Understanding Early Development of Infants and Toddlers

ConditionsEarly Childhood Development Infant Development Child Development

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

This trial accepts healthy volunteers

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 population

Infants and young children aged 16 days to 42 months, including children with typical development and children with increased developmental risk.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

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.

Treatment groups

1,200 Participants

are divided into 6 treatment groups

Treatment groups

See each treatment group below.

Group A: Control Group1 intervention

Group B: Developmental Delay1 intervention

Group C: Genetic Conditions1 intervention

Group D: Moderate to Late Preterm1 intervention

Group E: Extremely Preterm1 intervention

Group F: Cerebral Palsy1 intervention

Trial outcomes

Primary outcomes

Cognitive development

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.

Time frame

Baseline

Language Development

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.

Time frame

Baseline

Motor Development

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.

Time frame

Baseline

Secondary outcomes

Social-emotional functioning

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.

Time frame

Baseline

Adaptive behavior functioning

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.

Time frame

Baseline

Other outcomes

Socio-demographic data

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.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bartosz M. Radtke

Lead sponsor

Laboratory of Psychological and Educational Tests

Sponsor institution

Source ClinicalTrials.gov

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