Understanding Early Development of Infants and Toddlers

Condition(s) studied

Investigational drug(s) / intervention(s)

Psychological developmental assessment: All participants undergo a standardized psychological developmental assessment conducted by trained specialists. The assessment includes structured diagnostic tasks and direct observation of the child's behavior during play and natural interaction, carried out in the presence of a parent or legal guardian. In addition, parents or caregivers complete standardized questionnaires assessing the child's social-emotional functioning and adaptive behavior. No experimental intervention or therapeutic procedure is applied.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Cognitive development — Baseline
  Cognitive functioning assessed using the Cognitive Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4). The scale evaluates early cognitive abilities, including sensory-motor processing, exploration and manipulation, object relations, memory, problem solving, and early executive functioning. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better cognitive development.
• Language Development — Baseline
  Language functioning assessed using the Language Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), including receptive and expressive communication abilities appropriate to the child's developmental level. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better language development.
• Motor Development — Baseline
  Motor functioning assessed using the Motor Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), including fine and gross motor skills related to coordination, posture, locomotion, and motor planning. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better motor development.

Trial sites (1)

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