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?
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
240
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.
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.
University of Macau
Taipa, Macau
Eligibility rate
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.
Time frame: From date of initial registration until eligibility determination, typically within 2 days of registration (up to 10 days maximum)
Baseline questionnaire completion rate
Proportion of eligible registrants who completed the baseline assessment (n\_baseline / n\_eligible)
Time frame: From date of eligibility confirmation until completion of baseline assessment, up to 10 days maximum
Post-intervention questionnaire completion rate
Proportion of baseline completers who complete the post-intervention questionnaire (n\_post / n\_baseline)
Time frame: From date of completion of baseline assessment until completion of post-intervention assessment, typically within 1 day after intervention (up to 2 days maximum)
Follow-up questionnaire completion rate
Proportion of post-intervention assessment completers who provided follow-up data (n\_follow / n\_post).
Time frame: From date of completion of the post-intervention assessment until 14 days after completion of the follow-up assessment (up to 15 days maximum).
Intervention satisfaction
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.
Time frame: Measured at the post-intervention assessment, conducted within two days after the end of the intervention
Intervention adherence
Measured by the average number of entries submitted during the intervention period.
Time frame: During the 14-day intervention period.
Intervention fidelity
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.
Time frame: During the 14-day intervention period.
Self-compassion
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.
Time frame: 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).
Emotion regulation
A six-item scale (Emotion Regulation Questionnaire-Short Form, ERQ-S) measuring two emotion regulation strategies: cognitive reappraisal and expression suppression. Items are rated on a 7-point Likert scale. Subscale scores are calculated by summing item scores within each strategy. Higher scores indicate more frequent use of that emotion regulation strategy.
Time frame: 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
A six-item scale (Psy-Flex) measuring psychological flexibility. Items are rated on a 7-point Likert scale. Total scores are calculated by summing item scores. Higher scores indicate higher levels of psychological flexibility.
Time frame: 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
5 items (WHO Well-Being Index, WHO-5). Total scores are calculated by summing item scores, ranging from 0 to 25. Higher scores indicate higher levels of well-being.
Time frame: 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
8 items (Flourishing Scale). Total scores are calculated by averaging item scores, ranging from 1 to 7. Higher scores indicate higher levels of flourishing.
Time frame: 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
A single-item measuring life satisfaction rated on a 0-10 reponse scale (0 = not at all, 10 = completely).
Time frame: 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).
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Stress
Stress will be measured by the single-item subjective level of stress (SLS-1). 0 = not at all, 5 = moderate, 10 = extremely.
Time frame: 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
7 items (Generalized Anxiety Disorder-7, GAD-7). Total scores range from 0 to 21, with higher scores indicating higher levels of anxiety.
Time frame: 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
9 items (Patient Health Questionnaire-9, PHQ-9). Total scores range from 0 to 27, with higher scores indicating higher levels of depression.
Time frame: 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
1 item (Single-Item Sleep Quality Scale). Possible ratings range from 0 to 10, with higher ratings indicating better sleep quality.
Time frame: 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
15 items (Simplified Parenting Stress Index/Short Form-15, S-PSI/SF). Total scores are calculated by summing item scores, ranging from 15 to 75. Higher scores indicate higher levels of parenting stress.
Time frame: 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
4 items (Me as a Parent Scale-Short Form). Total scores are calculated by summing item scores, ranging from 4 to 20. Higher scores indicate higher levels of parenting efficacy.
Time frame: 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
27 items (Multidimensional Assessment of Parenting Scale) that reflect positive and negative parenting practices are used. Scores for positive parenting and negative parenting will be calculated by summing item scores, respectively.
Time frame: 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
24 items (Child Adjustment and Parent Efficacy Scale-Developmental Disability, CAPES-DD). To obtain a Behavioral Problems subscale score, sum ratings for items 1, 3, 4, 5, 6, 7, 8, 9, 10, and 12, with a possible range from 0 to 30. To obtain an Emotional Problems subscale score, sum ratings for items 2, 11, and 13 with a possible range from 0 to 9. Higher scores indicate greater levels of child emotional or behavioral problems. To obtain a Prosocial Behavior scale score, sum ratings for items 17, 18, 19, 20, 21, 22, 23, and 24, with a possible range from 0 to 24.
Time frame: 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
A 3-item measure assessing self-compassion components (mindfulness, common humanity, and self-kindness) immediately after each writing session. Items are rated on a 5-point Likert scale. Higher scores indicate greater self-compassion.
Time frame: Daily during the 14-day intervention period
Daily positive affect
A single-item measure assessing positive emotions immediately after each writing session. This item is rated on a 5-point Likert scale. Higher scores indicate greater positive emotions.
Time frame: Daily during the 14-day intervention period.
Daily life satisfaction
A single-item measure assessing life satisfaction immediately after each writing session. This item is rated on a 5-point Likert scale. Higher scores indicate greater life satisfaction.
Time frame: Daily during the 14-day intervention period
Daily parenting efficacy
A single-item measure assessing parenting efficacy immediately after each writing session. This item is rated on a 5-point Likert scale. Higher scores indicate greater parenting efficacy.
Time frame: Daily during the 14-day intervention period