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Mental HealthNCT07394465

First Tones: Artistic Communal Practices for 4 and 5 Year Old Children

A study testing Communal singing and Drawing in people with Mental Health, run by Harvard University at 2 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Mental Health
What is being tested?
Communal singing and Drawing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
2 sitesBrazil
Study dates
26 Feb 2024to 19 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites
  • Universidade Federal de Mato Grosso do Sul

    Campo Grande, Mato Grosso do Sul

  • Universidade Federal do ABC Paulista

    São Bernardo do Campo, São Paulo

Other trials in Brazil

About this study

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.

Read the detailed description

This project aims to investigate the effects of a communal musical practice intervention on behaviors and neural markers of mental health in 4- and 5-year-old children. Children primarily search for emotional security, relational stability, and a sense of belonging from their immediate families, apart from school environments. Thus, there is great concern for children who experience family adversity and struggle to find belonging and stability at home.

A growing body of literature suggests that children who are born into dysfunctional, unstable family environments are at a much higher risk of future family instability, poorer life outcomes, and mental illness compared to children in more protected environments. Childhood adversity such as abuse, being raised in poverty, impaired parenting, etc., has been shown to drastically increase the likelihood of childhood mental disorders, behavioral problems, and subsequent depression in adulthood.

A relationship between lower socioeconomic position and experiencing childhood adversity has been found, and despite being at higher risk for the development of mental disorders, individuals in lower socioeconomic positions have reduced access to mental health treatment. Therefore, developing low-cost group-based interventions for children experiencing childhood adversity is of fundamental importance.

Communal singing interventions are low-cost and have shown significant benefits in other populations. For instance, Sung et al. explored the effects of a communal music intervention on anxiety and agitation symptoms in institutionalized older individuals with dementia. Individuals who participated in the 12-session intervention experienced a significant decrease in anxiety compared to those in a control group. Similarly, Adery and Park reported lower depression scores in individuals with psychiatric symptoms, namely psychosis and depression, who underwent a one-hour, eight-week communal singing intervention. Although no difference was seen for psychotic symptoms, individuals reported lower levels of loneliness, which could help explain some of the mechanisms through which communal music-making improves mental health.

Neuroimaging studies have shown significant changes in brain activity and connectivity following music-based interventions. For example, Quinci et al. reported increased functional connectivity between a mask containing auditory processing regions (e.g., superior temporal gyrus, middle temporal gyrus, and Heschl's gyrus) and the medial prefrontal cortex (mPFC) following intervention. These results are promising because the mPFC, for example, has been shown to be implicated in the maintenance of psychiatric disorders such as depression and post-traumatic stress disorder (PTSD). Furthermore, the mPFC is associated with reward processing. Interestingly, investigating reward-related processes has helped explain the pathophysiology of many psychiatric disorders.

Improving reward processing may be one of the mechanisms through which communal music-making improves mental health. Music listening has been associated with reward responses in the brain, and exploring the interaction between communal music-making, reward processing, and mental health markers warrants investigation. For instance, current promising interventions for some psychiatric disorders focus on improving reward processing as a means to decrease symptoms.

Building a sense of belonging may also be a mechanism involved in communal music-making. Besides the decreased loneliness experienced by individuals with psychosis following a choir-singing intervention, suggesting that singing together increased their sense of being connected to others, one qualitative study with individuals suffering from PTSD who underwent a communal music-making intervention that included communal performances reported an increased sense of belonging as well as self-confidence following intervention. Furthermore, in another qualitative study investigating the effects of communal singing in individuals with different mental disorders, Dingle et al. report increased feelings of connectedness to other members of the choir and the community in general. Finally, singing together also increases the levels of oxytocin, an important mediator of social behavior. Like reward processing, understanding the role of the sense of belonging in communal music-making warrants investigation.

Conditions
Mental Health
Being tested
Communal singing, Drawing
Keywords
Mental health, Preschoolers, Music based intervention, Singing, Communal music
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Communal singingBehavioural

    Also called Rhythmic exercises

    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.

  • DrawingBehavioural

    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.

Study groups in NCT07394465
Study groupRoleWhat they receive
Communal SingingExperimentalWeekly music-based intervention including communal singing and rhythmic practices.
Receives: Behavioral: Communal singing
DrawingActive comparatorControl condition involving drawing in a group while passively listening to the songs worked in the experimental condition.
Receives: Behavioral: Drawing

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)
  1. Internalized Symptoms

    This scale will come from the Child Behavior Checklist 1.5-5 and will include the following sub scales: emotional reactivity, anxiety/depression, somatic complaints, withdrawn behavior.

    Measured: 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)

  2. Externalizing Symptoms

    These will come from the following sub scales of the Child Behavior Checklist 1.5-5: attention problems, and aggressive behavior.

    Measured: 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)

  3. Strengths & Difficulties Questionnaire

    Developed by Goodman (1997) and validated in Brazil by Fleitlich, Cartázar, and Goodman (2000), this questionnaire aims to track children's mental health problems based on reports from parents and teachers. It consists of 25 items, distributed across five subscales, with five items each, covering issues related to pro-social behavior, hyperactivity, emotional problems, conduct, and relationships. Responses can be false, somewhat true, or true. The scores classify the child's development into three categories: normal range (NR), borderline range (BR), or abnormal range (AR). In the pro-social behavior subscale, a higher score indicates fewer complaints, while in the other subscales (hyperactivity, emotional problems, conduct, and relationships), a higher score indicates more complaints (Stivanin, Scheuer \& Assumpção Jr, 2008).

    Measured: 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)

  4. Survey of Well-being of Young Children (SWYC)

    Developed by Perrin et al. (2016) and validated in Brazil by Moreira et al. (2019), this instrument aims to screen the developmental status of children under 65 months, based on parental reports. It consists of about 40 items, easy to understand and respond to (average application time of 15 minutes), addressing domains such as development, emotions/behavior, and family risk factors (Moreira et al., 2019). This instrument has an application called TEDI that assists the researcher in its application and minimizes filling errors.

    Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2026
  2. Study start26 Feb 2024
  3. Primary completion19 Dec 2024
  4. Study completion19 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07394465
Sponsor's protocol ID
IRB24-0032
Status last verified
Feb 2026
First submitted
23 Jan 2026
Last updated
23 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41028871

Questions about this trial

What is this clinical trial studying?

A study testing Communal singing and Drawing in people with Mental Health, run by Harvard University at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child Behavioral Checklist 1.5-5 Total Score (time frame: 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07394465, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.

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