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Clinical Trials/NCT07420829
NCT07420829
Recruiting
Not Applicable

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

Bartosz M. Radtke1 site in 1 country500 target enrollmentStarted: September 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Bartosz M. Radtke
Enrollment
500
Locations
1
Primary Endpoint
Cognitive Functioning Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6)

Overview

Brief 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:

  3. children with early intervention

  4. children with delayed speech development

  5. Control group

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
3 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Early intervention

Children between 3 to 6 years old with formal early development support.

Intervention: Psychological assessment (Other)

Delayed speech development

Children between 3 to 6 years old with formal diagnosis of delayed speech development

Intervention: Psychological assessment (Other)

Control group

Children between 3 to 6 years old without formal diagnosis of delayed speech development and without any formal early development support.

Intervention: Psychological assessment (Other)

Outcomes

Primary Outcomes

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).

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).

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).

Secondary Outcomes

  • Occurrence of perinatal complications(Baseline (retrospective data))
  • General intellectual functioning measured by the Stanford-Binet 5 (SB5)(Baseline)
  • Nonverbal Intelligence Quotient (NIQ) as measured by the Primary Test of Nonverbal Intelligence (PTONI)(Baseline)
  • Early social-emotional development(Baseline)
  • Birth weight(Baseline (retrospective data))
  • Gestational age at birth(Baseline (retrospective data))
  • Apgar score(Baseline (retrospective data))
  • Socio-demographic data(Baseline)

Investigators

Sponsor
Bartosz M. Radtke
Sponsor Class
Other Gov
Responsible Party
Sponsor Investigator
Principal Investigator

Bartosz M. Radtke

PhD

Laboratory of Psychological and Educational Tests

Study Sites (1)

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