- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01073657
Supported Education Pilot (SEd)
Supporting Education Goals of OIF/OEF Veterans With PTSD: Pilot Process & Outcome
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Real)
Estágio
- Fase inicial 1
Contactos e Locais
Locais de estudo
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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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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- PTSD
- OIF/OEF Service
Exclusion Criteria:
None
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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
Outros nomes:
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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
"Supported Education Process Measure"
Prazo: 6 months
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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
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- PPO 09-254
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .