Mindfulness for Informal Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness.
- Who it may be relevant to
- Registry conditions: Mental Health, Insomnia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of a Mindfulness-based Intervention on Stress, Mental Health, and Sleep Among Informal Caregivers of Children With Special Educational Needs
Overview
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.
Interventions
- Behavioral Mindfulness
Refer to the arm description
Primary outcome measures
- Change in stress level [Time frame: Baseline, end of treatment at 8 weeks]
Secondary outcome measures (4)
- Change in depressive symptoms [Time frame: Baseline, end of treatment at 8 weeks]
- Change in anxiety symptoms [Time frame: Baseline, end of treatment at 8 weeks]
- Change in insomnia symptoms [Time frame: Baseline, end of treatment at 8 weeks]
- Change in mindfulness ability [Time frame: Baseline, end of treatment at 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07496138 · EA240536