- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00867919
Designing and Testing a Family Therapy for Adolescent Depression
Family Therapy for Adolescent Depression: Deployment Focused Development, Phase 1
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Antecipado)
Estágio
- Fase 1
Contactos e Locais
Locais de estudo
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Oregon
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Eugene, Oregon, Estados Unidos, 97403
- Oregon Research Institute
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Eugene, Oregon, Estados Unidos, 97403
- Options Counseling
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 1
Participants will receive a cognitive behavioral family therapy for adolescent depression to be developed in this study.
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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:
|
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Comparador Ativo: 2
Participants will receive treatment as usual 1 year prior to the experimental treatment group.
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Treatment as usual, which will most likely consist of 8 to 10 sessions of community-based depression treatment
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Center for Epidemiological Studies-Depression (CES-D) Scale
Prazo: Measured pre- and post-intervention
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Measured pre- and post-intervention
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lisa B. Sheeber, PhD, Oregon Research Institute
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R34MH076966 (Concessão/Contrato do NIH dos EUA)
- DDTR B4-TBI (ClinicalTrials.gov)
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 .