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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness | Behavioral | Refer to the arm description |
|
| 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 |
| 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 |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shirley X Li, PhD, DClinPsy | Contact | 852-39177035 | shirley.li@hku.hk |
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| ID | Term |
|---|---|
| D000092862 | Psychological Well-Being |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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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 |
| 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 |
| D012893 |
| Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |