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- Ensayo clínico NCT00061698
Treatment for Depressed Preadolescent Girls
CBT vs CBT Plus Parent Training for Girls With Depression
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Depressive disorders during childhood are virulent, long-lasting disorders that are a risk factor for the development of future depressive episodes and other psychiatric difficulties. A dysfunctional family environment is a possible pathway to the development of depression in adolescents. The family environment is an especially salient context for the development of depression in preadolescent girls.
Depression is expressed differently between male and female adolescents; girls may not benefit as much as boys from treatments such as cognitive behavioral therapy (CBT) because the treatments may not target disturbances and skills that are specific to preadolescent girls. This study will identify effective treatments for depression in preadolescent girls.
Depressed participants are randomly assigned to receive CBT, CBT plus parent training (PT), or a minimal contact control (MCC). The CBT group receives treatment twice a week for 10 weeks. Participants in the CBT plus PT group receive therapy sessions and group treatment for 10 weeks. Participants in the MCC group meet with a research associate once a week for 10 weeks. During the control visits, the child's depressive symptoms are assessed, but no advice or treatment is given. Participants are assessed at baseline, post-treatment, and at yearly follow-up visits for up to 4 years. School performance, home environment, and the impact of the interventions on parent adjustment are evaluated.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Depressive Disorder
Exclusion Criteria:
- Learning disability or limited intellectual ability
- Health-related illness that would prevent the patient from completing the research study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Cognitive Behavior Therapy Child Only
Participants completed 20 sessions of CBT
|
Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.
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Comparador activo: CBT plus Parent training
Child participants completed 20 sessions of CBT and parents completed 8 sessions of parent training
|
Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.
Participants learned and applied coping skills, problem solving, cognitive restructuring strategies and built a positive core belief.
Parents learned skills that helped their child to apply the strategies they learned.
Parents learned how to better communicate positive information that helped their child build a positive core belief.
Parents learned how to use reinforcement to support healthy behavior.
|
Sin intervención: Minimal Contact Control
Participants waited 12 weeks for treatment but their safety and well-being were monitored during this time
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicaciones y enlaces útiles
Publicaciones Generales
- Cole DA, Cai L, Martin NC, Findling RL, Youngstrom EA, Garber J, Curry JF, Hyde JS, Essex MJ, Compas BE, Goodyer IM, Rohde P, Stark KD, Slattery MJ, Forehand R. Structure and measurement of depression in youths: applying item response theory to clinical data. Psychol Assess. 2011 Dec;23(4):819-33. doi: 10.1037/a0023518. Epub 2011 May 2.
- Stark, K. D. (2008). Experiences Implementing the ACTION Treatment Program: Implications for Preventive Interventions. Clinical Psychology: Science and Practice, 15, 342 - 345.
- Stapleton LM, Sander JB, Stark KD. Psychometric properties of the Beck Depression Inventory for Youth in a sample of girls. Psychol Assess. 2007 Jun;19(2):230-5. doi: 10.1037/1040-3590.19.2.230.
- Morey, M. E., Arora, P., & Stark, K. D. (in press). Multiple-Stage Screening of Youth Depression in Schools. Psychology in the Schools.
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 (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH063998 (Subvención/contrato del NIH de EE. UU.)
- DSIR 84-CTS (Division of Services and Intervention Research)
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. .
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