NCT06566235 Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders
| NCT ID | NCT06566235 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Mackay Memorial Hospital |
| Condition | Emotional Disorders |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2024-10-24 |
| Primary Completion | 2028-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2024-10-24 with a primary completion date of 2028-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Contact & Investigator
Shen-Ing Liu, Ph.D
PRINCIPAL INVESTIGATOR
Mackay Memorial Hospital
Frequently Asked Questions
Who can join the NCT06566235 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 18 Years, studying Emotional Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06566235 currently recruiting?
Yes, NCT06566235 is actively recruiting participants. Contact the research team at aihch@mmh.org.tw for enrollment information.
Where is the NCT06566235 trial being conducted?
This trial is being conducted at Taipei, Taiwan, Taipei, Taiwan.
Who is sponsoring the NCT06566235 clinical trial?
NCT06566235 is sponsored by Mackay Memorial Hospital. The principal investigator is Shen-Ing Liu, Ph.D at Mackay Memorial Hospital. The trial plans to enroll 160 participants.