- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01503138
Intervention for Abused Chinese Immigrant Women
2 de dezembro de 2014 atualizado por: TIWARI, Agnes, The University of Hong Kong
The Effect of a Purpose-built Intervention on Mental Health in Mainland Chinese Immigrant Women Survivors of Intimate Partner Violence: A Randomized Controlled Trial
The purpose of this study is to evaluate the efficacy of a purpose-built intervention in improving the mental health of abused Mainland Chinese immigrant women in a community in Hong Kong.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Depression is one of the most common mental health sequelae of Intimate partner violence.
Not only does depression have an adverse effect on abused women's health and well-being, it also reduces their capacity to cope with the abuse by limiting their ability to perform self-care, meet work requirement, maintain independence, establish relationships, and access social support.
Previously, the ability of abused women to take care of themselves was found to be a protective factor for depression.
In order to enhance abused women's self-care, advocacy interventions have been developed to help them make sense of the abusive situation, identify potential solutions, and achieve their goals.
Also, immigration status was shown to be significantly associated with a higher level of depressive symptoms among the abused women.
The findings are important as they point to the need for further research to develop and evaluate culturally congruent interventions to meet the needs of abused Mainland Chinese immigrant women in Hong Kong.
Therefore, the purpose of this study is to develop a purpose-built intervention to address the unmet needs of Mainland Chinese immigrant women survivors of Intimate partner violence and to assess its effect on the mental health of the women.
Tipo de estudo
Intervencional
Inscrição (Real)
250
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Hong Kong, China
- HKSKH Lady MacLehose Center
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos e mais velhos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Fêmea
Descrição
Inclusion Criteria:
- Mainland Chinese immigrant women,
- 18 years of age or older,
- holding a one-way or two-way permit,
- have settled in Hong Kong with their intimate partners for less than seven years,
- have at least one child under 18 years of age,
- residing in the Kwai Chung, Tsuen Wan or Tsing Yi districts, and
- assessed to be abused by an intimate partner, based on the Abuse Assessment Screen.
Exclusion Criteria:
- participated in our positive parenting program or advocacy intervention previously, or
- will not be in Hong Kong during the intervention/standard health education program or the follow-up telephone interview, or
- is abused by someone who is not her intimate partner, or
- is unable to communicate in Cantonese or Putonghua.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Purpose-built intervention
A purpose-built intervention consists of: (i) Empowerment; (ii) Parenting workshops; and (iii) Telephone social support and Peer support.
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A purpose-built intervention consists of: (i) Empowerment; (ii) Parenting workshops; and (iii) Telephone social support and Peer support.
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Sem intervenção: Standard community health education program
The community health education programme consists of two group sessions with one on the topic of osteoporosis and one on dietary therapy based on the concepts of Chinese medicine.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in depressive symptoms at 6-month post-intervention
Prazo: Baseline and 6-month post-intervention
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The Beck Depression Inventory version II is used to assess depressive symptoms at baseline and also at 6-month post-intervention
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Baseline and 6-month post-intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change from baseline in parenting stress at 6-month post-intervention
Prazo: Baseline and 6-month post-intervention
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The Parenting Stress Index is used to measure paretning stress at baseline and also at 6-month post-intervention
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Baseline and 6-month post-intervention
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Change from baseline in perceptions of social support at 6-month post-intervention
Prazo: Baseline and 6-month post-intervention
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The 12-item Interpersonal Support Evaluation List is used to assess perceptions of social supportat baseline and also at 6-month post-intervention
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Baseline and 6-month post-intervention
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Change from baseline in health-related quality of life at 6-month post-intervention
Prazo: Baseline and 6-month post-intervention
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The SF-12 Health Survey is used to assess health-related quality of life at baseline and also at 6-month post-intervention
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Baseline and 6-month post-intervention
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Change from baseline in intimate partner violence at 6-month post-intervention
Prazo: Baseline and 6-month post-intervention
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The Revised Conflict Tactics Scales is used to measure the type and frequency of behaviors used by the perpetrator during partner conflict at baseline and also at 6-month post-intervention.
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Baseline and 6-month post-intervention
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Change from baseline in safety behaviors at 6-month post-intervention
Prazo: Baseline and 6-month post-intervention.
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The Safety Assessment Checklist is used to to measure the safety behaviours used by abused women to avert intimate partner violence at baseline and also at 6-month post-intervention.
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Baseline and 6-month post-intervention.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Golding JM. Intimate partner violence as a risk factor for mental disorders: a meta-analysis. J Fam Viol 1999; 14: 99-132.
- Kendall-Tackett KA. Inflammation, cardiovascular disease, and metabolic syndrome as sequelae of violence against women: the role of depression, hostility, and sleep disturbance. Trauma Violence Abuse. 2007 Apr;8(2):117-26. doi: 10.1177/1524838007301161. Erratum In: Trauma Violence Abuse. 2007 Jul;8(3):table of contents.
- Constantino RE, Sekula LK, Rabin B, Stone C. Negative life experiences, depression, and immune function in abused and nonabused women. Biol Res Nurs. 2000 Jan;1(3):190-8. doi: 10.1177/109980040000100304.
- Brush LD. Battering, traumatic stress, and welfare-to-work transition. Violence Against Women 2000; 6:1039-1065.
- O'Brien SM. Staying alive: a client with chronic mental illness in an environment of domestic violence. Holist Nurs Pract. 2002 Apr;16(3):16-23. doi: 10.1097/00004650-200204000-00006.
- Carlson BE, McNutt L, Choi DY, Rose IM. Intimate partner abuse and mental health: The role of social support and other protective factors. Violence Against Women 2002; 8: 720-745.
- Campbell JC, Kub J, Belknap RA, Templin TN. Predictors of depression in battered women. Violence Against Women 1997; 3: 271-93. PMID: 12349116
- Ford-Gilboe M, Varcoe C, Wuest J, Merritt-Gray M. Intimate partner violence and nursing practice. In Humphreys J, Campbell JC, eds. Family violence and nursing practice (2nd ed). New York: Springer 2010; 115-154.
- Wong JY, Tiwari A, Fong DY, Humphreys J, Bullock L. Depression among women experiencing intimate partner violence in a Chinese community. Nurs Res. 2011 Jan-Feb;60(1):58-65. doi: 10.1097/NNR.0b013e3182002a7c.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de dezembro de 2011
Conclusão Primária (Real)
1 de março de 2014
Conclusão do estudo (Real)
1 de março de 2014
Datas de inscrição no estudo
Enviado pela primeira vez
30 de dezembro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
30 de dezembro de 2011
Primeira postagem (Estimativa)
2 de janeiro de 2012
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
3 de dezembro de 2014
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de dezembro de 2014
Última verificação
1 de dezembro de 2014
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- UW 11-051
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