Music Breathing Therapy for Children With Attention-deficit Hyperactivity Disorder and Their Caregivers

NCT ID: NCT06365346

Last Updated: 2025-09-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-15

Study Completion Date

2024-12-20

Brief Summary

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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

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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

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Resilience

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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".

Group Type EXPERIMENTAL

Dyadic video-assisted gamified group-based music breathing therapy

Intervention Type BEHAVIORAL

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 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.

Group Type ACTIVE_COMPARATOR

Online educational modules

Intervention Type BEHAVIORAL

Six weekly educational modules on ADHD and its management via email.

Interventions

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Dyadic video-assisted gamified group-based music breathing therapy

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).

Intervention Type BEHAVIORAL

Online educational modules

Six weekly educational modules on ADHD and its management via email.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Cheung Tan

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ankie Tan Cheung, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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2024.075-T

Identifier Type: -

Identifier Source: org_study_id

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