Conventional Versus Mindfulness Intervention in Parents of Children With Disabilities
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 2
- 主要终点
- Parenting Stress Index Scores
研究概览
简要总结
This application compares the effectiveness of a conventional Parent Group intervention to Mindfulness- Based Stress Reduction (MBSR) in parents of children with autism spectrum disorders (ASD) and other disabilities. Parent groups are widely-used to provide information, emotional support, education and advocacy. MBSR is efficacious for people with medical, psychiatric or other concerns, and teaches stress reduction through mindfulness training and practice. In contrast to conventional parent groups, the investigators' studies suggest that mindfulness-based interventions may be particularly effective in reducing stress and improving the health and mental health of parents of children with disabilities. The investigators will assess parent factors that may correlate with intervention efficacy in the 2 treatment arms.
详细描述
Specific Aim 1. To compare the effectiveness of Parent Groups versus MBSR interventions in parents of children with ASD or other developmental disabilities.
Hypothesis 1: Mothers and fathers in both treatment groups will show reduced stress, depression, and anxiety, and increased life satisfaction, health, and well-being. Treatment effects will be more pronounced in MBSR, including more normalized diurnal cortisol patterns.
Hypothesis 2: Improved parental outcomes will persist after treatment, and relate to booster session attendance, and/or the frequency that parents practice techniques learned in each treatment. Improvements will be sustained longer in the MBSR treatment. Parental benefits will impact families, and may be associated with improved child behaviors or less family conflict.
Hypothesis 3. The composition of intervention groups in Year 2 will be adjusted based on Year 1 data, and may reflect continued separation or integration of ASD vs other disability groups, or new combinations of participants.
Specific Aim 2: To identify aspects of maternal, family or child functioning that help explain variability in responses to Parent Group or MBSR interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •parent of a child with a known developmental disorder
- •parent of a child with a chronic medical condition with known lifelong physical and mental effects, e.g., childhood cancer, cystic fibrosis, and muscular dystrophy
排除标准
- •those who are not parent of a child with a known developmental disorder or medical condition
结局指标
主要结局
Parenting Stress Index Scores
时间窗: day 1 of week 6, active intervention phase
Parenting Stress Index standard scores will show treatment effects of intervention by day one of week six of active intervention phase.
次要结局
- Beck Depression Inventory, Parenting Stress Index, Epworth Sleep Scale, Positive Affect Index, Life Satisfaction Scale, Mindfulness Questionnaire, Ryff's Well being Scale, Health Questionnaire, Achenbach Child Behavior Checklist(at day 1 of week six -active intervention phase)
- Beck Anxiety Inventory(at day one of week 6, active intervention phase)
- Salivary Cortisol measures(at day 1 of week 6, active intervention phase)
- Ryff's scale of Well-being(on day 1 of week 6, active intervention phase)
研究者
Elisabeth Dykens
Director of Vanderbilt Kennedy Center
Vanderbilt University