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NCT Number: NCT07418528

Understanding Early Development of Infants and Toddlers

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.

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Key information

Conditions

Early Childhood Development Child Development Infant Development

Age range

16 day–42 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Laboratory of Psychological and Educational Tests

Gdansk, Pomeranian Voivodeship, 80-239, Poland

Location status: Recruiting

Location contact

Rafał Nowicki, M.A.

CONTACT

[email protected]

+48509805591

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Psychological developmental assessment

Diagnostic Test

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 procedure is applied.

Primary outcomes

  1. Cognitive development

    Time frame: Baseline

    Cognitive functioning assessed using the Cognitive Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4). The scale evaluates early cognitive abilities, including sensory-motor processing, exploration and manipulation, object relations, memory, problem solving, and early executive functioning. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better cognitive development.

  2. Language Development

    Time frame: Baseline

    Language functioning assessed using the Language Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), including receptive and expressive communication abilities appropriate to the child's developmental level. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better language development.

  3. Motor Development

    Time frame: Baseline

    Motor functioning assessed using the Motor Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), including fine and gross motor skills related to coordination, posture, locomotion, and motor planning. Data will be reported as a Composite Score ranging from 40 to 160, where higher scores indicate better motor development.

Secondary outcomes

  1. Social-emotional functioning

    Time frame: Baseline

    Social-emotional development assessed using the Social-Emotional Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), based on parent-reported information regarding emotional regulation, social engagement, communication of needs, and relationship development. Data will be reported as a Scaled Score ranging from 1 to 19, where higher scores indicate better performance.

  2. Adaptive behavior functioning

    Time frame: Baseline

    Adaptive behavior assessed using the Adaptive Behavior Scale of the Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4), based on parent or caregiver report of the child's everyday functional skills in communication, daily living skills, and socialization. Data will be reported as a Scaled Score ranging from 1 to 19, where higher scores indicate better performance.

Other outcomes

  1. Socio-demographic data

    Time frame: Baseline

    Author-designed socio-demographic questionnaire completed by parents or caregivers, including information on the child's sex, month and year of birth, gestational age at birth, place and region of residence, parental education level and selected perinatal characteristics.

Study contacts

Contact information is provided by the study sponsor or research team.

Rafał Nowicki, M.A.

CONTACT

[email protected]

+48509805591

Sponsors and collaborators

Lead sponsor

Bartosz M. Radtke

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 18, 2026
Registry last updated
Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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