NCT07418528

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
10mo left

Started Jan 2025

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress62%
Jan 2025Mar 2027

Study Start

First participant enrolled

January 2, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

February 11, 2026

Last Update Submit

February 19, 2026

Conditions

Early Childhood DevelopmentInfant DevelopmentChild Development

Keywords

Early developmentInfant developmentToddler developmentNeurodevelopmentCognitive developmentLanguage developmentMotor developmentSocial-emotional developmentAdaptive behavior

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Baseline

Secondary Outcomes (2)

  • Social-emotional functioning

    Baseline

  • Adaptive behavior functioning

    Baseline

Other Outcomes (1)

  • Socio-demographic data

    Baseline

Study Arms (6)

Control Group

Children without identified developmental delays, genetic conditions, or major perinatal complications, assessed as part of the general population.

Diagnostic Test: Psychological developmental assessment

Developmental Delay

Children with identified developmental delay based on prior clinical assessment or referral information, without a confirmed specific genetic diagnosis.

Diagnostic Test: Psychological developmental assessment

Genetic Conditions

Children with confirmed genetic conditions associated with developmental risk, based on medical documentation provided by parents or caregivers.

Diagnostic Test: Psychological developmental assessment

Moderate to Late Preterm

Children born preterm between 33 and 37 weeks of gestational age. This group includes infants and toddlers with a history of moderate to late prematurity, without severe neonatal complications requiring classification as extremely preterm.

Diagnostic Test: Psychological developmental assessment

Extremely Preterm

Children born before 33 weeks of gestational age. This group includes infants and toddlers with a history of extreme prematurity, associated with increased risk for developmental difficulties across multiple domains.

Diagnostic Test: Psychological developmental assessment

Cerebral Palsy

Children with a diagnosis of cerebral palsy documented in medical records. This group includes children with motor impairment of neurological origin, potentially accompanied by cognitive, language, or adaptive difficulties.

Diagnostic Test: Psychological developmental assessment

Interventions

Psychological developmental assessmentDIAGNOSTIC_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.

Cerebral PalsyControl GroupDevelopmental DelayExtremely PretermGenetic ConditionsModerate to Late Preterm

Eligibility Criteria

Age16 Days - 42 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratory of Psychological and Educational Tests

Gdansk, Pomeranian Voivodeship, 80-239, Poland

RECRUITING

Study Officials

  • Urszula Sajewicz-Radtke, Ph.D.

    Laboratory of Psychological and Educational Tests

    PRINCIPAL INVESTIGATOR

  • Bartosz M Radtke, Ph.D.

    Laboratory of Psychological and Educational Tests

    STUDY DIRECTOR

  • Ariadna Łada-Maśko, Ph.D.

    Laboratory of Psychological and Educational Tests

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafał Nowicki, M.A.

CONTACT

+48509805591nowicki@pracowniatestow.pl

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 11, 2026

First Posted

February 18, 2026

Study Start

January 2, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)