Suicidal Intentiondiscord-AdosNCT06036290
Discordance in the Evaluation of Suicidal Intent Between Parents and Adolescents in Adolescence and Evolution of the Suicidal Crisis : a Mixed Study
An observational study of Suicidal Intention and Suicide, Attempted, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Suicidal Intention, Suicide, Attempted, Parent-Child Relations
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jul 2023to 27 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Show all 11Show fewer
- 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
Who cannot join
- present a decompensated somatic or psychiatric pathology or a vigilance disorder
- refusal to participate in the research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre, 0473751195, promo_interne_drci@chu-clermontferrand.fr
Jonathan LACHAL
About this study
Official title: 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:
Read more
- 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
Read the 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.
- Medical subject headings
- Suicide, Attempted
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in adolescents' level of suicidal intent
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.
Measured: 3 months
Secondary outcomes (7)
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.
- Total number of new emergency room and/or child psychiatry team consultations related to suicidal crisis at 3 months.
- Total number of suicidal recurrences reported at 3 months.
- Total number of full-time inpatient hospital stays or psychiatry related to the suicidal crisis at 3 months.
- Total length of stay in full-time in-patient care in the hospital, and/or psychiatry, related to the 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 at 3 months
Measured: 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
Total score on FACES IV self-assessment scale of family functioning.
Measured: 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.
Gender, age, urban or rural environment, family organization (union, single parent, other other situations) and parents' socio-professional category.
Measured: 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.
- 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.
Measured: 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
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
Measured: 3 months
Explore 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 with regard to the elements they consider relevant in assessing the adolescent's suicidal intent.
Measured: 1 month
Explore the experience of adolescents and their parents in terms of their mutual understanding of the suicidal crisis experienced by the adolescent.
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start27 Jul 2023
- Primary completion27 May 2025 (estimated)
- Study completion27 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicidal IntentionStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06036290
- Sponsor's protocol ID
- RNI 2023 SIBUT
- Acronym
- discord-Ados
- Status last verified
- Sep 2023
- First submitted
- 8 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06036290
- Acronym / sponsor ID
- discord-Ados / RNI 2023 SIBUT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 27 May 2025 (estimated)
- Study completion
- 27 May 2025 (estimated)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (2 listed)
- present a decompensated somatic or psychiatric pathology or a vigilance disorder
- refusal to participate in the research
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
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
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Suicidal Intention
Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Suicidal Intention and Suicide, Attempted, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (0, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in adolescents' level of suicidal intent (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.