跳至主要内容
临床试验/NCT06831851
NCT06831851尚未招募不适用

The Influence of Music and Storytelling on the Linguistic, Socioemotional, and Adaptive Development of Children Aged 12-36 Months: an Intervention Protocol in an Enriched Environment Conducted in Municipal Early Childhood Education Centers (CMEIs)

Universidade Federal de Pernambuco1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年6月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
16
试验地点
1
主要终点
Developmental Assessment using Bayley-III Scales of Infant and Toddler Development

研究概览

简要总结

This randomized clinical trial aims to evaluate the impact of a structured enriched environment on the linguistic, adaptive behavior, and socioemotional development of children aged 12 to 36 months. The study addresses two main questions:

Does the intervention improve linguistic, adaptive behavior, and socioemotional development compared to standard care? Does parental guidance amplify the benefits of the intervention?

Participants will be randomly assigned to one of two groups:

Intervention Group:

Children will participate in musical activities twice per week (singing, exploring simple instruments, and musical games) and daily storytelling sessions using interactive and visual aids.

Within this group, parents in the "with guidance" subgroup will attend biweekly meetings to learn strategies for reinforcing the intervention at home, while the "without guidance" subgroup will not include parental training.

Control Group:

Children will receive standard care complemented by alternative artistic and pedagogical activities (e.g., drawing, painting), without the structured intervention.

详细描述

This study aims to evaluate the impact of an enriched intervention program on early childhood development, emphasizing the role of parental involvement. Participants will be randomly assigned to two main groups:

Control Group:

Children will follow routine childcare activities, including artistic and educational engagements (e.g., drawing, painting, storytelling).

Intervention Group:

Children in this group will participate in a structured program combining daily storytelling sessions and weekly musicalization activities.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

No other parties are masked in this study

入排标准

年龄范围
12 Months 至 36 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children of both sexes, aged between 12 and 36 months. Enrolled full-time in Municipal Early Childhood Education Centers (CMEIs). Attending with a daily workload of 10 hours, five days a week.

排除标准

  • •Diagnosis of atypical neurodevelopment. Use of sedative or stimulant medications for memory. Undergoing physical therapy for the locomotor system. Presence of any clinical or functional condition that prevents participation. More than five consecutive absences from the intervention program.

研究组 & 干预措施

Intervention Group with Parental Guidance

Experimental

Children in this group will participate in structured storytelling sessions (30 minutes per day, once a week) and music education activities (40 minutes, twice per week) in an enriched learning environment. The intervention aims to enhance cognitive, linguistic, socio-emotional, and motor development.

Additionally, parents or guardians will attend 8 biweekly guidance sessions (60 minutes each), where they will be trained in strategies to reinforce storytelling and musical activities at home. These sessions will provide tools to improve parent-child interaction and promote continuity of learning beyond the daycare setting

干预措施: Music Education Sessions (Behavioral)

Intervention Group with Parental Guidance

Experimental

Children in this group will participate in structured storytelling sessions (30 minutes per day, once a week) and music education activities (40 minutes, twice per week) in an enriched learning environment. The intervention aims to enhance cognitive, linguistic, socio-emotional, and motor development.

Additionally, parents or guardians will attend 8 biweekly guidance sessions (60 minutes each), where they will be trained in strategies to reinforce storytelling and musical activities at home. These sessions will provide tools to improve parent-child interaction and promote continuity of learning beyond the daycare setting

干预措施: Parental Guidance Sessions (Behavioral)

Intervention Group with Parental Guidance

Experimental

Children in this group will participate in structured storytelling sessions (30 minutes per day, once a week) and music education activities (40 minutes, twice per week) in an enriched learning environment. The intervention aims to enhance cognitive, linguistic, socio-emotional, and motor development.

Additionally, parents or guardians will attend 8 biweekly guidance sessions (60 minutes each), where they will be trained in strategies to reinforce storytelling and musical activities at home. These sessions will provide tools to improve parent-child interaction and promote continuity of learning beyond the daycare setting

干预措施: Storytelling Sessions (Behavioral)

Intervention Group without Parental Guidance

Experimental

Children in this group will participate in structured storytelling sessions (30 minutes per day, once a week) and music education activities (40 minutes, twice per week) in an enriched learning environment. The intervention is designed to stimulate cognitive, linguistic, socio-emotional, and motor development through interactive and engaging activities.

Unlike the parental guidance group, this intervention does not include parental training sessions. The activities will be conducted exclusively in the daycare setting, without reinforcement at home

干预措施: Storytelling Sessions (Behavioral)

Intervention Group without Parental Guidance

Experimental

Children in this group will participate in structured storytelling sessions (30 minutes per day, once a week) and music education activities (40 minutes, twice per week) in an enriched learning environment. The intervention is designed to stimulate cognitive, linguistic, socio-emotional, and motor development through interactive and engaging activities.

Unlike the parental guidance group, this intervention does not include parental training sessions. The activities will be conducted exclusively in the daycare setting, without reinforcement at home

干预措施: Music Education Sessions (Behavioral)

Control Group

Active Comparator

Children in this group will receive standard daycare activities without structured intervention. Activities will include artistic and pedagogical tasks (e.g., drawing, painting, modeling) as part of their regular curriculum. Additionally, storytelling will be conducted once a week, but without a structured approach or the integration of music education as applied in the experimental groups.

This group serves as a comparator to assess the effects of storytelling and music education interventions on cognitive, linguistic, socio-emotional, and motor development

干预措施: Standard Daycare Activities (Behavioral)

结局指标

主要结局

Developmental Assessment using Bayley-III Scales of Infant and Toddler Development

时间窗: The primary outcome measure (developmental assessment using Bayley-III) will be assessed at baseline (before the intervention) and after 4 months of intervention, focusing on linguistic, socio-emotional, and adaptive behavior domains

Developmental Assessment using the Bayley-III Scales The primary outcome measure will focus on evaluating the child's development through the Bayley Scales of Infant and Toddler Development (Bayley-III), a widely used tool for assessing multiple domains of early childhood development, including cognitive, motor, language, socio-emotional, and adaptive behavior. The aim is to detect any developmental delays or deviations, providing critical information for early intervention. The Bayley-III will be administered to children up to 42 months of age to ensure comprehensive developmental screening across different stages.

次要结局

未报告次要终点

研究者

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

Aline A de Lima, MA

Principal Investigator, MSc in Neuroscience

Universidade Federal de Pernambuco

研究点 (1)

Loading locations...

相似试验