- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina at Chapel Hill
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Otro: 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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Sin intervención: Control
A brief presentation about mood disorders.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Diagnostic accuracy
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Clinician attitudes toward intervention
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Melissa M Jenkins, M.A., University of North Carolina, Chapel Hill
- Silla de estudio: Eric A Youngstrom, Ph.D., University of North Carolina, Chapel Hill
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2KR401204-MMJ
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .