- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT03301831
Resourcefulness Intervention With Parents of Technology-Dependent Children
27 de setembro de 2021 atualizado por: Valerie Toly, University Hospitals Cleveland Medical Center
Intervention Pilot With Parents of Technology-Dependent Children
Technology-dependent children, those who live at home but rely on medical equipment such as mechanical ventilation or feeding tubes, require complex care for their chronic condition.
Parents usually provide a majority of their care and are often overwhelmed by the caregiving demands resulting in deterioration of their own mental and physical health.
The goal of this 2-arm (intervention vs. attention control) RCT is to test a cognitive-behavioral Resourcefulness Training intervention that includes teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
The intervention is proposed to improve these caregivers' mental and physical health outcomes and family functioning outcomes while they continue to provide vital care for these vulnerable children.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Descrição detalhada
Technology-dependent children, those who rely on medical equipment such as mechanical ventilation or feeding tubes for daily care at home, are among the sickest and most vulnerable subset of children with complex chronic conditions.
An estimated 600,000 children in the United States are technology dependent and live at home, and are cared for primarily by their parents.
These parents report greater levels of depressive symptoms and stress than other caregiver groups.
In addition, these caregivers report poor psychological and physical health that compromise their caregiving capacity and increase their use of emergency rooms (ER) for their children's care needs.
Despite these adverse consequences, there are no interventions to meet the needs of these caregivers and their children.
Resourcefulness Training, (cognitive-behavioral self-management intervention) has been shown to improve psychological and physical outcomes, mediate the effects of stress, and enhance the care provided to care-recipients.
It will be tested in a randomized trial against an attention-only control arm.
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
The aims of the study are to: 1) Determine whether Resourcefulness Training versus Attention Control improves psychological (general mental health, depressive cognitions, depressive symptoms, appraised stress, burden) and physical outcomes (general physical health, chronic stress [hair cortisol]) and family functioning over 6 months in parents of technology-dependent children, after controlling for the parents' race/ethnicity, sex, family income, and children's functional status; and 2) Determine whether changes in psychological and physical outcomes and family functioning are mediated by changes in parents' levels of resourcefulness (personal and social).
Data collection will take place at baseline then 6 weeks, 3 months, and 6 months post-enrollment.
Our study will be the first to test a resourcefulness intervention for this caregiver population and to include male as well as female caregivers.
This intervention is distinctive in that it uses web, telephone, and journal components for reinforcement-not multiple face-to-face visits that can be labor intensive.
If shown to be efficacious, it can be easily replicated with other populations with strong potential for translation into practice.
Tipo de estudo
Intervencional
Inscrição (Real)
93
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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Ohio
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Cleveland, Ohio, Estados Unidos, 44106-5065
- University Hospitals Cleveland Medical 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
Tudo
Descrição
Inclusion Criteria:
- parent caregiver (biological, adoptive, or foster mother, father, grandmother or grandfather) for a technology-dependent child based on the Office of Technology Assessment (OTA) classification criteria (Group 1, mechanical ventilator; Group 2, intravenous nutrition/medication; Group 3 respiratory or nutritional support)
- at least 18 years of age
- able to speak and understand English due to the availability of the intervention and instruments in English only
- the technology-dependent child must be age 17 years or younger and receive care in the home from his/her parent
Exclusion Criteria:
- Parents of children with a cancer diagnosis will be excluded from participation due to the potentially life-threatening, terminal nature of the illness and grief reactions associated with a cancer diagnosis that may limit their ability to participate over the 6 month study.
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: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: Resourcefulness Training Intervention
The intervention arm will receive an intervention that includes: a face-to-face session for teaching social (help-seeking) and personal (self-help) resourcefulness skills; ongoing access to video vignettes of caregivers of technology-dependent children describing resourcefulness skill application in daily life; 4 weeks of skills' reinforcement using daily journal writing; weekly phone calls for the first 4 weeks; and booster sessions at 2 and 4 months post enrollment.
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Cognitive-behavioral intervention that includes personal and social resourcefulness skills.
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Sem intervenção: Attention Control
The Attention Control arm will receive weekly phone calls for the first 4 weeks and at 2 and 4 months post enrollment plus any usual care.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Depressive Cognitions Scale
Prazo: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Subjective measure of participant depressive cognitions- precursor of depressive symptoms.
Score range for the instrument is 0-40, where a higher score indicates greater depressive cognition.
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From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Medical Outcomes Short Form Health Survey (SF-12) Physical Health
Prazo: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment.
Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
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From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Medical Outcomes Short Form Health Survey (SF-12) Mental Health
Prazo: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Change in General Mental and Physical Health from Baseline to 6 Months Post Enrollment.
Score range is 0-100, where a '0' indicates lowest level of health, and '100' indicates highest level of health.
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From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Feetham Family Functioning Survey
Prazo: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
|
Change in Family Functioning from Baseline to 6 Months Post Enrollment.
This subjective measure of family functioning is collected via participant survey.
The score range is 0-175, which is the sum of the "differences" between reality and life expectations.
Higher 'Difference' score indicates an imbalance between reality and life expectations
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From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Resourcefulness Scale
Prazo: From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Subjective survey of participants' personal and social resourcefulness.
Score range is 0-140, where a higher score indicates greater resourcefulness.
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From baseline to 6 weeks, 3 months, and 6 months post-enrollment
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Valerie A Toly, PhD, Frances Payne Bolton School of Nursing, Case Western Reserve University
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 (Real)
5 de fevereiro de 2018
Conclusão Primária (Real)
9 de dezembro de 2019
Conclusão do estudo (Real)
9 de dezembro de 2019
Datas de inscrição no estudo
Enviado pela primeira vez
24 de setembro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de setembro de 2017
Primeira postagem (Real)
4 de outubro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
25 de outubro de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
27 de setembro de 2021
Última verificação
1 de setembro de 2021
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 08-10-30
- 1R15NR017302-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano IPD
The study team is still conducting analysis and writing up study results for publication.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .
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