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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
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06566235
Enrollment
160
Registered
2024-08-22
Start date
2024-10-24
Completion date
2028-07-31
Last updated
2026-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Disorders

Keywords

Dialectical Behavior Therapy Skills Training Group, Adolescents, Emotional Disorders

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).

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

BEHAVIORALCulturally 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.

BEHAVIORALSatir-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): 12 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.

Sponsors

Mackay Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Only randomized participants have outcomes assessed by blinded assessors. For participants assigned to their preferred intervention, assessors are aware of treatment assignment.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
12 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Youth Self Report (YSR)at baseline, at 15 weeks, and at 3 months after completion of the interventionThe 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.
Child Behavior Checklist about their adolescents (CBCL)at baseline, at 15 weeks, and at 3 months after completion of the interventionThe 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.

Secondary

MeasureTime frameDescription
Hamilton Depression Scale-17 item (HAMD-17)at baseline, at 15 weeks, and at 3 months after completion of the interventionHDRS-17 is a clinician-rated measure of depressive symptoms that consists of 17 items rated using a semi-structured interview. Eight of the 17 HDRS-17 items are rated on a 5-point scale (0=absent; 1=doubtful or mild; 2=mild to moderate; 3=moderate to severe; 4=very severe), while the remaining 9 items are rated on a 3-point scale (0=absent; 1=doubtful or mild; 2=clearly present), yielding a minimum total score of 0 (least severe) and a maximum score of 52 (most severe).
Hamilton Anxiety Scale (HAM-A)at baseline, at 15 weeks, and at 3 months after completion of the interventionThe Hamilton Anxiety Scale (HAM-A) comprises 14 items. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 indicates mild to moderate severity, and 25-30 indicates moderate to severe severity.
Clinical Global Impressions-Severity (CGI-S)at baseline, at 15 weeks, and at 3 months after completion of the interventionClinical Global Impressions-Severity (CGI-S) is a standardized assessment tool used by clinicians to rate illness severity, monitor changes over time, and evaluate medication efficacy. It is rated on a seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Clinical Global Impressions-Improvement (CGI-I)at 15 weeks, and at 3 months after completion of the interventionThe Clinical Global Impression-Improvement (CGI-I) is a 7-point scale that measures the extent to which the patient's illness has improved or worsened relative to baseline at the start of treatment. It is rated on a scale from 1 to 7: 1 = very much improved since the beginning of treatment; 2 = much improved; 3 = minimally improved; 4 = no change from baseline (the start of treatment); 5 = minimally worse; 6 = much worse; 7 = very much worse since the start of treatment.

Countries

Taiwan

Contacts

CONTACTHui-Chun Huang, Ph.D
aihch@mmh.org.tw886-2-28094661
PRINCIPAL_INVESTIGATORShen-Ing Liu, Ph.D

Mackay Memorial Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 9, 2026