Evaluation of AIT Study

• Register: ClinicalTrials.gov
• Last refreshed on: 26 April 2021
• Main ID: NCT02518906
• Date of registration: 16/07/2015
• Prospective Registration: Yes
• Primary sponsor: Klaus Schmeck
• Public title: Evaluation of AIT Study
• Scientific title: Process-Outcome Study on Psychotherapeutic Interventions in Adolescents With Personality Disorders
• Date of first enrolment: September 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02518906
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Chile, Germany, Switzerland

Contacts

• Name: Klaus Schmeck, Prof.
• Affiliation: University Basel

Key inclusion & exclusion 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



Age minimum: 13 Years
Age maximum: 19 Years
Gender: All

Health Condition(s) or Problem(s) studied

Personality Disorders

Borderline Personality Disorder

Intervention(s)

Behavioral: DBT-A

Behavioral: Adolescent Identity Treatment

Primary Outcome(s)

Change in Children's Global Assessment Scale (CGAS) [Time Frame: Baseline, 12 months after Baseline]

Secondary Outcome(s)

Change in Personality Functioning [Time Frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)]

Borderline-specific Symptoms [Time Frame: Baseline, 12 months after Baseline (only Basel and Santiago)]

Change in Interpersonal Problems [Time Frame: Baseline, 12 months after Baseline (only Santiago)]

Change in Quality of Life [Time Frame: Baseline, 12 months after Baseline]

Change in Identity [Time Frame: Baseline, 12 months after Baseline]

Psychosocial functioning [Time Frame: Baseline, 12 months after Baseline]

Change in Depression [Time Frame: Baseline, 12 months after Baseline]

Change in Psychopathology [Time Frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)]

Change in Severity of Psychopathology [Time Frame: Baseline, 12 months after Baseline]

Self-injurious Behavior [Time Frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)]

Change in Hair Cortisol Level (only Basel and Heidelberg) [Time Frame: Baseline, 12 months after Baseline]

Change in Mentalizing Capacity [Time Frame: Baseline, 12 months after Baseline]

Change in Psychopathological Symptoms [Time Frame: Baseline, 12 months after Baseline]

School functioning [Time Frame: Baseline, 12 months after Baseline]

Change in Psychophysiological Measures (Only Basel and Heidelberg) [Time Frame: Baseline, 12 months after Baseline]

Borderline-specific Personality Pathology [Time Frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)]

Change in Parental Stress [Time Frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)]

Change in Personality Disorder Symptoms [Time Frame: Baseline, 12 months after Baseline (only Basel and Heidelberg)]

Secondary ID(s)

EAST

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Heidelberg University

Pontificia Universidad Catolica de Chile