Digital Self-Compassion Writing Intervention to Support Mental Health of Parents of Autistic Individuals

NCT07347717 | Active Not Recruiting

• 1 other identifier: MYRG-GRG2024-00269-FSS
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Digital self-compassion writing intervention

Outcome Measures

Primary Outcomes (8)

• 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.

  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)

  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)

  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).

  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 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.

  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.

  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 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

  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).

Other Outcomes (1)

• Personality

  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).

Study Arms (2)

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.

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.

Behavioral: Control group (placebo)

Interventions

Self-compassion writing group BEHAVIORAL

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.

Self-compassion writing group

Control group (placebo) BEHAVIORAL

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Macau: lead

Study Sites (1)

University of Macau

Taipa, Macau

Location

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 16, 2026
• Study Start: December 16, 2025
• Primary Completion: February 5, 2026
• Study Completion: February 5, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ANALYTIC CODE
• 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.
• 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.

Locations

MA (1)