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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02518906
Other study ID # EAST
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date November 2020

Study information

Verified date April 2021
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date November 2020
Est. primary completion date September 2019
Accepts healthy volunteers No
Gender All
Age group 13 Years to 19 Years
Eligibility 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

Study Design


Intervention

Behavioral:
Adolescent Identity Treatment
Integrative Approach for the treatment of adolescents with Personality Disorder. Manual was published in 2013.
DBT-A
Dialectic Behavioral Treatment for Adolescents is the most commonly used Approach for the Treatment of adolescents with Boderline Personality Disorder

Locations

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

Sponsors (3)

Lead Sponsor Collaborator
Klaus Schmeck Heidelberg University, Pontificia Universidad Catolica de Chile

Countries where clinical trial is conducted

Chile,  Germany,  Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Children's Global Assessment Scale (CGAS) Psychosocial functioning. Rated considering the results of the Columbia Impairment Scale - parent and patient versions Baseline, 12 months after Baseline
Secondary Psychosocial functioning Columbia Impairment Scale (CIS) (Patient and Parent versions) Baseline, 12 months after Baseline
Secondary School functioning School Functioning Rating (SFR) Baseline, 12 months after Baseline
Secondary Change in Psychopathology Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Change in Severity of Psychopathology Clinical Global Impression Scale Baseline, 12 months after Baseline
Secondary Change in Depression Beck Depression Inventory (BDI) Baseline, 12 months after Baseline
Secondary Change in Psychopathological Symptoms Strengths & Difficulties Questionnaires (SDQ) Baseline, 12 months after Baseline
Secondary Change in Personality Functioning Levels of Personality Functioning - Questionnaire for Adolescents (LoPF-QA) Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Change in Identity Assessment of Identity Development in Adolescence (AIDA) Baseline, 12 months after Baseline
Secondary Change in Personality Disorder Symptoms Structured Clinical Interview of Diagnostic and Statistical Manual of Mental Disorders (DSM) (SCID)-II Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Change in Interpersonal Problems Inventory of Interpersonal Problems (IIP-64) Baseline, 12 months after Baseline (only Santiago)
Secondary Change in Mentalizing Capacity Movie for the Assessment of Social Cognition (MASC) Baseline, 12 months after Baseline
Secondary Change in Quality of Life Health-related Quality of Life Screening Instrument for Children and Adolescents (KIDSCREEN) Baseline, 12 months after Baseline
Secondary Change in Parental Stress Eltern-Belastungs-Inventar (EBI) Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Self-injurious Behavior Self- Injurious Thoughts and Behaviors Interview Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Borderline-specific Personality Pathology Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Baseline, 12 months after Baseline (only Basel and Heidelberg)
Secondary Borderline-specific Symptoms Borderline Symptom List 23 (BSL-23) Baseline, 12 months after Baseline (only Basel and Santiago)
Secondary Change in Psychophysiological Measures (Only Basel and Heidelberg) Regression analysis will be used to evaluate change; Parameters: Heart Rate Variability and Electrodermal Activity (Basel only) Baseline, 12 months after Baseline
Secondary Change in Hair Cortisol Level (only Basel and Heidelberg) Baseline, 12 months after Baseline
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