- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07347717
Digital Self-Compassion Writing Intervention to Support Mental Health of Parents of Autistic Individuals
January 8, 2026 updated by: Peilian Chi, University of Macau
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?
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipa, Macau
- University of Macau
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
From date of initial registration until eligibility determination, typically within 2 days of registration (up to 10 days maximum)
|
|
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)
|
From date of eligibility confirmation until completion of baseline assessment, up to 10 days maximum
|
|
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)
|
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
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).
|
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
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.
|
Measured at the post-intervention assessment, conducted within two days after the end of the intervention
|
|
Intervention adherence
Time Frame: During the 14-day intervention period.
|
Measured by the average number of entries submitted during the intervention period.
|
During the 14-day 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.
|
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.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
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 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).
|
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 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).
|
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 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).
|
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 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).
|
A single-item measuring life satisfaction rated on a 0-10 reponse scale (0 = not at all, 10 = completely).
|
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).
|
Stress will be measured by the single-item subjective level of stress (SLS-1).
0 = not at all, 5 = moderate, 10 = extremely.
|
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).
|
7 items (Generalized Anxiety Disorder-7, GAD-7).
Total scores range from 0 to 21, with higher scores indicating higher levels of 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
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).
|
9 items (Patient Health Questionnaire-9, PHQ-9).
Total scores range from 0 to 27, with higher scores indicating higher levels of 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
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).
|
1 item (Single-Item Sleep Quality Scale).
Possible ratings range from 0 to 10, with higher ratings indicating better 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
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).
|
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 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).
|
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 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).
|
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 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).
|
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 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
|
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.
|
Daily during the 14-day intervention period
|
|
Daily positive affect
Time Frame: Daily during the 14-day intervention period.
|
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.
|
Daily during the 14-day intervention period.
|
|
Daily life satisfaction
Time Frame: Daily during the 14-day intervention period
|
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.
|
Daily during the 14-day intervention period
|
|
Daily parenting efficacy
Time Frame: Daily during the 14-day intervention period
|
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.
|
Daily during the 14-day intervention period
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Personality
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).
|
Will be measured by the Ten-Item Personality Inventory in Chinese.
Scale scoring ("R" denotes reverse-scored items): Extraversion: 1, 6R; Agreeableness: 2R, 7; Conscientiousness: 3, 8R; Emotional Stability: 4R, 9; Openness to Experiences: 5, 10R.
|
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).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 16, 2025
Primary Completion (Estimated)
February 5, 2026
Study Completion (Estimated)
February 5, 2026
Study Registration Dates
First Submitted
December 22, 2025
First Submitted That Met QC Criteria
January 8, 2026
First Posted (Estimated)
January 16, 2026
Study Record Updates
Last Update Posted (Estimated)
January 16, 2026
Last Update Submitted That Met QC Criteria
January 8, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MYRG-GRG2024-00269-FSS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPD that underlie results in a publication.
IPD Sharing Time Frame
The IPD and supporting information will be made available after the publication of study results, anticipated around December 2027.
There will be no specified end date for availability.
IPD Sharing Access Criteria
The IPD and supporting information will be available upon reasonable request to the corresponding author.
Researchers or qualified professionals may request access to de-identified data and analytic code for purposes such as secondary analysis or replication.
Requests will be reviewed to ensure appropriate use and data protection.
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Health
-
Sanctuary Mental Health MinistriesExcellence in Giving InsightsNot yet recruitingMental Health | Mental Health Help-Seeking | Mental Health LiteracyUnited States
-
Neslihan LokCompletedAdolescent | Mental Health | Mental Health Care | Mental Health ConditionsTurkey
-
GCS-CCOMSINSERM ECEVE 1123; L'Assistance Publique - Hopitaux de Paris (AP-HP)Active, not recruitingRecovery | Organization of Health Service | Mental Health Services | Mental Health CareFrance
-
King's College LondonCompletedMental Health Wellness 1 | Mental Health IssueUnited Kingdom
-
Cambridge Health AllianceNot yet recruitingMental Health | Adolescent Health | Minority Health | Community Health Services
-
Universidad Metropolitana de Ciencias de la EducacionNot yet recruitingMental Health | Physical Inactivity | Cardiovascular Health | Mental Health Care | Sedentary BehaviorsChile
-
VA Office of Research and DevelopmentCompletedMental Health | Veterans Health | Rural HealthUnited States
-
Chapin Hall at the University of ChicagoUniversity of ConnecticutCompletedMental Health | Physical Health
-
Chinese University of Hong KongRecruitingMental Health Wellness 1 | Mental Well-being | Mental Health Issue | Precision Mental HealthHong Kong
-
Chinese University of Hong KongThe University of Hong Kong; The Hong Kong Polytechnic University; The Hong Kong... and other collaboratorsRecruitingMental Well-being | Adolescent Health | Mental Health Help-Seeking | Mental Health Literacy | School Difficulties Associated With Mental Health ProblemsHong Kong
Clinical Trials on Self-compassion writing group
-
University of Maryland, College ParkCompletedChronic Pain
-
Marmara UniversityCompletedBullying | Bullying VictimisationTurkey (Türkiye)
-
Hospital de Clinicas de Porto AlegreCompletedBody Dissatisfaction | Disordered EatingBrazil
-
Beijing Normal UniversityCompleted
-
University of SheffieldCompletedBody Image Disturbance | Body Image | ShameUnited Kingdom
-
University of ManitobaUnknown
-
Robert SimpsonNot yet recruitingMultiple Sclerosis | Self-CompassionCanada
-
Robert SimpsonNot yet recruitingBurnout | CompassionCanada
-
Robert SimpsonRecruiting
-
Canterbury Christ Church UniversityCompletedAn Online, Compassion Intervention for Adults with Type 1 and Type 2 Diabetes Mellitus (T1DM; T2DM).Type 1 Diabetes | Type 2 DiabetesUnited Kingdom