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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05820581
Other study ID # 2021/646
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date April 2023
Est. completion date April 2024

Study information

Verified date March 2023
Source Centre Hospitalier Universitaire de Besancon
Contact Lauriane Vulliez, PR
Phone (0033)0381218154
Email lvulliez@chu-besancon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 65
Est. completion date April 2024
Est. primary completion date April 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 18 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Besancon

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary eye fixation duration evaluated with eyes tracker fixation duration (time in millisecond) 12 months
Primary eye dwell time evaluated with eyes tracker dwell time (time in millisecond) 12 months
Primary eye fixation count evaluated with eyes tracker fixation count ( time in millisecond) 12 months
Secondary MASC Score Mentalization score 12 months
Secondary YSR score youth self report score 12 months
Secondary RFQ-Y score Reflective Function Questionnaire for Youth 12 months
Secondary DERS score Difficulties in Emotion Regulation Scale (DERS) 12 months
Secondary ARSQ score Adolescent relationship scale questionnaire 12 months
Secondary parent's RFQ score Reflective Functioning Questionnaire for parents 12 months
Secondary GPACS interaction evaluation General Practitioner Attitudes and Confidence Scale is a tool to measure confidence and attitude. 12 months
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