Adaptation culturelle et mise en œuvre de la TCD pour les adolescents souffrant de troubles émotionnels
Adaptation culturelle et mise en œuvre d'un groupe de formation aux compétences en thérapie comportementale dialectique pour les adolescents souffrant de troubles émotionnels : une étude de faisabilité et un essai contrôlé randomisé
Le but de cette étude est de savoir si les compétences en thérapie comportementale dialectique
Training for Adolescents (DBT-A-ST) travaille sur les troubles émotionnels chez les adolescents. Les principales questions auxquelles elle vise à répondre sont :
Le DBT-A-ST produit-il des améliorations plus rapides (c'est-à-dire des pentes plus raides), par rapport à l'ASG, sur les mesures des résultats primaires et secondaires pendant le traitement et le suivi à 3 mois ?
Le DBT-A-ST produit-il de plus grandes améliorations, par rapport à l'ASG, sur les mesures des résultats primaires et secondaires ?
Les participants :
Attribué au hasard à (a) un DBT-A-ST culturellement adapté ou (b) un groupe de soutien basé sur des activités (ASG).
A reçu cinq évaluations avant le début de l'essai (T1), après 4, 8 séances (T2, T3), après l'intervention (T4) et un suivi à 3 mois (T5).
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Un essai contrôlé randomisé sera mené dans le service de psychiatrie pour enfants et adolescents d'un centre médical. Les participants âgés de 12 à 17 ans souffrant actuellement de troubles dépressifs ou anxieux diagnostiqués à l'aide du K-SADS-E seront recrutés et attribués au hasard 1:1 à l'un des deux bras d'étude : a) groupe DBT-A-ST culturellement adapté, b) Groupe de soutien basé sur des activités. Les deux interventions se déroulent en groupe et comprennent 15 séances hebdomadaires, 120 minutes/chaque séance. Sur la base du calcul de puissance, un échantillon cible de 160 jeunes sera inclus. Les évaluations auront lieu avant le début de l'essai, aux 4e et 8e séances de traitement, à la fin et au suivi de 3 mois.
Les principaux critères de jugement sont la gravité de la dépression et de l'anxiété, évaluées par des évaluateurs aveugles. Les critères de jugement secondaires comprennent la psychopathologie générale, le nombre de troubles du DSM-5, la qualité de vie et les mesures autodéclarées. Les mécanismes de traitement et les processus de mise en œuvre seront également examinés.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Hui-Chun Huang, Ph.D
- Numéro de téléphone: 3055 886-2-28094661
- E-mail: aihch@mmh.org.tw
Lieux d'étude
-
-
-
Taipei, Taïwan
- Recrutement
- Mackay Memorial Hospital
-
Contact:
- Dr.Hui-Chun Huang
- Numéro de téléphone: 3055 886 2 28094661
- E-mail: aihch@mmh.org.tw
-
Taipei, Taïwan
- Actif, ne recrute pas
- Mackay Memorial Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
Accepte les volontaires sains
La description
Critères d'intégration :
- 12-17 ans,
- le consentement éclairé est fourni par le jeune et l'un des parents,
- Maîtrise de la langue chinoise mandarin suffisante pour remplir le questionnaire d'étude,
- un score total soit du PHQ-9 ≥ 10, soit du GAD-7 ≥ 10,
- un diagnostic actuel de trouble dépressif ou anxieux issu d'un entretien K-SADS-E, y compris la dépression (F32-33) ; trouble de l'humeur persistant (F34), trouble d'anxiété phobique (F40), autre trouble anxieux (F41) et troubles de l'adaptation (F43.2).
Les personnes présentant des diagnostics comorbides de plusieurs troubles émotionnels sont également inscrites. Les comorbidités ne seront pas stratifiées car cela augmenterait considérablement la complexité de la conception (c'est-à-dire que certains patients peuvent avoir plusieurs diagnostics de comorbidités).
Critères d'exclusion :
- diagnostics de déficience intellectuelle, de schizophrénie, de trouble envahissant du développement, d'anorexie mentale et de trouble lié à l'usage de substances au cours des 3 derniers mois,
- idées suicidaires actives avec un projet ou des antécédents de risque de suicide fréquent ou récent au cours des 3 derniers mois,
- TDAH sans élévations dans les domaines de l'anxiété, de la dépression ou des problèmes de stress sur le CBCL,
- changement récent (au cours des 4 dernières semaines) de traitement psychiatrique ou refus de maintenir une dose stable de médicament pendant la participation à l'étude,
- avait reçu cinq séances ou plus de TCC dans le passé ou n'était pas disposé à arrêter une psychothérapie concomitante,
- toute condition mentale ou physique nécessitant une hospitalisation,
- état de santé grave.
Comme nous visons également un cadre naturaliste, nous n'excluons pas les patients qui subissent des changements de médicaments au cours de l'essai si le clinicien traitant le juge nécessaire ou cliniquement important.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Groupe DBT-A-ST culturellement adapté
Le DBT-A-ST culturellement adapté comprend 15 séances de groupe hebdomadaires, chacune d'une durée de 120 minutes, dont une pause de 10 minutes. Il conserve les éléments fondamentaux de la norme DBT-A, y compris son fondement philosophique et ses stratégies de traitement. Les thérapeutes se concentrent sur l'enseignement des compétences DBT à travers diverses méthodes telles que la modélisation, les répétitions comportementales structurées et le feedback. Chaque séance commence par un exercice de pleine conscience en groupe de 40 minutes et une révision des devoirs, suivis de 60 minutes consacrées à des activités didactiques et expérientielles spécifiques à des compétences, se terminant par un devoir de 10 minutes. Deux chefs de groupe animent les séances et les participants suivent quotidiennement l'utilisation de leurs compétences à l'aide de fiches de journal, qui sont révisées chaque semaine. |
Le DBT-A-ST culturellement adapté comprend 15 séances de groupe hebdomadaires, chacune d'une durée de 120 minutes, dont une pause de 10 minutes. Il conserve les éléments fondamentaux de la norme DBT-A, y compris son fondement philosophique et ses stratégies de traitement. Les thérapeutes se concentrent sur l'enseignement des compétences DBT à travers diverses méthodes telles que la modélisation, les répétitions comportementales structurées et le feedback. Chaque séance commence par un exercice de pleine conscience en groupe de 40 minutes et une révision des devoirs, suivis de 60 minutes consacrées à des activités didactiques et expérientielles spécifiques à des compétences, se terminant par un devoir de 10 minutes. Deux chefs de groupe animent les séances et les participants suivent quotidiennement l'utilisation de leurs compétences à l'aide de fiches de journal, qui sont révisées chaque semaine. |
|
Comparateur placebo: 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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Youth Self Report (YSR)
Délai: 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. |
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
Child Behavior Checklist about their adolescents (CBCL)
Délai: 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. |
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hamilton Depression Scale-17 item (HAMD-17)
Délai: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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).
|
at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
|
Hamilton Anxiety Scale (HAM-A)
Délai: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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)
Délai: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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)
Délai: at 15 weeks, and at 3 months after completion of the intervention
|
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
|
Autres mesures de résultats
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient Health Questionnaire-9 item (PHQ-9)
Délai: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
|
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
|
|
Generalized Anxiety Disorder Scale-7 item (GAD-7)
Délai: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
|
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
Délai: at baseline, at 15weeks, and at 3 months after completion of the intervention
|
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)
Délai: Baseline
|
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)
Délai: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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)
Délai: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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)
Délai: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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)
Délai: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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
Délai: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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
Délai: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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)
Délai: Baseline
|
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)
Délai: at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
|
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)
Délai: at baseline, at 4, 8, and 15 weeks, and at 3 months after completion of the intervention
|
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
Délai: at baseline, at 15 weeks, and at 3 months after completion of the intervention
|
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
Délai: at baseline, at 8 and 15 weeks, and at 3 months after completion of the intervention
|
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)
Délai: at 4, 8, and 15 weeks
|
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
Délai: Completed by adolescents: at 4, 8, and 15 weeks Completed by therapists: at 8 and 15 weeks
|
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
|
|
Client Satisfaction Questionnaire (CSQ-8)
Délai: at 15 weeks
|
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
Délai: From the first group session to the final (15th) group session, satisfaction for each session was assessed immediately after 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.
|
|
The Adolescent Dialectical Behavior Therapy Group Skills Learning Experience Scale (ADBT-SLES)
Délai: at 15 weeks
|
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
|
|
A short drop-out questionnaire
Délai: at the time of participant withdrawal during the 15-session group treatment program (up to 15 sessions)
|
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)
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Shen-Ing Liu, Ph.D, Mackay Memorial Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NSTC 113-2314-B-195 -012 -MY3
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .