Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2025-12-24 @ 11:52 PM
NCT ID:
NCT06831851
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.
Study:
NCT06831851
Study Brief:
Protocol Section:
NCT06831851