Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders

Официальное название

Cultural Adaptation and Implementation of Dialectical Behavior Therapy Skills Training Group for Adolescents With Emotional Disorders: a Feasibility Study and a Randomized Controlled Trial

Обзор

The goal of this study is to learn if Dialectical behavior therapy Skills Training for Adolescents (DBT-A-ST) works on emotional disorders in adolescents. The main questions it aims to answer are: Does DBT-A-ST produce faster improvements (i.e., steeper slopes), compared to ASG, on primary and secondary outcome measures during treatment and 3-month follow-up? Does DBT-A-ST produce greater improvements, compared to SBG, on primary and secondary outcome measures? Participants is: Randomly assigned to (a) a culturally adapted DBT-A-ST or (b) Satir-based group (SBG). Received five assessments before the start of the trial (T1), after 4, 8 sessions (T2, T3), at post-intervention (T4), and 3-month follow-up (T5).

Подробное описание

The 1st-year project is to develop the culturally adapted DBT-A-ST using a consensus method and to test its feasibility and acceptability through a pilot study and focus groups. Twenty adolescents with emotional disorders attended a 15-session 120-min DBT-A-ST. After finishing the treatment, they were invited to participate in a 90-min focus group. Cultural adaptation of the treatment is based on these results. From the 2nd to 4th year, a partially randomized patient preference (PRPP) trial is conducted in the child and adolescent psychiatry department of a medical center. Participants aged 12-18 years with current depressive or anxiety disorders as diagnosed using the K-SADS-E are recruited and randomly allocated 1:1 or patient preference to one of two study arms: a) culturally adapted DBT-A-ST group, b) Satir group. Both interventions in group format include 15 weekly sessions, 120 min/ each session. A target sample size of 160 youths is included, based on power calculation. Five assessments are conducted: before the start of the trial (T1), after 4 sessions (T2), after 8 sessions (T3), at post-intervention (T4), and at 3-month follow-up (T5). Primary outcomes are the severity of depression and anxiety, rated by blind assessors. Secondary outcomes include general psychopathology, number of DSM-5 disorders, quality of life, and a battery of self-reported measures. The treatment mechanisms and implementation processes are also examined.

Вмешательства

• Поведенческое Culturally adapted DBT-A-ST group
  The culturally adapted DBT-A-ST consists of 15 weekly group sessions, each lasting 120 minutes, including a 10-minute break. It maintains the core elements of standard DBT-A, including its philosophical foundation and treatment strategies. Therapists focus on teaching DBT skills through various methods such as modeling, structured behavioral rehearsals, and feedback. Each session begins with a 40-minute group mindfulness exercise and homework review, followed by 60 minutes dedicated to skill-sp
• Поведенческое Satir-based group (SBG)
  SBG, grounded in Satir's Iceberg Theory, aims to enhance self-awareness and communication by exploring participants' deeper emotions and beliefs. Sessions include emotional sharing, communication skills training, and role-play exercises. The program spans 15 weekly sessions (2 hours each): 10 for adolescents and 3 involving both adolescents and their parents. Activities focus on practicing communication stances, reflection, and group discussion to foster personal growth and improved relationship

Первичные конечные точки

• Youth Self Report (YSR) [Срок оценки: at baseline, at 15 weeks, and at 3 months after completion of the intervention]
• Child Behavior Checklist about their adolescents (CBCL) [Срок оценки: at baseline, at 15 weeks, and at 3 months after completion of the intervention]

Вторичные конечные точки (4)

• Hamilton Depression Scale-17 item (HAMD-17) [Срок оценки: at baseline, at 15 weeks, and at 3 months after completion of the intervention]
• Hamilton Anxiety Scale (HAM-A) [Срок оценки: at baseline, at 15 weeks, and at 3 months after completion of the intervention]
• Clinical Global Impressions-Severity (CGI-S) [Срок оценки: at baseline, at 15 weeks, and at 3 months after completion of the intervention]
• Clinical Global Impressions-Improvement (CGI-I) [Срок оценки: at 15 weeks, and at 3 months after completion of the intervention]

Критерии участия

Критерии включения

• Age 12-18 years.
• Informed consent provided by the youth and one parent.
• Sufficient Mandarin Chinese proficiency to complete study questionnaires.
• Total score of PHQ-9 ≥ 8 or GAD-7 ≥ 8, or SDQ total score ≥ 10, or SDQ hyperactivity subscale score ≥ 3.
• Primary diagnosis of depressive, anxiety disorder, or ADHD based on K-SADS-

E interview, including:

Depression (F32-33) Persistent mood disorder (F34) Phobic anxiety disorder (F40) Other anxiety disorder (F41) Adjustment disorders (F43.2) ADHD (F90)

• Stable medication use for at least four weeks and willingness to maintain stable dosage during the study.
• Individuals with comorbid emotional disorders are included; comorbidities are not stratified to avoid increasing study design complexity.

Критерии исключения

• Educational level of elementary school or university.
• Comorbid intellectual disability or psychotic disorder.
• Acute suicidality.
• Insufficient Chinese language skills.
• Unwillingness to discontinue current psychotherapy.
• Unwillingness to accept video recording during group therapy.
• Medication changes during the trial are not exclusionary if judged necessary or clinically important by the treating clinician, to maintain a naturalistic setting.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Тайвань · 2 центра

• MacKay Memorial Hospital — Taipei
• MacKay Memorial Hospital — Taipei

Идентификаторы

NCT: NCT06566235 · NSTC 113-2314-B-195 -012 -MY3

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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