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NCT Number: NCT06831851

Effects of Music and Storytelling on Linguistic, Socioemotional, and Adaptive Development in Children Aged 12-36 Months: an Intervention Protocol in Municipal Early Childhood Centers

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.

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Key information

Conditions

Child Development Adaptive Behavior Early Child Development Music Education Preschool Education

Age range

12 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal de Pernambuco (UFPE) - Department of Neuropsychiatry and Behavioral Sciences

Recife, Pernambuco, 50790020, Brazil

Location contact

Sandra Lopes Souza, PhD in Morphofunctional Scienc

CONTACT

[email protected]

+55 81 98740-2484

About this study

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.

This group will be further divided into two subgroups:

With Parental Guidance: Parents or guardians will attend bi-weekly guidance meetings to receive strategies for reinforcing the intervention at home.

Without Parental Guidance: No parental meetings will be conducted; children will participate in the program independently.

Intervention Activities:

The intervention includes:

Storytelling: Interactive, daily sessions (30 minutes/day) designed to foster creativity and imagination using visual and verbal methods.

Musicalization: Interactive, twice-weekly sessions (40 minutes each) incorporating singing, rhythm games, and exploration of simple musical instruments to enhance motor and cognitive skills.

Assessment Measures:

The primary developmental domains-linguistic, socio-emotional, and adaptive behaviors-will be assessed using the Bayley Scales of Infant and Toddler Development (Bayley-III). Secondary measures include parental adherence (in the guidance subgroup) and engagement levels during activities.

This pilot study will provide foundational data to support the development of larger-scale, evidence-based interventions focused on enhancing early childhood developmental outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Storytelling Sessions

Behavioral

Children will participate in structured storytelling sessions, held once a week for 30 minutes per session. The sessions will use interactive narrative techniques, including voice modulation, gestures, and visual aids, to enhance cognitive, linguistic, and socio-emotional development. The intervention is designed to promote active engagement, stimulate imagination, and improve attention and language skills in early childhood.

Music Education Sessions

Behavioral

Children will participate in structured music education sessions, conducted twice per week for 40 minutes each. The sessions will include rhythm exercises, vocalization, body percussion, and instrumental exploration using age-appropriate musical instruments. Activities will be designed to enhance cognitive, motor, and socio-emotional development by fostering auditory discrimination, fine and gross motor coordination, and social interaction. The intervention follows an interactive and play-based methodology, ensuring active engagement and progressive learning.

Parental Guidance Sessions

Behavioral

Parents or guardians will attend 8 biweekly training sessions (60 minutes each) designed to equip them with strategies for cognitive, linguistic, and socio-emotional stimulation in early childhood. The sessions will include practical guidance on storytelling techniques, musical interaction, and play-based learning to reinforce the intervention at home. The goal is to create continuity between structured intervention activities and the home environment, maximizing developmental outcomes for the children. Sessions will be interactive, combining theoretical content with practical exercises and demonstrations

Standard Daycare Activities

Behavioral

Children in this group will participate in regular daycare activities, including artistic and pedagogical tasks such as drawing, painting, and modeling. These activities are part of the standard curriculum and do not include structured storytelling or music education interventions

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Aline A Lima, Master in Arts and Music, Mast

CONTACT

[email protected]

+ 55 81 996094074

Sponsors and collaborators

Lead sponsor

Universidade Federal de Pernambuco

Other

Collaborators

  • Coordination for the Improvement of Higher Education Personnel

Registry information

Official study title

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)

Acronym: MUS-STORY

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2025
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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