A Digital Self-Compassion Writing Intervention to Improve the Mental Health of Parents of Autistic Individuals
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Eligibility rate
研究概览
简要总结
This randomized controlled trial aims to evaluate the feasibility, acceptability, and preliminary efficacy of a digital self-compassion writing intervention for parents of autistic individuals. Participants will engage in a 14-day self-compassion writing program delivered via a WeChat mini-program. The study seeks to answer the following questions:
- Is the study design and digital self-compassion writing intervention feasible and acceptable for parents of autistic individuals?
- Does the intervention lead to greater improvements in self-compassion and mental health outcomes compared to the control group?
- Do baseline characteristics moderate the intervention effect compared to the control group?
- Among intervention participants, do satisfaction and usage patterns predict greater improvements in outcomes?
- Does improvement in self-compassion mediate changes in mental health outcomes?
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
- 否
入选标准
- •are parents of individuals with either a formal autism diagnosis or a provisional diagnosis from a medical institution
- •are living with the autistic individual
- •are aged 18 years or older
- •regularly use WeChat
- •are willing to commit to the study procedure
排除标准
- •current experience of acute mental health issues (e.g., severe depression, anxiety, suicidal tendencies)
- •undergoing serious health crises (e.g., undergoing major surgery or diagnosed with a life-threatening illness)
- •pregnancy
研究组 & 干预措施
Self-compassion writing group
This digital intervention is a 14-day writing program delivered via a WeChat mini-program. Each day, participants complete a two-step writing task: (1) mindfully describe an event and their feelings, and (2) support themselves with self-kindness. Daily reminders are sent to encourage engagement. Each session takes approximately 5 minutes. The program is tailored for parents of autistic individuals to provide a brief, low-cost mental health support option for chronically stressed caregivers.
干预措施: Self-compassion writing group (Behavioral)
Control group
Participants in the control group use the same mini-program for 14 days but complete factual writing tasks. They are instructed to recall their day and describe events objectively, without emotional content or cognitive reframing. This controls for time, attention, and writing activity.
干预措施: Control group (placebo) (Behavioral)
结局指标
主要结局
Eligibility rate
时间窗: From date of initial registration until eligibility determination, typically within 2 days of registration (up to 10 days maximum)
Proportion of registrants who met all inclusion criteria (n\_eligible / n\_registered). This metric evaluates the effectiveness of the registration form in screening for eligibility.
Baseline questionnaire completion rate
时间窗: From date of eligibility confirmation until completion of baseline assessment, up to 10 days maximum
Proportion of eligible registrants who completed the baseline assessment (n\_baseline / n\_eligible)
Post-intervention questionnaire completion rate
时间窗: From date of completion of baseline assessment until completion of post-intervention assessment, typically within 1 day after intervention (up to 2 days maximum)
Proportion of baseline completers who complete the post-intervention questionnaire (n\_post / n\_baseline)
Follow-up questionnaire completion rate
时间窗: From date of completion of the post-intervention assessment until 14 days after completion of the follow-up assessment (up to 15 days maximum).
Proportion of post-intervention assessment completers who provided follow-up data (n\_follow / n\_post).
Intervention satisfaction
时间窗: Measured at the post-intervention assessment, conducted within two days after the end of the intervention
A 4-item measure assessing satisfaction with the intervention. Items are rated on a 5-point Likert scale. Total scores are obtained by averaging item scores. Higher scores indicate higher satisfaction with the intervention.
Intervention adherence
时间窗: During the 14-day intervention period.
Measured by the average number of entries submitted during the intervention period.
Intervention fidelity
时间窗: During the 14-day intervention period.
Measured by the proportion of entries that meet the criteria for intervention and control groups, respectively. Evaluated after intervention completion by reviewing all entries submitted during the 14-day intervention period.
Self-compassion
时间窗: Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).
A 13-item measure (positive subscale of the Self-Compassion Scale) assessing self-compassion across three components: mindfulness, common humanity, and self-kindness. Items are rated on a 5-point Likert scale (1 = almost never, 5 = almost always). Total and subscale scores are calculated by averaging item responses. Higher scores indicate greater self-compassion.
次要结局
- Emotion regulation(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Psychological flexibility(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Well-being(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Flourishing(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Life satisfaction(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Stress(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Anxiety(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Depression(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Sleep quality(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Parenting stress(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Parenting efficacy(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Parenting practices(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Child adjustment(Measured at three time points: baseline (prior to intervention), immediately post-intervention (within 2 days after intervention ends), and at two-week follow-up (15-16 days after intervention completion).)
- Daily self-compassion(Daily during the 14-day intervention period)
- Daily positive affect(Daily during the 14-day intervention period.)
- Daily life satisfaction(Daily during the 14-day intervention period)
- Daily parenting efficacy(Daily during the 14-day intervention period)
研究者
Peilian Chi
Associate Professor
University of Macau