Understanding Early Development of Infants and Toddlers

The goal of this observational study is to analyze early development in infants and young children from a biopsychosocial perspective, with a particular focus on cognitive, language, motor, social-emotional, and adaptive functioning during the first years of life. The study will include infants and young children from 16 days of age up to 42 months of age, assessed during a single diagnostic session conducted by qualified specialists. The developmental assessment will include standardized diagnostic tasks and direct observation of behavior in the form of play and natural interaction, carried out in the presence of a parent or legal guardian. In addition, information regarding the child's everyday functioning will be collected from parents or caregivers using standardized questionnaires, including data on social-emotional competencies, communication, and adaptive skills. The main research questions addressed by this study are: What is the developmental profile of infants and young children in the first years of life? What relationships exist between different domains of early development within a biopsychosocial model of child functioning? Can specific developmental patterns be identified that indicate an increased risk of developmental difficulties in early childhood? How does age differentiate the structure and variability of developmental functioning across assessed domains? The study is non-invasive and observational in nature. Data will be analyzed exclusively in aggregated form and will contribute to a better understanding of early child development as well as to the development of norms and tools supporting early diagnosis and developmental intervention.

NCT Number	NCT07418528
Lead Sponsor	Bartosz M. Radtke
Conditions	Early Childhood Development, Infant Development, Child Development
Enrollment	1,200 participants
Start Date	2025-01-02
Primary Completion	2026-11 (estimated)
Study Completion	2027-03 (estimated)
Updated on ClinicalTrials.gov	2026-02-23