- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06036290
Discordance in the Evaluation of Suicidal Intent Between Parents and Adolescents in Adolescence and Evolution of the Suicidal Crisis : a Mixed Study (discord-Ados)
Study of the Association Between the Discordance in the Evaluation of Suicidal Intentionality Between Parents and Adolescents After a Suicide Attempt in Adolescence and the Evolution of the Suicidal Crisis at 3 Months: a Mixed Study
The goal of this mixed-methods study is to describe the association between the level of parent/adolescent discordance in the assessment of the adolescent's level of suicidal intentionality after a suicid attempt and the evolution of the suicidal crisis by assessing the evolution of the adolescent's suicidal intentionality between T0 and 3 months.
The main questions it aims to answer are:
- To show the association between the level of parent/adolescent discordance in the assessment of the adolescent's level of suicidal intent after a suicid attempt and various markers of the evolution of the suicidal crisis at 3 months.
- Explore the experience of adolescents and their parents regarding the elements they consider relevant in assessing the adolescent's suicidal intent.
Participants will be asked to complete various self- and hetero-questionnaires at T0 and T3
Study Overview
Status
Detailed Description
Mixed quantitative and qualitative descriptive observational study. Participants will be included at the various sites by the investigators attached to the three inclusion sites.
Primary outcome
Difference in adolescents' level of suicidal intent between T0 and 3 months. All measurements are with a Visual Analogue Scale (VAS) graded from 0 to 10.
Secondary outcomes Quantitative study
- Total number of new suicidal crisis-related visits to the emergency department and/or the child psychiatry emergency and mobile team at 3 months.
- Total number of suicidal recurrences at 3 months.
- Total number of full-time inpatient stays in MCO and/or psychiatry related to suicidal crisis at 3 months.
- Total length of stay in full-time inpatient care (MCO and/or psychiatry) related to suicidal crisis at 3 months.
- Proportion of the number of days of absence out of the total number of school days at 3 months.
- Proportion of number of child psychiatric consultations honored out of total number of scheduled consultations at 3 months.
- Proportion of the number of psychological consultations honored out of the total number of consultations scheduled for 3 months.
- Total score on FACES IV self-assessment scale of family functioning.
- Gender, age, urban or rural environment, family organization (union, single parent, other situations) and parents' socio-professional category.
- i) Presence of a family psychiatric history; ii) Presence of a family suicide history; iii) Presence of a family history of TS; iv) Presence of a personal history of TS; v) Presence of a personal history of psychological or psychiatric follow-up; vi) Presence of a personal history of self-harm; vii) Type of TS and viii) Type of ICD-10 diagnosis made during the child psychiatric assessment.
- Difference in adolescents' level of suicidal intentionality measured using a Visual Analog Scale at: i) T0 (measurement of level 1 week prior to TS, level at time of TS, level at time of assessment) and ii) T3 months.
- Difference in level of parent/adolescent suicidal intentionality measured at T0 and T3 months using the VAS.
Qualitative study
- Obtaining a thematic grid describing the experience of adolescents and their parents regarding the elements they consider relevant in assessing the adolescent's suicidal intent.
- Obtained a thematic grid describing the experience of adolescents and their parents regarding their mutual understanding of the suicidal crisis experienced by the adolescent.
The study is descriptive, and qualitative for a subsample of participants.
- Hetero-questionnaire 1: Hetero-questionnaire 1 collects socio-familial and clinical data at T0. Data are collected by the investigator on the day of inclusion in the study. The main elements collected are
- Patient's gender
- Patient's age
- rural or urban environment
- Family organization
- Parents' socio-professional category
- Family history of suicide
- Presence of a family history of suicidal attempt
- Presence of a personal history of suicidal attempt
- Personal history of psychological or psychiatric treatment
- Personal history of self-mutilation
- Type of suicidal attempt
- ICD-10 diagnosis made during child psychiatric assessment
- Hetero-questionnaire 2:
Hetero-questionnaire 2 is used to collect declarative data on progress at T3months. Data are collected by an authorized member of the study, by videoconference. Parents will be informed of the need for the child to be alone at the time of the interview, in a quiet, dedicated room. The main data collected are
- The total number of new consultations with the emergency department and/or the mobile child psychiatry team in connection with the suicidal crisis at 3 months.
- Total number of suicidal attempts recurrences
- Total number of full-time hospital stays related to the suicidal crisis.
- Total length of stay in full-time hospitalization related to suicidal crisis.
- Number of days of absence as a proportion of school days
- The proportion of the number of child psychiatric consultations honored out of the total number of scheduled consultations
- The proportion of the number of psychological consultations honored out of the number of scheduled consultations
- Auto-questionnaire FACES IV
- Semi-structured interviews Semi-structured interviews are specifically designed to explore the various themes announced. An interview guide is drawn up by the research group, made up of specialists in adolescent psychiatry and qualitative methods. The guide is not fixed, contains "starter" questions and can be modulated as the research progresses. The researcher has in mind a list of themes that must necessarily be addressed, but the discussion remains very open, in order to enter the subject's internal world. The subject acts as an expert, and may bring up one or more themes that the researcher hadn't thought of, depending on his or her concerns and interests.
Two interviews are conducted, one with the adolescent, the other with his or her parents. The interviews with the patients and their parents explore the parents' and the adolescent's experience of the suicidal crisis, family relationships and how they evolved during the crisis.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
Study Locations
-
-
-
Clermont-Ferrand, France
- Recruiting
- Chu Clermont-Ferrand
-
Contact:
- Lise Laclautre
- Phone Number: 0473751195
- Email: promo_interne_drci@chu-clermontferrand.fr
-
Sub-Investigator:
- Jonathan LACHAL
-
Principal Investigator:
- Romain SIBUT
-
Sub-Investigator:
- Julie GENESTE SALAENS
-
Sub-Investigator:
- Matthieu VERDAN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Adolescents: aged 11 to 17, admitted to a pediatric or adult emergency department following a suicide attempt.
Parents: 18 years of age or older, parent or guardian of an adolescent admitted to a pediatric or adult emergency department following a suicide attempt.
Description
Inclusion Criteria:
- Adolescents:
- aged 11 to 17
- admitted to a pediatric or adult emergency department following a suicide attempt
- proficient in spoken French
- not opposed to participation in the research
- accompanied by at least one parent who is not opposed to the adolescent's participation in the research.
- Parents:
- 18 years of age or older
- parent or guardian of an adolescent admitted to a pediatric or adult emergency department following a suicide attempt
- fluent in spoken French
- not opposed to participation in the research
Exclusion Criteria:
- present a decompensated somatic or psychiatric pathology or a vigilance disorder
- refusal to participate in the research
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in adolescents' level of suicidal intent
Time Frame: 3 months
|
Difference in adolescents' level of suicidal intent between T0 and 3 months.
All measurements are based on a Visual Analogue Scale (VAS) graduated from 0 to 10.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Association between the level of parent/adolescent discordance in the assessment of the adolescent's level of suicidal intent after a suicidal attempt and various indicators of the evolution of the suicidal crisis at 3 months.
Time Frame: 3 months
|
|
3 months
|
|
association between the level of parent/adolescent discordance in assessing the adolescent's level of suicidal intent after a suicid attempt and the degree of family cohesion
Time Frame: 1 week
|
Total score on FACES IV self-assessment scale of family functioning.
|
1 week
|
|
socio-familial factors associated with a high level of parent/adolescent discordance in assessing the adolescent's level of suicidal intentionality after a suicidal act.
Time Frame: 1 week
|
Gender, age, urban or rural environment, family organization (union, single parent, other other situations) and parents' socio-professional category.
|
1 week
|
|
clinical factors associated with a high level of parent/adolescent discordance in assessing the adolescent's level of suicidal intent after a suicide attempt.
Time Frame: 1 week
|
i) presence of a family psychiatric history; ii) presence of a family suicide history; iii) presence of a family history of suicide attempt; iv) presence of a personal history of suicide attempt; v) presence of a personal history of psychological or psychiatric follow-up; vi) presence of a personal history of self-harm; vii) type of suicide attempt and viii) type of ICD-10 diagnosis made during the child psychiatric evaluation.
|
1 week
|
|
evolution of the level of parent/adolescent discordance on the evaluation of the adolescent's level of suicidal intent after a suicide attempt at 0 and 3 months
Time Frame: 3 months
|
Difference in the level suicidal intent of adolescents measured with a Visual Analog Scale at scale at: i) T0 (measurement of level 1 week prior to suicidal event, level at time of suicidal event level at the time of TS, level at the time of assessment) and ii) T3 months
|
3 months
|
|
Explore the experience of adolescents and their parents regarding the elements they consider relevant in assessing the adolescent's suicidal intent.
Time Frame: 1 month
|
Obtained a thematic grid describing the experience of adolescents and their parents with regard to the elements they consider relevant in assessing the adolescent's suicidal intent.
|
1 month
|
|
Explore the experience of adolescents and their parents in terms of their mutual understanding of the suicidal crisis experienced by the adolescent.
Time Frame: 1 month
|
Obtaining a thematic grid describing the experience of adolescents and their parents in terms of their mutual understanding of the suicidal crisis experienced by the adolescent.
|
1 month
|
Collaborators and Investigators
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
- RNI 2023 SIBUT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Suicide, Attempted
-
Brown UniversityButler HospitalCompleted
-
Vastra Gotaland RegionGöteborg UniversityRecruitingSuicidal Ideation | Suicide | Suicide AttemptSweden
-
University of BernCompletedSuicidal Ideation | Suicide | Suicide AttemptSwitzerland
-
Vestre Viken Hospital TrustNorwegian Institute of Public Health; Helse Sor-Ost; The Catholic University...Completed
-
Hillerod Hospital, DenmarkUnknownHepatic InjuryDenmark
-
Pakistan Institute of Living and LearningUniversity of Manchester; Dow University of Health Sciences; Abbasi Shaheed HospitalCompletedDepression | Attempted SuicidePakistan
-
Karolinska InstitutetRecruitingSuicide, Attempted | Suicidal and Self-injurious Behavior | Suicide Attempt | Suicide AttemptedSweden
-
Boston Children's HospitalAmerican Foundation for Suicide PreventionCompletedAlcohol Drinking | SuicideUnited States
-
Dartmouth-Hitchcock Medical CenterNational Institute of Nursing Research (NINR); Trustees of Dartmouth CollegeNot yet recruitingSuicide Attempt | Suicide IdeationUnited States
-
University of Sao PauloNot yet recruitingSuicide Ideation | Suicide Attempts