- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06566235
Kulturel tilpasning og implementering af DBT for unge med følelsesmæssige lidelser
Kulturel tilpasning og implementering af dialektisk adfærdsterapi færdighedstræningsgruppe for unge med følelsesmæssige lidelser: en gennemførlighedsundersøgelse og et randomiseret kontrolleret forsøg
Målet med denne undersøgelse er at lære om Dialektisk adfærdsterapi færdigheder
Training for Adolescents (DBT-A-ST) arbejder med følelsesmæssige lidelser hos unge. De vigtigste spørgsmål, den sigter mod at besvare er:
Giver DBT-A-ST hurtigere forbedringer (dvs. stejlere skråninger) sammenlignet med ASG på primære og sekundære resultatmål under behandling og 3-måneders opfølgning?
Giver DBT-A-ST større forbedringer sammenlignet med ASG på primære og sekundære resultatmål?
Deltagerne vil:
Tilfældigt tildelt til (a) en kulturelt tilpasset DBT-A-ST eller (b) aktivitetsbaseret støttegruppe (ASG).
Modtog fem vurderinger før starten af forsøget (T1), efter 4, 8 sessioner (T2, T3), ved post-intervention (T4) og 3-måneders opfølgning (T5).
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Et randomiseret kontrolleret forsøg vil blive gennemført på et lægecenters børne-ungdomspsykiatriske afdeling. Deltagere i alderen 12-17 år med aktuelle depressive eller angstlidelser som diagnosticeret ved hjælp af K-SADS-E vil blive rekrutteret og tilfældigt allokeret 1:1 til en af to undersøgelsesarme: a) kulturelt tilpasset DBT-A-ST-gruppe, b) Aktivitetsbaseret støttegruppe. Begge interventioner er i gruppeformat og omfatter 15 ugentlige sessioner, 120 min/hver session. Baseret på effektberegning vil en målstikprøvestørrelse på 160 unge blive inkluderet. Vurderinger vil finde sted før forsøget starter, ved 4. og 8. behandlingssession, til sidst og ved 3-måneders opfølgning.
Primære resultater er sværhedsgraden af depression og angst, vurderet af blinde bedømmere. Sekundære resultater omfatter generel psykopatologi, antallet af DSM-5 lidelser, livskvalitet og selvrapporterede mål. Behandlingsmekanismerne og implementeringsprocesserne vil også blive undersøgt.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Hui-Chun Huang, Ph.D
- Telefonnummer: 3055 886-2-28094661
- E-mail: aihch@mmh.org.tw
Studiesteder
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Taipei, Taiwan
- Rekruttering
- Mackay Memorial Hospital
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Kontakt:
- Dr.Hui-Chun Huang
- Telefonnummer: 3055 886 2 28094661
- E-mail: aihch@mmh.org.tw
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Taipei, Taiwan
- Aktiv, ikke rekrutterende
- Mackay Memorial Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- 12-17 år,
- informeret samtykke gives af den unge og en af forældrene,
- Mandarin kinesisk sprogfærdighed tilstrækkelig til at udfylde undersøgelsesspørgeskema,
- en samlet score på enten PHQ-9≥ 10 eller GAD-7 ≥ 10,
- en aktuel diagnose af depressiv eller angstlidelse fra et K-SADS-E-interview, inklusive depression (F32-33); vedvarende stemningslidelse (F34), fobisk angstlidelse (F40), anden angstlidelse (F41) og tilpasningsforstyrrelser (F43.2).
Personer med komorbide diagnoser af flere følelsesmæssige lidelser er også indskrevet. Komorbiditeter vil ikke blive stratificeret, fordi dette vil øge kompleksiteten af designet betydeligt (dvs. nogle patienter kan have flere komorbide diagnoser).
Ekskluderingskriterier:
- diagnoser udviklingshæmning, skizofreni, gennemgribende udviklingsforstyrrelse, anorexia nervosa og stofmisbrugslidelse inden for de seneste 3 måneder,
- aktive selvmordstanker med en plan eller en historie med hyppig eller nylig selvmordsrisiko inden for de seneste 3 måneder,
- ADHD uden stigninger i områderne angst, depression eller stressproblemer på CBCL,
- nylig (seneste 4 uger) ændring i psykiatrisk medicin eller manglende vilje til at opretholde en stabil dosis af medicin under undersøgelsesdeltagelse,
- havde modtaget fem eller flere sessioner med CBT tidligere eller uvillige til at stoppe samtidig psykoterapi,
- enhver psykisk eller fysisk tilstand, der kræver hospitalsindlæggelse,
- alvorlig medicinsk tilstand.
Da vi også tilstræber en naturalistisk setting, udelukker vi ikke patienter, der gennemgår medicinændringer under forsøget, hvis den behandlende kliniker vurderer, at dette er nødvendigt eller klinisk vigtigt.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Kulturtilpasset DBT-A-ST gruppe
Det kulturelt tilpassede DBT-A-ST består af 15 ugentlige gruppeforløb, der hver varer 120 minutter, inklusive 10 minutters pause. Det fastholder kerneelementerne i standard DBT-A, herunder dets filosofiske grundlag og behandlingsstrategier. Terapeuter fokuserer på at undervise i DBT-færdigheder gennem forskellige metoder såsom modellering, strukturerede adfærdsprøver og feedback. Hver session begynder med en 40-minutters gruppe mindfulness-øvelse og lektiegennemgang, efterfulgt af 60 minutter dedikeret til færdighedsspecifik didaktik og oplevelsesmæssige aktiviteter, der afsluttes med en 10-minutters lektieopgave. To gruppeledere faciliterer sessionerne, og deltagerne sporer deres færdighedsforbrug dagligt med dagbogskort, som gennemgås ugentligt. |
Det kulturelt tilpassede DBT-A-ST består af 15 ugentlige gruppeforløb, der hver varer 120 minutter, inklusive 10 minutters pause. Det fastholder kerneelementerne i standard DBT-A, herunder dets filosofiske grundlag og behandlingsstrategier. Terapeuter fokuserer på at undervise i DBT-færdigheder gennem forskellige metoder såsom modellering, strukturerede adfærdsprøver og feedback. Hver session begynder med en 40-minutters gruppe mindfulness-øvelse og lektiegennemgang, efterfulgt af 60 minutter dedikeret til færdighedsspecifik didaktik og oplevelsesmæssige aktiviteter, der afsluttes med en 10-minutters lektieopgave. To gruppeledere faciliterer sessionerne, og deltagerne sporer deres færdighedsforbrug dagligt med dagbogskort, som gennemgås ugentligt. |
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Placebo komparator: 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.
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Youth Self Report (YSR)
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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
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Child Behavior Checklist about their adolescents (CBCL)
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Hamilton Depression Scale-17 item (HAMD-17)
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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).
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Hamilton Anxiety Scale (HAM-A)
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Clinical Global Impressions-Severity (CGI-S)
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Clinical Global Impressions-Improvement (CGI-I)
Tidsramme: at 15 weeks, and at 3 months after completion of the intervention
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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.
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at 15 weeks, and at 3 months after completion of the intervention
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Patient Health Questionnaire-9 item (PHQ-9)
Tidsramme: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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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).
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at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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Generalized Anxiety Disorder Scale-7 item (GAD-7)
Tidsramme: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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The number of the DSM-5 diagnoses
Tidsramme: at baseline, at 15weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 15weeks, and at 3 months after completion of the intervention
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The Strengths and Difficulties Questionnaire (SDQ)
Tidsramme: Baseline
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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.
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Baseline
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10-item Positive and Negative Affect Schedule- Child/Parent (PANAS-C/P)
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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).
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Perceived Stress Scale (PSS-10)
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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World Health Organization Quality of Life Scale, Brief Version (WHOQOL-BREF)
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Adult Self-Report (ASR)
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Academic Pressure subscale of Inventory of Influencing Factors of Trait Anxiety
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Chinese Adolescent Life Event Scale checklist
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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The Treatment History Interview (THI)
Tidsramme: Baseline
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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.
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Baseline
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Emotion Regulation Questionnaire, Child and Adolescent Form (ERQ-C/A)
Tidsramme: at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
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The Distress tolerance Scale-Short Form (DTS-SF)
Tidsramme: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
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DBT skills subscale (DSS) of the DBT Ways of Coping Checklist
Tidsramme: at baseline, at 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 15 weeks, and at 3 months after completion of the intervention
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Mindful Attention Awareness Scale-Children
Tidsramme: at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
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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.
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at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
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Group Climate Questionnaire-Short Form (GCQ-S)
Tidsramme: at 4, 8, and 15 weeks
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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).
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at 4, 8, and 15 weeks
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Therapy Alliance Scale for Adolescence
Tidsramme: Completed by adolescents: at 4, 8, and 15 weeks Completed by therapists: at 8 and 15 weeks
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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.
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Completed by adolescents: at 4, 8, and 15 weeks Completed by therapists: at 8 and 15 weeks
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Client Satisfaction Questionnaire (CSQ-8)
Tidsramme: at 15 weeks
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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.
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at 15 weeks
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Satisfaction of each session
Tidsramme: From the first group session to the final (15th) group session, satisfaction for each session was assessed immediately after each session.
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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.
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From the first group session to the final (15th) group session, satisfaction for each session was assessed immediately after each session.
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The Adolescent Dialectical Behavior Therapy Group Skills Learning Experience Scale (ADBT-SLES)
Tidsramme: at 15 weeks
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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.
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at 15 weeks
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A short drop-out questionnaire
Tidsramme: at the time of participant withdrawal during the 15-session group treatment program (up to 15 sessions)
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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.
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at the time of participant withdrawal during the 15-session group treatment program (up to 15 sessions)
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Shen-Ing Liu, Ph.D, Mackay Memorial Hospital
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NSTC 113-2314-B-195 -012 -MY3
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