Process-Outcome Study on Psychotherapeutic Interventions in Adolescents With Personality Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Change in Children's Global Assessment Scale (CGAS)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Identity Diffusion (AIDA T-score > 60)
- •borderline Criteria (SKID-II)
排除标准
- •intelligence quotient (IQ) < 80
- •psychotic disorder
- •pervasive developmental disorders
- •heavy and persistent substance abuse
- •major somatic or neurological disease
- •hospital treatment
结局指标
主要结局
Change in Children's Global Assessment Scale (CGAS)
时间窗: Baseline, 12 months after Baseline
Psychosocial functioning. Rated considering the results of the Columbia Impairment Scale - parent and patient versions
次要结局
- Change in Interpersonal Problems(Baseline, 12 months after Baseline (only Santiago))
- Change in Psychopathology(Baseline, 12 months after Baseline (only Basel and Heidelberg))
- Change in Identity(Baseline, 12 months after Baseline)
- Change in Mentalizing Capacity(Baseline, 12 months after Baseline)
- Borderline-specific Symptoms(Baseline, 12 months after Baseline (only Basel and Santiago))
- School functioning(Baseline, 12 months after Baseline)
- Change in Personality Disorder Symptoms(Baseline, 12 months after Baseline (only Basel and Heidelberg))
- Self-injurious Behavior(Baseline, 12 months after Baseline (only Basel and Heidelberg))
- Borderline-specific Personality Pathology(Baseline, 12 months after Baseline (only Basel and Heidelberg))
- Change in Personality Functioning(Baseline, 12 months after Baseline (only Basel and Heidelberg))
- Psychosocial functioning(Baseline, 12 months after Baseline)
- Change in Severity of Psychopathology(Baseline, 12 months after Baseline)
- Change in Depression(Baseline, 12 months after Baseline)
- Change in Psychopathological Symptoms(Baseline, 12 months after Baseline)
- Change in Quality of Life(Baseline, 12 months after Baseline)
- Change in Parental Stress(Baseline, 12 months after Baseline (only Basel and Heidelberg))
- Change in Hair Cortisol Level (only Basel and Heidelberg)(Baseline, 12 months after Baseline)
- Change in Psychophysiological Measures (Only Basel and Heidelberg)(Baseline, 12 months after Baseline)
研究者
Klaus Schmeck
Professor of Child and Adolescent Psychiatry
University Hospital, Basel, Switzerland