Evaluation of AIT Study

Borderline Personality Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518906
• Other study ID #: EAST
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Disease
• Personality Disorders

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