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Recruiting NCT06566235

Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders

No phase Interventional Emotional Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Culturally adapted DBT-A-ST group, Satir-based group (SBG).
Who it may be relevant to
Registry conditions: Emotional Disorders. Basic parameters: 12 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Detailed description

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.

Interventions

  • Behavioral 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
  • Behavioral 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

Primary outcome measures

  • Youth Self Report (YSR) [Time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention]
  • Child Behavior Checklist about their adolescents (CBCL) [Time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention]
Secondary outcome measures (4)
  • Hamilton Depression Scale-17 item (HAMD-17) [Time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention]
  • Hamilton Anxiety Scale (HAM-A) [Time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention]
  • Clinical Global Impressions-Severity (CGI-S) [Time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention]
  • Clinical Global Impressions-Improvement (CGI-I) [Time frame: at 15 weeks, and at 3 months after completion of the intervention]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Taiwan · 2 centers
  • MacKay Memorial Hospital — Taipei
  • MacKay Memorial Hospital — Taipei

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗