NCT05820581

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
1mo left

Started Jun 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress98%
Jun 2023Jun 2026

First Submitted

Initial submission to the registry

March 27, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 26, 2023

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

2.9 years

First QC Date

March 27, 2023

Last Update Submit

September 5, 2024

Conditions

Keywords

MentalisationEmotion regulationAdolescentsNeurophysiological parameters

Outcome Measures

Primary Outcomes (3)

  • eye fixation duration evaluated with eyes tracker

    fixation duration (time in millisecond)

    12 months

  • eye dwell time evaluated with eyes tracker

    dwell time (time in millisecond)

    12 months

  • eye fixation count evaluated with eyes tracker

    fixation count ( time in millisecond)

    12 months

Secondary Outcomes (7)

  • MASC Score

    12 months

  • YSR score

    12 months

  • RFQ-Y score

    12 months

  • DERS score

    12 months

  • ARSQ score

    12 months

  • +2 more secondary outcomes

Study Arms (1)

Mentalisation

EXPERIMENTAL

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

Behavioral: Mentalisation

Interventions

MentalisationBEHAVIORAL

Hypomentalisation, hypermentalisation, correct mentalisation, lack of mentalisation

Mentalisation

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Intellectually disabled
  • Autism Spectrum Disorder
  • Psychotic disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Besançon

Besançon, France

RECRUITING

Related Publications (5)

  • 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.

    PMID: 30165119BACKGROUND
  • 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.

    PMID: 28701091BACKGROUND
  • 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.

    PMID: 21621140BACKGROUND
  • 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.

    PMID: 23342954BACKGROUND
  • 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.

    PMID: 29727808BACKGROUND

MeSH Terms

Conditions

Emotional Regulation

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Study Officials

  • Astrid Pozet, MS

    CHU Besancon, DRCI

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 19, 2023

Study Start

June 26, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations