NCT07394465

Brief Summary

This project aims to develop therapeutic communal music interventions to support the mental health of preschool-aged children, identifying the psychological and neural mechanisms underlying these effects and comparing brain responses to communal versus non-communal music. The central hypothesis is that group musical practice will strengthen mental health indicators, promoting a sense of belonging and stimulating brain areas associated with reward. Communal singing interventions are economically viable and have demonstrated significant benefits in several populations. The research intends to fill gaps in the literature by identifying psychological mechanisms underlying the benefits of music and developing an assessment tool for the sense of belonging in preschoolers. Innovation also lies in exploring the emerging concept of communal music. The study will involve 30 children between the ages of 4 and 5, divided into an intervention group and a control group. Pre- and post-intervention assessments over a 10-week period will include behavioral, psychiatric, brain connectivity, and brain activity measures. In summary, this project seeks to develop accessible communal music interventions to enhance the mental health of 4- and 5-year-old children. Our central hypothesis is that communal musical practice improves mental health markers in our sample by promoting a sense of belonging and differentially activating putative reward regions in the brain. By enhancing the sense of belonging and generating feelings of reward, we anticipate that the behavioral and psychiatric symptoms experienced by the target population will be attenuated. Our hypothesis was partially formulated based on recently obtained pilot data suggesting that communal music has protective effects against negative affect caused by ostracism, as well as literature on communal singing in other populations. The rationale for this proposed project is that understanding the therapeutic value of communal musical practice and identifying the mechanisms by which this occurs is likely to provide a strong scientific foundation for new strategies to support the mental health of at-risk groups and potentially reduce health disparities within these populations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 26, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2026

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

10 months

First QC Date

January 23, 2026

Last Update Submit

February 20, 2026

Conditions

Keywords

Mental healthPreschoolersMusic based interventionSingingCommunal music

Outcome Measures

Primary Outcomes (1)

  • Child Behavioral Checklist 1.5-5 Total Score

    Developed by Achenbach and Rescorla, with studies in the Brazilian context indicating good reliability, this instrument seeks to obtain standardized measures of emotional and behavioral problems in preschool children, based on parent reports. It consists of 99 items, responded to on a 3-point likert scale (0 = not true, 1 = somewhat or sometimes true, 2 = very true or often true).

    Pre-test measures taken up to one day before the beginning of the intervention. Post-test measures taken starting the day to follow the last session until one month following completion (10 weeks)

Secondary Outcomes (4)

  • Internalized Symptoms

    Pre-test measures taken up to one day before the beginning of the intervention. Post-test measures taken starting the day to follow the last session until one month following completion (10 weeks)

  • Externalizing Symptoms

    Pre-test measures taken up to one day before the beginning of the intervention. Post-test measures taken starting the day to follow the last session until one month following completion (10 weeks)

  • Strengths & Difficulties Questionnaire

    Pre-test measures taken up to one day before the beginning of the intervention. Post-test measures taken starting the day to follow the last session until one month following completion (10 weeks)

  • Survey of Well-being of Young Children (SWYC)

    Pre-test measures taken up to one day before the beginning of the intervention. Post-test measures taken starting the day to follow the last session until one month following completion (10 weeks).

Other Outcomes (1)

  • Subscales of the Child Behavior Checklist 1.5-5

    Pre-test measures taken up to one day before the beginning of the intervention. Post-test measures taken starting the day to follow the last session until one month following completion (10 weeks)

Study Arms (2)

Communal Singing

EXPERIMENTAL

Weekly music-based intervention including communal singing and rhythmic practices.

Behavioral: Communal singing

Drawing

ACTIVE COMPARATOR

Control condition involving drawing in a group while passively listening to the songs worked in the experimental condition.

Behavioral: Drawing

Interventions

The intervention group will participate in communal music sessions over a period of 10 weeks, once a week, after school. During this time, children will engage in age-specific communal music interventions, and sessions will be recorded on video.

Also known as: Rhythmic exercises
Communal Singing
DrawingBEHAVIORAL

The control group will participate in drawing sessions over a period of 10 weeks, once a week. During this time, children will engage in artistic drawing activities while listening to the same music worked on in the intervention group, without, however, singing them together.

Drawing

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Age Group: Children who are 4 and 5 years old throughout the duration of the study will be included in the research.
  • Interest: The child expresses a desire to participate in artistic activities.
  • Informed Consent: Parents or legal guardians of children must provide informed consent for the children's participation in the project.
  • Availability to participate: Children must be available and willing to participate in all activities.

You may not qualify if:

  • Age outside the age range: Children outside the age range of 48 and 60 months will be excluded from the study.
  • Lack of Consent: If parents or guardians do not agree to provide informed consent for the children's participation, they will be excluded from the study.
  • Pre-existing Health Conditions: Children with health conditions that could significantly interfere with participation in activities, such as serious neurological disorders, serious mental disorders, or medical problems that contraindicate participation, will be excluded. This data will be collected in the registration form through a declaration from the child's parent or guardian. As a way of guaranteeing the anonymity of the research participant, all data collected will be carried out using an ID that will be linked to the participant's name. The name and respective ID will only be recorded on paper, which will be stored in a locked cabinet with access restricted to the responsible researcher.
  • Participation in Simultaneous Activities: Children who are participating in other music teaching activities simultaneously that may interfere with the objectives or activities of this project will be excluded.
  • Inability to Tolerate Activities: If a child demonstrates this during the familiarization session or at any time during the study, a significant inability to tolerate the proposed activities, including music lessons, playful quizzes, or the use of functional near-infrared spectroscopy (fNIRS), will be excluded.
  • Non-Availability: If a child is not available to participate in all sessions or they and their guardians refuse to participate in any phase of the study, they will be excluded. The child is expected to attend all sessions.
  • Incomplete Information: If parents or guardians do not provide complete and accurate information in the initial questionnaires, the child will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universidade Federal de Mato Grosso do Sul

Campo Grande, Mato Grosso do Sul, Brazil

Location

Universidade Federal do ABC Paulista

São Bernardo do Campo, São Paulo, Brazil

Location

Related Publications (1)

  • Piccolo M, Dos Santos DW, Herold S, Hooley JM. Communal music as a tool to improve positive affect after social ostracism or negative autobiographical memory recollection. Sci Rep. 2025 Sep 30;15(1):33821. doi: 10.1038/s41598-025-05119-5.

    PMID: 41028871BACKGROUND

Related Links

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Mayron Piccolo, PhD

    Harvard University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer in Psychology

Study Record Dates

First Submitted

January 23, 2026

First Posted

February 6, 2026

Study Start

February 26, 2024

Primary Completion

December 19, 2024

Study Completion

December 19, 2024

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations