NCT07165925

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
17mo left

Started Sep 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress32%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

September 3, 2025

Completed
5 days until next milestone

Study Start

First participant enrolled

September 8, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2025

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2027

Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

September 3, 2025

Last Update Submit

December 17, 2025

Conditions

Keywords

Musical trainingResilienceunderprivileged childrenmental health

Outcome Measures

Primary Outcomes (1)

  • Resilience

    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.

    Change from baseline to 12-month post-intervention

Secondary Outcomes (5)

  • Social competence aspect of resilience

    Change from baseline to 12-month post-intervention

  • Depressive symptoms

    Change from baseline to 12-month post-intervention

  • Anxiety

    Change from baseline to 12-month post-intervention

  • Self-esteem

    Change from baseline to 12-month post-intervention

  • Quality of life

    Change from the baseline to 12-month post-intervention

Study Arms (2)

Gamified musical training

EXPERIMENTAL

Participants in the gamified musical training group will receive weekly 1-hour lessons on a musical instrument for 6 months, delivered by professionally certified musicians. The intervention will be conducted in small groups (7-8 children/group). Two types of musical instruments (keyboard and ukulele) will be assigned to the participants based on their preferences.

Behavioral: Gamified music training

Active placebo control group

PLACEBO COMPARATOR

Participants in the active placebo control group will participate in weekly 1-hour group-based (7-8 children/group) indoor community leisure activities for 6 months.

Behavioral: Active placebo intervention

Interventions

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.

Gamified musical training

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.

Active placebo control group

Eligibility Criteria

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

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersPersonal Satisfaction

Central Study Contacts

Tan Cheung, PhD, MPhil

CONTACT

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

September 3, 2025

First Posted

September 10, 2025

Study Start

September 8, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

September 30, 2027

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations