- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06365346
Music Breathing Therapy for Children With Attention-deficit Hyperactivity Disorder and Their Caregivers
Dyadic Video-assisted Gamified Group-based Music Breathing Therapy on Enhancing Resilience Among Children With Attention-deficit Hyperactivity Disorder and Their Caregivers: A Pilot Randomized Controlled Trial
Study Overview
Status
Conditions
Detailed Description
Attention-deficit hyperactivity disorder (ADHD) is a prevalent neurodevelopmental disorder characterized by persistent inattention, hyperactivity, and impulsivity that impact various aspects of both the child's and the caregiver's functioning. Evidence shows that cultivating resilience helps children with ADHD manage emotional dysregulation and improve caregivers' psychological well-being. Music breathing therapy - an adaptation of the Bonny Method of Guided Imagery and Music (GIM) - has shown beneficial effects in enhancing resilience and alleviating psychological distress among different populations. However, it remains unclear whether it is a feasible and effective intervention to enhance the resilience of Chinese school-aged children with ADHD and their caregivers.
Aims:
- To determine the feasibility (in terms of rates of recruitment, retention, and attendance), and acceptability of the intervention
- To examine the effects of the dyadic video-assisted gamified music breathing therapy on dyads' resilience, children's emotional and behavioral symptoms, parents' parenting stress, and psychological distress.
Hypotheses:
It is hypothesized that compared with dyads in the control group, those who receive the dyadic video-assisted gamified music breathing therapy will report the following outcomes: higher levels of dyads' resilience, reduced children's emotional and behavioral symptoms, lower levels of parents' parenting stress and psychological distress at immediately post-intervention (i.e., the 6-week follow-up).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ankie Tan Cheung, PhD
- Phone Number: 852 3943 0515
- Email: ankiecheung@cuhk.edu.hk
Study Locations
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Hong Kong, Hong Kong
- The Chinese University of Hong Kong
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Contact:
- Ankie Tan Cheung, PhD
- Phone Number: 852 39430515
- Email: ankiecheung@cuhk.edu.hk
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Children
- have a clinically documented diagnosis/suspected ADHD diagnosis according to DSM-5 criteria
- aged 7 to 12 years (school age)
- can read and communicate in Chinese
Parents
- aged 21 years or above
- are the primary caregivers and living together with the child
- can read and communicate in Chinese
Exclusion Criteria:
Children
- have other disabling diseases (physical disability, mental disability, autism) that might limit their full participation in the study.
- have been engaged in any music intervention in the past 6 months
Parents
- are caring for more than one child with a chronic or critical illness or caring for another family member with a chronic illness
- has a diagnosed mental illness, cognitive impairment, or learning problem, and/or is taking regular psychotropic medications that might limit their full participation in the study
- have been engaged in any music intervention in the past 6 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dyadic video-assisted gamified group-based music breathing therapy
Parent-child dyads in the intervention group will receive video-assisted gamified music breathing therapy comprising 75-minute weekly sessions (first sessions: parents only; reminding 5 sessions: parent-child dyads) delivered face-to-face by a qualified music breathing practitioner with the aid of animations (mainly for sessions involving children) for 6 weeks.
The music breathing therapy comprises four breathing phases, namely "Discovery Breathing", "Triangular Breathing", "Silent Breathing", and "Music Breathing".
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Dyadic video-assisted gamified music breathing therapy comprising six 75-min weekly sessions delivered in a group size of 6-8 (first sessions: parents only; reminding 5 sessions: parent-child dyads).
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Active Comparator: Online educational modules
Parent-child dyads in the control group will receive weekly online educational modules via email for 6 weeks.
Such information will include definition, etiology, risk factors, signs and symptoms, and therapeutic interventions (pharmacological and nonpharmacological), its complications, and how to manage it.
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Six weekly educational modules on ADHD and its management via email.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resilience levels of children
Time Frame: Change from baseline assessment to immediate post-intervention
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The Chinese version of Resilience Scale for Children-10 (RS10) will be used to assess participants' levels of resilience.
This scale consists of 10 items.
rated on a 4-point Likert scale (from 1 to 4).
A higher total score indicates higher level of resilience.
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Change from baseline assessment to immediate post-intervention
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Resilience levels of parents
Time Frame: Change from baseline assessment to immediate post-intervention
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The Chinese version of the Connor-Davidson Resilience Scale will be used to assess the caregivers' levels of resilience.
This scale consists of 25 items, rated on a 5-point Likert scale from 0 (not true at all) to 4 (true nearly all of the time).
A higher total score indicates higher level of resilience.
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Change from baseline assessment to immediate post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children's emotional and behavioral symptoms
Time Frame: Change from baseline assessment to immediate post-intervention
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The Strengths and Difficulties Questionnaire will be used to assess children's emotional and behavioral symptoms in five domains: (1) emotional symptoms, (2) conduct problems, (3) hyperactivity/inattention, (4) peer relationship problems, and (5) prosocial behavior.
This scale consists of 25 items, rated on a 3-point Likert scale.
A higher total score indicates greater symptom severity for the emotional and behavioral problem domains and greater prosocial behavior for the prosocial behavior domain.
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Change from baseline assessment to immediate post-intervention
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Parenting stress
Time Frame: Change from baseline assessment to immediate post-intervention
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The Parenting Stress Index-Short Form will be used to assess parenting stress across three domains: (1) parental distress, (2) parent-child dysfunctional interaction, and (3) difficult child behavior.
The scale consists of 36 items, rated on a 5-point Likert scale.
A higher score indicates higher levels of parenting stress.
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Change from baseline assessment to immediate post-intervention
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Parents' psychological distress (i.e., depression, anxiety and stress)
Time Frame: Change from baseline assessment to immediate post-intervention
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The Chinese version of the 21-item Depression Anxiety Stress Scale (DASS-21) will be used to measure caregivers' mental health states of depression, anxiety and stress over the past week.
The scale consists of 21 items, rated on a 4-point Likert scale from 0 (did not apply at all over the last week) to 3 (applied very much or most of the time).
A higher score indicates higher levels of depression, anxiety and/or stress.
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Change from baseline assessment to immediate post-intervention
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Feasibility outcomes - recruitment rate
Time Frame: Change from baseline assessment to immediate post-intervention
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Recruitment rates will be calculated as the number of participants who consented to participate in the study divided by the number of participants who meet the inclusion criteria.
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Change from baseline assessment to immediate post-intervention
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Feasibility outcomes - retention rate
Time Frame: Change from baseline assessment to immediate post-intervention
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Retention rate will be calculated as the number of participants who have completed the study divided by the number of randomised participants.
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Change from baseline assessment to immediate post-intervention
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Feasibility outcomes - attendance
Time Frame: Change from baseline assessment to immediate post-intervention
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Attendance rates will be calculated as the number of dyads who have completed the sessions
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Change from baseline assessment to immediate post-intervention
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Acceptability of the intervention - level of satisfaction
Time Frame: Immediate post-intervention
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Dyads' perceived satisfaction of the intervention will be assessed using an 12-item investigator-designed satisfaction survey, a higher total score indicates a higher level of satisfaction.
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Immediate post-intervention
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Acceptability of the intervention
Time Frame: Immediate post-intervention
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Semi-structured individual interviews will be used to evaluate the acceptability of the interventuon by exploring dyads' perceptions and experiences of the intervention.
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Immediate post-intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ankie Tan Cheung, PhD, Chinese University of Hong Kong
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024.075-T
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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