Clinical trial NCT06365346: Music Breathing Therapy for Children With Attention-deficit Hyperactivity Disorder and Their Caregivers
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Resilience
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 48
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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

Primary outcomes:
measure: Resilience levels of children
timeFrame: Change from baseline assessment to immediate post-intervention
measure: Resilience levels of parents
timeFrame: Change from baseline assessment to immediate post-intervention
Secondary outcomes:
measure: Children's emotional and behavioral symptoms
timeFrame: Change from baseline assessment to immediate post-intervention
measure: Parenting stress
timeFrame: Change from baseline assessment to immediate post-intervention
measure: Parents' psychological distress (i.e., depression, anxiety and stress)
timeFrame: Change from baseline assessment to immediate post-intervention
measure: Feasibility outcomes - recruitment rate
timeFrame: Change from baseline assessment to immediate post-intervention
measure: Feasibility outcomes - retention rate
timeFrame: Change from baseline assessment to immediate post-intervention
measure: Feasibility outcomes - attendance
timeFrame: Change from baseline assessment to immediate post-intervention
measure: Acceptability of the intervention - level of satisfaction
timeFrame: Immediate post-intervention
measure: Acceptability of the intervention
timeFrame: Immediate post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Ankie Tan Cheung, PhD
role: PRINCIPAL_INVESTIGATOR
References: