Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07496138

Mindfulness for Informal Caregivers

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Mental Health Behavior Dyssomnias Insomnia Mental Disorders Nervous System Diseases Personal Satisfaction Psychological Well-Being Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Mindfulness

Behavioral

Refer to the arm description

Primary outcomes

  1. Change in stress level

    Time frame: Baseline, end of treatment at 8 weeks

    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.

Secondary outcomes

  1. Change in depressive symptoms

    Time frame: Baseline, end of treatment at 8 weeks

    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.

  2. Change in anxiety symptoms

    Time frame: Baseline, end of treatment at 8 weeks

    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.

  3. Change in insomnia symptoms

    Time frame: Baseline, end of treatment at 8 weeks

    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.

  4. Change in mindfulness ability

    Time frame: Baseline, end of treatment at 8 weeks

    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.

Other outcomes

  1. Attendance, practice, and overall impression

    Time frame: End of treatment at 8 weeks

    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.

  2. Unpleasant experiences and harm

    Time frame: End of treatment at 8 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shirley X Li, PhD, DClinPsy

CONTACT

[email protected]

852-39177035

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.