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Recruiting NCT05820581

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

No phase Interventional Adolescent Behavior Disorder Eye Movements

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mentalisation.
Who it may be relevant to
Registry conditions: Adolescent Behavior Disorder, Eye Movements. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral Mentalisation
    Hypomentalisation, hypermentalisation, correct mentalisation, lack of mentalisation

Primary outcome measures

  • eye fixation duration evaluated with eyes tracker [Time frame: 12 months]
  • eye dwell time evaluated with eyes tracker [Time frame: 12 months]
  • eye fixation count evaluated with eyes tracker [Time frame: 12 months]
Secondary outcome measures (7)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

France · 1 center
  • CHU de Besançon — Besançon

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. PMID 30165119
  • 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. PMID 28701091
  • 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. PMID 21621140
  • 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. PMID 23342954
  • 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. PMID 29727808

Identifiers

NCT: NCT05820581 · 2021/646

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗