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Completed

NCT Number: NCT06365346

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

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.

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Key information

Conditions

Resilience

Age range

7 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Chinese University of Hong Kong

Hong Kong

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dyadic video-assisted gamified group-based music breathing therapy

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

Behavioral

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Children's emotional and behavioral symptoms

    Time frame: Change from baseline assessment to immediate post-intervention

    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.

  2. Parenting stress

    Time frame: Change from baseline assessment to immediate post-intervention

    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.

  3. Parents' psychological distress (i.e., depression, anxiety and stress)

    Time frame: Change from baseline assessment to immediate post-intervention

    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.

  4. Feasibility outcomes - recruitment rate

    Time frame: Change from baseline assessment to immediate post-intervention

    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.

  5. Feasibility outcomes - retention rate

    Time frame: Change from baseline assessment to immediate post-intervention

    Retention rate will be calculated as the number of participants who have completed the study divided by the number of randomised participants.

  6. Feasibility outcomes - attendance

    Time frame: Change from baseline assessment to immediate post-intervention

    Attendance rates will be calculated as the number of dyads who have completed the sessions

  7. Acceptability of the intervention - level of satisfaction

    Time frame: Immediate post-intervention

    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.

  8. Acceptability of the intervention

    Time frame: Immediate post-intervention

    Semi-structured individual interviews will be used to evaluate the acceptability of the interventuon by exploring dyads' perceptions and experiences of the intervention.

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Apr 15, 2024
Registry last updated
Sep 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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