Emotional DisordersNCT06566235
Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders
A study testing Culturally adapted DBT-A-ST group and Satir-based group (SBG) in people with Emotional Disorders, run by Mackay Memorial Hospital at 2 sites in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Emotional Disorders
- What is being tested?
- Culturally adapted DBT-A-ST group and Satir-based group (SBG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 2 sitesTaiwan
- Study dates
- 24 Oct 2024to 31 Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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:
Show all 9Show fewer
- 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.
Who cannot join
- 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.
- Medication changes during the trial are not exclusionary if judged necessary or clinically important by the treating clinician, to maintain a naturalistic setting.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan2 sites, 1 recruiting
- Active, not recruiting
MacKay Memorial Hospital
Taipei
- Recruiting
MacKay Memorial Hospital
Taipei
Dr.Hui-Chun Huang, 886 2 28094661 ext. 3055, aihch@mmh.org.tw
About this study
Official title: Cultural Adaptation and Implementation of Dialectical Behavior Therapy Skills Training Group for Adolescents With Emotional Disorders: a Feasibility Study and a Randomized Controlled Trial
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:
Read more
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.
- Conditions
- Emotional Disorders
- Being tested
- Culturally adapted DBT-A-ST group, Satir-based group (SBG)
- Keywords
- Dialectical Behavior Therapy Skills Training Group, Adolescents, Emotional Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally adapted DBT-A-ST groupBehavioural
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.
Satir-based group (SBG)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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): 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. Receives: Behavioral: Satir-based group (SBG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: at baseline, at 15 weeks, and at 3 months after completion of the intervention
Secondary outcomes (4)
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).
Measured: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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.
Measured: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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.
Measured: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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.
Measured: at 15 weeks, and at 3 months after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start24 Oct 2024
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen-Ing,Liu, Mackay Memorial Hospital
- Investigators
- Shen-Ing Liu, Ph.D, Principal investigator, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566235
- Sponsor's protocol ID
- NSTC 113-2314-B-195 -012 -MY3
- Status last verified
- Apr 2026
- First submitted
- 10 Aug 2024
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cultural Adaptation and Implementation of Dialectical Behavior Therapy Skills Training Group for Adolescents With Emotional Disorders: a Feasibility Study and a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06566235
- Acronym / sponsor ID
- NSTC 113-2314-B-195 -012 -MY3
- Conditions
- Emotional Disorders
- Keywords
- Dialectical Behavior Therapy Skills Training Group, Adolescents, Emotional Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Culturally adapted DBT-A-ST group | Experimental | Behavioral: Culturally adapted DBT-A-ST groupThe 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. |
| Satir-based group (SBG) | Placebo comparator | Behavioral: 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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-
Key exclusion criteria (7 listed)
- Educational level of elementary school or university.
- Comorbid intellectual disability or psychotic disorder.
- Acute suicidality.
- Insufficient Chinese language skills.
- Unwillingness to discontinue current psychotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally adapted DBT-A-ST groupThe 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. | Behavioural | Culturally adapted DBT-A-ST group |
| 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. | Behavioural | Satir-based group (SBG) |
Primary outcome
Youth Self Report (YSR)
Time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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.
Child Behavior Checklist about their adolescents (CBCL)
Time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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.
4 secondary outcomes
Hamilton Depression Scale-17 item (HAMD-17)
Time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention
Hamilton Anxiety Scale (HAM-A)
Time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention
Clinical Global Impressions-Severity (CGI-S)
Time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention
Clinical Global Impressions-Improvement (CGI-I)
Time frame: at 15 weeks, and at 3 months after completion of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shen-Ing Liu, Ph.D principal investigator
Mackay Memorial Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally adapted DBT-A-ST group and Satir-based group (SBG) in people with Emotional Disorders, run by Mackay Memorial Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hui-Chun Huang, Ph.D (886-2-28094661 ext. 3055, aihch@mmh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Youth Self Report (YSR) (time frame: at baseline, at 15 weeks, and at 3 months after completion of the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.