Skip to content

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06365346
Enrollment
48
Registered
2024-04-15
Start date
2024-04-15
Completion date
2024-12-20
Last updated
2025-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Resilience

Brief 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' 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).

Interventions

BEHAVIORALDyadic 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).

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

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Resilience levels of childrenChange from baseline assessment to immediate post-interventionThe 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 parentsChange from baseline assessment to immediate post-interventionThe 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.

Secondary

MeasureTime frameDescription
Parents' psychological distress (i.e., depression, anxiety and stress)Change from baseline assessment to immediate post-interventionThe 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.
Feasibility outcomes - recruitment rateChange from baseline assessment to immediate post-interventionRecruitment 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.
Feasibility outcomes - retention rateChange from baseline assessment to immediate post-interventionRetention rate will be calculated as the number of participants who have completed the study divided by the number of randomised participants.
Children's emotional and behavioral symptomsChange from baseline assessment to immediate post-interventionThe 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.
Acceptability of the intervention - level of satisfactionImmediate post-interventionDyads' 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.
Acceptability of the interventionImmediate post-interventionSemi-structured individual interviews will be used to evaluate the acceptability of the interventuon by exploring dyads' perceptions and experiences of the intervention.
Feasibility outcomes - attendanceChange from baseline assessment to immediate post-interventionAttendance rates will be calculated as the number of dyads who have completed the sessions
Parenting stressChange from baseline assessment to immediate post-interventionThe 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.

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026