Kulturell tilpasning og implementering av DBT for ungdom med emosjonelle lidelser
Kulturell tilpasning og implementering av ferdighetsopplæringsgruppe for dialektisk atferdsterapi for ungdom med emosjonelle lidelser: en mulighetsstudie og en randomisert kontrollert prøvelse
Målet med denne studien er å lære om Dialektisk atferdsterapi ferdigheter
Training for Adolescents (DBT-A-ST) arbeider med emosjonelle lidelser hos ungdom. Hovedspørsmålene den tar sikte på å besvare er:
Gir DBT-A-ST raskere forbedringer (dvs. brattere bakker), sammenlignet med ASG, på primære og sekundære utfallsmål under behandling og 3-måneders oppfølging?
Gir DBT-A-ST større forbedringer, sammenlignet med ASG, på primære og sekundære resultatmål?
Deltakerne vil:
Tilfeldig tildelt (a) en kulturelt tilpasset DBT-A-ST eller (b) aktivitetsbasert støttegruppe (ASG).
Fikk fem vurderinger før studiestart (T1), etter 4, 8 økter (T2, T3), ved postintervensjon (T4), og 3 måneders oppfølging (T5).
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
En randomisert kontrollert studie vil bli gjennomført i et legesenters barne-ungdomspsykiatriske avdeling. Deltakere i alderen 12-17 år med aktuelle depressive lidelser eller angstlidelser som diagnostisert ved bruk av K-SADS-E vil bli rekruttert og tilfeldig allokert 1:1 til en av to studiearmer: a) kulturelt tilpasset DBT-A-ST-gruppe, b) Aktivitetsbasert støttegruppe. Begge intervensjonene er i gruppeformat og inkluderer 15 ukentlige økter, 120 min/hver økt. Basert på kraftberegning vil en målutvalgsstørrelse på 160 ungdommer inkluderes. Vurderinger vil skje før utprøvingen starter, ved 4. og 8. behandlingsøkt, til slutt, og ved 3-måneders oppfølging.
Primære utfall er alvorlighetsgraden av depresjon og angst, vurdert av blinde bedømmere. Sekundære utfall inkluderer generell psykopatologi, antall DSM-5 lidelser, livskvalitet og selvrapporterte mål. Behandlingsmekanismene og implementeringsprosessene vil også bli undersøkt.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Hui-Chun Huang, Ph.D
- Telefonnummer: 3055 886-2-28094661
- E-post: aihch@mmh.org.tw
Studiesteder
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Taipei, Taiwan
- Rekruttering
- Mackay Memorial Hospital
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Ta kontakt med:
- Dr.Hui-Chun Huang
- Telefonnummer: 3055 886 2 28094661
- E-post: aihch@mmh.org.tw
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Taipei, Taiwan
- Aktiv, ikke rekrutterende
- Mackay Memorial Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
Tar imot friske frivillige
Beskrivelse
Inkluderingskriterier:
- 12-17 år,
- informert samtykke gis av ungdommen og en av foreldrene,
- Mandarin kinesisk språkferdigheter tilstrekkelig til å fylle ut spørreskjemaet,
- en total poengsum på enten PHQ-9≥ 10 eller GAD-7 ≥ 10,
- en nåværende diagnose av depressiv eller angstlidelse fra et K-SADS-E-intervju, inkludert depresjon (F32-33); vedvarende stemningslidelse (F34), fobisk angstlidelse (F40), annen angstlidelse (F41) og tilpasningsforstyrrelser (F43.2).
Personer med komorbide diagnoser av flere emosjonelle lidelser er også registrert. Komorbiditeter vil ikke bli stratifisert fordi dette vil øke kompleksiteten til designet betydelig (dvs. at noen pasienter kan ha flere komorbide diagnoser).
Ekskluderingskriterier:
- diagnoser utviklingshemning, schizofreni, gjennomgripende utviklingsforstyrrelse, anorexia nervosa og rusforstyrrelser de siste 3 månedene,
- aktive selvmordstanker med en plan eller en historie med hyppig eller nylig selvmordsrisiko de siste 3 månedene,
- ADHD uten forhøyninger i områdene angst, depresjon eller stressproblemer på CBCL,
- nylig (siste 4 uker) endring i psykiatrisk medisinering eller manglende vilje til å opprettholde en stabil dosering av medisiner under studiedeltakelse,
- hadde mottatt fem eller flere økter med CBT tidligere eller uvillig til å stoppe samtidig psykoterapi,
- enhver mental eller fysisk tilstand som krever sykehusinnleggelse,
- alvorlig medisinsk tilstand.
Siden vi også tar sikte på en naturalistisk setting, utelukker vi ikke pasienter som gjennomgår medisinendring under utprøvingen dersom behandlende kliniker vurderer dette som nødvendig eller klinisk viktig.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Kulturtilpasset DBT-A-ST gruppe
Den kulturtilpassede DBT-A-ST består av 15 ukentlige gruppeøkter, hver på 120 minutter, inkludert 10 minutters pause. Den opprettholder kjerneelementene i standard DBT-A, inkludert dets filosofiske grunnlag og behandlingsstrategier. Terapeuter fokuserer på å undervise i DBT-ferdigheter gjennom ulike metoder som modellering, strukturerte atferdsøvelser og tilbakemeldinger. Hver økt begynner med en 40-minutters gruppe mindfulness-øvelse og leksegjennomgang, etterfulgt av 60 minutter dedikert til ferdighetsspesifikk didaktikk og erfaringsaktiviteter, og avsluttes med en 10-minutters lekseoppgave. To gruppeledere legger til rette for øktene, og deltakerne sporer ferdighetsbruken deres daglig med dagbokkort, som gjennomgås ukentlig. |
Den kulturtilpassede DBT-A-ST består av 15 ukentlige gruppeøkter, hver på 120 minutter, inkludert 10 minutters pause. Den opprettholder kjerneelementene i standard DBT-A, inkludert dets filosofiske grunnlag og behandlingsstrategier. Terapeuter fokuserer på å undervise i DBT-ferdigheter gjennom ulike metoder som modellering, strukturerte atferdsøvelser og tilbakemeldinger. Hver økt begynner med en 40-minutters gruppe mindfulness-øvelse og leksegjennomgang, etterfulgt av 60 minutter dedikert til ferdighetsspesifikk didaktikk og erfaringsaktiviteter, og avsluttes med en 10-minutters lekseoppgave. To gruppeledere legger til rette for øktene, og deltakerne sporer ferdighetsbruken deres daglig med dagbokkort, som gjennomgås ukentlig. |
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Shen-Ing Liu, Ph.D, Mackay Memorial Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NSTC 113-2314-B-195 -012 -MY3
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