- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00461539
Reducing Health Risk Behavior and Improving Health in Adolescents With Depression
Reducing Health Risk Behavior and Improving Health in Adolescent Depression
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Depression is a common disorder among adolescents. If left untreated, it can cause significant disability, illness, and even death. Teens with depression often engage in risky health behaviors, such as smoking, drug and alcohol use, unprotected sex, and unhealthy eating and exercise patterns. By reducing these health risk behaviors, depressed adolescents may be able to avoid negative health consequences and improve their physical and mental health. This study will determine the effectiveness of a health education intervention in reducing risky health behaviors in adolescents with depression.
Participants in this study will be invited to enroll during a visit to a participating primary care clinic. Participants will be randomly assigned to either partake in a health education intervention or receive standard care. Both groups will continue to receive treatment through their primary care clinic. Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors. Participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators. Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant. Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity. Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention. The intervention will be tailored to target the specific risky behaviors in which each participant engages. Motivational interviewing will also be used to build positive attitudes to support behavior change. All participants will attend follow-up visits to assess behavior change at Months 6 and 12 following study entry.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
California
-
Los Angeles, California, Estados Unidos, 90027
- Kaiser Permanente Los Angeles Medical Center
-
Los Angeles, California, Estados Unidos, 90024
- University of California, Los Angeles, Semel Institute for Neuroscience and Human Behavior
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- CIDI diagnosis of major depression or probable depression based on youth self report
- Availability of a family member to provide informed consent
Exclusion Criteria:
- Lacks contact information (e.g., address, telephone number)
- Any functioning deficits or other characteristics that might interfere with study participation
- Currently in a living situation that might interfere with study participation (e.g., lives over 1 hour away from the study site)
- Lacks family available to participate in the intervention
- Mental retardation
- Does not speak English or Spanish
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: 2
Los participantes recibirán el tratamiento habitual.
|
Those participants receiving standard care will be referred to special programs as needed to reduce their involvement in risky health behaviors.
|
Experimental: 1
Participants will receive the behavioral health intervention
|
Participants assigned to the health education intervention will attend 10 weekly education sessions that will be led by trained health educators.
Parents or guardians may be asked to attend sessions depending on their interest in the intervention and the age of the youth participant.
Topics covered will include teenage smoking, alcohol and drug abuse, risky sexual behaviors, and obesity.
Cognitive-behavioral strategies, role playing, and media clips will be used to stimulate discussion and involvement in the intervention.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
Composite health risk behavior score
Periodo de tiempo: Measured at Months 6 and 12
|
Measured at Months 6 and 12
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
Composite International Diagnostic Interview (CIDI) depression diagnosis
Periodo de tiempo: Measured at Months 6 and 12
|
Measured at Months 6 and 12
|
Satisfaction with care, as measured by the SF-12 health survey
Periodo de tiempo: Measured at Months 6 and 12
|
Measured at Months 6 and 12
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Joan Asarnow, PhD, University of California, Los Angeles, Semel Institute of Neuroscience and Human Behavior
Publicaciones y enlaces útiles
Publicaciones Generales
- Bai S, Zeledon LR, D'Amico EJ, Shoptaw S, Avina C, LaBorde AP, Anderson M, Fitzpatrick OM, Asarnow JR. Reducing Health Risk Behaviors and Improving Depression in Adolescents: A Randomized Controlled Trial in Primary Care Clinics. J Pediatr Psychol. 2018 Oct 1;43(9):1004-1016. doi: 10.1093/jpepsy/jsy048.
- Asarnow JR, Zeledon LR, D'Amico E, LaBorde A, Anderson M, Avina C, Arslanian T, Do MC, Harwood J, Shoptaw S. Depression and Health Risk Behaviors: Towards Optimizing Primary Care Service Strategies for Addressing Risk. Prim Health Care. 2014 Mar 1;4(1):152.
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
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01MH078596 (Subvención/contrato del NIH de EE. UU.)
- DAHBR 96-BHB
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los 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. .
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