Mindfulness Intervention for Parents of Children With ASD
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Ecological assessment and intervention, Audio-based Mindfulness intervention.
- Кому может быть актуально
- Состояния в реестре: Mindfulness. Базовые параметры: 18 лет — 75 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Список центров уточняется — проверьте первичный протокол.
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
The Mechanism and Effectiveness of Mindfulness-based Intervention for Reducing the Psychological Distress of Parents of Children With Autism Spectrum Disorder: An Ecological Momentary Intervention and Randomized Controlled Trial
Обзор
This study aims to develop a smartphone app based on mindfulness-based interventions and test its effectiveness in parents of children with ASD. This study aims: 1. To establish the relationship between different life events, cognitive appraisal, and the psychological distress between parents of children with autism spectrum disorder (ASD); 2. To demonstrate the relationship between parents' cognitive appraisal of life events and psychological distress moderated by mindfulness; 3. To examine the effectiveness of mindfulness-based intervention (MBI) via ecological momentary intervention (EMI) in reducing the psychological distress of parents of children with ASD; 4. To calculate the cost-effectiveness of MBI via EMI in reducing the psychological distress of parents of children with ASD.
Подробное описание
Existing studies have unequivocally demonstrated that parents of children with autism spectrum disorder (ASD) experience various daily life events and suffer from psychological distress. Mindfulness-based intervention (MBI) was found to be an effective buffer between parents' appraisal of life events and psychological distress. However, the mechanism behind the effectiveness was unclear, and traditional MBI in experimental settings were not tailored to personal real-life needs. This study proposed to conduct a randomized controlled trial (RCT) to examine the effectiveness and cost-effectiveness of MBI in the platform of ecological momentary intervention (EMI) in changing participants' cognitive appraisal of daily life events and reducing the psychological distress of parents of children with ASD.
This study aims to answer four research questions:
1. What's the relationship between participants' cognitive appraisal of their life events and psychological distress? 2. Will an increased level of mindfulness moderate the relationship between participants' cognitive appraisal of life events and psychological distress? 3. Will the participants who received MBI via EMI report significantly lower levels of psychological distress compared with those who did not? 4. Will the MBI via EMI be a more cost-effective option compared with the control group?
The proposed study will recruit 526 parents of children with ASD and randomly assign them into the intervention and control groups (263 in each group). Participants in the intervention group will install the EMI app on their smartphone. In the app, participants can browse different mindfulness exercises in the intervention bank at any time, talk to a virtual counselor and receive tailored mindfulness practice daily, practice formal mindfulness exercise every week, complete ecological momentary assessments on the cognitive appraisal of life events and receive a daily log of change of psychological status. Participants in the control group will only receive standardized mindfulness practice instructions 3 times/week. The effects of MBI will be assessed at the end of the intervention and at the 2-month follow-up.
The primary outcome will be participants' psychological distress measured by the depression anxiety stress scale. The secondary outcomes will include participants' subjective well-being, measured by the satisfaction with life scale, level of resilience measured by the psychological empowerment scale and the feasibility and acceptability of the EMI, measured by the treatment acceptability and adherence scale.
The potential benefit of the proposed study is to increase psychological well-being of parents of children with ASD and the method may extend to other participants in the future.
Вмешательства
- Поведенческое Ecological assessment and intervention
The MBI-EMI app will include five main parts, including virtual counselor, intervention library, weekly mindfulness practice, assessment bank and daily emotion log. In the eight weeks, the virtual counselor will initiate the conversation every day for three times (morning, afternoon and evening) to check the status of the participants. If the participants responded, the virtual counselor would invite the participants to rate their level of depression, stress and anxiety and then recommend approp - Поведенческое Audio-based Mindfulness intervention
The control group will receive audio recordings of how to practice mindfulness at home.
Первичные конечные точки
- Cognitive Appraisal of Health Scale [Срок оценки: right after the intervention]
- Cognitive Appraisal of Health Scale [Срок оценки: 2 months after the intervention]
Вторичные конечные точки (4)
- The Five Facet Mindfulness Questionnaire (FFMQ)-short version [Срок оценки: right after the intervention]
- The Depression Anxiety Stress Scale [Срок оценки: right after the intervention]
- Satisfaction with Life Scale [Срок оценки: right after the intervention]
- Psychological Empowerment Scale for parents of children with a disability [Срок оценки: right after the intervention]
Критерии участия
The inclusion criteria will comprise
- parents of children with ASD (children aged between 6-18 and diagnosed with different functional levels of ASD by certified psychologists);
- own a mobile smartphone with internet access;
- will stay in Hong Kong during the 8-week EMI study period, and
- able to read and write in Chinese.
The exclusion criteria will include
- parents diagnosed with depression, anxiety, and stress disorder by certified doctors; and
- parents who do not live together with their children with ASD on the daily basis.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Двойное слепое
- Основная цель
- Поддерживающая терапия
Центры проведения
Список центров уточняется — проверьте первичный протокол.
Публикации
- Wang Q, Ng SM, Zhou X. The mechanism and effectiveness of mindfulness-based intervention for reducing the psychological distress of parents of children with autism spectrum disorder: A protocol of randomized control trial of ecological momentary intervention and assessment. PLoS One. 2023 Sep 13;18(9):e0291168. doi: 10.1371/journal.pone.0291168. eCollection 2023. PMID 37703248
Идентификаторы
NCT: NCT05746468 · EC077/2223