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

Resilience Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06365346
• Other study ID #: 2024.075-T
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2024
• Source: Chinese University of Hong Kong
• Contact: Ankie Tan Cheung, PhD
• Phone: 852 3943 0515
• Email: ankiecheung[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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' parenting stress, and psychological distress.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 48
• Est. completion date: August 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Resilience

Intervention

Behavioral:
• 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).
• Online educational modules
Six weekly educational modules on ADHD and its management via email.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	Change from baseline assessment to immediate post-intervention
Secondary	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.	Change from baseline assessment to immediate post-intervention
Secondary	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.	Change from baseline assessment to immediate post-intervention
Secondary	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.	Change from baseline assessment to immediate post-intervention
Secondary	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.	Change from baseline assessment to immediate post-intervention
Secondary	Feasibility outcomes - attendance	Attendance rates will be calculated as the number of dyads who have completed the sessions	Change from baseline assessment to immediate post-intervention
Secondary	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.	Immediate post-intervention
Secondary	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.	Immediate post-intervention