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

NCT06365346 | Completed

• 1 other identifier: 2024.075-T
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Resilience

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Change from baseline assessment to immediate post-intervention

Secondary Outcomes (8)

• Children's emotional and behavioral symptoms

  Change from baseline assessment to immediate post-intervention

• Parenting stress

  Change from baseline assessment to immediate post-intervention

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

  Change from baseline assessment to immediate post-intervention

• Feasibility outcomes - recruitment rate

  Change from baseline assessment to immediate post-intervention

• Feasibility outcomes - retention rate

  Change from baseline assessment to immediate post-intervention

Study Arms (2)

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".

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.

Behavioral: Online educational modules

Interventions

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).

Dyadic video-assisted gamified group-based music breathing therapy

Online educational modules BEHAVIORAL

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

Online educational modules

Eligibility Criteria

• Age: 7 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

Study Officials

• Ankie Tan Cheung, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 15, 2024
• Study Start: April 15, 2024
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: September 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)