Evaluation of AIT Study

April 18, 2021 updated by: Klaus Schmeck

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago de Chile, Chile
        • Millennium Institute for Research in Depression and Personality - Pontificia Universidad Católica de Chile
  • Germany
      • Heidelberg, Germany
        • Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg
  • Switzerland
      • Basel, Switzerland, 4056
        • Psychiatric Universitiy Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 19 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klaus Schmeck

Collaborators

Pontificia Universidad Catolica de Chile
Heidelberg University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

September 1, 2019

Study Completion (Actual)

November 1, 2020

Study Registration Dates

First Submitted

July 16, 2015

First Submitted That Met QC Criteria

August 5, 2015

First Posted (Estimate)

August 10, 2015

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 18, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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