Adolescent Behavior DisorderCARMENNCT05820581
Characterization of Mentalization Profiles Related to Emotional Regulation Among Teenagers With Behavioral Disorders
A study testing Mentalisation in people with Adolescent Behavior Disorder and Eye Movements, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
Behavioral disorders in adolescents are defined by a set of diverse behaviors (such as aggressiveness, agitation, clastic crisis, running away and endangerment) whose common characteristic is the predominance of action/ mentalization. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Adolescent Behavior Disorder, Eye Movements
- What is being tested?
- Mentalisation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 26 Jun 2023to Jun 2026
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Teenage girls or boys aged 12 to 17
- Adolescent(s) with externalized behavioral disorder(s):
- running away, suicide attempts, self-aggression (scarification, self-mutilation), taking drugs, hetero-aggressive behavior, theft, conduct disorders sexual, oppositional behavior, lies, clastic anger.
- Non-objection of the adolescent to participate in the study.
- Written consent of the two holders of parental authority
Who cannot join
- Intellectually disabled
- Autism Spectrum Disorder
- Psychotic disorder
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Besançon
Besançon
Monika Szymanska, 00000000, mszymanska@chu-besancon.fr
About this study
Behavioral disorders in adolescents are defined by a set of diverse behaviors (such as aggressiveness, agitation, clastic crisis, running away and endangerment) whose common characteristic is the predominance of action/ mentalization. These disorders are associated with significant morbidity and high mortality linked to a high rate of suicide or attempted suicide. Behavioral disorders are also associated with an alteration of mentalizing capacities, that is the psychic process by which the adolescent imagines and interprets his behavior and that of others on the basis of mental states such as needs, desires, beliefs or feelings. The disorders are also associated with emotional dysregulation. To date, the psychopathological processes underlying behavioral disorders in adolescents are unknown and prevent from offering appropriate psychological care. Thus, it seems essential to characterize this clinical population by integrating both its intrapsychic representations and the physiological parameters of emotional regulation associated with it.
This project is a first step towards a larger-scale research project aimed at evaluating treatment by TBM (therapies based on mentalization) in adolescents with behavioral disorders.
Read the detailed description
Behavioral disorders in adolescents are defined by a set of behaviors (such as aggressiveness, agitation, clastic crisis, running away and endangerment) whose common characteristic is the predominance of action over mentalization and opposition to normal socialization processes.
These disorders are associated with significant morbidity and high mortality linked to a high rate suicide or attempted suicide. Behavioral disorders in adolescence are linked to defects of mentalization (i.e. the psychic process by which the adolescent imagines and interprets his behaviors and to alterations in emotional regulation capacities. This emotional dysregulation has several components, including motor and physiological components. Moreover, this dysregulation is constructed in a dynamic process linked to the environment, including the adolescent's relationship with parents. To date, the psychopathological processes underlying behavioral disorders in the teenager are unknown, which prevents from offering appropriate psychological care. Thus, it seems essential to characterize adolescents behavior, by integrating both mentalizing capacities, the physiological parameters of their emotional regulation and the interactive patterns with their parents. This approach allow to overcome the difficulty of adolescents to use words to express what they feel and thus to understand their psychic functioning and the strategies, which they put in place to regulate their emotions.
This study is a monocentric cross-sectional descriptive observational study.
Objectives of this study is to describe the mentalization profiles of adolescents with mental disorders behavior and to evaluate:
- Oculomotor parameters of emotional regulation
- Physiological parameters of emotional regulation (Electrodermal Activity, RED)
- Self-assessed mentalizing abilities (RFQ-Y scale)
- Emotional regulation (DERS scale)
- The emotional and behavioral functioning of adolescents (YSR scale)
- Attachment characteristics of adolescents (ARSQ scale)
- The interactions of the adolescent with his parent (GPACS scale)
- Parental reflexive capacities (RFQ scale). This research was developed to support a comprehensive understanding of adolescent processes with the integration of bio-neuro-social parameters.
The aim of this study is to establish mentalization profiles of the clinical population of adolescents with behavioral disorders and their neurophysiological correlates of emotional regulation.
These first data are essential for a better understanding of this clinical population and a starting point for future research; particularly to develop therapies based on mentalization in this population and to evaluate their effectiveness.
- Conditions
- Adolescent Behavior Disorder, Eye Movements
- Being tested
- Mentalisation
- Keywords
- Mentalisation, Emotion regulation, Adolescents, Neurophysiological parameters
- Medical subject headings
- Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MentalisationBehavioural
Hypomentalisation, hypermentalisation, correct mentalisation, lack of mentalisation
| Study group | Role | What they receive |
|---|---|---|
| Mentalisation | Experimental | 4 mentalisation groups will be defined: hypomentalisation, hypermentalisation, mentalisation correct and lack of mentalisation Receives: Behavioral: Mentalisation |
What is being measured
The primary outcome is the main question the study is designed to answer.
eye fixation duration evaluated with eyes tracker
fixation duration (time in millisecond)
Measured: 12 months
eye dwell time evaluated with eyes tracker
dwell time (time in millisecond)
Measured: 12 months
eye fixation count evaluated with eyes tracker
fixation count ( time in millisecond)
Measured: 12 months
Secondary outcomes (7)
MASC Score
Mentalization score
Measured: 12 months
YSR score
youth self report score
Measured: 12 months
RFQ-Y score
Reflective Function Questionnaire for Youth
Measured: 12 months
DERS score
Difficulties in Emotion Regulation Scale (DERS)
Measured: 12 months
ARSQ score
Adolescent relationship scale questionnaire
Measured: 12 months
parent's RFQ score
Reflective Functioning Questionnaire for parents
Measured: 12 months
GPACS interaction evaluation
General Practitioner Attitudes and Confidence Scale is a tool to measure confidence and attitude.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start26 Jun 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Adolescent Behavior DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Astrid Pozet, MS, Study chair, CHU Besancon, DRCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820581
- Sponsor's protocol ID
- 2021/646
- Acronym
- CARMEN
- Status last verified
- Sep 2024
- First submitted
- 27 Mar 2023
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szymanska M, Monnin J, Tio G, Vidal C, Girard F, Galdon L, Smith CC, Bifulco A, Nezelof S, Vulliez-Coady L. How do adolescents regulate distress according to attachment style? A combined eye-tracking and neurophysiological approach. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:39-47. doi: 10.1016/j.pnpbp.2018.08.019. Epub 2018 Aug 27.
PubMed 30165119Taubner S, Volkert J, Gablonski TC, Rossouw T. [Mentalization-Based Treatment for Adolescents with Borderline Personality Disorder - Concept and Efficacy]. Prax Kinderpsychol Kinderpsychiatr. 2017 Jul;66(6):423-434. doi: 10.13109/prkk.2017.66.6.423. German.
PubMed 28701091Sharp C, Pane H, Ha C, Venta A, Patel AB, Sturek J, Fonagy P. Theory of mind and emotion regulation difficulties in adolescents with borderline traits. J Am Acad Child Adolesc Psychiatry. 2011 Jun;50(6):563-573.e1. doi: 10.1016/j.jaac.2011.01.017. Epub 2011 Mar 9.
PubMed 21621140Sharp C, Ha C, Carbone C, Kim S, Perry K, Williams L, Fonagy P. Hypermentalizing in adolescent inpatients: treatment effects and association with borderline traits. J Pers Disord. 2013 Feb;27(1):3-18. doi: 10.1521/pedi.2013.27.1.3.
PubMed 23342954Quek J, Bennett C, Melvin GA, Saeedi N, Gordon MS, Newman LK. An investigation of the mentalization-based model of borderline pathology in adolescents. Compr Psychiatry. 2018 Jul;84:87-94. doi: 10.1016/j.comppsych.2018.04.005. Epub 2018 Apr 14.
PubMed 29727808
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Mentalization Profiles Related to Emotional Regulation Among Teenagers With Behavioral Disorders
- ClinicalTrials.gov ID
- NCT05820581
- Acronym / sponsor ID
- CARMEN / 2021/646
- Conditions
- Adolescent Behavior Disorder, Eye Movements
- Keywords
- Mentalisation, Emotion regulation, Adolescents, Neurophysiological parameters
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 26 Jun 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Apr 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.
Behavioral disorders in adolescents are defined by a set of diverse behaviors (such as aggressiveness, agitation, clastic crisis, running away and endangerment) whose common characteristic is the predominance of action/ mentalization. These disorders are associated with significant morbidity and high mortality linked to a high rate of suicide or attempted suicide. Behavioral disorders are also associated with an alteration of mentalizing capacities, that is the psychic process by which the adolescent imagines and interprets his behavior and that of others on the basis of mental states such as needs, desires, beliefs or feelings. The disorders are also associated with emotional dysregulation. To date, the psychopathological processes underlying behavioral disorders in adolescents are unknown and prevent from offering appropriate psychological care. Thus, it seems essential to characterize this clinical population by integrating both its intrapsychic representations and the physiological parameters of emotional regulation associated with it.
This project is a first step towards a larger-scale research project aimed at evaluating treatment by TBM (therapies based on mentalization) in adolescents with behavioral disorders.
Detailed description
Behavioral disorders in adolescents are defined by a set of behaviors (such as aggressiveness, agitation, clastic crisis, running away and endangerment) whose common characteristic is the predominance of action over mentalization and opposition to normal socialization processes.
These disorders are associated with significant morbidity and high mortality linked to a high rate suicide or attempted suicide. Behavioral disorders in adolescence are linked to defects of mentalization (i.e. the psychic process by which the adolescent imagines and interprets his behaviors and to alterations in emotional regulation capacities. This emotional dysregulation has several components, including motor and physiological components. Moreover, this dysregulation is constructed in a dynamic process linked to the environment, including the adolescent's relationship with parents. To date, the psychopathological processes underlying behavioral disorders in the teenager are unknown, which prevents from offering appropriate psychological care. Thus, it seems essential to characterize adolescents behavior, by integrating both mentalizing capacities, the physiological parameters of their emotional regulation and the interactive patterns with their parents. This approach allow to overcome the difficulty of adolescents to use words to express what they feel and thus to understand their psychic functioning and the strategies, which they put in place to regulate their emotions.
This study is a monocentric cross-sectional descriptive observational study.
Objectives of this study is to describe the mentalization profiles of adolescents with mental disorders behavior and to evaluate:
- Oculomotor parameters of emotional regulation
- Physiological parameters of emotional regulation (Electrodermal Activity, RED)
- Self-assessed mentalizing abilities (RFQ-Y scale)
- Emotional regulation (DERS scale)
- The emotional and behavioral functioning of adolescents (YSR scale)
- Attachment characteristics of adolescents (ARSQ scale)
- The interactions of the adolescent with his parent (GPACS scale)
- Parental reflexive capacities (RFQ scale). This research was developed to support a comprehensive understanding of adolescent processes with the integration of bio-neuro-social parameters.
The aim of this study is to establish mentalization profiles of the clinical population of adolescents with behavioral disorders and their neurophysiological correlates of emotional regulation.
These first data are essential for a better understanding of this clinical population and a starting point for future research; particularly to develop therapies based on mentalization in this population and to evaluate their effectiveness.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mentalisation | Experimental | Behavioral: Mentalisation4 mentalisation groups will be defined: hypomentalisation, hypermentalisation, mentalisation correct and lack of mentalisation |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Teenage girls or boys aged 12 to 17
- Adolescent(s) with externalized behavioral disorder(s):
- running away, suicide attempts, self-aggression (scarification, self-mutilation), taking drugs, hetero-aggressive behavior, theft, conduct disorders sexual, oppositional behavior, lies, clastic anger.
- Non-objection of the adolescent to participate in the study.
- Written consent of the two holders of parental authority
Key exclusion criteria (3 listed)
- Intellectually disabled
- Autism Spectrum Disorder
- Psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MentalisationHypomentalisation, hypermentalisation, correct mentalisation, lack of mentalisation | Behavioural | Mentalisation |
Primary outcome
eye fixation duration evaluated with eyes tracker
Time frame: 12 months
fixation duration (time in millisecond)
eye dwell time evaluated with eyes tracker
Time frame: 12 months
dwell time (time in millisecond)
eye fixation count evaluated with eyes tracker
Time frame: 12 months
fixation count ( time in millisecond)
7 secondary outcomes
MASC Score
Time frame: 12 months
YSR score
Time frame: 12 months
RFQ-Y score
Time frame: 12 months
DERS score
Time frame: 12 months
ARSQ score
Time frame: 12 months
parent's RFQ score
Time frame: 12 months
GPACS interaction evaluation
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 30165119Szymanska M, Monnin J, Tio G, Vidal C, Girard F, Galdon L, Smith CC, Bifulco A, Nezelof S, Vulliez-Coady L. How do adolescents regulate distress according to attachment style? A combined eye-tracking and neurophysiological approach. Prog Neuropsychopharmacol Biol Psychiatry. 2019 Mar 8;89:39-47. doi: 10.1016/j.pnpbp.2018.08.019. Epub 2018 Aug 27.
- Background: PubMed 28701091Taubner S, Volkert J, Gablonski TC, Rossouw T. [Mentalization-Based Treatment for Adolescents with Borderline Personality Disorder - Concept and Efficacy]. Prax Kinderpsychol Kinderpsychiatr. 2017 Jul;66(6):423-434. doi: 10.13109/prkk.2017.66.6.423. German.
- Background: PubMed 21621140Sharp C, Pane H, Ha C, Venta A, Patel AB, Sturek J, Fonagy P. Theory of mind and emotion regulation difficulties in adolescents with borderline traits. J Am Acad Child Adolesc Psychiatry. 2011 Jun;50(6):563-573.e1. doi: 10.1016/j.jaac.2011.01.017. Epub 2011 Mar 9.
- Background: PubMed 23342954Sharp C, Ha C, Carbone C, Kim S, Perry K, Williams L, Fonagy P. Hypermentalizing in adolescent inpatients: treatment effects and association with borderline traits. J Pers Disord. 2013 Feb;27(1):3-18. doi: 10.1521/pedi.2013.27.1.3.
- Background: PubMed 29727808Quek J, Bennett C, Melvin GA, Saeedi N, Gordon MS, Newman LK. An investigation of the mentalization-based model of borderline pathology in adolescents. Compr Psychiatry. 2018 Jul;84:87-94. doi: 10.1016/j.comppsych.2018.04.005. Epub 2018 Apr 14.
- Individual participant dataSharing planned: No
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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.
Astrid Pozet, MS study chair
CHU Besancon, DRCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mentalisation in people with Adolescent Behavior Disorder and Eye Movements, run by Centre Hospitalier Universitaire de Besancon 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 5 inclusion and 3 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 19 Sep 2024. 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 Lauriane Vulliez, PR ((0033)0381218154, lvulliez@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eye fixation duration evaluated with eyes tracker (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05820581, which also lists 5 linked publications.
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 19 Sep 2024.