- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01073657
Supported Education Pilot (SEd)
Supporting Education Goals of OIF/OEF Veterans With PTSD: Pilot Process & Outcome
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Goal: The goal of this project is to gather data on feasibility and effect size necessary for a full scale trial of a supported education service for Operation Iraq and Enduring Freedom (OIF/OEF) veterans with PTSD that will contribute to its evidence-base. Supported education is a rehabilitation and recovery based intervention that is new to VHA services and that responds to an expressed but unmet need among these warriors with war-related trauma. We propose to conduct a pilot of a supported education service and employ a process and outcome evaluation.
Anticipated Impacts on Veterans Healthcare: Veterans with post traumatic stress disorder (PTSD) possess educational aspirations. Due to limited education and disability adjustment, many such veterans unsuccessfully locate employment or obtain entry level jobs with limited advancement opportunities. Even with current GI Bill funding increases, veterans experience non-financial barriers to their pursuit of educational goals. Supported education is a strategy developed within the civilian population that facilitates skill, career, and educational goals within post-secondary educational settings. It has been shown to increase educational engagement, participation, and completion, as well as improve empowerment and school efficacy. We hypothesize that supported education tailored to returning Veterans will result in similar outcomes.
Aims and Objectives: The goal of this project is to gather data necessary for a full scale trial of a supported education service for OIF/OEF veterans with PTSD. The following are the aims and objectives:
Aim 1: Using a randomized controlled design, assess the magnitude of the effect of a supported education service on hours of participation in community educational settings and on acquiring an educational goal. Objective: Assess the number of hours of participation in community education settings and on acquiring an educational goal for 40 Veterans with PTSD who are randomly assigned to an intervention group (N=20) that receives a weekly supported education intervention and a control group that receives services as usual plus an hour of attentive intervention not focused on education.
Aim 2. To examine whether the supported education intervention has secondary effects for improving PTSD symptoms and attitudes on recovery. Objective: Conduct pre- and post assessments of recovery attitudes and of PTSD symptoms, and then compare the control and intervention group for changes in these scores.
Aim 3. To acquire additional process information on the design and implementation of a supported education service necessary for a successful larger trial. Objective: Conduct a process evaluation of the implementation strategies for: participant recruitment, participant drop-out, technician training procedures, technician recovery promoting competence, and curriculum content and pacing using a standardized assessment, exit interviews, peer notes and study records.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase temprana 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Massachusetts
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Bedford, Massachusetts, Estados Unidos, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- PTSD
- OIF/OEF Service
Exclusion Criteria:
None
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Supported Education
Veterans received supported education services.
A Veteran peer met weekly as needed with a subject for up to six months in a psycho-social rehabilitation service for meeting education goals.
Goals included choosing a college, getting admitted or enrolled, and maintaining enrollment and completing classes.
|
Rehabilitation counseling using peers to achieve educational goals
Otros nombres:
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Comparador activo: General Peer Support
Matched attention was provided by a Veteran peer who met weekly with Veterans but who focused on help with any personal goal (eg, employment, housing) but not on education.
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Matched peer support for any personal goal other than education
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
"Supported Education Process Measure"
Periodo de tiempo: 6 months
|
Number of quarter hours spent in activities related to acquiring an education goal e.g., preparing applications, attending classes.
Hours will be logged on a tally sheet adapted from the "Supported Education Process Measure" (Corrigan, 2009).
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Marsha Langer Ellison, PhD MSW, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Publicaciones y enlaces útiles
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
Otros números de identificación del estudio
- PPO 09-254
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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-
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-
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-
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