ClinicalTrials.gg
RecruitingNCT06566235Updated Sep 8, 2026

Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders

An interventional study of Culturally adapted DBT-A-ST group and Satir-based group (SBG) in Emotional Disorders, sponsored by Mackay Memorial Hospital. Recruiting at 2 sites in Taiwan. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Mackay Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started Oct 2024; still recruiting 2 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
12 Years to 18 Years
Sex
All
01

Study 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).

Read the 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.

02

Conditions studied

  • Emotional Disorders

Keywords

  • Dialectical Behavior Therapy Skills Training Group
  • Adolescents
  • Emotional Disorders
03

In context

Lead sponsor

Mackay Memorial Hospital is the lead sponsor of 118 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 12-18 years.
  2. 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

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 by the treating clinician, to maintain a naturalistic setting.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

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Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    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: Culturally adapted DBT-A-ST group

  • Placebo comparator
    Satir-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.

    Behavioral: Satir-based group (SBG)

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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

Secondary outcomes

  1. Hamilton Depression Scale-17 item (HAMD-17)

    HDRS-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).

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

  2. Hamilton Anxiety Scale (HAM-A)

    The 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.

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

  3. Clinical Global Impressions-Severity (CGI-S)

    Clinical 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.

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

  4. Clinical Global Impressions-Improvement (CGI-I)

    The 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.

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

Other outcomes

  1. Patient Health Questionnaire-9 item (PHQ-9)

    It consists of nine items evaluating the presence of the nine DSM-5 criteria of major depression in the past 2 weeks. Each item is scored 0-3. Total scores indicate: 0-4 (None/Minimal), 5-9 (Mild), 10-14 (Moderate), 15-19 (Moderately Severe), and 20-27 (Severe).

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

  2. Generalized Anxiety Disorder Scale-7 item (GAD-7)

    It is a self-report 7-item scale to measure the severity of anxiety and has been validated in Chinese adolescent populations. The total scores of the GAD-7 range from 0 to 21, with the higher scores indicating higher severity of anxiety disorders. For the cutoff points of the GAD-7 scores, in general, the scores of 5, 10, and 15 match categorization of none/normal (0-4), mild anxiety (5-9), moderate anxiety (10-14), and severe anxiety (15-21), respectively.

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

  3. The number of the DSM-5 diagnoses

    The number of DSM-5 diagnoses is assessed using the Mandarin version of the Schedule for Affective Disorders and Schizophrenia for School-Age Children - Epidemiologic version (K-SADS-E), modified to align with DSM-5 criteria.

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

  4. The Strengths and Difficulties Questionnaire (SDQ)

    It aims to evaluate emotional and behavioral challenges in children and adolescents, covering four problem areas: emotional symptoms, conduct issues, hyperactivity/inattention, and peer relationship difficulties. All items are rated on a three-point scale (0=not true, 1=somewhat true, and 2=certainly true). Five positively worded items from different SDQ difficulty scales are reverse-coded. High scores on the difficulties scales indicate a high degree of difficulty; a high score on the prosocial scale indicates a high degree of prosocial behavior.

    Time frame: Baseline

  5. 10-item Positive and Negative Affect Schedule- Child/Parent (PANAS-C/P)

    The 10-item Positive and Negative Affect Schedule for Children/Parents (PANAS-C/P) is used to assess positive and negative emotional states in youth, based on self-report or parent-report of recent emotional experiences. The measure yields two subscale scores: Positive Affect (range 10-50; higher scores indicate greater positive affect) and Negative Affect (range 10-50; lower scores indicate less negative affect).

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

  6. Perceived Stress Scale (PSS-10)

    The Perceived Stress Scale (PSS) is a self-reported measure used to assess the degree to which individuals appraise situations in their lives as stressful. Each item is rated on a 5-point Likert scale (0 = never to 4 = very often). Total scores range from 0 to 40, with higher scores indicating greater perceived stress. Scores of 0-13 indicate low stress, 14-26 indicate moderate stress, and 27-40 indicate high perceived stress.

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

  7. World Health Organization Quality of Life Scale, Brief Version (WHOQOL-BREF)

    The WHOQOL-BREF assesses quality of life across physical, psychological, social, and environmental domains. Each item is rated on a 1-5 scale. Domain scores are transformed to a 0-100 scale, with higher scores indicating better quality of life. Interpretation is based on comparisons across domains, changes over time, and reference to population norms; lower scores (e.g., below the 30th percentile) may indicate areas requiring clinical attention.

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

  8. The Adult Self-Report (ASR)

    The Adult Self-Report is a self-report instrument assessing behavioral, emotional, and social functioning over the past 6 months. Items are rated on a 3-point scale (0 = not true, 1 = somewhat true, 2 = very true). A Total Problems score is calculated by summing all problem items, with higher scores indicating greater overall difficulties.

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

  9. Academic Pressure subscale of Inventory of Influencing Factors of Trait Anxiety

    It includes 10 items that describe daily events related to students' academic pressure. Each item is rated on a 5-point Likert scale ranging from 1 = never to 5 = always. The items are averaged to calculate scale scores; the higher the average score, the higher the level of self-reported academic pressure.

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

  10. Chinese Adolescent Life Event Scale checklist

    The Stressful Life Events Scale assesses the occurrence of stressful life events. In this study, only eight items related to controllable negative events are included. Each item is rated as 0 = no, 1 = yes, and a Total Score is calculated by summing all items, ranging from 0 to 8, with higher scores indicating a greater number of stressful life events.

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

  11. The Treatment History Interview (THI)

    The Treatment History Questionnaire assesses the types and amounts of previous medical and psychological treatments received. Items include self-reported hospital admissions, days in hospital, emergency department visits, medications, and outpatient psychosocial treatments. Each item is rated 0 = no, 1 = yes, and a Total Score is calculated by summing all items, with higher scores indicating greater use of treatment resources.

    Time frame: Baseline

  12. Emotion Regulation Questionnaire, Child and Adolescent Form (ERQ-C/A)

    The Emotion Regulation Questionnaire for Children and Adolescents is a 10-item self-report measure assessing emotion regulation strategies, including cognitive reappraisal and emotion suppression. Items are rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Subscale scores range from 6-30 for cognitive reappraisal and 4-20 for emotion suppression. Higher scores indicate greater emotion dysregulation.

    Time frame: at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention

  13. The Distress tolerance Scale-Short Form (DTS-SF)

    The DTS-SF is a modification of the DTS and contains the highest-loading item from each subscale, forming a single DT factor. As with the DTS, items are rated on a 5-point Likert scale (1 = strongly agree, 5 = strongly disagree), with lower scores indicating poorer ability to withstand and tolerate distress.

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

  14. DBT skills subscale (DSS) of the DBT Ways of Coping Checklist

    The Dialectical Behavior Therapy Skills Use Scale is a 38-item self-report measure assessing the frequency of DBT skills use over the past month. Participants rate how often they used specific skills when facing stressors on a 4-point scale (0 = never to 3 = regularly). A Total Score (range: 0-114) is calculated by summing item scores, with higher scores indicating more frequent use of DBT skills.

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

  15. Mindful Attention Awareness Scale-Children

    The Mindful Attention Awareness Scale is a 15-item self-report measure assessing mindfulness across cognitive, emotional, physical, interpersonal, and general domains. Items are rated on a 6-point scale (1 = almost always to 6 = almost never), reverse-scored, and averaged to yield a total score. Higher scores indicate greater mindfulness.

    Time frame: at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention

  16. Group Climate Questionnaire-Short Form (GCQ-S)

    It is a 12-item self-report instrument used to measure youths' perceptions of the atmosphere in therapy groups. It contains 12 items rated on a 7-point Likert scale, indicating the extent of agreement, ranging from "not at all" (0) to "extremely" (6).

    Time frame: at 4, 8, and 15 weeks

  17. Therapy Alliance Scale for Adolescence

    It is widely used to measure therapeutic alliance in research with adolescent populations. The higher the score, the better the therapeutic alliance. Items are rated on a 4-point Likert scale ranging from 1 (Strongly Disagree) to 4 (Strongly Agree) and summed to create a single Total score with a maximum of 48.

    Time frame: Completed by adolescents: at 4, 8, and 15 weeks Completed by therapists: at 8 and 15 weeks

  18. The Adolescent Dialectical Behavior Therapy Group Skills Learning Experience Scale (ADBT-SLES)

    The ADBT-SLES is a 12-item questionnaire assessing adolescents' perceived helpfulness of DBT group skills, rated on a 5-point Likert scale (1 = not helpful at all, 5 = extremely helpful). It also includes four open-ended questions exploring participants' learning experiences in the group.

    Time frame: at 15 weeks

  19. Client Satisfaction Questionnaire (CSQ-8)

    It consists of eight questions (quality of service, kind of service, whether needs were met, likelihood to recommend to a friend, amount of help received, handling of problems, overall satisfaction, and likelihood to return), each rated on a 4-point Likert scale (1-4). Total scores range from 8 to 32, with higher scores indicating greater satisfaction.

    Time frame: at 15 weeks

  20. Satisfaction of each session

    This 4-item, content-specific scale is completed by patients after each session using a 5-point Likert scale (1 = very unsatisfied to 5 = excellent). Total scores range from 4 to 20, with higher scores indicating better session evaluation. It is designed to facilitate collaborative adjustments to therapy, including the therapeutic alliance, session content, and relevance.

    Time frame: From the first group session to the final (15th) group session, satisfaction for each session was assessed immediately after each session.

  21. A short drop-out questionnaire

    It contains 6 questions (i.e., reason for drop-out, date of drop-out, number of sessions attended, person who initiated the stop of treatment) to gather information about drop-outs, which is filled in by adolescents.

    Time frame: at the time of participant withdrawal during the 15-session group treatment program (up to 15 sessions)

07

Study locations

1 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06566235
Responsible party
Shen-Ing,Liu (Senior Attending Psychiatrist, Professor, Mackay Memorial Hospital) — Principal investigator
First posted
Aug 22, 2024
Start date
Oct 24, 2024
Primary completion
Jul 31, 2028 (estimated)
Completion
Jul 31, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Hui-Chun Huang, Ph.D
Contact
aihch@mmh.org.tw
886-2-28094661 ext. 3055
Shen-Ing Liu, Ph.D
principal investigator · Mackay Memorial Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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