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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention |
Inclusion Criteria:
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.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui-Chun Huang, Ph.D | Contact | 886-2-28094661 | 3055 | aihch@mmh.org.tw |
| Name | Affiliation | Role |
|---|---|---|
| Shen-Ing Liu, Ph.D | Mackay Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MacKay Memorial Hospital | Active, not recruiting | Taipei | Taiwan | |||
| MacKay Memorial Hospital |
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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.
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Only randomized participants have outcomes assessed by blinded assessors. For participants assigned to their preferred intervention, assessors are aware of treatment assignment.
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| 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. |
|
| 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. | 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. | 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. | at 15 weeks, and at 3 months after completion of the intervention |
| 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. | at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention |
| 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. | at baseline, at 15weeks, and at 3 months after completion of the intervention |
| 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. | Baseline |
| 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). | at baseline, at 15 weeks, and at 3 months after completion of the intervention |
| 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. | at baseline, at 15 weeks, and at 3 months after completion of the intervention |
| 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. | at baseline, at 15 weeks, and at 3 months after completion of the intervention |
| 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. | at baseline, at 15 weeks, and at 3 months after completion of the intervention |
| 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. | at baseline, at 15 weeks, and at 3 months after completion of the intervention |
| 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. | at baseline, at 15 weeks, and at 3 months after completion of the intervention |
| 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. | Baseline |
| 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. | at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention |
| 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. | at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention |
| 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. | at baseline, at 15 weeks, and at 3 months after completion of the intervention |
| 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. | at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention |
| 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). | at 4, 8, and 15 weeks |
| 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. | Completed by adolescents: at 4, 8, and 15 weeks Completed by therapists: at 8 and 15 weeks |
| 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. | at 15 weeks |
| 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. | at 15 weeks |
| 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. | From the first group session to the final (15th) group session, satisfaction for each session was assessed immediately after each session. |
| 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. | at the time of participant withdrawal during the 15-session group treatment program (up to 15 sessions) |
| Recruiting |
| Taipei |
| Taiwan |
|