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临床试验/NCT07394465
NCT07394465已完成不适用

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

Harvard University2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年2月26日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
Child Behavioral Checklist 1.5-5 Total Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Communal Singing

Experimental

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

干预措施: Communal singing (Behavioral)

Drawing

Active Comparator

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

干预措施: Drawing (Behavioral)

结局指标

主要结局

Child Behavioral Checklist 1.5-5 Total Score

时间窗: 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).

次要结局

  • 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).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mayron Piccolo

Lecturer in Psychology

Harvard University

研究点 (2)

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