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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04638205
Other study ID # 2018_20
Secondary ID 2018-A03065-50
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2019
Est. completion date November 2022

Study information

Verified date February 2022
Source University Hospital, Lille
Contact Charles-Edouard Notredame, MD
Phone 03 20 30 23 40
Email charles-edouard.notredame@chru-lille.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Suicidal behaviors seriously alter the vital and functional prognosis of adolescents. Although the literature has lighted out a considerable number of risk factors for suicide attempts in youth, theoretical models - among which bio-psycho-social models - still lack empirical evidence. More specifically, the way adverse life events dynamically interact together and with the individual's diathesis to precipitate suicidal attempts remains unclear. Studies of life trajectories have opened an alternative approach to traditional linear epidemiological analysis to capture such a complex process. To date, adverse trajectories approaches never have been applied to the period immediately preceding the occurrence of the suicidal gesture (proximal adverse trajectories).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date November 2022
Est. primary completion date November 2022
Accepts healthy volunteers No
Gender All
Age group 15 Years to 24 Years
Eligibility Inclusion Criteria: - Inclusion criteria for cases - Youth aged 15-24 inclusive - Who stayed at the hospital or in the emergency room for less than 15 days after a first suicide attempt - Who were discharged less than 15 days ago - Who gave their informed consent for majors, or whose parents gave their informed consent for minors Inclusion criteria for controls - Youth aged 15-24 inclusive - Who have never experienced any suicidal ideation or suicide attempt - Who gave their informed consent for majors, or whose parents gave their informed consent for minors Inclusion criteria for informants - Close relatives of the participant - Who are major - Who lived in the same household as the participant or have interacted with him/her for more than half the weeks of the year preceding the index suicide attempt Exclusion Criteria: - No consent or consent withdrawal for majors and/or their parents for minors - Neurological or psychiatric condition altering the capacity to understand

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hop Fontan - Chu Lille Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Growth parameters of the patterns of proximal adverse trajectories in adolescents who attempted suicide, as compared to non-suicidal adolescents We will build growth mixture models to account for the 1-year longitudinal evolution of the Burden of Adversity values. Each group will be characterized by the parameters (intercepts and slopes) of the best-fitting model.
We will the compare the parameters of the 2 groups to search for statistical differences
1 year
Secondary Statistical tests comparing the sociodemographic, vulnerabily and psychopathological indicators between the sub-group of adolescents identified from the mixture model. Growth mixture models will allow for identifying sub-groups of individuals who are similar as regards to their burden of adversity trajectories. We will compare the characteristics of theses subgroups 1 year
Secondary Growth parameters of the patterns of evolution of psychological pain Parallel to the burden of adversity growth models, we will build, for each group, growth models to predict the longitudinal evolution of psychological pain.
We will then test whether the growth parameters of the ideation/pain trajectories correlate with those of the adversity trajectories
1 year
Secondary Growth parameters of the patterns of evolution of suicidal ideation intensity Parallel to the burden of adversity growth models, we will build, for each group, growth models to predict the longitudinal evolution of the severity of the suicidal ideations.
We will then test whether the growth parameters of the ideation/pain trajectories correlate with those of the adversity trajectories
1 year
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