Understanding early development in infants and toddlers
Understanding Early Development: A Biopsychosocial Perspective on Infant and Toddler Functioning
This project will try to describe cognitive, language, motor, social-emotional, and adaptive development in infants and toddlers aged 16 days to 42 months using a one-time developmental session and parent questionnaires.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1200 (estimated) |
| Ages | 16 Days to 42 Months |
| Sex | All |
| Sponsor | Laboratory of Psychological and Educational Tests Government |
| Locations | 1 site (Gdansk, Pomeranian Voivodeship) |
| Trial ID | NCT07418528 on ClinicalTrials.gov |
What this trial studies
This observational study enrolls infants and young children from 16 days to 42 months for a single, standardized diagnostic session conducted by qualified specialists. Assessments combine age-appropriate standardized tasks, direct behavioral observation during play and natural interaction, and parent- or caregiver-reported questionnaires about everyday functioning. Basic medical and perinatal history is recorded and participants are assigned to predefined cohorts (general population, developmental delay, confirmed genetic conditions, various prematurity groups, or cerebral palsy). Data will be used to map developmental profiles across cognitive, language, motor, social-emotional, and adaptive domains during the earliest years.
Who should consider this trial
Good fit: Ideal candidates are children aged 16 days to 42 months whose parent or legal guardian can provide consent and who can participate in an age-appropriate standardized developmental assessment.
Not a fit: Children with a severe acute medical condition at the time of assessment, uncorrected profound sensory impairments, or those older than 42 months are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the work could improve early identification of atypical developmental patterns and inform earlier referrals and supports for young children.
How similar studies have performed: Similar observational developmental cohorts have been widely used and have successfully characterized early developmental trajectories, so the approach is well established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Gdansk, Pomeranian Voivodeship
- Laboratory of Psychological and Educational Tests — Gdansk, Pomeranian Voivodeship, Poland (Recruiting)
Study contacts
- Principal investigator: Urszula Sajewicz-Radtke, Ph.D. — Laboratory of Psychological and Educational Tests
- Study coordinator: Rafał Nowicki, M.A.
- Email: nowicki@pracowniatestow.pl
- Phone: +48509805591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.