ResilienceNCT06365346
Music Breathing Therapy for Children With Attention-deficit Hyperactivity Disorder and Their Caregivers
A study testing Dyadic video-assisted gamified group-based music breathing therapy and Online educational modules in people with Resilience, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This pilot randomized controlled trial aims to evaluate the feasibility (in terms of rates of recruitment, retention, and attendance), acceptability, and potential effects of the dyadic video-assisted gamified music breathing therapy on dyads' resilience, children's emotional and behavioral symptoms, parents'… Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Resilience
- What is being tested?
- Dyadic video-assisted gamified group-based music breathing therapy and Online educational modules
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Apr 2024to 20 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
This pilot randomized controlled trial aims to evaluate the feasibility (in terms of rates of recruitment, retention, and attendance), acceptability, and potential 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.
Read the 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).
- Conditions
- Resilience
- Being tested
- Dyadic video-assisted gamified group-based music breathing therapy, Online educational modules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dyadic video-assisted gamified group-based music breathing therapyBehavioural
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).
Online educational modulesBehavioural
Six weekly educational modules on ADHD and its management via email.
| Study group | Role | What they receive |
|---|---|---|
| Dyadic video-assisted gamified group-based music breathing therapy | Experimental | 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". Receives: Behavioral: Dyadic video-assisted gamified group-based music breathing therapy |
| Online educational modules | Active comparator | 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. Receives: Behavioral: Online educational modules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resilience levels of children
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.
Measured: Change from baseline assessment to immediate post-intervention
Resilience levels of parents
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.
Measured: Change from baseline assessment to immediate post-intervention
Secondary outcomes (8)
Children's emotional and behavioral symptoms
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.
Measured: Change from baseline assessment to immediate post-intervention
Parenting stress
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.
Measured: Change from baseline assessment to immediate post-intervention
Parents' psychological distress (i.e., depression, anxiety and stress)
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.
Measured: Change from baseline assessment to immediate post-intervention
Feasibility outcomes - recruitment rate
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.
Measured: Change from baseline assessment to immediate post-intervention
Feasibility outcomes - retention rate
Retention rate will be calculated as the number of participants who have completed the study divided by the number of randomised participants.
Measured: Change from baseline assessment to immediate post-intervention
Feasibility outcomes - attendance
Attendance rates will be calculated as the number of dyads who have completed the sessions
Measured: Change from baseline assessment to immediate post-intervention
Acceptability of the intervention - level of satisfaction
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.
Measured: Immediate post-intervention
Acceptability of the intervention
Semi-structured individual interviews will be used to evaluate the acceptability of the interventuon by exploring dyads' perceptions and experiences of the intervention.
Measured: Immediate post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start15 Apr 2024
- Primary completion20 Dec 2024
- Study completion20 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ResilienceStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheung Tan, Chinese University of Hong Kong
- Investigators
- Ankie Tan Cheung, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06365346
- Sponsor's protocol ID
- 2024.075-T
- Status last verified
- Sep 2025
- First submitted
- 10 Apr 2024
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06365346
- Acronym / sponsor ID
- 2024.075-T
- Conditions
- Resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 20 Dec 2024 (actual)
- Study completion
- 20 Dec 2024 (actual)
- First posted
- 15 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot randomized controlled trial aims to evaluate the feasibility (in terms of rates of recruitment, retention, and attendance), acceptability, and potential 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dyadic video-assisted gamified group-based music breathing therapy | Experimental | Behavioral: Dyadic video-assisted gamified group-based music breathing therapyParent-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". |
| Online educational modules | Active comparator | Behavioral: Online educational modulesParent-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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dyadic video-assisted gamified group-based music breathing therapyDyadic 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). | Behavioural | Dyadic video-assisted gamified group-based music breathing therapy |
| Online educational modulesSix weekly educational modules on ADHD and its management via email. | Behavioural | Online educational modules |
Primary outcome
Resilience levels of children
Time frame: Change from baseline assessment to immediate post-intervention
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.
Resilience levels of parents
Time frame: Change from baseline assessment to immediate post-intervention
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.
8 secondary outcomes
Children's emotional and behavioral symptoms
Time frame: Change from baseline assessment to immediate post-intervention
Parenting stress
Time frame: Change from baseline assessment to immediate post-intervention
Parents' psychological distress (i.e., depression, anxiety and stress)
Time frame: Change from baseline assessment to immediate post-intervention
Feasibility outcomes - recruitment rate
Time frame: Change from baseline assessment to immediate post-intervention
Feasibility outcomes - retention rate
Time frame: Change from baseline assessment to immediate post-intervention
Feasibility outcomes - attendance
Time frame: Change from baseline assessment to immediate post-intervention
Acceptability of the intervention - level of satisfaction
Time frame: Immediate post-intervention
Acceptability of the intervention
Time frame: Immediate post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ankie Tan Cheung, PhD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dyadic video-assisted gamified group-based music breathing therapy and Online educational modules in people with Resilience, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resilience levels of children (time frame: Change from baseline assessment to immediate post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.