- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00737035
Effectiveness of a Web-based Intervention for Guardians of Children Whose One Parent Has Murdered the Other
Testing an IHCA for Guardians of Survivors of Intraparental Homicide
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Intraparental homicide (IPH), when one parent kills the other, leaves approximately 4,000 children bereaved each year, adding to a total of 70,000 currently in the United States. Although few studies have focused on this phenomenon, available data indicate children of IPH suffer short- and long-term mental health consequences, including post-traumatic stress disorder (PTSD). Prior research also indicates that guardians, often family members under stress themselves, do not know how to help the children. No interventions directed at guardians of child survivors of IPH are found in scientific and clinical literature. Use of a specialized Web site called an Interactive Healthcare Communication Application (IHCA) has been found effective in treating multiple health conditions, including breast cancer in women and asthma in children. This study aims to refine an IHCA Web site for use by guardians of child survivors of IPH, to determine the safety and effectiveness of this Web site, and to determine how it is used by targeted guardians.
In the first phase of this study researchers will develop the IHCA based on feedback from a small focus group of guardians of child survivors of IPH. Then guardians of survivors of IPH up to 16 years old will be randomly assigned either to receive access to the IHCA created for them or to have access only to generally available Internet information. The IHCA will have six components: (1) an Instant Library of articles on topics of interest; (2) a resource directory of both national and local support and service organizations; (3) access to a peer communication system; (4) a Frequently Asked Questions section, updated with responses to user generated questions; (5) an "Ask an Expert" system staffed by researchers; and (6) personal stories of others dealing with IPH. Participants with access to the IHCA will receive print and phone instructions explaining the Web site and have their usage monitored by tracking software. Those in the control group will be directed to a Web site linking to publically available, pre-existing support Web sites. After 16 weeks of unlimited access to the IHCA or control group Web sites from their home computers, all participants will complete four evaluation reviews: the Family Crisis Oriented Personal Evaluation Scales, the Parenting Stress Index, the Child Behavior Checklist, and the Child PTSD Inventory - Parent.
Tipo de estudo
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Virginia
-
Charlottesville, Virginia, Estados Unidos, 22908
- University of Virginia
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Able to speak and read English at a 7th grade level
- Guardian of a child survivor of parental homicide aged 0 to 16 years
Exclusion Criteria:
- None
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: 1-Intervention
For 16 weeks, participants will have access to an interactive healthcare communication application (IHCA).
|
The IHCA is an Internet-based tool that integrates multiple resources for guardians of survivors of interparental homicide.
The IHCA will have six components: (1) an instant library of articles on topics of interest; (2) a resource directory of both national and local support and service organizations; (3) access to a peer communication system; (4) a Frequently Asked Questions section, updated with responses to user generated questions; (5) an "Ask an Expert" system staffed by researchers; and (6) personal stories of others dealing with IPH.
Outros nomes:
|
|
Comparador Ativo: 2- Control
For 16 weeks, participants will have access to generally available Internet-based information about parenting, trauma, and child development.
|
Only publicly available Web sites on parenting, child development, and trauma will be used.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
|
Family Crisis Oriented Personal Evaluation Scales (F-COPES)
Prazo: Measured at 16 weeks
|
Measured at 16 weeks
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
Parenting Stress Index (PSI)
Prazo: Measured at 16 weeks
|
Measured at 16 weeks
|
|
Child Behavior Checklist (CBCL/6-18) Parent form
Prazo: Measured at 16 weeks
|
Measured at 16 weeks
|
|
Child PTSD Inventory-Parent (CPTSDI-P):
Prazo: Measured at 16 weeks
|
Measured at 16 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kathryn S. Laughon, PhD RN, University of Virginia School of Nursing
Publicações e links úteis
Publicações Gerais
- Laughon K, Steeves RH, Parker B, Knopp A, Sawin EM. Forgiveness, and other themes, in women whose fathers killed their mothers. ANS Adv Nurs Sci. 2008 Apr-Jun;31(2):153-63. doi: 10.1097/01.ANS.0000319565.68760.4d.
- Steeves R, Laughon K, Parker B, Weierbach F. Talking about talk: the experiences of boys who survived intraparental homicide. Issues Ment Health Nurs. 2007 Aug;28(8):899-912. doi: 10.1080/01612840701493576.
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2008-0130-00
- DDTR B3-PDS (Outro identificador: FDAAA)
- R21MH082197 (Concessão/Contrato do NIH dos EUA)
- 1R21MH082197-01A1 (Concessão/Contrato do NIH dos EUA)
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 .