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Evaluation of AIT Study

Primary Purpose

Personality Disorders, Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Adolescent Identity Treatment
DBT-A
Sponsored by
Klaus Schmeck
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Personality Disorders focused on measuring Psychotherapy, psychotherapy process, therapeutic alliance, psychotherapeutic change, psychophysiology

Eligibility Criteria

13 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Millennium Institute for Research in Depression and Personality - Pontificia Universidad Católica de Chile
  • Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg
  • Psychiatric Universitiy Hospital Basel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adolescent Identity Treatment

DBT-A

Arm Description

Psychotherapeutic treatment performed routinely at the centres in Basel and Santiago de Chile

Psychotherapeutic treatment performed routinely at the centre in Heidelberg

Outcomes

Primary Outcome Measures

Change in Children's Global Assessment Scale (CGAS)
Psychosocial functioning. Rated considering the results of the Columbia Impairment Scale - parent and patient versions

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2015
Last Updated
April 18, 2021
Sponsor
Klaus Schmeck
Collaborators
Heidelberg University, Pontificia Universidad Catolica de Chile
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1. Study Identification

Unique Protocol Identification Number
NCT02518906
Brief Title
Evaluation of AIT Study
Official Title
Process-Outcome Study on Psychotherapeutic Interventions in Adolescents With Personality Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Klaus Schmeck
Collaborators
Heidelberg University, Pontificia Universidad Catolica de Chile

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Personality Disorders, Borderline Personality Disorder
Keywords
Psychotherapy, psychotherapy process, therapeutic alliance, psychotherapeutic change, psychophysiology

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adolescent Identity Treatment
Arm Type
Experimental
Arm Description
Psychotherapeutic treatment performed routinely at the centres in Basel and Santiago de Chile
Arm Title
DBT-A
Arm Type
Experimental
Arm Description
Psychotherapeutic treatment performed routinely at the centre in Heidelberg
Intervention Type
Behavioral
Intervention Name(s)
Adolescent Identity Treatment
Intervention Description
Integrative Approach for the treatment of adolescents with Personality Disorder. Manual was published in 2013.
Intervention Type
Behavioral
Intervention Name(s)
DBT-A
Intervention Description
Dialectic Behavioral Treatment for Adolescents is the most commonly used Approach for the Treatment of adolescents with Boderline Personality Disorder
Primary Outcome Measure Information:
Title
Change in Children's Global Assessment Scale (CGAS)
Description
Psychosocial functioning. Rated considering the results of the Columbia Impairment Scale - parent and patient versions
Time Frame
Baseline, 12 months after Baseline
Secondary Outcome Measure Information:
Title
Psychosocial functioning
Description
Columbia Impairment Scale (CIS) (Patient and Parent versions)
Time Frame
Baseline, 12 months after Baseline
Title
School functioning
Description
School Functioning Rating (SFR)
Time Frame
Baseline, 12 months after Baseline
Title
Change in Psychopathology
Description
Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)
Time Frame
Baseline, 12 months after Baseline (only Basel and Heidelberg)
Title
Change in Severity of Psychopathology
Description
Clinical Global Impression Scale
Time Frame
Baseline, 12 months after Baseline
Title
Change in Depression
Description
Beck Depression Inventory (BDI)
Time Frame
Baseline, 12 months after Baseline
Title
Change in Psychopathological Symptoms
Description
Strengths & Difficulties Questionnaires (SDQ)
Time Frame
Baseline, 12 months after Baseline
Title
Change in Personality Functioning
Description
Levels of Personality Functioning - Questionnaire for Adolescents (LoPF-QA)
Time Frame
Baseline, 12 months after Baseline (only Basel and Heidelberg)
Title
Change in Identity
Description
Assessment of Identity Development in Adolescence (AIDA)
Time Frame
Baseline, 12 months after Baseline
Title
Change in Personality Disorder Symptoms
Description
Structured Clinical Interview of Diagnostic and Statistical Manual of Mental Disorders (DSM) (SCID)-II
Time Frame
Baseline, 12 months after Baseline (only Basel and Heidelberg)
Title
Change in Interpersonal Problems
Description
Inventory of Interpersonal Problems (IIP-64)
Time Frame
Baseline, 12 months after Baseline (only Santiago)
Title
Change in Mentalizing Capacity
Description
Movie for the Assessment of Social Cognition (MASC)
Time Frame
Baseline, 12 months after Baseline
Title
Change in Quality of Life
Description
Health-related Quality of Life Screening Instrument for Children and Adolescents (KIDSCREEN)
Time Frame
Baseline, 12 months after Baseline
Title
Change in Parental Stress
Description
Eltern-Belastungs-Inventar (EBI)
Time Frame
Baseline, 12 months after Baseline (only Basel and Heidelberg)
Title
Self-injurious Behavior
Description
Self- Injurious Thoughts and Behaviors Interview
Time Frame
Baseline, 12 months after Baseline (only Basel and Heidelberg)
Title
Borderline-specific Personality Pathology
Description
Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)
Time Frame
Baseline, 12 months after Baseline (only Basel and Heidelberg)
Title
Borderline-specific Symptoms
Description
Borderline Symptom List 23 (BSL-23)
Time Frame
Baseline, 12 months after Baseline (only Basel and Santiago)
Title
Change in Psychophysiological Measures (Only Basel and Heidelberg)
Description
Regression analysis will be used to evaluate change; Parameters: Heart Rate Variability and Electrodermal Activity (Basel only)
Time Frame
Baseline, 12 months after Baseline
Title
Change in Hair Cortisol Level (only Basel and Heidelberg)
Time Frame
Baseline, 12 months after Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Klaus Schmeck, Prof.
Organizational Affiliation
University Basel
Official's Role
Study Director
Facility Information:
Facility Name
Millennium Institute for Research in Depression and Personality - Pontificia Universidad Católica de Chile
City
Santiago de Chile
Country
Chile
Facility Name
Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg
City
Heidelberg
Country
Germany
Facility Name
Psychiatric Universitiy Hospital Basel
City
Basel
ZIP/Postal Code
4056
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35587408
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.
Results Reference
derived
PubMed Identifier
32324008
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.
Results Reference
derived

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Evaluation of AIT Study

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