Understanding Early Development of Infants and Toddlers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age16-42
SponsorBartosz M. Radtke
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Psychological developmental assessment
Treatment groups
1,200 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Bartosz M. Radtke
Lead sponsor
Laboratory of Psychological and Educational Tests
Sponsor institution
Source ClinicalTrials.gov