NCT02518906

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Longer than P75 for not_applicable

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 10, 2015

Completed
22 days until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

April 20, 2021

Status Verified

April 1, 2021

Enrollment Period

4 years

First QC Date

July 16, 2015

Last Update Submit

April 18, 2021

Conditions

Keywords

Psychotherapypsychotherapy processtherapeutic alliancepsychotherapeutic changepsychophysiology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (18)

  • Psychosocial functioning

    Baseline, 12 months after Baseline

  • School functioning

    Baseline, 12 months after Baseline

  • Change in Psychopathology

    Baseline, 12 months after Baseline (only Basel and Heidelberg)

  • Change in Severity of Psychopathology

    Baseline, 12 months after Baseline

  • Change in Depression

    Baseline, 12 months after Baseline

  • +13 more secondary outcomes

Study Arms (2)

Adolescent Identity Treatment

EXPERIMENTAL

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

Behavioral: Adolescent Identity Treatment

DBT-A

EXPERIMENTAL

Psychotherapeutic treatment performed routinely at the centre in Heidelberg

Behavioral: DBT-A

Interventions

Integrative Approach for the treatment of adolescents with Personality Disorder. Manual was published in 2013.

Adolescent Identity Treatment
DBT-ABEHAVIORAL

Dialectic Behavioral Treatment for Adolescents is the most commonly used Approach for the Treatment of adolescents with Boderline Personality Disorder

DBT-A

Eligibility Criteria

Age13 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Identity Diffusion (AIDA T-score \> 60)
  • borderline Criteria (SKID-II)

You may not qualify if:

  • intelligence quotient (IQ) \< 80
  • psychotic disorder
  • pervasive developmental disorders
  • heavy and persistent substance abuse
  • major somatic or neurological disease
  • hospital treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Millennium Institute for Research in Depression and Personality - Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Department of Child and Adolescent Psychiatry, Centre for Psychosocial Medicine, University of Heidelberg

Heidelberg, Germany

Location

Psychiatric Universitiy Hospital Basel

Basel, 4056, Switzerland

Location

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Conditions

Personality DisordersBorderline Personality Disorder

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Klaus Schmeck, Prof.

    University Basel

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Child and Adolescent Psychiatry

Study Record Dates

First Submitted

July 16, 2015

First Posted

August 10, 2015

Study Start

September 1, 2015

Primary Completion

September 1, 2019

Study Completion

November 1, 2020

Last Updated

April 20, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations