Musical Training to Enhance Resilience in Children From Low-income Families

July 27, 2023 updated by: Cheung Tan, Chinese University of Hong Kong

Musical Training Programme to Enhance Resilience and Self-esteem Among School-aged Children From Low-income Families: A Pilot Randomised Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

8 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Musical training programme
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
The musical training intervention comprised songs, rhythm and visual creativity to encourage the children to experience music-making as fun.
Active Comparator: Wait-list control group
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
The musical training intervention comprised songs, rhythm and visual creativity to encourage the children to experience music-making as fun.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resilience - Resilience Scale for Children
Time Frame: 6-month follow-up
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Level of self-esteem - Rosenberg self-esteem scale
Time Frame: Baseline, and 6-month follow-up
Levels of self-esteem will be measured by the Chinese version of the Rosenberg self-esteem scale (RSES), which is a tool designed to measure the global self-esteem of children and adolescents. Total scores ranging from 10 to 40, with higher scores indicate higher levels of self-esteem.
Baseline, and 6-month follow-up
Depressive symptoms - Center for Epidemiological Studies Depression Scale
Time Frame: Baseline, and 6-month follow-up
The Chinese version of the Center for Epidemiological Studies Depression Scale for Children (CES-DC) will be used to assess the participants' depressive symptoms. Total scores ranging from 0 to 60, with higher scores indicate higher level of depressive symptoms.
Baseline, and 6-month follow-up
Quality of life - Pediatric Quality of Life Inventory 4.0 Generic Core
Time Frame: Baseline, and 6-month follow-up
The Chinese version of the Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0) will be used to assess children's quality of life. Total scores ranging from 0 to 100, with higher scores represent better quality of life.
Baseline, and 6-month follow-up
Acceptability and satisfaction
Time Frame: 6-month follow-up
Acceptability and satisfaction will be determined upon the completion of the intervention using a short one-to-one semi-structured interview, which aims to explore the perception of the children and their parents towards the musical training programme; both children and parents will be asked to comment on their experience and feelings of the program; and to provide recommendation for improvement of the programme.
6-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alice Ho Miu Ling Nethersole Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ankie Tan Cheung, PhD, Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 3, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 1, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2021.590-T

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings