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Characterization of Mentalization Profiles Related to Emotional Regulation Among Teenagers With Behavioral Disorders (CARMEN)

Primary Purpose

Adolescent Behavior Disorder, Eye Movements

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mentalisation
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adolescent Behavior Disorder focused on measuring Mentalisation, Emotion regulation, Adolescents, Neurophysiological parameters

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Intellectually disabled Autism Spectrum Disorder Psychotic disorder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Mentalisation

    Arm Description

    4 mentalisation groups will be defined: hypomentalisation, hypermentalisation, mentalisation correct and lack of mentalisation

    Outcomes

    Primary Outcome Measures

    eye fixation duration evaluated with eyes tracker
    fixation duration (time in millisecond)
    eye dwell time evaluated with eyes tracker
    dwell time (time in millisecond)
    eye fixation count evaluated with eyes tracker
    fixation count ( time in millisecond)

    Secondary Outcome Measures

    MASC Score
    Mentalization score
    YSR score
    youth self report score
    RFQ-Y score
    Reflective Function Questionnaire for Youth
    DERS score
    Difficulties in Emotion Regulation Scale (DERS)
    ARSQ score
    Adolescent relationship scale questionnaire
    parent's RFQ score
    Reflective Functioning Questionnaire for parents
    GPACS interaction evaluation
    General Practitioner Attitudes and Confidence Scale is a tool to measure confidence and attitude.

    Full Information

    First Posted
    March 27, 2023
    Last Updated
    April 24, 2023
    Sponsor
    Centre Hospitalier Universitaire de Besancon
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05820581
    Brief Title
    Characterization of Mentalization Profiles Related to Emotional Regulation Among Teenagers With Behavioral Disorders
    Acronym
    CARMEN
    Official Title
    Characterization of Mentalization Profiles Related to Emotional Regulation Among Teenagers With Behavioral Disorders
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 2023 (Anticipated)
    Primary Completion Date
    April 2024 (Anticipated)
    Study Completion Date
    April 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Centre Hospitalier Universitaire de Besancon

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Behavior Disorder, Eye Movements
    Keywords
    Mentalisation, Emotion regulation, Adolescents, Neurophysiological parameters

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    65 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mentalisation
    Arm Type
    Experimental
    Arm Description
    4 mentalisation groups will be defined: hypomentalisation, hypermentalisation, mentalisation correct and lack of mentalisation
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mentalisation
    Intervention Description
    Hypomentalisation, hypermentalisation, correct mentalisation, lack of mentalisation
    Primary Outcome Measure Information:
    Title
    eye fixation duration evaluated with eyes tracker
    Description
    fixation duration (time in millisecond)
    Time Frame
    12 months
    Title
    eye dwell time evaluated with eyes tracker
    Description
    dwell time (time in millisecond)
    Time Frame
    12 months
    Title
    eye fixation count evaluated with eyes tracker
    Description
    fixation count ( time in millisecond)
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    MASC Score
    Description
    Mentalization score
    Time Frame
    12 months
    Title
    YSR score
    Description
    youth self report score
    Time Frame
    12 months
    Title
    RFQ-Y score
    Description
    Reflective Function Questionnaire for Youth
    Time Frame
    12 months
    Title
    DERS score
    Description
    Difficulties in Emotion Regulation Scale (DERS)
    Time Frame
    12 months
    Title
    ARSQ score
    Description
    Adolescent relationship scale questionnaire
    Time Frame
    12 months
    Title
    parent's RFQ score
    Description
    Reflective Functioning Questionnaire for parents
    Time Frame
    12 months
    Title
    GPACS interaction evaluation
    Description
    General Practitioner Attitudes and Confidence Scale is a tool to measure confidence and attitude.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: Intellectually disabled Autism Spectrum Disorder Psychotic disorder
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Lauriane Vulliez, PR
    Phone
    (0033)0381218154
    Email
    lvulliez@chu-besancon.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Julie Mathieu, MD
    Phone
    (0033)0381218154
    Email
    jmathieu@chu-besancon.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Astrid Pozet, MS
    Organizational Affiliation
    CHU Besancon, DRCI
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    30165119
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28701091
    Citation
    Taubner 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.
    Results Reference
    background
    PubMed Identifier
    21621140
    Citation
    Sharp 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.
    Results Reference
    background
    PubMed Identifier
    23342954
    Citation
    Sharp 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.
    Results Reference
    background
    PubMed Identifier
    29727808
    Citation
    Quek 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.
    Results Reference
    background

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