Evaluation of AIT Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Personality Disorders, Borderline Personality Disorder

Intervention / Treatment
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* Behavioral: Adolescent Identity Treatment
* Behavioral: DBT-A


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adolescent Identity Treatment<br>Psychotherapeutic treatment performed routinely at the centres in Basel and Santiago de Chile | Behavioral: Adolescent Identity Treatment<br>* Integrative Approach for the treatment of adolescents with Personality Disorder. Manual was published in 2013.<br>|
| Experimental: DBT-A<br>Psychotherapeutic treatment performed routinely at the centre in Heidelberg | Behavioral: DBT-A<br>* Dialectic Behavioral Treatment for Adolescents is the most commonly used Approach for the Treatment of adolescents with Boderline Personality Disorder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychosocial functioning | Columbia Impairment Scale (CIS) (Patient and Parent versions) | Baseline, 12 months after Baseline | 
| School functioning | School Functioning Rating (SFR) | Baseline, 12 months after Baseline | 
| Change in Psychopathology | Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) | Baseline, 12 months after Baseline (only Basel and Heidelberg) | 
| Change in Severity of Psychopathology | Clinical Global Impression Scale | Baseline, 12 months after Baseline | 
| Change in Depression | Beck Depression Inventory (BDI) | Baseline, 12 months after Baseline | 
| Change in Psychopathological Symptoms | Strengths & Difficulties Questionnaires (SDQ) | Baseline, 12 months after Baseline | 
| Change in Personality Functioning | Levels of Personality Functioning - Questionnaire for Adolescents (LoPF-QA) | Baseline, 12 months after Baseline (only Basel and Heidelberg) | 
| Change in Identity | Assessment of Identity Development in Adolescence (AIDA) | Baseline, 12 months after Baseline | 
| 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) | 
| Change in Interpersonal Problems | Inventory of Interpersonal Problems (IIP-64) | Baseline, 12 months after Baseline (only Santiago) | 
| Change in Mentalizing Capacity | Movie for the Assessment of Social Cognition (MASC) | Baseline, 12 months after Baseline | 
| Change in Quality of Life | Health-related Quality of Life Screening Instrument for Children and Adolescents (KIDSCREEN) | Baseline, 12 months after Baseline | 
| Change in Parental Stress | Eltern-Belastungs-Inventar (EBI) | Baseline, 12 months after Baseline (only Basel and Heidelberg) | 
| Self-injurious Behavior | Self- Injurious Thoughts and Behaviors Interview | Baseline, 12 months after Baseline (only Basel and Heidelberg) | 
| Borderline-specific Personality Pathology | Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) | Baseline, 12 months after Baseline (only Basel and Heidelberg) | 
| Borderline-specific Symptoms | Borderline Symptom List 23 (BSL-23) | Baseline, 12 months after Baseline (only Basel and Santiago) | 
| 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 | 
| Change in Hair Cortisol Level (only Basel and Heidelberg) |  | Baseline, 12 months after Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Psychotherapy, psychotherapy process, therapeutic alliance, psychotherapeutic change, psychophysiology