Does Mindfulness Training Enhance Early Evidence-based Parent-coaching Interventions for Autism Spectrum Disorder?: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Change in parent relationship quality
研究概览
简要总结
Caregivers of children with autism spectrum disorder (ASD) report higher levels of depression and distress than caregivers of typically developing children as well as children with other developmental disabilities. The proposed work tests a novel treatment paradigm that blends Mindfulness Based Stress Reduction (MBSR) with an empirically supported and manualized parent training program (Parent-Implemented Early Start Denver Model [P-ESDM]). We hypothesize that directly treating parental distress, while simultaneously providing evidence-based parent training, may greatly enhance child-focused intervention and provide benefits that resonate across the family.
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
- 12 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child has diagnosis of autism spectrum disorder
- •Child at least 12 months of age but less than 36 months at time of consent
- •Parent speaks and reads fluent English
排除标准
- •Severe child sensorimotor impairment that would impact participation in treatment
结局指标
主要结局
Change in parent relationship quality
时间窗: Baseline to end of study (Every 6 weeks for 9 months)
The Dyadic Adjustment Scale (DAS; Spanier, 1989) is a 32-item measure that assesses relationship satisfaction. It includes four subscales scored using a mix of Likert and dichotomous responses. Higher scores indicate higher relationship satisfaction.
Change in parental sleep quality
时间窗: Baseline to end of study (Every 6 weeks for 9 months)
Parents completed the Insomnia Severity Index (ISI; Bastien et al., 2011). The ISI consists of seven items scored from 0-4, with higher scores reflecting more sleep-related impairment.
Change in parental stress
时间窗: Baseline to end of study (Every 6 weeks for 9 months)
The Parenting Stress Index - Short Form, Third Edition (PSI-SF; Abidin, 1995), is a 36-item measure that yields three subscale scores (Parent Child Dysfunctional Interaction, Parenting Distress, Difficult Child) used in present analyses. Each item is rated as by parents as: SA (strongly agree), A (agree), NS (not sure), D (disagree), SD (strongly disagree). Scores are converted to percentile ranks, with higher scores indicating higher levels of stress. Percentile ranks of 15-80 considered typical, and ranks of 81 and above are considered high.
Change in parental depression
时间窗: Baseline to end of study (Every 6 weeks for 9 months)
Parents completed the Beck Depression Inventory (BDI; Beck et al., 1984). This instrument consists of 21 items, with higher scores reflecting higher levels of symptomatology.
Change in parental anxiety
时间窗: Baseline to end of study (Every 6 weeks for 9 months)
Parents completed the Beck Anxiety Inventory (BAI; Beck et al., 1988). This instrument consists of 21 items, with higher scores reflecting higher levels of symptomatology.
Change in parental mindfulness
时间窗: Baseline to end of study (Every 6 weeks for 9 months)
. Parents completed the Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006). The FFMQ consists of 44 items that yield five subscales: Observing, Describing, Acting with Awareness, Nonreactivity, and Nonjudging. Higher scores indicate more mindfulness.
Change in parental life satisfaction
时间窗: Baseline to end of study (Every 6 weeks for 9 months)
Parents completed the Satisfaction with Life Scale (SLS; Diener et al., 1984). The SLS is a 5-item measure of subjective wellbeing, with each item scored along a 7-point Likert scale (higher scores indicate more satisfaction).
次要结局
- Change in child autism symptom severity(Baseline, end of treatment (12 weeks), end of study (9 months))
- Change in child adaptive behavior(Baseline, end of treatment (12 weeks), end of study (9 months))
- Change in child problem behaviors(Baseline, end of treatment (12 weeks), end of study (9 months))
- Change in child cognitive functioning(Baseline, end of treatment (12 weeks), end of study (9 months))
- Change in child communication behaviors(Baseline, end of treatment (12 weeks), end of study (9 months))
研究者
Amy Weitlauf
Assistant Professor
Vanderbilt University Medical Center