- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01534377
Interpersonal Psychotherapy for Adolescent Girls (IPT)
Prevention of Depression in Maltreated and Nonmaltreated Adolescents
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Child maltreatment poses a serious public health problem and heightens the risk of psychopathology across the life course. Adolescence also represents a peak time for the emergence of depressive disorders particularly in girls. Effective interventions to prevent and treat depression in low income adolescent girls with or without histories of maltreatment are needed.
Three groups will be recruited: Maltreated Depressive Symptoms (MDS), Nonmaltreated Depressive Symptoms (NDS), and a Nonmaltreated Nonsymptomatic Comparison (NNC), comparable in SES, race/ethnicity, and household composition. The MDS and NDS groups will be randomized into IPT-A or Enhanced Care (EC). Adolescent girls in these groups will receive 13 sessions of therapy. Girls in the NNC group will only complete research visits.
Research assessments will be conducted at T1 (baseline/prior to intervention), T2 (6-weeks mid-intervention), T3 (end of intervention), T4 (1-year post) and T5 (18 months post). Girls and their mothers will participate in these research sessions. A multi-level-of-analysis approach, integrating genotyping, hormone assays, cognitive testing, adolescent- and maternal-report, mother-teen observation, and DHS and school records will be utilized to assess the effectiveness of the interventions.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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New York
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Rochester, New York, Estados Unidos, 14608
- Mt. Hope Family Center
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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:
- girls
- ages 13-15 years old
- low SES status
- live in Rochester or surrounding counties
- girls in the maltreated depressive symptom group will have CPS-documented child maltreatment
- girls in the nonmaltreated depressive symptom group will not have CPS- documented child maltreatment
- girls in the nonmaltreated nonsymptomatic comparison group will have no current or past mental illness and no documented child maltreatment
Exclusion Criteria:
- taking antidepressants or prescription medications for anxiety
- already receiving mental health treatment
- actively suicidal
- diagnosed with a severe mental disorder
- abusing drugs or alcohol
- evidence of compromised cognitive ability
- evidence of a pervasive developmental disorder
- evidence of a major physical or neurological disorder
- non-English speaking
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Interpersonal Psychotherapy
Adolescents will receive Interpersonal Psychotherapy for the treatment and prevention of depression.
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Adolescents will receive IPT-A a manualized intervention for depression and prevention of depression that emphasizes current interpersonal relationships, focusing on their immediate social context.
Otros nombres:
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Experimental: Enhanced Care
Adolescents will receive the Enhanced care model or care that they would typically receive in community setting to treat and prevent depression.
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Adolescents will receive enhanced care which is consistent with care typically provided in community settings to treat and prevent depression.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in adolescent depressive symptoms from baseline to post-intervention
Periodo de tiempo: Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention
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To evaluate the efficacy of Interpersonal Psychotherapy for Adolescents (IPT-A) for decreasing depressive symptoms and preventing depression in low-income ethnically and culturally diverse adolescent girls with and without histories of child maltreatment
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Baseline and 12 weeks, follow up at 1 year & again at 18 months post intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Sheree Toth, PhD, University of Rochester
- Investigador principal: Dante Cicchetti, Ph.D., University of Minnesota
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 035457
- 1R01MH091070-01A1 (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. .