Eye Movements Clinical Trial
— CARMENOfficial title:
Characterization of Mentalization Profiles Related to Emotional Regulation Among Teenagers With Behavioral Disorders
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 |
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Centre Hospitalier Universitaire de Besancon |
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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
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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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
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