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Evaluation of AIT Study

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ClinicalTrials.gov Identifier: NCT02518906
Recruitment Status : Recruiting
First Posted : August 10, 2015
Last Update Posted : March 16, 2018
Sponsor:
Collaborators:
Heidelberg University
Pontificia Universidad Catolica de Chile
Information provided by (Responsible Party):
Klaus Schmeck, University Hospital, Basel, Switzerland

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Personality Disorders Borderline Personality Disorder Behavioral: Adolescent Identity Treatment Behavioral: DBT-A Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Process-Outcome Study on Psychotherapeutic Interventions in Adolescents With Personality Disorders
Study Start Date : September 2015
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Adolescent Identity Treatment
Psychotherapeutic treatment performed routinely at the centres in Basel and Santiago de Chile
Behavioral: Adolescent Identity Treatment

Integrative Approach for the treatment of adolescents with Personality Disorder.

Manual was published in 2013.


Experimental: DBT-A
Psychotherapeutic treatment performed routinely at the centre in Heidelberg
Behavioral: DBT-A
Dialectic Behavioral Treatment for Adolescents is the most commonly used Approach for the Treatment of adolescents with Boderline Personality Disorder




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   13 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02518906


Contacts
Contact: Klaus Schmeck, Prof. +41 (0)61 265 89 60 klaus.schmeck@upkbs.ch

Locations
Chile
Millennium Institute for Research in Depression and Personality - Pontificia Universidad Católica de Chile Recruiting
Santiago de Chile, Chile
Contact: Mariane Krause, Prof. Dr.         
Germany
Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg Recruiting
Heidelberg, Germany
Contact: Michael Kaess, PD Dr.         
Switzerland
Psychiatric Universitiy Hospital Basel Recruiting
Basel, Switzerland, 4056
Contact: Klaus Schmeck, Prof.         
Sponsors and Collaborators
Klaus Schmeck
Heidelberg University
Pontificia Universidad Catolica de Chile
Investigators
Study Director: Klaus Schmeck, Prof. University Basel

Responsible Party: Klaus Schmeck, Professor of Child and Adolescent Psychiatry, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02518906     History of Changes
Other Study ID Numbers: EAST
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Klaus Schmeck, University Hospital, Basel, Switzerland:
Psychotherapy
psychotherapy process
therapeutic alliance
psychotherapeutic change
psychophysiology

Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder
Pathologic Processes
Mental Disorders
Psychotropic Drugs