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

NCT06831851 | Not Yet Recruiting

• 1 other identifier: INF-MUSIC-STORY01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Child Development; Adaptive Behavior; Early Child Development; Music Education; Preschool Education

Keywords

Environmental enrichment; Child development; Early childhood education; Adaptive behavior; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

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

  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.

  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

Study Arms (3)

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

Behavioral: Storytelling Sessions; Behavioral: Music Education Sessions; Behavioral: Parental Guidance Sessions

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

Behavioral: Storytelling Sessions; Behavioral: Music Education Sessions

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

Behavioral: Standard Daycare Activities

Interventions

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.

Intervention Group with Parental Guidance; Intervention Group without Parental Guidance

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.

Intervention Group with Parental Guidance; Intervention Group without Parental Guidance

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

Intervention Group with Parental Guidance

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

Control Group

Eligibility Criteria

• Age: 12 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead
• Coordination for the Improvement of Higher Education Personnel: collaborator

Study Sites (1)

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

Recife, Pernambuco, 50790020, Brazil

Location

Central Study Contacts

Aline A Lima, Master in Arts and Music, Mast

CONTACT

+ 55 81 996094074; aline.alima@ufpe.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: No other parties are masked in this study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MSc in Neuroscience

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 18, 2025
• Study Start: June 2, 2025
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: March 26, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

BR (1)