Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders

NCT06566235 | Recruiting

• 1 other identifier: NSTC 113-2314-B-195 -012 -MY3
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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).

Conditions

Emotional Disorders

Keywords

Dialectical Behavior Therapy Skills Training Group; Adolescents; Emotional Disorders

Outcome Measures

Primary Outcomes (2)

• Youth Self Report (YSR)

  The Youth Self Report (YSR) is a self-reported measure assessing emotional and behavioral problems in adolescents. Each item is rated on a 3-point scale (0 = not true, 1 = sometimes true, 2 = mostly or completely true). The scale includes internalizing problems (withdrawal, anxiety/depression, and somatic complaints) and externalizing problems (rule-breaking and aggressive behaviors). Raw scores are converted to standardized T-scores based on normative data, with higher scores indicating more severe emotional and behavioral problems. T scores range approximately from 50 to 100, with scores above 70 indicating the clinical range.

  at baseline, at 15 weeks, and at 3 months after completion of the intervention

• Child Behavior Checklist about their adolescents (CBCL)

  The Child Behavior Checklist (CBCL) is used to assess behavioral and emotional problems in children and adolescents. Each item is rated on a 3-point Likert scale (0-2). Raw scores are converted to standardized T-scores based on age- and gender-specific norms, with higher scores indicating more severe behavioral and emotional problems. T scores of ≤59 indicate nonclinical symptoms, scores of 60-64 suggest a risk for problem behaviors, and scores ≥65 indicate clinically significant symptoms.

  at baseline, at 15 weeks, and at 3 months after completion of the intervention

Secondary Outcomes (4)

• Hamilton Depression Scale-17 item (HAMD-17)

  at baseline, at 15 weeks, and at 3 months after completion of the intervention

• Hamilton Anxiety Scale (HAM-A)

  at baseline, at 15 weeks, and at 3 months after completion of the intervention

• Clinical Global Impressions-Severity (CGI-S)

  at baseline, at 15 weeks, and at 3 months after completion of the intervention

• Clinical Global Impressions-Improvement (CGI-I)

  at 15 weeks, and at 3 months after completion of the intervention

Other Outcomes (21)

• Patient Health Questionnaire-9 item (PHQ-9)

  at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention

• Generalized Anxiety Disorder Scale-7 item (GAD-7)

  at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention

• The number of the DSM-5 diagnoses

  at baseline, at 15weeks, and at 3 months after completion of the intervention

Study Arms (2)

Culturally adapted DBT-A-ST group

EXPERIMENTAL

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: Culturally adapted DBT-A-ST group

Satir-based group (SBG)

PLACEBO COMPARATOR

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 relationships. The inclusion of parents is designed to help teens build supportive, resilient connections.

Behavioral: Satir-based group (SBG)

Interventions

Satir-based group (SBG) BEHAVIORAL

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 relationships. The inclusion of parents is designed to help teens build supportive, resilient connections.

Satir-based group (SBG)

Culturally adapted DBT-A-ST group BEHAVIORAL

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.

Culturally adapted DBT-A-ST group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (2)

MacKay Memorial Hospital

Taipei, Taiwan

ACTIVE NOT RECRUITING

MacKay Memorial Hospital

Taipei, Taiwan

RECRUITING

Study Officials

• Shen-Ing Liu, Ph.D

  Mackay Memorial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hui-Chun Huang, Ph.D

CONTACT

886-2-28094661; aihch@mmh.org.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Only randomized participants have outcomes assessed by blinded assessors. For participants assigned to their preferred intervention, assessors are aware of treatment assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Attending Psychiatrist, Professor

Model Details: This study is conducted in two phases under a single protocol. The first-year pilot phase assessed feasibility and optimized study procedures. The main study comprises two parallel intervention groups. The trial was originally designed as a 1:1 randomized controlled trial (RCT); however, due to recruitment challenges and participants' treatment preferences, the protocol was amended with IRB approval to a partially randomized patient preference (PRPP) design. Participants who express a treatment preference are assigned to their chosen intervention, whereas those without a preference are randomized to one of the two study arms.

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 22, 2024
• Study Start: October 24, 2024
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 12, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)