- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00951821
Concurrent Treatment for Depressed Parents and DepressedAdolescents
Concurrent Treatment for Parents and Adolescents Who Attempt Suicide
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Depression, like many psychiatric disorders, has a genetic component that makes it more likely that members of the same family will have the disorder. Depression in parents, particularly mothers, may put the children at greater risk for depression. When an adolescent whose parent is depressed develops depression himself or herself, treating both the parent and the adolescent may be more effective than treating only the adolescent. This study will test a depression treatment that targets depressed suicidal adolescents with a parent or primary caretaker who is also depressed and has a history of suicidality.
Participation in this study will last 6 months. Participants will be randomly assigned to receive either concurrent parent and adolescent treatment or adolescent only treatment. For those assigned to concurrent treatment, both the adolescent participants and one of their parents will receive individual cognitive behavioral therapy (CBT) counseling sessions and joint family counseling sessions. In the adolescent only treatment condition, adolescent participants will receive individual CBT sessions, but parents will not, and both will receive joint family sessions. Counseling sessions will last 1 hour and occur weekly for 3 months, and then every other week for 3 months. CBT identifies and attempts to change problematic thought patterns. All participants will receive medication consultation if necessary.
Participants will complete assessments at baseline, post-treatment, and 6 months after completing treatment. These assessments will include questionnaires and interviews about depression, suicidal thoughts, mood regulation, behavioral problems, and family. At post-treatment and the 6-month follow-up, participants will also be asked to give feedback about the counseling, medication consultation, and their satisfaction.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Rhode Island
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Providence, Rhode Island, Estados Unidos, 02912
- Brown University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria for Adolescents:
- Lives at home with at least one parent or guardian
- Speaks English
- Must have made a suicide attempt and be diagnosed with major depressive disorder (MDD)
Inclusion Criteria for Primary Caretakers:
- Speaks English
- Current diagnosis of MDD and a history of suicidality
Exclusion Criteria for Adolescents:
- Judged to have developmental or cognitive delays or psychotic disorders on the basis of a standard psychiatric exam
- Diagnosis of bipolar disorder or a substance dependence (people with a diagnosis of substance abuse are eligible)
- Only one adolescent per family is eligible
Exclusion Criteria for Primary Caretakers:
- Diagnosis of bipolar disorder or substance dependence
- If taking antidepressants, not on a stable dose for 3 months
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 |
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Experimental: Concurrent treatment
Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
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Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase.
The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment.
Otros nombres:
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Comparador activo: Adolescent treatment only
Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.
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Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Beck Depression Inventory - Adolescent Report, Change in Symptom Level
Periodo de tiempo: 12 months
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self-report measure of depressed mood - range of scores 0 to 60; higher scores indicate worse depression.
The data in this outcome refer to change from baseline to 12 month follow-up, per the adolescent self-report.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Beck Suicide Scale - Adolescent Response
Periodo de tiempo: Measured at 12 months
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measure of suicidal ideation - scale ranges from 0 to 38 - higher scores indicate higher suicidal ideation.
These data refer to adolescent respondents.
The outcome is a change score so range is from -38 to 38.
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Measured at 12 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R34MH082211 (Subvención/contrato del NIH de EE. UU.)
- DSIR 84 CTS
- NCT00951821 (Identificador de registro: Clinical Trials.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 Concurrent treatment
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University of OklahomaTerminadoAumento de peso | Trastorno de alimentación Neonatal | Lactante de muy bajo peso al nacerEstados Unidos