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

April 24, 2023 updated by: Centre Hospitalier Universitaire de Besancon

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eye fixation duration evaluated with eyes tracker
Time Frame: 12 months
fixation duration (time in millisecond)
12 months
eye dwell time evaluated with eyes tracker
Time Frame: 12 months
dwell time (time in millisecond)
12 months
eye fixation count evaluated with eyes tracker
Time Frame: 12 months
fixation count ( time in millisecond)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
RFQ-Y score
Time Frame: 12 months
Reflective Function Questionnaire for Youth
12 months
DERS score
Time Frame: 12 months
Difficulties in Emotion Regulation Scale (DERS)
12 months
ARSQ score
Time Frame: 12 months
Adolescent relationship scale questionnaire
12 months
parent's RFQ score
Time Frame: 12 months
Reflective Functioning Questionnaire for parents
12 months
GPACS interaction evaluation
Time Frame: 12 months
General Practitioner Attitudes and Confidence Scale is a tool to measure confidence and attitude.
12 months
MASC Score
Time Frame: 12 months
Mentalization score
12 months
YSR score
Time Frame: 12 months
youth self report score
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 7, 2023

First Posted (Actual)

April 19, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/646

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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