Understanding Early Development of Infants and Toddlers

Официальное название

Understanding Early Development: A Biopsychosocial Perspective on Infant and Toddler Functioning

Обзор

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.

Вмешательства

• Диагностический тест 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 pr

Первичные конечные точки

• Cognitive development [Срок оценки: Baseline]
• Language Development [Срок оценки: Baseline]
• Motor Development [Срок оценки: Baseline]

Вторичные конечные точки (2)

• Social-emotional functioning [Срок оценки: Baseline]
• Adaptive behavior functioning [Срок оценки: Baseline]

Критерии участия

Критерии включения

• Infants and young children aged from 16 days to 42 months at the time of assessment.
• Participation of a parent or legal guardian able to provide informed consent.
• Child's ability to participate in a standardized developmental assessment appropriate for age and developmental level.
• Availability of basic medical and perinatal information provided by parents or caregivers.
• Assignment to one of the predefined study cohorts based on medical history and developmental status:

children from the general population (control group), children with developmental delay, children with confirmed genetic conditions, children born preterm between 33 and 37 weeks of gestation, children born before 33 weeks of gestation, children with a diagnosis of cerebral palsy.

Критерии исключения

• Severe acute medical condition at the time of assessment preventing participation in the psychological evaluation.
• Uncorrected severe sensory impairments (e.g., profound visual or hearing impairment) that preclude valid administration or interpretation of the developmental assessment.
• Medical instability or conditions requiring immediate intensive medical care.
• Lack of informed consent from a parent or legal guardian.
• Inability of the parent or caregiver to provide reliable information required for questionnaire-based assessment.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Польша · 1 центр

• Laboratory of Psychological and Educational Tests — Gdansk

Идентификаторы

NCT: NCT07418528 · 2026/PTPiP/1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗