Understanding Early Development of Infants and Toddlers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psychological developmental assessment.
- Who it may be relevant to
- Registry conditions: Early Childhood Development, Infant Development, Child Development. Basic parameters: 16 Days — 42 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Understanding Early Development: A Biopsychosocial Perspective on Infant and Toddler Functioning
Overview
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.
Interventions
- Diagnostic test 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
Primary outcome measures
- Cognitive development [Time frame: Baseline]
- Language Development [Time frame: Baseline]
- Motor Development [Time frame: Baseline]
Secondary outcome measures (2)
- Social-emotional functioning [Time frame: Baseline]
- Adaptive behavior functioning [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Poland · 1 center
- Laboratory of Psychological and Educational Tests — Gdansk
Identifiers
NCT: NCT07418528 · 2026/PTPiP/1