Effectiveness of a Positive Psychology and Mindfulness Based App for Parents of Children with a Neurodevelopmental Disorder (NDD): Study Protocol of a Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 212
- 试验地点
- 1
- 主要终点
- Ability to Adapt
研究概览
简要总结
An app based on positive psychology and mindfulness to support the mental well-being of parents of children with a Neurodevelopmental Disorder (NDD) was developed and will be evaluated on effectiveness.
详细描述
This pragmatic randomized controlled trial aims to assess the effectiveness of the Adappt app, an app developed to support the mental well-being of parents of children with a neurodevelopmental disorder (NDD), such as autism and ADHD. This app was developed since research has shown that these parents experience higher stress levels than parents of typically developing children. Furthermore, the app was developed in collaboration with parents of children with a NDD, mental health care professionals and scientists in Europe.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least 18 years
- •parent of one or more children (< 18 years) diagnosed with or suspected of a NDD
- •having access to internet
- •in possession of an e-mail address,
- •in possession of a smartphone or tablet
- •willing to use the digital intervention for a month, daily for approximately 15 minutes a day.
排除标准
- •presence of severe anxiety symptoms
- •presence of moderately severe to severe depressive symptoms
- •being in treatment for mental health issues (the parent self)
结局指标
主要结局
Ability to Adapt
时间窗: Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline)
Measured with the10-item Generic Sense of Ability to Adapt Scale (GSAAS). An average score will be calculated ranging from 0 to 4, with higher scores being indicative of higher perceived ability to adapt.
次要结局
- Anxiety(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
- Savoring the moment(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
- Self-reassuring(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
- Mental well-being(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
- Depressive symptoms(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
- Parenting self-efficay and behavior of child(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
- Postive aspects of caregiving(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
- Stress(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
- Psychological flexibility(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
- Positive coping skills(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
- Mindfulness(Change from baseline to post intervention (1 month post baseline) and first follow up (4 months post baseline))
研究者
Kim Tonis
Principal Investigator
University of Twente