Dissemination and Implementation Field Trial of Dialectical Behavior Therapy for Adolescents With Bipolar Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- therapists will adhere to the DBT Adherence Rating Scale
研究概览
简要总结
The overarching goal of this project is to evaluate the feasibility of implementing dialectical behavior therapy DBT for adolescents with bipolar disorder in an outpatient mental health clinic. In collaboration with the University of Pittsburgh, this study will measure study therapists' knowledge of the DBT model, adherence to the treatment model, and satisfaction with the treatment model.
详细描述
This study proposes to implement dialectical behavior therapy (DBT) for adolescents with bipolar disorder (BD) in an outpatient mental health clinic serving youth with bipolar spectrum disorders. In collaboration with the University of Pittsburgh, this study will systemically operationalize, implement, and examine the specific training, supervision, and programmatic systems needed to successfully implement and sustain the intervention in an adherent manner to achieve positive patient outcomes. This study therefore presents a unique opportunity to enhance understanding of the necessary procedures for implementing the treatment in the community, while allowing us to examine effectiveness of the intervention at the community level.
Aim 1: To examine the short- and longer-term feasibility and acceptability of a training program in DBT for adolescents with BD through clinician satisfaction ratings.
Aim 2: To examine the short- and longer-term effects of the training on practitioner knowledge and performance, and patient outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •English-speaking
- •Age 13 years, 0 months to 19 years, 11 months
- •Meet diagnostic criteria for BD by KSADS-PL
- •Engaged in, or willing to proceed with, a pharmacotherapy regimen
- •At least one parent/guardian with whom the patient lives or regularly interacts (>5 hours per week) is willing to participate in skills training
- •Able and willing to give informed consent/assent to participate.
排除标准
- •Evidence of mental retardation, moderate to severe pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records
- •A life-threatening medical condition requiring immediate treatment
- •Current victim of sexual or physical abuse.
结局指标
主要结局
therapists will adhere to the DBT Adherence Rating Scale
时间窗: End of study year 2
Tapes will be rated for adherence using the DBT Adherence Rating scale. The scale generates a Global Score of DBT adherence and subscale scores for the 12 DBT strategy domains. To examine sustained adherence, each therapist will submit 3 consecutive sessions for adherence coding. The rating scale is not available to the public and is utilized by the DBT-Linehan Board of Certification (copyright). Please see http://www.dbt-lbc.org/downloads/Applicant_Handbook_final_with_RW_review_2018.pdf for more information.
Therapist satisfaction and acceptability
时间窗: 24 months
Therapists will complete a questionnaire (Therapist Satisfaction and Acceptability Questionnaire) assessing their satisfaction with the training and treatment approach at 24 months. Acceptability will be defined as mean acceptability ratings \> 5 ("acceptable") on a likert scale from 1 ("very unacceptable") to 7 ("very acceptable").
Therapists will obtain a passing grade of the DBT Certification Exam
时间窗: 1 year
Clinicians will attain knowledge and fidelity required to pass the DBT certification examination (exam total score ≥ 80%; passing score on case conceptualization; two of three consecutive tapes coded at or above adherence). Please see the certification manual http://www.dbt-lbc.org/downloads/Applicant_Handbook_final_with_RW_review_2018.pdf for more information.
次要结局
- Change in symptoms using the Structured Interview for DSM-IV Personality (SIDP-IV): Borderline Personality Disorder(6 months to 12 months)
- Schedule for Affective Disorders and Schizophrenia for School Age Children, Present and Life Version (K-SADS-PL)(Baseline)
- Depression section of the K-SADS-Present Episode Version (K-SADS-Dep)(Baseline)
- Change in suicidality using the Columbia-Suicide Severity Rating Scale (C-SSRS)(6 months to 12 months)
- Change in suicidality using the Suicidal Ideation Questionnaire (SIQ)(9 months to 12 months)
- Change in hypo/mania symptoms using the Child Mania Rating Scale (CMRS)(9 months to 12 months)
- Change in emotion regulation using the Difficulties in Emotion Regulation Scale (DERS)(9 months to 12 months)
- Change in affective lability using the Children's Affective Lability Scale (CALS)(9 months to 12 months)
- K-SADS Mania Rating Scale (MRS)(Baseline)
- Treatment Satisfaction Questionnaire (18-item)(6 months)
- Dialectical Behavior Therapy Barriers to Implementation(12 months to 24 months)
- Change in symptoms using the Longitudinal Interval Follow-up Evaluation (LIFE)(6 months to 12 months)
- Change in symptoms using the Mood and Feelings Questionnaire (MFQ)(9 months to 12 months)
- Barriers and Facilitators Assessment Instrument (name of scale)(12 months to 24 months)
- Implementation Climate Scale(12 months to 24 months)
- Change in therapist self-assessment(Every month for two years through study completion, an average 24 months.)
研究者
Dr. Benjamin Goldstein
Senior Scientist, Psychiatrist
Sunnybrook Health Sciences Centre