Psychological Correlates of Developmental Delays in Preschool Children

NCT07420829 | Recruiting

• 1 other identifier: 2024/PTPiP/2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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. 1.Is there a relationship between perinatal factors and risk of occurrence of developmental delay disorder?
2. 2.Is there a specific pattern of cognitive functioning in preschool children with indicated developmental delay disorder?
3. 3.Is there a specific pattern of social-emotional functioning in preschool children with indicated developmental delay disorder?
4. 4.Do gender and age moderates specific patterns of cognitive and socialemotional functioning in the studied groups?
5. 5.With perinatal risks factors
6. 6.With developmental delay disorder:
7. 7.children with early intervention
8. 8.children with delayed speech development
9. 9.Control group

Conditions

Development Delay; Child Development; Social Functioning; Speech Delay

Keywords

early intervention; development; language

Outcome Measures

Primary Outcomes (3)

• Cognitive Functioning Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6)

  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)

  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)

  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 Outcomes (8)

• 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)

Study Arms (3)

Early intervention

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

Other: Psychological assessment

Delayed speech development

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

Other: Psychological assessment

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

Interventions

Psychological assessment OTHER

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

Control group; Delayed speech development; Early intervention

Eligibility Criteria

• Age: 3 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Polish preschool children aged 3 to 6 years.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bartosz M. Radtke: lead

Study Sites (1)

Laboratory of Psychological and Educational Tests

Gdansk, Pomeranian Voivodeship, 80-239, Poland

RECRUITING

MeSH Terms

Conditions

Learning Disabilities; Social Adjustment; Language Development Disorders; Language

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior; Language Disorders; Communication

Study Officials

• Ariadna Łada-Maśko, PhD

  Laboratory of Psychological and Educational Tests

  STUDY DIRECTOR

• Urszula Sajewicz-Radtke, PhD

  Laboratory of Psychological and Educational Tests

  PRINCIPAL INVESTIGATOR

• Bartosz M Radtke, PhD

  Laboratory of Psychological and Educational Tests

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rafał Nowicki, MA

CONTACT

+48509805591; nowicki@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 4, 2026
• First Posted: February 19, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: February 19, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)