Mental HealthNCT07347717
Digital Self-Compassion Writing Intervention to Support Mental Health of Parents of Autistic Individuals
A study testing Self-compassion writing group in people with Mental Health, run by University of Macau at 1 site in Macau.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Self-compassion writing group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 1 siteMacau
- Study dates
- 16 Dec 2025to 5 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Macau1 site
University of Macau
Taipa
About this study
Official title: A Digital Self-Compassion Writing Intervention to Improve the Mental Health of Parents of Autistic Individuals
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?
- Conditions
- Mental Health
- Being tested
- Self-compassion writing group, Control group (placebo)
- Keywords
- Digital self-compassion writing intervention
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-compassion writing groupBehavioural
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.
Control group (placebo)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Self-compassion writing group | Experimental | 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. Receives: Behavioral: Self-compassion writing group |
| Control group | Active comparator | 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. Receives: Behavioral: Control group (placebo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Secondary outcomes (17)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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
Stress will be measured by the single-item subjective level of stress (SLS-1). 0 = not at all, 5 = moderate, 10 = extremely.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Daily during the 14-day intervention period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start16 Dec 2025
- Primary completion5 Feb 2026 (estimated)
- Study completion5 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Macau
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peilian Chi, University of Macau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07347717
- Sponsor's protocol ID
- MYRG-GRG2024-00269-FSS
- Status last verified
- Jan 2026
- First submitted
- 22 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Self-Compassion Writing Intervention to Improve the Mental Health of Parents of Autistic Individuals
- ClinicalTrials.gov ID
- NCT07347717
- Acronym / sponsor ID
- MYRG-GRG2024-00269-FSS
- Conditions
- Mental Health
- Keywords
- Digital self-compassion writing intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of MacauUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 5 Feb 2026 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-compassion writing group | Experimental | Behavioral: Self-compassion writing groupThis 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. |
| Control group | Active comparator | Behavioral: Control group (placebo)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-compassion writing groupThis 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. | Behavioural | Self-compassion writing group |
| Control group (placebo)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. | Behavioural | Control group |
Primary outcome
Eligibility rate
Time frame: 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
Time frame: 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
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)
Proportion of baseline completers who complete the post-intervention questionnaire (n_post / n_baseline)
Follow-up questionnaire completion rate
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).
Proportion of post-intervention assessment completers who provided follow-up data (n_follow / n_post).
Intervention satisfaction
Time frame: 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
Time frame: During the 14-day intervention period.
Measured by the average number of entries submitted during the intervention period.
Intervention fidelity
Time frame: 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
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).
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.
17 secondary outcomes
Emotion regulation
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
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
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
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
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).
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).
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
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
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
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
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
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
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
Time frame: Daily during the 14-day intervention period
Daily positive affect
Time frame: Daily during the 14-day intervention period.
Daily life satisfaction
Time frame: Daily during the 14-day intervention period
Daily parenting efficacy
Time frame: Daily during the 14-day intervention period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-compassion writing group in people with Mental Health, run by University of Macau at 1 site in Macau.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Macau. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility rate (time frame: From date of initial registration until eligibility determination, typically within 2 days of registration (up to 10 days maximum)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.