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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Communal Singing | Experimental | Weekly music-based intervention including communal singing and rhythmic practices. Receives: Behavioral: Communal singing |
| Drawing | Active comparator | Control 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.
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)
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)
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)
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)
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.
- First posted6 Feb 2026
- Study start26 Feb 2024
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Harvard University
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Mato Grosso, Universidade Federal do ABC
- Responsible party
- Principal investigator, Mayron Piccolo, Harvard University
- Investigators
- Mayron Piccolo, PhD, Principal investigator, Harvard University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Tones: Artistic Communal Practices for 4 and 5 Year Old Children
- ClinicalTrials.gov ID
- NCT07394465
- Acronym / sponsor ID
- IRB24-0032
- Conditions
- Mental Health
- Keywords
- Mental health, Preschoolers, Music based intervention, Singing, Communal music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Harvard UniversityUniversity, hospital or other
- Collaborators
- Federal University of Mato Grosso, Universidade Federal do ABC
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 6 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Communal Singing | Experimental | Behavioral: Communal singingWeekly music-based intervention including communal singing and rhythmic practices. |
| Drawing | Active comparator | Behavioral: DrawingControl condition involving drawing in a group while passively listening to the songs worked in the experimental condition. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Communal singingAlso: Rhythmic exercisesThe 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. | Behavioural | Communal Singing |
| DrawingThe 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. | Behavioural | Drawing |
Primary outcome
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)
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).
4 secondary outcomes
Internalized Symptoms
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)
Externalizing Symptoms
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)
Strengths & Difficulties Questionnaire
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)
Survey of Well-being of Young Children (SWYC)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Background: PubMed 41028871Piccolo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayron Piccolo, PhD principal investigator
Harvard University
2 sites in 1 country: see every site and its status.
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.