NCT06975163

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 8, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 16, 2025

Completed
Last Updated

May 22, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

May 8, 2025

Last Update Submit

May 19, 2025

Conditions

Keywords

MindfulnessStigma stressParents

Outcome Measures

Primary Outcomes (1)

  • 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".

    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

    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

    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

    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

    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

    Before intervention, immediately after intervention, and one month after intervention

Study Arms (2)

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.

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).

Interventions

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.

Mindfulness-Based Stigma Stress Reduction (MBSSR) group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Having participated in any mindfulness-based programs before
  • Currently using psychiatric medications or receiving mental health services from professionals

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Education University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Kevin Ka Shing Chan

    The Education University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Head of Department of Psychology

Study Record Dates

First Submitted

May 8, 2025

First Posted

May 16, 2025

Study Start

August 1, 2024

Primary Completion

November 30, 2024

Study Completion

November 30, 2024

Last Updated

May 22, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations