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

Bartosz M. Radtke1 个研究点分布在 1 个国家目标入组 1,200 人开始时间: 2025年1月2日最近更新: 2026年2月23日

干预措施Psychological developmental assessment

概览

阶段: 不适用
状态: 招募中
发起方: Bartosz M. Radtke
入组人数: 1,200
试验地点: 1
主要终点: Cognitive development

概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

概览

简要总结

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.

研究设计

研究类型: Observational
观察模型: Other
时间视角: Cross Sectional

入排标准

年龄范围: 16 Days 至 42 Months（Child）
性别: All
接受健康志愿者: 是

入选标准

•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.

排除标准

•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.

研究组 & 干预措施

Extremely Preterm

Children born before 33 weeks of gestational age. This group includes infants and toddlers with a history of extreme prematurity, associated with increased risk for developmental difficulties across multiple domains.