Autism Spectrum DisorderNCT06975163
Effectiveness of Mindfulness-Based Intervention in Reducing Stigma Stress Among Parents of Autistic Children
A study testing Mindfulness-Based Stigma Stress Reduction (MBSSR) program in people with Autism Spectrum Disorder, run by Education University of Hong Kong at 1 site in Hong Kong.
Trial summary
Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental condition that usually becomes apparent in early childhood. Those diagnosed with ASD commonly struggle with social communication and behavioral regulation, often facing widespread societal stigma across different cultures. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Mindfulness-Based Stigma Stress Reduction (MBSSR) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Aug 2024to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Having a child formally diagnosed with Autism Spectrum Disorder (ASD) under Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria by a registered medical practitioner
- Acting as the principal caregiver for the child
- Having the ability to read and write in Chinese
- Demonstrating the experience of stigma stress on the Family Stigma Stress Scale, defined as agreeing with item(s) that gauge perceived stigma harm and disagreeing with item(s) that evaluate perceived coping resources
Who cannot join
- Having participated in any mindfulness-based programs before
- Currently using psychiatric medications or receiving mental health services from professionals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mindfulness-Based Intervention in Reducing Stigma Stress Among Parents of Autistic Children: A Randomized Controlled Trial
Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental condition that usually becomes apparent in early childhood. Those diagnosed with ASD commonly struggle with social communication and behavioral regulation, often facing widespread societal stigma across different cultures. This prejudice extends beyond the affected children to their parents, who are routinely subjected to baseless blame and viewed as incapable of proper parenting. Such persistent negative perceptions can foster profound emotional suffering and chronic stress linked to societal judgment.
To date, there are no empirically supported interventions specifically aimed at alleviating stigma-induced stress in parents of autistic children. Nevertheless, studies in related fields indicate that mindfulness-based strategies could offer a potential coping mechanism. Addressing this gap, the current research presents a newly developed 4-week Mindfulness-Based Stigma Stress Reduction (MBSSR) program tailored for these parents. Using a randomized controlled trial, participants were divided into an MBSSR group or a waitlist control group, with both undergoing standardized evaluations at three distinct time points.
Read the detailed description
Autism Spectrum Disorder (ASD) is a well-known neurodevelopmental condition that emerges in early childhood and continues into adulthood. Children with ASD frequently face social and behavioral difficulties, and research indicates that stigma surrounding autism is prevalent in many societies. These children are sometimes mistakenly perceived as deliberately unruly, resulting in social prejudice and exclusion. This stigma also affects their parents, who endure societal judgment due to their emotional and biological ties to their children. Parents may be wrongly blamed for passing on "faulty" genes or accused of causing their child's condition. Additionally, they are often labeled as incompetent caregivers and criticized for failing to properly handle their child's behavior. Prolonged exposure to such bias can trigger deep-seated shame and psychological distress, leading to persistent stress linked to stigma.
Although stigma-related stress significantly impacts parents of autistic children, there are currently no scientifically validated interventions specifically designed to help them manage it. However, studies in similar areas propose that mindfulness practices may help individuals deal with stigma-induced stress. To bridge this research gap, this study introduces a novel 4-week Mindfulness-Based Stigma Stress Reduction (MBSSR) program tailored for parents of children with autism in Hong Kong. Using a randomized controlled trial approach, participants were divided into either the MBSSR treatment group or a waitlist control group, with both groups undergoing standardized evaluations at three separate intervals.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Mindfulness-Based Stigma Stress Reduction (MBSSR) program
- Keywords
- Mindfulness, Stigma stress, Parents
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stigma Stress Reduction (MBSSR) programBehavioural
The MBSSR program was developed by modifying elements from the Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) programs to create a distinct mindfulness intervention targeted at alleviating stigma stress among parents of autistic children. This program consisted of four group sessions, each incorporating mindfulness practices, group discussions, and activities that helped participants apply mindfulness principles to their daily lives.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stigma Stress Reduction (MBSSR) group | Experimental | Participants in the MBSSR group received a 4-week MBSSR program immediately after randomization. Participants completed the post-intervention assessment right after the intervention and the follow-up assessment one month after the intervention. Receives: Behavioral: Mindfulness-Based Stigma Stress Reduction (MBSSR) program |
| Waitlist control group | No intervention | Participants in the waitlist control group waited for 4 weeks without the Mindfulness-Based Stigma Stress Reduction (MBSSR) program. Participants completed the post-intervention assessment and the follow-up assessment simultaneously with the MBSSR group. After completing the follow-up assessment, the waitlist control participants started the MBSSR program (equivalent to that of the MBSSR group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Assessment in Stigma Stress on the Stigma Stress Scale at Post-Intervention Assessment and Follow-up Assessment
The Stigma Stress Scale was utilized to assess perceived stigma harm and perceived coping resources on a 5-point scale where 1 indicated "strong disagreement" and 5 indicated "strong agreement".
Measured: Before intervention, immediately after intervention, and one month after intervention
Secondary outcomes (5)
Change from Baseline Assessment in Well-being on the World Health Organization Well-Being Index at Post-Intervention Assessment and Follow-up Assessment
The World Health Organization Well-Being Index was utilized to assess well-being on a 6-point scale where 0 indicated "at no time" and 5 indicated "all of the time".
Measured: Before intervention, immediately after intervention, and one month after intervention
Change from Baseline Assessment in Caregiving Gain on the Positive Aspects of Caregiving at Post-Intervention Assessment and Follow-up Assessment
The Positive Aspects of Caregiving was utilized to assess caregiving gain on a 5-point scale where 1 indicated "disagree a lot" and 5 indicated "agree a lot".
Measured: Before intervention, immediately after intervention, and one month after intervention
Change from Baseline Assessment in Caregiving Burden on the Zarit Burden Interview at Post-Intervention Assessment and Follow-up Assessment
The Short Version of the Zarit Burden Interview was utilized to assess caregiving burden on a 5-point scale where 1 indicated "never" and 5 indicated "nearly always".
Measured: Before intervention, immediately after intervention, and one month after intervention
Change from Baseline Assessment in Mindful Parenting on the Interpersonal Mindfulness in Parenting Scale at Post-Intervention Assessment and Follow-up Assessment
The Interpersonal Mindfulness in Parenting Scale was utilized to assess mindful parenting on a 5-point scale where 1 indicated "never true" and 5 indicated "always true".
Measured: Before intervention, immediately after intervention, and one month after intervention
Change from Baseline Assessment in Child Autistic Symptoms on the Childhood Autism Rating Scale at Post-Intervention Assessment and Follow-up Assessment
The Childhood Autism Rating Scale was utilized to assess child autistic symptoms on a 4-point scale where 1 indicated "normal" and 4 indicated "severely abnormal".
Measured: Before intervention, immediately after intervention, and one month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Aug 2024
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Education University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHAN Ka Shing Kevin, Education University of Hong Kong
- Investigators
- Kevin Ka Shing Chan, Principal investigator, The Education University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975163
- Sponsor's protocol ID
- 2020-2021-0126
- Status last verified
- Mar 2025
- First submitted
- 8 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness-Based Intervention in Reducing Stigma Stress Among Parents of Autistic Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06975163
- Acronym / sponsor ID
- 2020-2021-0126
- Conditions
- Autism Spectrum Disorder
- Keywords
- Mindfulness, Stigma stress, Parents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Education University of Hong KongUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 16 May 2025 (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.
Autism Spectrum Disorder (ASD) is a lifelong neurodevelopmental condition that usually becomes apparent in early childhood. Those diagnosed with ASD commonly struggle with social communication and behavioral regulation, often facing widespread societal stigma across different cultures. This prejudice extends beyond the affected children to their parents, who are routinely subjected to baseless blame and viewed as incapable of proper parenting. Such persistent negative perceptions can foster profound emotional suffering and chronic stress linked to societal judgment.
To date, there are no empirically supported interventions specifically aimed at alleviating stigma-induced stress in parents of autistic children. Nevertheless, studies in related fields indicate that mindfulness-based strategies could offer a potential coping mechanism. Addressing this gap, the current research presents a newly developed 4-week Mindfulness-Based Stigma Stress Reduction (MBSSR) program tailored for these parents. Using a randomized controlled trial, participants were divided into an MBSSR group or a waitlist control group, with both undergoing standardized evaluations at three distinct time points.
Detailed description
Autism Spectrum Disorder (ASD) is a well-known neurodevelopmental condition that emerges in early childhood and continues into adulthood. Children with ASD frequently face social and behavioral difficulties, and research indicates that stigma surrounding autism is prevalent in many societies. These children are sometimes mistakenly perceived as deliberately unruly, resulting in social prejudice and exclusion. This stigma also affects their parents, who endure societal judgment due to their emotional and biological ties to their children. Parents may be wrongly blamed for passing on "faulty" genes or accused of causing their child's condition. Additionally, they are often labeled as incompetent caregivers and criticized for failing to properly handle their child's behavior. Prolonged exposure to such bias can trigger deep-seated shame and psychological distress, leading to persistent stress linked to stigma.
Although stigma-related stress significantly impacts parents of autistic children, there are currently no scientifically validated interventions specifically designed to help them manage it. However, studies in similar areas propose that mindfulness practices may help individuals deal with stigma-induced stress. To bridge this research gap, this study introduces a novel 4-week Mindfulness-Based Stigma Stress Reduction (MBSSR) program tailored for parents of children with autism in Hong Kong. Using a randomized controlled trial approach, participants were divided into either the MBSSR treatment group or a waitlist control group, with both groups undergoing standardized evaluations at three separate intervals.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stigma Stress Reduction (MBSSR) group | Experimental | Behavioral: Mindfulness-Based Stigma Stress Reduction (MBSSR) programParticipants in the MBSSR group received a 4-week MBSSR program immediately after randomization. Participants completed the post-intervention assessment right after the intervention and the follow-up assessment one month after the intervention. |
| Waitlist control group | No intervention | –Participants in the waitlist control group waited for 4 weeks without the Mindfulness-Based Stigma Stress Reduction (MBSSR) program. Participants completed the post-intervention assessment and the follow-up assessment simultaneously with the MBSSR group. After completing the follow-up assessment, the waitlist control participants started the MBSSR program (equivalent to that of the MBSSR group). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Having a child formally diagnosed with Autism Spectrum Disorder (ASD) under Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria by a registered medical practitioner
- Acting as the principal caregiver for the child
- Having the ability to read and write in Chinese
- Demonstrating the experience of stigma stress on the Family Stigma Stress Scale, defined as agreeing with item(s) that gauge perceived stigma harm and disagreeing with item(s) that evaluate perceived coping resources
Key exclusion criteria (2 listed)
- Having participated in any mindfulness-based programs before
- Currently using psychiatric medications or receiving mental health services from professionals
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 |
|---|---|---|
| Mindfulness-Based Stigma Stress Reduction (MBSSR) programThe MBSSR program was developed by modifying elements from the Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT) programs to create a distinct mindfulness intervention targeted at alleviating stigma stress among parents of autistic children. This program consisted of four group sessions, each incorporating mindfulness practices, group discussions, and activities that helped participants apply mindfulness principles to their daily lives. | Behavioural | Mindfulness-Based Stigma Stress Reduction (MBSSR) group |
Primary outcome
Change from Baseline Assessment in Stigma Stress on the Stigma Stress Scale at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, immediately after intervention, and one month after intervention
The Stigma Stress Scale was utilized to assess perceived stigma harm and perceived coping resources on a 5-point scale where 1 indicated "strong disagreement" and 5 indicated "strong agreement".
5 secondary outcomes
Change from Baseline Assessment in Well-being on the World Health Organization Well-Being Index at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, immediately after intervention, and one month after intervention
Change from Baseline Assessment in Caregiving Gain on the Positive Aspects of Caregiving at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, immediately after intervention, and one month after intervention
Change from Baseline Assessment in Caregiving Burden on the Zarit Burden Interview at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, immediately after intervention, and one month after intervention
Change from Baseline Assessment in Mindful Parenting on the Interpersonal Mindfulness in Parenting Scale at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, immediately after intervention, and one month after intervention
Change from Baseline Assessment in Child Autistic Symptoms on the Childhood Autism Rating Scale at Post-Intervention Assessment and Follow-up Assessment
Time frame: Before intervention, immediately after intervention, and one month after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: No
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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.
Kevin Ka Shing Chan principal investigator
The Education University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Stigma Stress Reduction (MBSSR) program in people with Autism Spectrum Disorder, run by Education University of Hong Kong at 1 site in Hong Kong.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 22 May 2025. 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline Assessment in Stigma Stress on the Stigma Stress Scale at Post-Intervention Assessment and Follow-up Assessment (time frame: Before intervention, immediately after intervention, and one month after intervention). 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 22 May 2025.