CBCT for Parents of Children With Autism
29 января 2020 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
- Поведенческий: Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind
- Поведенческий: Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience
- Поведенческий: Cognitive Based Compassion Training Session: Self-compassion
- Поведенческий: Cognitive Based Compassion Training Session: Cultivating Equanimity
- Поведенческий: Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others
- Поведенческий: Cognitive Based Compassion Training Session: Developing Affection and Empathy
- Поведенческий: Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion
- Поведенческий: Cognitive Based Compassion Training Session: Realizing Active Compassion
- Поведенческий: Meditation Session
Подробное описание
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.
Тип исследования
Интервенционный
Регистрация (Действительный)
29
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
Georgia
-
Atlanta, Georgia, Соединенные Штаты, 30322
- Children's Healthcare of Atlanta
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Atlanta, Georgia, Соединенные Штаты, 30322
- Emory University
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-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Поддерживающая терапия
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Caregiver of Child With Autism Spectrum Disorder
Caregivers attending eight weekly sessions of Cognitive Based Compassion Training Sessions and Meditation.
|
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
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Aberrant Behavior Checklist (ABC) Score
Временное ограничение: 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.
|
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Parenting Stress Index/Short Form (PSI/SF) Score
Временное ограничение: 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.
|
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
|
Change in Perceived Stress Scale (PSS) Score
Временное ограничение: 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
Временное ограничение: 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").
|
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
|
Change in Interpersonal Reactivity Index (IRI) Score
Временное ограничение: 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).
|
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
|
Change in Mindful Attention Awareness Scale (MAAS) Score
Временное ограничение: 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").
|
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
|
Change in Behavior Rating Inventory of Executive Function- Adult Version (BRIEF-A) Score
Временное ограничение: 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.
|
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
|
Change in Parenting Sense of Competence Scale Score
Временное ограничение: Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
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.
|
Baseline, Completion of Treatment (up to eight weeks), Follow-Up (up to three months post-participation)
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Следователи
- Главный следователь: Samuel Fernandez-Carriba, PhD, Emory University Assistant Professor
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 июня 2014 г.
Первичное завершение (Действительный)
11 февраля 2016 г.
Завершение исследования (Действительный)
11 февраля 2016 г.
Даты регистрации исследования
Первый отправленный
9 октября 2015 г.
Впервые представлено, что соответствует критериям контроля качества
9 октября 2015 г.
Первый опубликованный (Оценивать)
14 октября 2015 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
31 января 2020 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
29 января 2020 г.
Последняя проверка
1 января 2020 г.
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- IRB00074454
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .