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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01948167
Bending Adolescent Depression Trajectories Through Personalized Prevention
2 de marzo de 2021 actualizado por: Children's Hospital of Philadelphia
Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Investigators will innovatively combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.
A randomized controlled trial will examine the benefits of matching youth to two depression prevention programs of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) and Coping with Stress (CWS) for the prevention of depression in adolescents.
These two programs are designed to address distinct risk factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks.
A total of 210 participants across two sites, University of Denver and Rutgers University, will be stratified on cognitive and interpersonal risk and randomized to the two conditions.
The goals of the study are to (1) demonstrate that prevention programs can modify depression trajectories among youth by examining within person changes in trajectories over time (three years before and three years after the prevention programs) and by comparing trajectories of prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention approach to bending depression trajectories by matching and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression trajectories and test whether the prevention programs operate via their hypothesized processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament may affect individual response to IPT-AST and CWS.
By implementing evidence-based prevention programs after 3-years of prospective naturalistic data collection, this study will contribute essential data on personalized medicine and altering developmental trajectories of first-onset depression.
Tipo de estudio
Intervencionista
Inscripción (Actual)
205
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Colorado
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Denver, Colorado, Estados Unidos, 80208
- University of Denver
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Illinois
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Champaign, Illinois, Estados Unidos, 61820
- University of Illinois Urbana Champaign
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New Jersey
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Piscataway, New Jersey, Estados Unidos, 08854
- Rutgers University
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19146
- Children's Hospital of Philadelphia
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
12 años a 17 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Currently in the 6th to 11th grades
- Adolescent and parent must be English-speaking
- Parental consent and adolescent consent
Exclusion Criteria:
- Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis
- Suicide attempt in the past week or significant suicidal ideation in the past week
- Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Interpersonal Psychotherapy- Adolescent Skills Training
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A group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions.
IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence.
Otros nombres:
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Experimental: Coping with Stress
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A group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each.
Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Presence of a Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Periodo de tiempo: Post intervention (approximately 3 months post baseline)
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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Post intervention (approximately 3 months post baseline)
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Periodo de tiempo: 6-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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6-months post-intervention
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Periodo de tiempo: 12-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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12-months post-intervention
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Periodo de tiempo: 18-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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18-months post-intervention
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Periodo de tiempo: 24-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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24-months post-intervention
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Periodo de tiempo: 30-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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30-months post-intervention
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Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Periodo de tiempo: 36-months post-intervention
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Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
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36-months post-intervention
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Children's Depression Inventory (CDI)
Periodo de tiempo: Post intervention (approximately 3 months after baseline)
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Self-reported depression scores
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Post intervention (approximately 3 months after baseline)
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Children's Depression Inventory (CDI)
Periodo de tiempo: 6-months post-intervention
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Self-reported depression scores
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6-months post-intervention
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Children's Depression Inventory (CDI)
Periodo de tiempo: 12-months post-intervention
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Self-reported depression scores
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12-months post-intervention
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Children's Depression Inventory (CDI)
Periodo de tiempo: 18-months post-intervention
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Self-reported depression scores
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18-months post-intervention
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Children's Depression Inventory (CDI)
Periodo de tiempo: 24-months post-intervention
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Self-reported depression scores
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24-months post-intervention
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Children's Depression Inventory (CDI)
Periodo de tiempo: 30-months post-intervention
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Self-reported depression scores
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30-months post-intervention
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Children's Depression Inventory (CDI)
Periodo de tiempo: 36-months post-intervention
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Self-reported depression scores
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36-months post-intervention
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Children's Global Assessment Scale (CGAS)
Periodo de tiempo: Post Intervention (approximately 3 months following baseline)
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Assesses global functioning
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Post Intervention (approximately 3 months following baseline)
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Children's Global Assessment Scale (CGAS)
Periodo de tiempo: 6-months followup
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Assesses global functioning
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6-months followup
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Children's Global Assessment Scale (CGAS)
Periodo de tiempo: 12-months followup
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Assesses global functioning
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12-months followup
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Children's Global Assessment Scale (CGAS)
Periodo de tiempo: 18-months followup
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Assesses global functioning
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18-months followup
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Children's Global Assessment Scale (CGAS)
Periodo de tiempo: 24-months followup
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Assesses global functioning
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24-months followup
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Children's Global Assessment Scale (CGAS)
Periodo de tiempo: 30-months followup
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Assesses global functioning
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30-months followup
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Children's Global Assessment Scale (CGAS)
Periodo de tiempo: 36-months followup
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Assesses global functioning
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36-months followup
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Jami F Young, Ph.D., Children's Hospital of Philadelphia
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2013
Finalización primaria (Actual)
1 de agosto de 2019
Finalización del estudio (Actual)
1 de agosto de 2019
Fechas de registro del estudio
Enviado por primera vez
18 de septiembre de 2013
Primero enviado que cumplió con los criterios de control de calidad
18 de septiembre de 2013
Publicado por primera vez (Estimar)
23 de septiembre de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
4 de marzo de 2021
Última actualización enviada que cumplió con los criterios de control de calidad
2 de marzo de 2021
Última verificación
1 de marzo de 2021
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 17-013831
- R01MH077178 (Subvención/contrato del NIH de EE. UU.)
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. .
Ensayos clínicos sobre Interpersonal Psychotherapy- Adolescent Skills Training
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Ludwig-Maximilians - University of MunichREFUGIO MunichTerminado