CBCT for Parents of Children With Autism
29 de janeiro de 2020 atualizado por: Samuel Fernandez-Carriba, Emory University
Cognitively Based Compassion Training for Parents of Children With Autism Spectrum Disorders
The purpose of this study is to determine if caregivers of children with a developmental delay experience a decrease in stress by participating in a meditation/cognitive training protocol.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
- Comportamental: Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind
- Comportamental: Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience
- Comportamental: Cognitive Based Compassion Training Session: Self-compassion
- Comportamental: Cognitive Based Compassion Training Session: Cultivating Equanimity
- Comportamental: Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others
- Comportamental: Cognitive Based Compassion Training Session: Developing Affection and Empathy
- Comportamental: Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion
- Comportamental: Cognitive Based Compassion Training Session: Realizing Active Compassion
- Comportamental: Meditation Session
Descrição detalhada
A pilot-test, eight week, Cognitive Based Compassion Training (CBCT) program for caregivers of children with developmental delays that is comprised of eight two-hour weekly long sessions with a certified instructor followed by a twenty minute long meditation session.
Sessions will focus on developing attention and stability of mind through focused attention training; cultivating insight into the nature of mental experience; cultivating self-compassion; developing equanimity; developing appreciation and gratitude; developing affection and empathy; realizing aspirational compassion; and realizing active compassion.
Tipo de estudo
Intervencional
Inscrição (Real)
29
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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Georgia
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Atlanta, Georgia, Estados Unidos, 30322
- Children's Healthcare of Atlanta
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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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
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Caregiver of child(ren) with developmental delay (including parents, grandparents, other extended family, family friends, and providers)
- Spend significant amount of time (more than 10 hours/week) with children with special needs.
Exclusion Criteria:
- Started to use any psychotropic medication within one year.
- Had any changes in any psychotropic medication doses taken within one year.
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: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Caregiver of Child With Autism Spectrum Disorder
Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.
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Completed at Week 1.
Initial meditation exercises will be described and practiced to train attention skills (on breath) and create mental stability.
Completed at Week 2. Exercises to develop mindfulness will continue in order to promote mental stability and clarity.
Completed at Week 3: Techniques to analyze mental processes are introduced.
Completed at Week 4. Further analysis of mental processes.
Completed at Week 5. A reflection of all the things that bring us well-being are provided by or dependent upon other beings is encouraged.
Completed at Week 6.
The following concepts are presented and carefully considered: (1) cooperation and solidarity is essential for our survival and flourishing, as we are all extremely vulnerable and need each other; (2) hate and selfishness only cause suffering to others and ourselves and can only be prevented by cultivating sincere affection for others.
Completed at Week 7. Participants are invited to deepen their reflection on the reasons for gratitude, empathy, and affection for others, and see how they lead to feelings of compassion, or the wish for others to be free from suffering.
Completed at Week 8.
The strategies used until this point will be reviewed in order to move from the wish for others to be free of suffering, toward the sense that we want to and must take steps to relieve their suffering.
20 minute session completed weekly after the Cognitive Training Session
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Aberrant Behavior Checklist (ABC) Score
Prazo: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
Designed to assess behavior problems in children with developmental difficulties and it consists of 58 items grouped in five subscales (irritability, social withdrawal, stereotypic behaviors, hyperactivity, and inappropriate behavior).
The irritability subscale comprises of 15 statements that have been used as an index of Autism Spectrum Disorder-specific disability.
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Change in Parenting Stress Index/Short Form (PSI/SF) Score
Prazo: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
A 36-item measure designed to evaluate the magnitude of stress in caregiver-child relationships.
All items have a 5-point response scale (roughly, Strongly Agree, Agree, Not Sure, Disagree, Strongly Disagree) and yield a Total Stress score from three scales: Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child.
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
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Change in Perceived Stress Scale (PSS) Score
Prazo: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
An instrument to measure non-specific appraised stress which correlates with biological markers like cortisol, immune markers, and depression.
It consists of 14 items rated on a 5 point scale (from never to very often) that refer to feelings and thoughts over the past month.
|
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
|
Change in Acceptance and Action Questionnaire (AAQ) Score
Prazo: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
A list of 10 statements rated from 1 (never true) to 7 (always true) measures psychological acceptance or assent to the reality of a situation (e.g., "it's okay if I remember something unpleasant").
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
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Change in Interpersonal Reactivity Index (IRI) Score
Prazo: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
A self-report questionnaire of 28 items answered on a 5-point scale ranging from "Does not describe me well" to "Describes me very well".
It is considered a measure of empathy as a multidimensional construct that can be factored in four first-order factors, corresponding to the four subscales of the IRI: Perspective Taking, Fantasy (or tendency to transpose into the feelings and actions of fictitious characters in books and movies), Empathic Concern (interpersonal sympathy and concern), and Personal Distress (interpersonal distress).
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
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Change in Mindful Attention Awareness Scale (MAAS) Score
Prazo: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
A questionnaire to measure attentiveness and mindfulness as a trait and it includes 15 items with answers on a 6-point scale (from "almost always" to "almost never").
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
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Change in Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A) Score
Prazo: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
A self-report assessment of executive function behaviors for adults aged 18-90.
It contains 86 items in two validity scales and eight clinical scales that form two indexes: a) Behavioral Regulation (four scales: inhibit, shift, emotional control, and self-monitor) and b) Metacognition (five scales: initiate, working memory, plan/organize, organization of materials, and monitor), as well as a Global Executive Composite score.
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
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Change in Parenting Sense of Competence Scale Score
Prazo: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
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A 16 item questionnaire (on a 6 point scale ranging from strongly agree to strongly disagree), it includes a section on Satisfaction, with nine questions that examine the parents' anxiety, motivation and frustration, and an Efficacy scale, with 7 questions covering parents' sense of competence, capability levels, and problem-solving abilities in their parenting role.
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Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Samuel Fernandez-Carriba, PhD, Emory University Assistant Professor
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 junho de 2014
Conclusão Primária (Real)
11 de fevereiro de 2016
Conclusão do estudo (Real)
11 de fevereiro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
9 de outubro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
9 de outubro de 2015
Primeira postagem (Estimativa)
14 de outubro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Real)
31 de janeiro de 2020
Última atualização enviada que atendeu aos critérios de controle de qualidade
29 de janeiro de 2020
Última verificação
1 de janeiro de 2020
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB00074454
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