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Recruiting NCT06566235

Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders

Conditions: Emotional Disorders

Sex: All
Ages: 12 Years – 18 Years
Healthy volunteers: No
Phase: NA
Enrollment: 160
Sponsor: Mackay Memorial Hospital

Location: MacKay Memorial Hospital Taipei

Summary

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).

Eligibility Criteria

Inclusion Criteria: 1. Age 12-18 years. 2. Informed consent provided by the youth and one parent. 3. Sufficient Mandarin Chinese proficiency to complete study questionnaires. 4. Total score of PHQ-9 ≥ 8 or GAD-7 ≥ 8, or SDQ total score ≥ 10, or SDQ hyperactivity subscale score ≥ 3. 5. 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) 6. Stable medication use for at least four weeks and willingness to maintain stable dosage during the study. 7. Individuals with comorbid emotional disorders are included; comorbidities are not stratified to avoid increasing study design complexity. Exclusion Criteria: 1. Educational level of elementary school or university. 2. Comorbid intellectual disability or psychotic disorder. 3. Acute suicidality. 4. Insufficient Chinese language skills. 5. Unwillingness to discontinue current psychotherapy. 6. Unwillingness to accept video recording during group therapy. 7. Medication changes during the trial are not exclusionary if judged necessary or clinically important by the treating clinician, to maintain a naturalistic setting.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06566235). StuddyBuddy aggregates publicly available trial information.