Mindfulness for Informal Caregivers

Effects of a Mindfulness-based Intervention on Stress, Mental Health, and Sleep Among Informal Caregivers of Children With Special Educational Needs

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Insomnia; Mental Health
• Intervention / Treatment: Behavioral: Mindfulness

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shirley X Li, PhD, DClinPsy; Phone Number: 852-39177035; Email: shirley.li@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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
2. In the opinion of the research clinician, having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt)
3. Currently receiving any structured psychotherapy
4. With a hearing or speech deficit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness; 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; Refer to the arm description

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in depressive symptoms	Depressive symptoms were measured using the 9-item Patient Health Questionnaire (PHQ-9). Possible scores range from 0 to 27, with higher scores indicating higher depression severity.	Baseline, end of treatment at 8 weeks
Change in anxiety symptoms	Axniety symptoms were measured using the Generalized Anxiety Disorder 7-item (GAD-7). Possible scores range from 0 to 21, with higher scores indicating higher anxiety severity.	Baseline, end of treatment at 8 weeks
Change in insomnia symptoms	Insomnia symptoms were measured using the Insomnia Severity Index (ISI). It consists of 7 items. Possible scores range from 0 to 28, with higher scores indicating higher insomnia severity.	Baseline, end of treatment at 8 weeks
Change in mindfulness ability	Mindfulness ability was measured using the 15-item Five-Facet Mindfulness Questionnaire (FFMQ-15). Possible scores range from 15 to 75, with higher scores indicating a higher mindfulness level.	Baseline, end of treatment at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Attendance, practice, and overall impression	Attendance, practice, and overall impression were measured using a 9-question survey, with 3 questions on attendance, 2 on overall impression, and 4 on practice. In particular, there are 2 rating-scale items in the overall impression construct and 1 in the practice construct for the probability of future use of mindfulness practice. The scales range from 0 to 10, where higher scores indicate a better overall impression/greater probability for continued use of the practice.	End of treatment at 8 weeks
Unpleasant experiences and harm	Unpleasant experiences and harm were assessed using a 10-question survey: 3 on unpleasant experiences, 2 on harm, and 5 on coping. In particular, one Likert scale was used to assess the perceived helpfulness item in the coping construct. The scale ranges from 1 to 5, where a higher score indicates greater helpfulness of the support.	End of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 21, 2026
• First Submitted That Met QC Criteria: March 21, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: March 27, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Mental Disorders; Sleep Wake Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Behavior; Personal Satisfaction; Sleep Initiation and Maintenance Disorders; Psychological Well-Being; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness
• Other Study ID Numbers: EA240536

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No