Development DelayNCT07420829
Psychological Correlates of Developmental Delays in Preschool Children
An observational study of Development Delay and Child Development, run by Bartosz M. Radtke at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Development Delay, Child Development, Social Functioning
- What is being tested?
- Psychological assessment
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 1 Sep 2025to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Polish preschool children aged 3 to 6 years.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Laboratory of Psychological and Educational Tests
Gdansk, Pomeranian Voivodeship, 80-239
Rafał Nowicki, MA, +48509805591, nowicki@pracowniatestow.pl
Ariadna Łada-Maśko, PhD
About this study
Official title: 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.
Read more
The main questions it aims to answer are:
- Is there a relationship between perinatal factors and risk of occurrence of developmental delay disorder?
- Is there a specific pattern of cognitive functioning in preschool children with indicated developmental delay disorder?
- Is there a specific pattern of social-emotional functioning in preschool children with indicated developmental delay disorder?
- 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:
- With perinatal risks factors
- With developmental delay disorder:
- children with early intervention
- children with delayed speech development
- Control group
- Conditions
- Development Delay, Child Development, Social Functioning, Speech Delay
- Being tested
- Psychological assessment
- Keywords
- early intervention, development, language
- Medical subject headings
- Learning Disabilities, Social Adjustment, Language Development Disorders, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological assessmentOther
Psychological assessment of cognitive, linguistic and social-emotional functioning.
| Study group | Role | What they receive |
|---|---|---|
| Early intervention | Children between 3 to 6 years old with formal early development support. Receives: Other: Psychological assessment | |
| Delayed speech development | Children between 3 to 6 years old with formal diagnosis of delayed speech development Receives: 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. Receives: Other: Psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Baseline
Secondary outcomes (8)
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).
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
Birth weight
Description: The weight of the newborn at birth, collected retrospectively from medical records or parental report. Data will be reported in grams.
Measured: Baseline (retrospective data)
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.
Measured: Baseline (retrospective data)
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.
Measured: Baseline (retrospective data)
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).
Measured: Baseline (retrospective data)
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start1 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bartosz M. Radtke
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Bartosz M. Radtke, Laboratory of Psychological and Educational Tests
- Investigators
- Ariadna Łada-Maśko, PhD, Study director, Laboratory of Psychological and Educational TestsUrszula Sajewicz-Radtke, PhD, Principal investigator, Laboratory of Psychological and Educational TestsBartosz M Radtke, PhD, Principal investigator, Laboratory of Psychological and Educational Tests
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07420829
- Sponsor's protocol ID
- 2024/PTPiP/2
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal, Cognitive, Linguistic, and Social-emotional Correlates of Developmental Delay in Polish Preschool Children From a Biopsychosocial Perspective
- ClinicalTrials.gov ID
- NCT07420829
- Acronym / sponsor ID
- 2024/PTPiP/2
- Conditions
- Development Delay, Child Development, Social Functioning, Speech Delay
- Keywords
- early intervention, development, language
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Bartosz M. RadtkeOther government
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 19 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Is there a relationship between perinatal factors and risk of occurrence of developmental delay disorder?
- Is there a specific pattern of cognitive functioning in preschool children with indicated developmental delay disorder?
- Is there a specific pattern of social-emotional functioning in preschool children with indicated developmental delay disorder?
- 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:
- With perinatal risks factors
- With developmental delay disorder:
- children with early intervention
- children with delayed speech development
- Control group
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early intervention | – | Other: Psychological assessmentChildren between 3 to 6 years old with formal early development support. |
| Delayed speech development | – | Other: Psychological assessmentChildren between 3 to 6 years old with formal diagnosis of delayed speech development |
| Control group | – | Other: Psychological assessmentChildren between 3 to 6 years old without formal diagnosis of delayed speech development and without any formal early development support. |
Who may qualify
- Ages
- 3 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Polish preschool children aged 3 to 6 years.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological assessmentPsychological assessment of cognitive, linguistic and social-emotional functioning. | Other | Control group, Delayed speech development, Early intervention |
Primary outcome
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).
8 secondary outcomes
General intellectual functioning measured by the Stanford-Binet 5 (SB5)
Time frame: Baseline
Nonverbal Intelligence Quotient (NIQ) as measured by the Primary Test of Nonverbal Intelligence (PTONI)
Time frame: Baseline
Early social-emotional development
Time frame: Baseline
Birth weight
Time frame: Baseline (retrospective data)
Gestational age at birth
Time frame: Baseline (retrospective data)
Apgar score
Time frame: Baseline (retrospective data)
Occurrence of perinatal complications
Time frame: Baseline (retrospective data)
Socio-demographic data
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development Delay and Child Development, run by Bartosz M. Radtke at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rafał Nowicki, MA (+48509805591, nowicki@pracowniatestow.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.