Trials / Recruiting
RecruitingNCT06566235
Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders
Cultural Adaptation and Implementation of Dialectical Behavior Therapy Skills Training Group for Adolescents With Emotional Disorders: a Feasibility Study and a Randomized Controlled Trial
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- Sponsor
- Mackay Memorial Hospital · Academic / Other
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
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 ASG, on primary and secondary outcome measures? Participants will: Randomly assigned to (a) a culturally adapted DBT-A-ST or (b) activities-based support group (ASG). 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
A randomized controlled trial will be conducted in a medical center's child adolescent psychiatry department. Participants aged 12-17 years with current depressive or anxiety disorders as diagnosed using the K-SADS-E will be recruited and randomly allocated 1:1 to one of two study arms: a) culturally adapted DBT-A-ST group, b) Activities-based support group. Both interventions are in group format and include 15 weekly sessions, 120 min/each session. Based on power calculation, a target sample size of 160 youths will be included. Assessments will occur before the trial starts, at the 4th and 8th treatment sessions, in the end, and at the 3-month follow-up. 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 self-reported measures. The treatment mechanisms and implementation processes will also be examined.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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-specific didactics and experiential activities, concluding with a 10-minute homework assignment. Two group leaders facilitate the sessions, and participants track their skill usage daily with diary cards, which are reviewed weekly. |
| BEHAVIORAL | Activities-based support group (ASG) | ASG, based on principles of client-centered supportive therapy, is widely used by occupational therapists in mental health settings. ASG therapists aim to foster a sense of belongingness, maintain unconditional positive regard, provide empathy, psychoeducational and a treatment structure. Two group leaders held the sessions, teaching DBT skills and using cognitive behavioral strategies are prohibited. Each session starts with a review of their experiences over the last week (30 min), a support-building activity (30 min), and ends with an open group discussion about topics participants choose each week (50 min). For homework, participants will be asked to think about issues discussed and to track daily social support on diary cards. |
Timeline
- Start date
- 2024-11-05
- Primary completion
- 2027-07-31
- Completion
- 2027-07-31
- First posted
- 2024-08-22
- Last updated
- 2025-11-20
Locations
2 sites across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT06566235. Inclusion in this directory is not an endorsement.