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Recruiting Observational

Psychological Correlates of Developmental Delays in Preschool Children

NCT07420829 · tracked via the Priya Life Science Poland tracker
Phase
Observational
Started
2025-09-01
Last updated
2026-02-19

Condition(s) studied

Development DelayChild DevelopmentSocial FunctioningSpeech Delay

Investigational drug(s) / intervention(s)

Psychological assessment

Psychological assessment: Psychological assessment of cognitive, linguistic and social-emotional functioning.

Study summary

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

Eligibility

Sex
ALL
Min age
3 Years
Max age
6 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Cognitive Functioning Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6) — 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).
  • Phonological Processing Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6) — 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).
  • Social-Emotional Development Score as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6) — 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).

Trial sites (1)

FacilityCityRegionStatus
Laboratory of Psychological and Educational Tests Gdansk Pomeranian Voivodeship Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07420829 on ClinicalTrials.gov ↗ ← All trials in Poland