescents and Young Adults After a First Suicide Attempt, a Prospective Cohort Study. Study Protocol of the SURAYA Project. Front Psychiatry. 2022 Jun 29;13:916640. doi: 10.3389/fpsyt.2022.916640. eCollection 2022.
Results Reference
derived
Learn more about this trial
Suicide Re Attempts in Young Adults After First Suicide Attempt : Socio-demographic, Clinical and Biological Correlates
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