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NCT Number: NCT05820581

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

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.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Besançon

Besançon, France

Location status: Recruiting

Location contact

Monika Szymanska

CONTACT

[email protected]

00000000

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mentalisation

Behavioral

Hypomentalisation, hypermentalisation, correct mentalisation, lack of mentalisation

Primary outcomes

  1. eye fixation duration evaluated with eyes tracker

    Time frame: 12 months

    fixation duration (time in millisecond)

  2. eye dwell time evaluated with eyes tracker

    Time frame: 12 months

    dwell time (time in millisecond)

  3. eye fixation count evaluated with eyes tracker

    Time frame: 12 months

    fixation count ( time in millisecond)

Secondary outcomes

  1. MASC Score

    Time frame: 12 months

    Mentalization score

  2. YSR score

    Time frame: 12 months

    youth self report score

  3. RFQ-Y score

    Time frame: 12 months

    Reflective Function Questionnaire for Youth

  4. DERS score

    Time frame: 12 months

    Difficulties in Emotion Regulation Scale (DERS)

  5. ARSQ score

    Time frame: 12 months

    Adolescent relationship scale questionnaire

  6. parent's RFQ score

    Time frame: 12 months

    Reflective Functioning Questionnaire for parents

  7. GPACS interaction evaluation

    Time frame: 12 months

    General Practitioner Attitudes and Confidence Scale is a tool to measure confidence and attitude.

Study contacts

Contact information is provided by the study sponsor or research team.

Julie Mathieu, MD

CONTACT

[email protected]

(0033)0381218154

Lauriane Vulliez, PR

CONTACT

[email protected]

(0033)0381218154

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Registry information

Acronym: CARMEN

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2023
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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