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Personality DisordersNCT02518906

Evaluation of AIT Study

A study testing Adolescent Identity Treatment and DBT-A in people with Personality Disorders and Borderline Personality Disorder, run by Klaus Schmeck at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 13 to 19 years
What is being tested?
Adolescent Identity Treatment and DBT-A
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesin 3 countries
Study dates
Sep 2015to Nov 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 19 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Chile1 site

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

    Santiago

Other trials in Chile

Germany1 site

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

    Heidelberg

Other trials in Germany

Switzerland1 site

  • Psychiatric Universitiy Hospital Basel

    Basel, 4056

Other trials in Switzerland

About this study

Official title: 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.

Read more

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.

Being tested
Adolescent Identity Treatment, DBT-A
Keywords
Psychotherapy, psychotherapy process, therapeutic alliance, psychotherapeutic change, psychophysiology
Medical subject headings
Personality Disorders, Borderline Personality Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adolescent Identity TreatmentBehavioural

    Integrative Approach for the treatment of adolescents with Personality Disorder.

    Manual was published in 2013.

  • DBT-ABehavioural

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

Study groups in NCT02518906
Study groupRoleWhat they receive
Adolescent Identity TreatmentExperimentalPsychotherapeutic treatment performed routinely at the centres in Basel and Santiago de Chile
Receives: Behavioral: Adolescent Identity Treatment
DBT-AExperimentalPsychotherapeutic treatment performed routinely at the centre in Heidelberg
Receives: Behavioral: DBT-A

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Children's Global Assessment Scale (CGAS)

    Psychosocial functioning. Rated considering the results of the Columbia Impairment Scale - parent and patient versions

    Measured: Baseline, 12 months after Baseline

Secondary outcomes (18)

  1. Psychosocial functioning

    Columbia Impairment Scale (CIS) (Patient and Parent versions)

    Measured: Baseline, 12 months after Baseline

  2. School functioning

    School Functioning Rating (SFR)

    Measured: Baseline, 12 months after Baseline

  3. Change in Psychopathology

    Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID)

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

  4. Change in Severity of Psychopathology

    Clinical Global Impression Scale

    Measured: Baseline, 12 months after Baseline

  5. Change in Depression

    Beck Depression Inventory (BDI)

    Measured: Baseline, 12 months after Baseline

  6. Change in Psychopathological Symptoms

    Strengths \& Difficulties Questionnaires (SDQ)

    Measured: Baseline, 12 months after Baseline

  7. Change in Personality Functioning

    Levels of Personality Functioning - Questionnaire for Adolescents (LoPF-QA)

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

  8. Change in Identity

    Assessment of Identity Development in Adolescence (AIDA)

    Measured: Baseline, 12 months after Baseline

  9. Change in Personality Disorder Symptoms

    Structured Clinical Interview of Diagnostic and Statistical Manual of Mental Disorders (DSM) (SCID)-II

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

  10. Change in Interpersonal Problems

    Inventory of Interpersonal Problems (IIP-64)

    Measured: Baseline, 12 months after Baseline (only Santiago)

  11. Change in Mentalizing Capacity

    Movie for the Assessment of Social Cognition (MASC)

    Measured: Baseline, 12 months after Baseline

  12. Change in Quality of Life

    Health-related Quality of Life Screening Instrument for Children and Adolescents (KIDSCREEN)

    Measured: Baseline, 12 months after Baseline

  13. Change in Parental Stress

    Eltern-Belastungs-Inventar (EBI)

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

  14. Self-injurious Behavior

    Self- Injurious Thoughts and Behaviors Interview

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

  15. Borderline-specific Personality Pathology

    Zanarini Rating Scale for Borderline Personality Disorder (ZAN-BPD)

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

  16. Borderline-specific Symptoms

    Borderline Symptom List 23 (BSL-23)

    Measured: Baseline, 12 months after Baseline (only Basel and Santiago)

  17. 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)

    Measured: Baseline, 12 months after Baseline

  18. Change in Hair Cortisol Level (only Basel and Heidelberg)

    Measured: Baseline, 12 months after Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2019
  4. Study completionNov 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02518906
Sponsor's protocol ID
EAST
Status last verified
Apr 2021
First submitted
16 Jul 2015
Last updated
20 Apr 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35587408

  • 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.

    PubMed 32324008

Questions about this trial

What is this clinical trial studying?

A study testing Adolescent Identity Treatment and DBT-A in people with Personality Disorders and Borderline Personality Disorder, run by Klaus Schmeck at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Chile, Germany, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Children's Global Assessment Scale (CGAS) (time frame: Baseline, 12 months after Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02518906, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.

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