ClinicalTrials.gg
RecruitingNCT07420829Updated Feb 19, 2026

Psychological Correlates of Developmental Delays in Preschool Children

An observational study in Development Delay, Child Development and Social Functioning, sponsored by Bartosz M. Radtke. Recruiting at 1 site in Poland. Open to participants aged 3 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-19.

Sponsored by Bartosz M. Radtke · Observational

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 2 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
500
Ages
3 Years to 6 Years
Sex
All
01

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
02

Conditions studied

  • Development Delay
  • Child Development
  • Social Functioning
  • Speech Delay

Keywords

  • early intervention
  • development
  • language
03

In context

Learning Disabilities

270 studies on the registry are indexed under Learning Disabilities; 62 are open to participants now.

This study's planned enrollment of 500 is above the median of 150 across 82 observational studies indexed under Learning Disabilities.

Browse Learning Disabilities studies →

Lead sponsor

Bartosz M. Radtke is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 6 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Polish preschool children aged 3 to 6 years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Children aged 3 to 6 years at the time of assessment.
  • Attendance at preschool education.
  • Written 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

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 .
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • OtherPsychological assessment

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline

  2. 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).

    Time frame: Baseline

  3. 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).

    Time frame: Baseline

Secondary outcomes

  1. General intellectual functioning measured by the Stanford-Binet 5 (SB5)

    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).

    Time frame: Baseline

  2. Nonverbal Intelligence Quotient (NIQ) as measured by the Primary Test of Nonverbal Intelligence (PTONI)

    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).

    Time frame: Baseline

  3. Early social-emotional development

    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.

    Time frame: Baseline

  4. Birth weight

    Description: The weight of the newborn at birth, collected retrospectively from medical records or parental report. Data will be reported in grams.

    Time frame: Baseline (retrospective data)

  5. Gestational age at birth

    Description: The number of completed weeks of pregnancy at the time of delivery, collected retrospectively. Data will be reported in weeks.

    Time frame: Baseline (retrospective data)

  6. Apgar score

    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.

    Time frame: Baseline (retrospective data)

  7. Occurrence of perinatal complications

    Description: Number of participants who experienced medical complications during the perinatal period (e.g., hypoxia, infections). Reported as a categorical frequency (Yes/No).

    Time frame: Baseline (retrospective data)

  8. Socio-demographic data

    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

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Laboratory of Psychological and Educational Tests
    Gdansk, Pomeranian Voivodeship 80-239, Poland
    Recruiting
    • Rafał Nowicki, MA · Contactnowicki@pracowniatestow.pl · +48509805591
    • Ariadna Łada-Maśko, PhD · Principal investigator
    • Urszula Sajewicz-Radtke, PhD · Principal investigator
    • Bartosz Radtke, PhD · Principal investigator
    • Łucja Bielenik, PhD · Sub investigator
    • Dorota Kalka, PhD · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2026
First posted
Feb 19, 2026
StartActual
Sep 1, 2025
Primary completionEst.
Sep 2026
CompletionEst.
Jan 2027
Last update
Feb 19, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 19, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07420829
Lead sponsor
Bartosz M. Radtke
Responsible party
Bartosz M. Radtke (PhD, Laboratory of Psychological and Educational Tests) — Sponsor-investigator
First posted
Feb 19, 2026
Start date
Sep 1, 2025
Primary completion
Sep 2026 (estimated)
Completion
Jan 2027 (estimated)
Last update
Feb 19, 2026

Study contacts

Rafał Nowicki, MA
Contact
nowicki@pracowniatestow.pl
+48509805591
Ariadna Łada-Maśko, PhD
study director · Laboratory of Psychological and Educational Tests
Urszula Sajewicz-Radtke, PhD
principal investigator · Laboratory of Psychological and Educational Tests
Bartosz M Radtke, PhD
principal investigator · Laboratory of Psychological and Educational Tests

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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