Clinical trial 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
Official 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
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
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
Collaborators: name: Coordination for the Improvement of Higher Education Personnel
First posted: 2025-02-18
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Developmental Assessment using Bayley-III Scales of Infant and Toddler Development
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Universidade Federal de Pernambuco (UFPE) - Department of Neuropsychiatry and Behavioral Sciences
state: Pernambuco
Study officials:
References: