About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Storytelling Sessions
BehavioralChildren 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
BehavioralChildren 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
BehavioralParents 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
BehavioralChildren 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
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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Universidade Federal de Pernambuco
Lead sponsor
Coordination for the Improvement of Higher Education Personnel
Collaborator
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