Clinical trial NCT02518906: Evaluation of AIT Study
Official title: Process-Outcome Study on Psychotherapeutic Interventions in Adolescents With Personality Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Personality Disorders
Borderline Personality Disorder
Keywords: Psychotherapy
psychotherapy process
therapeutic alliance
psychotherapeutic change
psychophysiology
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Heidelberg University
name: Pontificia Universidad Catolica de Chile
First posted: 2015-08-10
Enrollment: 60
Sex: ALL
Minimum age (years): 13
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in Children's Global Assessment Scale (CGAS)
timeFrame: Baseline, 12 months after Baseline
Secondary outcomes:
measure: Psychosocial functioning
timeFrame: Baseline, 12 months after Baseline
measure: School functioning
timeFrame: Baseline, 12 months after Baseline
measure: Change in Psychopathology
timeFrame: Baseline, 12 months after Baseline (only Basel and Heidelberg)
measure: Change in Severity of Psychopathology
timeFrame: Baseline, 12 months after Baseline
measure: Change in Depression
timeFrame: Baseline, 12 months after Baseline
measure: Change in Psychopathological Symptoms
timeFrame: Baseline, 12 months after Baseline
measure: Change in Personality Functioning
timeFrame: Baseline, 12 months after Baseline (only Basel and Heidelberg)
measure: Change in Identity
timeFrame: Baseline, 12 months after Baseline
measure: Change in Personality Disorder Symptoms
timeFrame: Baseline, 12 months after Baseline (only Basel and Heidelberg)
measure: Change in Interpersonal Problems
timeFrame: Baseline, 12 months after Baseline (only Santiago)
measure: Change in Mentalizing Capacity
timeFrame: Baseline, 12 months after Baseline
measure: Change in Quality of Life
timeFrame: Baseline, 12 months after Baseline
measure: Change in Parental Stress
timeFrame: Baseline, 12 months after Baseline (only Basel and Heidelberg)
measure: Self-injurious Behavior
timeFrame: Baseline, 12 months after Baseline (only Basel and Heidelberg)
measure: Borderline-specific Personality Pathology
timeFrame: Baseline, 12 months after Baseline (only Basel and Heidelberg)
measure: Borderline-specific Symptoms
timeFrame: Baseline, 12 months after Baseline (only Basel and Santiago)
measure: Change in Psychophysiological Measures (Only Basel and Heidelberg)
timeFrame: Baseline, 12 months after Baseline
measure: Change in Hair Cortisol Level (only Basel and Heidelberg)
timeFrame: Baseline, 12 months after Baseline
Other outcomes:
Locations:
city: Santiago de Chile
country: Chile
facility: Millennium Institute for Research in Depression and Personality - Pontificia Universidad Católica de Chile
city: Heidelberg
country: Germany
facility: Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg
city: Basel
country: Switzerland
facility: Psychiatric Universitiy Hospital Basel
Study officials:
affiliation: University Basel
name: Klaus Schmeck, Prof.
role: STUDY_DIRECTOR
References:
citation: Schmeck K, Weise S, Schluter-Muller S, Birkholzer M, Furer L, Koenig J, Krause M, Lerch S, Schenk N, Valdes N, Zimmermann R, Kaess M. Effectiveness of adolescent identity treatment (AIT) versus DBT-a for the treatment of adolescent borderline personality disorder. Personal Disord. 2023 Mar;14(2):148-160. doi: 10.1037/per0000572. Epub 2022 May 19.
citation: Zimmermann R, Furer L, Schenk N, Koenig J, Roth V, Schluter-Muller S, Kaess M, Schmeck K. Silence in the psychotherapy of adolescents with borderline personality pathology. Personal Disord. 2021 Mar;12(2):160-170. doi: 10.1037/per0000402. Epub 2020 Apr 23.