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Evaluation of AIT Study

Sponsor
Klaus Schmeck (Other)
Overall Status
Completed
CT.gov ID
NCT02518906
Collaborator
Heidelberg University (Other), Pontificia Universidad Catolica de Chile (Other)
60
Enrollment
3
Locations
2
Arms
62
Actual Duration (Months)
20
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: Adolescent Identity Treatment
  • Behavioral: DBT-A
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Process-Outcome Study on Psychotherapeutic Interventions in Adolescents With Personality Disorders
Actual Study Start Date :
Sep 1, 2015
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Nov 1, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Change in Children's Global Assessment Scale (CGAS) [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 [Baseline, 12 months after Baseline]

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

  2. School functioning [Baseline, 12 months after Baseline]

    School Functioning Rating (SFR)

  3. Change in Psychopathology [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 [Baseline, 12 months after Baseline]

    Clinical Global Impression Scale

  5. Change in Depression [Baseline, 12 months after Baseline]

    Beck Depression Inventory (BDI)

  6. Change in Psychopathological Symptoms [Baseline, 12 months after Baseline]

    Strengths & Difficulties Questionnaires (SDQ)

  7. Change in Personality Functioning [Baseline, 12 months after Baseline (only Basel and Heidelberg)]

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

  8. Change in Identity [Baseline, 12 months after Baseline]

    Assessment of Identity Development in Adolescence (AIDA)

  9. Change in Personality Disorder Symptoms [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 [Baseline, 12 months after Baseline (only Santiago)]

    Inventory of Interpersonal Problems (IIP-64)

  11. Change in Mentalizing Capacity [Baseline, 12 months after Baseline]

    Movie for the Assessment of Social Cognition (MASC)

  12. Change in Quality of Life [Baseline, 12 months after Baseline]

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

  13. Change in Parental Stress [Baseline, 12 months after Baseline (only Basel and Heidelberg)]

    Eltern-Belastungs-Inventar (EBI)

  14. Self-injurious Behavior [Baseline, 12 months after Baseline (only Basel and Heidelberg)]

    Self- Injurious Thoughts and Behaviors Interview

  15. Borderline-specific Personality Pathology [Baseline, 12 months after Baseline (only Basel and Heidelberg)]

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

  16. Borderline-specific Symptoms [Baseline, 12 months after Baseline (only Basel and Santiago)]

    Borderline Symptom List 23 (BSL-23)

  17. Change in Psychophysiological Measures (Only Basel and Heidelberg) [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) [Baseline, 12 months after Baseline]

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 19 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Millennium Institute for Research in Depression and Personality - Pontificia Universidad Católica de Chile Santiago de Chile Chile
2 Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg Heidelberg Germany
3 Psychiatric Universitiy Hospital Basel Basel Switzerland 4056

Sponsors and Collaborators

  • Klaus Schmeck
  • Heidelberg University
  • Pontificia Universidad Catolica de Chile

Investigators

  • Study Director: Klaus Schmeck, Prof., University Basel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Klaus Schmeck, Professor of Child and Adolescent Psychiatry, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT02518906
Other Study ID Numbers:
  • EAST
First Posted:
Aug 10, 2015
Last Update Posted:
Apr 20, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Klaus Schmeck, Professor of Child and Adolescent Psychiatry, University Hospital, Basel, Switzerland
Psychotherapy
psychotherapy process
therapeutic alliance
psychotherapeutic change
psychophysiology
Additional relevant MeSH terms:
Disease
Personality Disorders
Borderline Personality Disorder

Study Results

No Results Posted as of Apr 20, 2021