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Completed

NCT Number: NCT02518906

Evaluation of AIT Study

Specialized treatment of personality disorders (PD) in youth has been neglected for a long time, because these disorders were not diagnosed before the age of 18. Since 2013 the age threshold has been dropped in the Diagnostic and Statistical Manual (DSM)-5, and such change is also announced for the International Classification of Diseases (ICD)-11. There is broad consensus from both scientific evidence and clinical experience that specialized early interventions in adolescents with PD are urgently needed.

In the last decades a number of specialized psychotherapeutic treatment programs have been developed. Despite their conceptual differences, many of the treatment models have shown significant effects in the treatment of PD in adults. However, the treatment of adolescents with PD remains difficult and further enhancement and development of treatments is needed.

Given the different therapeutic approaches available, the present project aims to go beyond the comparison of integral therapeutic models in the classical outcome study design. While outcome research is important to build on the evidence of the effectiveness of an intervention, it contributes little to its understanding and refinement. The aim of the present multi-center project is to compare two therapeutic methods used in routine care:

* Adolescent Identity Treatment (AIT) * Dialectic Behavioral Treatment for Adolescents (DBT-A)

Treatments will be performed at different study centers and compared using the same measures of outcome. The main outcome will be psychosocial functioning.

Additionally, the psychotherapy process will be investigated to explore specific and unspecific mechanisms of the therapeutic process, its outcome and mediators.

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Key information

Age range

13 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Millennium Institute for Research in Depression and Personality - Pontificia Universidad Católica de Chile, Santiago, Chile

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Identity Diffusion (AIDA T-score > 60)
  • borderline Criteria (SKID-II)

Exclusion criteria

  • intelligence quotient (IQ) < 80
  • psychotic disorder
  • pervasive developmental disorders
  • heavy and persistent substance abuse
  • major somatic or neurological disease
  • hospital treatment

Treatment and study plan

Adolescent Identity Treatment

Behavioral

Integrative Approach for the treatment of adolescents with Personality Disorder.

Manual was published in 2013.

DBT-A

Behavioral

Dialectic Behavioral Treatment for Adolescents is the most commonly used Approach for the Treatment of adolescents with Boderline Personality Disorder

Primary outcomes

  1. Change in Children's Global Assessment Scale (CGAS)

    Time frame: Baseline, 12 months after Baseline

    Psychosocial functioning. Rated considering the results of the Columbia Impairment Scale - parent and patient versions

Secondary outcomes

  1. Psychosocial functioning

    Time frame: Baseline, 12 months after Baseline

    Columbia Impairment Scale (CIS) (Patient and Parent versions)

  2. School functioning

    Time frame: Baseline, 12 months after Baseline

    School Functioning Rating (SFR)

  3. Change in Psychopathology

    Time frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)

    Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

  4. Change in Severity of Psychopathology

    Time frame: Baseline, 12 months after Baseline

    Clinical Global Impression Scale

  5. Change in Depression

    Time frame: Baseline, 12 months after Baseline

    Beck Depression Inventory (BDI)

  6. Change in Psychopathological Symptoms

    Time frame: Baseline, 12 months after Baseline

    Strengths & Difficulties Questionnaires (SDQ)

  7. Change in Personality Functioning

    Time frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)

    Levels of Personality Functioning - Questionnaire for Adolescents (LoPF-QA)

  8. Change in Identity

    Time frame: Baseline, 12 months after Baseline

    Assessment of Identity Development in Adolescence (AIDA)

  9. Change in Personality Disorder Symptoms

    Time frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)

    Structured Clinical Interview of Diagnostic and Statistical Manual of Mental Disorders (DSM) (SCID)-II

  10. Change in Interpersonal Problems

    Time frame: Baseline, 12 months after Baseline (only Santiago)

    Inventory of Interpersonal Problems (IIP-64)

  11. Change in Mentalizing Capacity

    Time frame: Baseline, 12 months after Baseline

    Movie for the Assessment of Social Cognition (MASC)

  12. Change in Quality of Life

    Time frame: Baseline, 12 months after Baseline

    Health-related Quality of Life Screening Instrument for Children and Adolescents (KIDSCREEN)

  13. Change in Parental Stress

    Time frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)

    Eltern-Belastungs-Inventar (EBI)

  14. Self-injurious Behavior

    Time frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)

    Self- Injurious Thoughts and Behaviors Interview

  15. Borderline-specific Personality Pathology

    Time frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)

    Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)

  16. Borderline-specific Symptoms

    Time frame: Baseline, 12 months after Baseline (only Basel and Santiago)

    Borderline Symptom List 23 (BSL-23)

  17. Change in Psychophysiological Measures (Only Basel and Heidelberg)

    Time frame: Baseline, 12 months after Baseline

    Regression analysis will be used to evaluate change; Parameters: Heart Rate Variability and Electrodermal Activity (Basel only)

  18. Change in Hair Cortisol Level (only Basel and Heidelberg)

    Time frame: Baseline, 12 months after Baseline

Sponsors and collaborators

Lead sponsor

Klaus Schmeck

Other

Collaborators

  • Heidelberg University
  • Pontificia Universidad Catolica de Chile

Registry information

Official study title

Process-Outcome Study on Psychotherapeutic Interventions in Adolescents With Personality Disorders

Important dates

Study start
2015
Primary completion
2019
Study completion
2020
First posted
Aug 10, 2015
Registry last updated
Apr 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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