Psychological Correlates of Developmental Delays in Preschool Children

February 11, 2026 updated by: Bartosz M. Radtke

Perinatal, Cognitive, Linguistic, and Social-emotional Correlates of Developmental Delay in Polish Preschool Children From a Biopsychosocial Perspective

The goal of this observational study is to investigate perinatal, cognitive, linguistic and social-emotional correlates of developmental delays of preschool children.

The study group consist of minimal 500 children between 3 and 6 years of age who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: cognitive functioning, linguistic skills and social-emotional functioning. Furthermore informations regarding social-emotional functioning of children, will be collected from parents.

The main questions it aims to answer are:

  1. Is there a relationship between perinatal factors and risk of occurrence of developmental delay disorder?
  2. Is there a specific pattern of cognitive functioning in preschool children with indicated developmental delay disorder?
  3. Is there a specific pattern of social-emotional functioning in preschool children with indicated developmental delay disorder?
  4. Do gender and age moderates specific patterns of cognitive and socialemotional functioning in the studied groups?

Researchers will compare the following groups of children between 3 and 6 years old:

  1. With perinatal risks factors

  2. With developmental delay disorder:

    1. children with early intervention
    2. children with delayed speech development
  3. Control group

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-239
        • Recruiting
        • Laboratory of Psychological and Educational Tests
        • Principal Investigator:
          • Urszula Sajewicz-Radtke, PhD
        • Principal Investigator:
          • Ariadna Łada-Maśko, PhD
        • Contact:
        • Principal Investigator:
          • Bartosz Radtke, PhD
        • Sub-Investigator:
          • Łucja Bielenik, PhD
        • Sub-Investigator:
          • Dorota Kalka, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Polish preschool children aged 3 to 6 years.

Description

Inclusion Criteria:

  • Children aged 3 to 6 years at the time of assessment.
  • Attendance at preschool education.
  • Written informed consent provided by a parent or legal guardian.
  • Ability to participate in standardized psychological assessment.
  • Assignment to one of the predefined study cohorts based on developmental history and clinical information.

Exclusion Criteria:

  • Age below 3 years or above 6 years.
  • Severe acute medical condition preventing participation.
  • Severe uncorrected sensory impairment interfering with valid assessment.
  • Lack of parental informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Early intervention
Children between 3 to 6 years old with formal early development support.
Other: Psychological assessment
Psychological assessment of cognitive, linguistic and social-emotional functioning.
Delayed speech development
Children between 3 to 6 years old with formal diagnosis of delayed speech development
Other: Psychological assessment
Psychological assessment of cognitive, linguistic and social-emotional functioning.
Control group
Children between 3 to 6 years old without formal diagnosis of delayed speech development and without any formal early development support.
Other: Psychological assessment
Psychological assessment of cognitive, linguistic and social-emotional functioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive Functioning Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6)
Time Frame: Baseline
The Cognitive Functioning Index is a composite score derived from the Cognitive Area of the B3/6 battery. It evaluates visual-spatial processing (Blocks, Puzzles), working memory (Frog recall tasks, Sentence repetition), planning (Mazes), and naming speed. Data will be reported as a standardized score (mean=100, SD=15).
Baseline
Phonological Processing Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6)
Time Frame: Baseline
Description: This index assesses linguistic skills through the Phonological Processing scale of the B3/6 battery. It includes tasks measuring syllabic and phonemic analysis and synthesis, as well as sound abstraction. Data will be reported as a standardized score (mean=100, SD=15).
Baseline
Social-Emotional Development Score as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6)
Time Frame: Baseline
Description: This score evaluates the child's social-emotional competence through the Social-Emotional Area of the B3/6 battery. The assessment covers three key components: naming emotions, recognizing emotions, and empathy. Data will be reported as a standardized score (mean=100, SD=15).
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General intellectual functioning measured by the Stanford-Binet 5 (SB5)
Time Frame: Baseline
Stanford-Binet Intelligence Scales-Fifth Edition (SB5). A standardized test which assessment two main intellectual domain (Nonverbal and Verbal). Each domain consist of five scales (Fluid Reasoning, Knowledge, Quantitative Reasoning, Visual-Spatial Processing, and Working Memory). This test is based on the Cattel-Horn-Carroll Intelligence Theory (CHC).
Baseline
Nonverbal Intelligence Quotient (NIQ) as measured by the Primary Test of Nonverbal Intelligence (PTONI)
Time Frame: Baseline
Description: The PTONI is a standardized, norm-referenced instrument designed to assess nonverbal reasoning and problem-solving skills in young children. It measures abilities such as analogical reasoning, categorical classification, and sequential reasoning. The test requires no verbal response from the child. The results will be reported as a standardized index score (mean=100, SD=15).
Baseline
Early social-emotional development
Time Frame: Baseline
The Emotional Development Scale for Children Aged 3-6. A standardized test for assessing the emotional development of preschool children, which consists of three diagnostic scales: 1) Recognizing emotions, 2) Naming emotions and 3) Emotions in social situations.
Baseline
Birth weight
Time Frame: Baseline (retrospective data)
Description: The weight of the newborn at birth, collected retrospectively from medical records or parental report. Data will be reported in grams.
Baseline (retrospective data)
Gestational age at birth
Time Frame: Baseline (retrospective data)
Description: The number of completed weeks of pregnancy at the time of delivery, collected retrospectively. Data will be reported in weeks.
Baseline (retrospective data)
Apgar score
Time Frame: Baseline (retrospective data)
Description: The Apgar score recorded 5 minutes after birth, representing the newborn's physical condition. The score ranges from 0 to 10, where higher scores indicate better health status.
Baseline (retrospective data)
Occurrence of perinatal complications
Time Frame: Baseline (retrospective data)
Description: Number of participants who experienced medical complications during the perinatal period (e.g., hypoxia, infections). Reported as a categorical frequency (Yes/No).
Baseline (retrospective data)
Socio-demographic data
Time Frame: Baseline
Authors survey of socio-demographic data, including: gender, month and year of birth, size of place of residence, region of residence, age of starting preschool, diagnosis (if any), parents education level
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bartosz M. Radtke

Investigators

  • Study Director: Ariadna Łada-Maśko, PhD, Laboratory of Psychological and Educational Tests
  • Principal Investigator: Urszula Sajewicz-Radtke, PhD, Laboratory of Psychological and Educational Tests
  • Principal Investigator: Bartosz M Radtke, PhD, Laboratory of Psychological and Educational Tests

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 11, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 11, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/PTPiP/2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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