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Designing and Testing a Family Therapy for Adolescent Depression

16 de abril de 2013 actualizado por: Oregon Research Institute

Family Therapy for Adolescent Depression: Deployment Focused Development, Phase 1

This study will design and test a cognitive behavioral therapy for depressed adolescents that uses family interactions to help with treatment.

Descripción general del estudio

Descripción detallada

Adolescent depression causes persistent feelings of sadness, loss of self-worth, discouragement, and loss of interest in usual activities. Treatments for adolescent depression have mixed success, with 25% to 40% of depressed adolescents still experiencing depressive symptoms at the end of the most effective treatments and gains made in treatment sometimes fading over time. Research suggests that family processes are associated with the effectiveness of treatments for adolescent depression and with reducing symptoms over time. Evidence also shows that treatments developed and tested in a research setting are not easily applied to community settings. This study will first design a cognitive behavioral therapy for adolescent depression that will involve the families of the depressed adolescents and then test the therapy in several settings, including clinics.

Development of this therapy will involve five different groups of participants. Each group will include both depressed adolescents and a parent or guardian. The first group of participants will partake in a focus group, in which they will break into two discussion groups, one of parents and guardians and one of adolescents, that will discuss what kind of help and information would be useful to them and why they would consider seeing a therapist.

The second group will participate in alpha testing, which will involve receiving the first version of the therapy. The therapy is anticipated to include 8 to 12 weekly treatment sessions, with homework assignments to practice their learned skills in everyday life. Participants in alpha testing will also complete interviews and questionnaires at Week 7 and at the end of treatment to assess satisfaction with treatment, treatment clarity, and usefulness of the information and strategies they learned. After alpha testing, the therapy will be revised based on the feedback received. The third group will participate in beta testing, which will involve receiving the second version of the therapy and completing the same assessments as those done by the alpha group.

The fourth group of participants will receive pilot testing of the finalized therapy. This finalized version will involve 11 to 15 weekly sessions. The fifth group will receive treatment as usual from a mental health clinic and serve as a control group to compare to the pilot testing group. Before and after treatment, both of these groups will complete questionnaires and interviews assessing the effectiveness of their treatment and questionnaires and observations of family functioning. All sessions throughout the study involving the newly designed family therapy will be videotaped.

Tipo de estudio

Intervencionista

Inscripción (Anticipado)

56

Fase

  • Fase 1

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

    • Oregon
      • Eugene, Oregon, Estados Unidos, 97403
        • Oregon Research Institute
      • Eugene, Oregon, Estados Unidos, 97403
        • Options Counseling

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

14 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Family with an adolescent between 14 and 18 years of age and at least one parent or permanent guardian with whom the adolescent resides
  • Family's primary concerns include depressive symptoms
  • Adolescent has a score above 24 on the Center for Epidemiological Studies-Depression Scale
  • Family will be seeking services at the community mental health center that is associated with the study

Exclusion Criteria:

  • Adolescents presenting with evidence of severe difficulties associated with comorbid conditions, such that the focus of treatment would need to shift to nonaffective symptoms
  • Adolescents evidencing symptoms of mania or psychoses or with suicidal behaviors requiring inpatient care
  • Adolescents with cognitive limitations of severity that will preclude meaningful participation in the study

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: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 1
Participants will receive a cognitive behavioral family therapy for adolescent depression to be developed in this study.

11 to 15 sessions of a cognitive behavioral family therapy that will be developed during the course of this study and will address the following:

  • parent-adolescent conflict
  • adolescent development
  • support and closeness
  • behavioral activation
  • response to adolescent negative affect
  • relapse prevention
  • suicide prevention, if necessary
Comparador activo: 2
Participants will receive treatment as usual 1 year prior to the experimental treatment group.
Treatment as usual, which will most likely consist of 8 to 10 sessions of community-based depression treatment

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Center for Epidemiological Studies-Depression (CES-D) Scale
Periodo de tiempo: Measured pre- and post-intervention
Measured pre- and post-intervention

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Lisa B. Sheeber, PhD, Oregon Research Institute

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 abril de 2009

Finalización primaria (Actual)

1 de noviembre de 2012

Finalización del estudio (Actual)

1 de diciembre de 2012

Fechas de registro del estudio

Enviado por primera vez

23 de marzo de 2009

Primero enviado que cumplió con los criterios de control de calidad

23 de marzo de 2009

Publicado por primera vez (Estimar)

24 de marzo de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

18 de abril de 2013

Última actualización enviada que cumplió con los criterios de control de calidad

16 de abril de 2013

Última verificación

1 de abril de 2013

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • R34MH076966 (Subvención/contrato del NIH de EE. UU.)
  • DDTR B4-TBI (ClinicalTrials.gov)

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 Behavioral Family Treatment

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