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

Sponsor
Centre Hospitalier Universitaire de Besancon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05820581
Collaborator
(none)
65
1
12

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mentalisation
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Characterization of Mentalization Profiles Related to Emotional Regulation Among Teenagers With Behavioral Disorders
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mentalisation

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

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

Outcome Measures

Primary Outcome Measures

  1. eye fixation duration evaluated with eyes tracker [12 months]

    fixation duration (time in millisecond)

  2. eye dwell time evaluated with eyes tracker [12 months]

    dwell time (time in millisecond)

  3. eye fixation count evaluated with eyes tracker [12 months]

    fixation count ( time in millisecond)

Secondary Outcome Measures

  1. MASC Score [12 months]

    Mentalization score

  2. YSR score [12 months]

    youth self report score

  3. RFQ-Y score [12 months]

    Reflective Function Questionnaire for Youth

  4. DERS score [12 months]

    Difficulties in Emotion Regulation Scale (DERS)

  5. ARSQ score [12 months]

    Adolescent relationship scale questionnaire

  6. parent's RFQ score [12 months]

    Reflective Functioning Questionnaire for parents

  7. GPACS interaction evaluation [12 months]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Besancon

Investigators

  • Study Chair: Astrid Pozet, MS, CHU Besancon, DRCI

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier:
NCT05820581
Other Study ID Numbers:
  • 2021/646
First Posted:
Apr 19, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire de Besancon
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2023