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Recruiting NCT07165925

Musical Training to Enhance Resilience of Underprivileged School-aged Children

No phase Interventional Resilience Depressive Symptom Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Gamified music training, Active placebo intervention.
Who it may be relevant to
Registry conditions: Resilience, Depressive Symptom, Anxiety. Basic parameters: 8 years — 12 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Gamified Instrumental Musical Training to Enhance Resilience of Underprivileged School-aged Children at Risk of Mental Health Problems: A Randomised Controlled Trial

Overview

This is a multi-centre randomised controlled trial aims to examine the effects of a group-based gamified instrumental musical training in enhancing resilience (primary outcome), reducing psychological distress (depressive symptoms and anxiety), enhancing self-esteem, and improving HRQoL (secondary outcomes) among underprivileged school-aged children at risk of mental health problems (depression and anxiety) during a 12-month follow-up.

Detailed description

Background: 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.

Therefore, there is an urgent need to design and implement promising and novel approaches for this vulnerable population to prevent children from developing mental health problems.

Growing evidence indicates the importance of fostering children's resilience to enable them to cope with adversity. Research found that resilience exerts a protective effect on the mental well-being of individuals facing adversity (i.e. exposure to poverty).

Emerging evidence reveals the promising effects of musical training of music-based interventions on enhancing resilience and psychosocial outcomes in paediatric populations. Yet, whether music-based interventions can enhance resilience in underprivileged school-aged children remains unclear.

If the proposed instrumental musical training programme is proven to be effective and sustainable, it can be recommended as usual care in the community care service for underprivileged children.

Hypothesis to be tested: Participants who receive the 6-month gamified instrumental musical training would report higher levels of resilience, reduced levels of psychological distress (depressive symptoms and anxiety), higher self-esteem, and better QoL than the placebo control group.

Design and subjects: A mulit-centre assessor-blind, randomised controlled trial will be conducted following the CONSORT guidelines; 174 underprivileged children aged 8 to 12 who are at risk of depression and/or anxiety will be randomised 1:1 to intervention or control groups.

Instruments: Validated questionnaires (RSES, CES-DC, SAS-C, RS10,and PedsQL 4.0).

Interventions: Weekly one-hour group-based gamified instrumental musical training session delivered by certified musicians for 6 months. The control group will receive weekly one-hour group-based indoor community leisure activities for 6 months.

Main outcome measures: Data collection will be conducted at baseline (T0), 6-month (T1;immediately post-intervention), 9-(T2), and 12-month(T3). The primary outcome is resilience level. Secondary outcomes include psychological distress (i.e., depressive symptoms and anxiety levels), self-esteem, and quality of life.

Interventions

  • Behavioral Gamified music training
    Instrumental musical training will progress from basic (playing simple notes) to advanced levels (playing an entire song). Key training elements will include fundamental music knowledge and skills, music improvisation, rhythm, and pitch identification exercises. In particular, the core concepts of resilience will be incorporated into the training process through various gamified music activities.
  • Behavioral Active placebo intervention
    Participants in the active placebo control group will participate in weekly 1-hour group-based indoor community leisure activities for 6 months. These activities will include (i) drawing, (ii) drama workshops, (iii) cartoon film screenings, (iv) handcraft workshops, (v) board games, and (vi) exercise classes. Each activity will span for four sessions, that is, totally 24 sessions and will be delivered by trained staff at the study centres of the collaborating non-governmental organisations.

Primary outcome measures

  • Resilience [Time frame: Change from baseline to 12-month post-intervention]
Secondary outcome measures (5)
  • Social competence aspect of resilience [Time frame: Change from baseline to 12-month post-intervention]
  • Depressive symptoms [Time frame: Change from baseline to 12-month post-intervention]
  • Anxiety [Time frame: Change from baseline to 12-month post-intervention]
  • Self-esteem [Time frame: Change from baseline to 12-month post-intervention]
  • Quality of life [Time frame: Change from the baseline to 12-month post-intervention]

Eligibility criteria

Inclusion criteria

  • Hong Kong Chinese children aged 8-12 years.
  • Able to read Chinese and communicate in Cantonese/Mandarin.
  • From low-income families.
  • Have a risk of mental health problems, specifically depression and/or anxiety (determined through screening during the recruitment process using the Center for Epidemiological Studies Depression Scale for Children, with a cut-off score of ≥16 indicating a high risk of depression, and/or the State Anxiety Scale for Children, with scores between 36 and 60 indicating a significant level of anxiety)

Exclusion criteria

  • Have chronic health conditions, cognitive and learning difficulties
  • if they or their siblings are currently receiving or have received any music-based interventions before the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Hong Kong · 1 center
  • The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07165925 · CRE-2024.498

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗