NCT07496138

Brief Summary

The goal of this single-arm pilot clinical trial is to evaluate whether a group-based mindfulness intervention can improve mental health and sleep among parents who are informal caregivers of children with autism spectrum disorder (ASD) or attention-deficit/hyperactivity disorder (ADHD). The main questions it aims to answer are: Does participating in an 8-week mindfulness program reduce symptoms of stress, anxiety, depression, and insomnia in caregivers? Does participating in an 8-week mindfulness program improve mindfulness in caregivers? What are the caregivers' experiences in participating in the 8-week mindfulness program? Participants will:

  • Attend weekly group-based mindfulness sessions for 1.5 hours over eight weeks.
  • Complete assessments before starting the program (baseline) and immediately after the final session.
  • Participate in a qualitative feedback interview after the final session.

Trial Health

65
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Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
18mo left

Started Apr 2026

Status
not yet recruiting

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 Progress9%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 21, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 2, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 21, 2026

Last Update Submit

March 27, 2026

Conditions

Mental HealthInsomnia

Outcome Measures

Primary Outcomes (1)

  • Change in stress level

    Stress was measured using the 14-item Perceived Stress Scale (PSS). Possible scores range from 0 to 56, with higher scores indicating a higher stress level.

    Baseline, end of treatment at 8 weeks

Secondary Outcomes (4)

  • Change in depressive symptoms

    Baseline, end of treatment at 8 weeks

  • Change in anxiety symptoms

    Baseline, end of treatment at 8 weeks

  • Change in insomnia symptoms

    Baseline, end of treatment at 8 weeks

  • Change in mindfulness ability

    Baseline, end of treatment at 8 weeks

Other Outcomes (2)

  • Attendance, practice, and overall impression

    End of treatment at 8 weeks

  • Unpleasant experiences and harm

    End of treatment at 8 weeks

Study Arms (1)

Mindfulness

EXPERIMENTAL

The group-based mindfulness programme will consist of 8 weekly sessions (\~90 min each, 12-18 participants per group). Each session includes a homework practice review, guided, structured mindfulness practices, and a discussion of experiences and learning.

Behavioral: Mindfulness

Interventions

MindfulnessBEHAVIORAL

Refer to the arm description

Mindfulness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chinese aged at least 18 years old;
  • Written informed consent of participation in the study is given by the participant
  • Willing to comply with the study protocol
  • having a child with neurodevelopment disorder (e.g., ASD, ADHD)

You may not qualify if:

  • having been enrolled in any other clinical trial or investigational product within one month at the entry of the study, or having extensive experience in mindfulness practice
  • In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt)
  • Currently receiving any structured psychotherapy
  • With a hearing or speech deficit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psychological Well-BeingSleep Initiation and Maintenance Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Personal SatisfactionBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

Shirley X Li, PhD, DClinPsy

CONTACT

852-39177035shirley.li@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 21, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 2, 2026

Record last verified: 2026-03