- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01799291
Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder
Decision Making and Mental Health: Cognitive De-Biasing and the Assessment of Pediatric Bipolar Disorder
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
A randomized controlled trial (RCT) of 100 participants will test the efficacy of a new intervention to improve clinical judgment.
Eligible participants will be licensed or currently supervised by a licensed mental health professional and have experience working with pediatric populations.
Participants will be randomly assigned to either Treatment or Control conditions. All participants receive a 5 minute pre-recorded presentation about mood disorders, then read several case vignettes and respond to questions regarding judgments about probable diagnoses and next clinical actions.
Study administration is Web-based via a secure portal. After answering questions to confirm eligibility and provide informed consent, participants will complete a background questionnaire. The Web software, Qualtrics, will randomize participants to watch a brief presentation on mood disorders (i.e., Control condition) versus the same presentation on mood disorders combined with the intervention (i.e., Treatment condition). The intervention is a 20-minute training on decision-making errors and cognitive de-biasing strategies.
Next, all participants review four clinical vignettes. Using only four vignettes reduces participant burden and maximizes response rate. Qualtrics presents the case vignettes in random orders.
After completing the last vignette and corresponding questions, participants in the treatment condition rate their experience of the intervention. These questions address the secondary study aims: (a) how participants will use these new techniques in their clinical practice; and, (b) how the investigators can tailor the intervention to make it even more user-friendly and appealing to clinical audiences.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- University of North Carolina at Chapel Hill
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Participants need to be: (a) licensed or currently supervised by a licensed mental health professional; and, (b) have experience treating child and adolescent patient populations for mental health issues.
Exclusion Criteria:
- Not meeting criterion (a) or (b) above.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Diagnostique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Autre: Treatment: Decision Making Tutorial
A brief presentation on mood disorders (i.e., Control condition) combined with the intervention (i.e., Treatment condition): a 20-minute training on decision-making errors and cognitive de-biasing strategies.
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A web-based presentation focused on key "cognitive de-biasing" strategies, including helping clinician participants: consider alternative diagnoses (e.g., symptom checklists); decrease reliance on memory (e.g., mnemonics); and incorporate Bayesian reasoning (e.g., actuarial approaches).
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Aucune intervention: Control
A brief presentation about mood disorders.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Diagnostic accuracy
Délai: one time, immediately following Web-based presentation(s)
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Participants in treatment and control conditions report vignette characters' probable diagnoses after reading each vignette.
These diagnoses were rated on a 3-point Likert scale of (1 = inaccurate diagnosis, 2 = somewhat accurate, and 3 = accurate diagnosis) using criteria established by the research team (which includes expert diagnosticians).
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one time, immediately following Web-based presentation(s)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Clinician attitudes toward intervention
Délai: one time, immediately after Web-based intervention
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Participants in the treatment group complete a brief questionnaire (4 items) about their attitudes toward the cognitive de-biasing intervention.
This measure describes different aspects of the intervention (e.g., how helpful it was in making diagnostic decisions), and requires participants to make ratings on a 6-point scale: (1) strong agree; (2) agree; (3) somewhat agree; (4) somewhat disagree; (5) disagree; and, (6) strong disagree.
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one time, immediately after Web-based intervention
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Melissa M Jenkins, M.A., University of North Carolina, Chapel Hill
- Chaise d'étude: Eric A Youngstrom, Ph.D., University of North Carolina, Chapel Hill
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2KR401204-MMJ
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