NCT05346965

Brief Summary

Child poverty is a prominent global health issue owing to its detrimental impact on a child's physical and psychosocial well-being. Nearly 356 million children lived in extreme poverty globally before the pandemic and this is estimated to worsen significantly. children growing up in poverty are more vulnerable to its effect and have an increased risk of psychosocial and developmental problems than children from affluent families. The impact of poverty is not only immediate during childhood but can persist into adulthood. Previous studies have shown that Chinese children from low-income families reported significantly higher levels of depressive symptoms, lower levels of self-esteem, quality of life, and life satisfaction than children from affluent families. Recent studies have revealed the promising effects of musical training to promote psychological well-being among children and adolescents and paediatric brain tumour survivors, improving psychosocial skills of children with autism, to enhance the quality of life and psychological health by promoting positive emotions and cognitive and social development. Promoting the psychological health of school-aged children from low-income families through enhancing their resilience has received limited research attention. Additionally, there is a lack of intervention studies to promote resilience in school-aged children from low-income families. This proposed research, therefore, aims to conduct a pilot randomised controlled trial to determine the feasibility, acceptability and preliminary effects of a musical training programme in enhancing resilience and self-esteem, reducing depressive symptoms and improving the quality of life among children from low-income families. The findings from the study could inform the policymakers and healthcare professionals in health services design and the importance of advocating the psychological needs of children from low-income families by providing adequate community resources and support. If the programme demonstrates its effectiveness in promoting resilience and self-esteem among children from low-income families, further implementation could be done to maintain its sustainability in the community. Most importantly, the programme may potentially enhance the resilience of the vulnerable children from low-income families to combat poverty and hence break the intergenerational transmission of poverty.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 26, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

May 16, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

April 20, 2022

Last Update Submit

July 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Resilience - Resilience Scale for Children

    Children's resilience will be measured by the Resilience Scale for Children- 10 (RS10) which was developed based on the Resilience Scale originally developed by Wagnild and Young. Total scores ranging from 10 to 40, with higher scores indicate higher levels of resilience.

    6-month follow-up

Secondary Outcomes (4)

  • Level of self-esteem - Rosenberg self-esteem scale

    Baseline, and 6-month follow-up

  • Depressive symptoms - Center for Epidemiological Studies Depression Scale

    Baseline, and 6-month follow-up

  • Quality of life - Pediatric Quality of Life Inventory 4.0 Generic Core

    Baseline, and 6-month follow-up

  • Acceptability and satisfaction

    6-month follow-up

Study Arms (2)

Musical training programme

EXPERIMENTAL

Participants in the experimental group received a weekly 1-hour musical training lesson for 6 months delivered by professionally qualified musicians. The participants will be assigned a particular musical instrument to learn, and this is based on their interests as well as their capabilities (i.e., fine motor skills), The training will begin at the lowest level (hitting simple notes) and end at the highest level (able to play an entire song).

Behavioral: Musical training

Wait-list control group

ACTIVE COMPARATOR

To ensure equity of access to potentially effective intervention (i.e. musical training programme), participants in the wait-list control group will receive the same musical training programme as participants in the intervention group after the completion of all assessments.

Behavioral: Musical training

Interventions

The musical training intervention comprised songs, rhythm and visual creativity to encourage the children to experience music-making as fun.

Musical training programmeWait-list control group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Chinese children aged between 8-12 years
  • able to read Chinese and communicate in Cantonese
  • from low-income families, that is, less than half the median monthly household income or recipients of Comprehensive Social Security Assistance

You may not qualify if:

  • children who are currently receiving or had received musical training before the study
  • children have chronic diseases, cognitive and learning difficulties

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
Principal Investigator

Study Record Dates

First Submitted

April 20, 2022

First Posted

April 26, 2022

Study Start

May 16, 2022

Primary Completion

July 3, 2023

Study Completion

July 3, 2023

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations