Cultural Adaptation and Implementation of DBT for Adolescents With Emotional Disorders
ConditionEmotional Disorders
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorMackay Memorial Hospital
About this 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:
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Educational level of elementary school or university.
Comorbid intellectual disability or psychotic disorder.
Acute suicidality.
Insufficient Chinese language skills.
Trial design
Design model
Parallel
Treatments tested in this trial
Culturally adapted DBT-A-ST group
BehavioralThe 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)
BehavioralSBG, 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.
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Culturally adapted DBT-A-ST groupExperimental treatment 1 intervention
Group B: Satir-based group (SBG)Placebo comparator 1 intervention
Trial outcomes
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 intervention2
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 interventionSecondary 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 intervention2
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 intervention3
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 intervention4
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 interventionOther 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 intervention2
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 intervention3
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 intervention4
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
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Source ClinicalTrials.gov