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临床试验/NCT06365346
NCT06365346已完成不适用

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

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2024年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Resilience levels of parents

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
7 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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
  • aged 21 years or above
  • are the primary caregivers and living together with the child
  • can read and communicate in Chinese

排除标准

  • 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
  • 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

结局指标

主要结局

Resilience levels of parents

时间窗: 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.

Resilience levels of children

时间窗: 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.

次要结局

  • Children's emotional and behavioral symptoms(Change from baseline assessment to immediate post-intervention)
  • Parenting stress(Change from baseline assessment to immediate post-intervention)
  • Feasibility outcomes - attendance(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)
  • Parents' psychological distress (i.e., depression, anxiety and stress)(Change from baseline assessment to immediate post-intervention)
  • Acceptability of the intervention(Immediate post-intervention)
  • Acceptability of the intervention - level of satisfaction(Immediate post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cheung Tan

Assistant Professor

Chinese University of Hong Kong

研究点 (1)

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