Perinatal ConditionNCT06215092
Perinatal and Psychological Correlates of Neurodevelopmental Disorders in Children.
An observational study of Perinatal Condition and Neurodevelopmental Disorders, run by Bartosz M. Radtke at 1 site in Poland.
Trial summary
The goal of this observational study is to investigate perinatal, cognitive and social-emotional correlates of neurodevelopmental disorders and educational difficulties in children and adolescents. The study group consist of minimal 500 childrens over 5 years of age who will be examined by qualified diagnosticians. Read more about this study
- Who is it for?
- Ages 5 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Perinatal Condition, Neurodevelopmental Disorders, Social Functioning
- What is being tested?
- Psychological assessment
- How many people
- 500 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jul 2022to 19 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 5 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Polish children and adolescents attending to formal education schools in age 5 to 18 years old.
Who may be able to join
- age between 5 to 18 y.o.
- diagnosed neurodevelopmental disorders, depending on the study group: 1) Developmental learning disorder; 2) Disorder of intellectual development, mild; 3) Attention deficit hyperactivity disorder; 4) Autism spectrum disorder
- age between 5 to 18 y.o.
- difficulty in reading and/or writing without a diagnosis of Developmental learning disorder
- age between 5 to 18 y.o.
- without a diagnosis of any neurodevelopmental disorder
Who cannot join
- diagnosis of Developmental learning disorder
- age below 5 y.o. and equal to or above 19 y.o.
- diagnosis of any neurodevelopmental disorders
Trial locations and contacts
1 site in 1 country.
Poland1 site
Laboratory of Psychological and Educational Tests
Gdansk, Pomeranian Voivodeship, 80-239
About this study
Official title: Perinatal, Cognitive and Social-emotional Correlates of Neurodevelopmental Disorders and Learning Difficulties in Children and Adolescents, From a Biopsychosocial Perspective.
The goal of this observational study is to investigate perinatal, cognitive and social-emotional correlates of neurodevelopmental disorders and educational difficulties in children and adolescents.
The study group consist of minimal 500 childrens over 5 years of age who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: cognitive functioning, social-emotional functioning. Furthermore informations regarding social-emotional functioning of children, will be collected from parents and teachers.
Read more
The main questions it aims to answer are:
- Is there a relationship between perinatal factors and the risk of occurrence of neurodevelopmental disorders and/or learning difficulties?
- Is there a specific pattern of cognitive functioning in children and adolescents with indicated neurodevelopmental disorders and/or learning difficulties?
- Is there a specific pattern of social-emotional functioning in children and adolescents with indicated neurodevelopmental disorders and/or learning difficulties?
- Do gender and age moderates specific patterns of cognitive and social-emotional functioning in the studied groups?
Researchers will compare the following groups of children over 5 years old:
- With perinatal risks factors
- With neurodevelopmental disorders:
- Developmental learning disorder
- Disorder of intellectual development, mild
- Attention deficit hyperactivity disorder
- Autism spectrum disorder
- With Learning difficulties
- Control group
- Conditions
- Perinatal Condition, Neurodevelopmental Disorders, Social Functioning, Child Development, Adolescent Development
- Being tested
- Psychological assessment
- Keywords
- hypoxia, dyslexia, mild intellectual disability, ADHD, ASD, Learning difficulties, social-emotional functioning
- Medical subject headings
- Neurodevelopmental Disorders, Social Adjustment, Hypoxia, Dyslexia, Attention Deficit Disorder with Hyperactivity
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 and social-emotional functioning.
| Study group | Role | What they receive |
|---|---|---|
| Developmental learning disorder | Children above 5 years old, with formal diagnosis of Developmental learning disorder. Receives: Other: Psychological assessment | |
| Disorder of intellectual development, mild | Children above 5 years old, with formal diagnosis of Disorder of intellectual development, mild. Receives: Other: Psychological assessment | |
| Attention deficit hyperactivity disorder | Children above 5 years old, with formal diagnosis of Attention deficit hyperactivity disorder (ADHD). Receives: Other: Psychological assessment | |
| Autism spectrum disorder | Children above 5 years old, with formal diagnosis of Autism spectrum disorder (ASD). Receives: Other: Psychological assessment | |
| Learning difficulties | Children above 5 years old, with difficulties in reading and/or writing without formal diagnosis of Developmental learning disorder. Receives: Other: Psychological assessment | |
| Control group | Children above 5 years old without formal diagnosis of neurodevelopmental disorders. Receives: Other: Psychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perinatal risks factors
Data from medical documentations including: birth weight, body length, head and chest circumference, Apgar score, interventions supporting breathing and blood circulation.
Measured: Data collected immediately after childbirth.
Memory and learning
Test of Memory and Learning (second edition). A standardized test measuring memory functioning and learning abilities in children and adolescents. The test includes four basic factors (Verbal Memory, Nonverbal Memory, Complex Memory, and Delayed Recall) and five supplementary factors (Attention/Concentration, Sequential Memory, Free Recall, Associative Recall and Learning).
Measured: Juli 1, 2022 until April 30, 2024
Cognitive abilities
Specialized Learning Disabilities Battery. A standardized test allowing the assessment of cognitive processes important in learning and selected school skills in children and adolescents. The test consists of six scales and fifteen subscales: 1) Visuospatial Processing (Analysis and Synthesis, Rotation Rate, Visual Memory); 2) Auditory-Linguistic Processing (Phonetic Coding - Linguistic Aspect, Phonetic Coding - Cognitive Complexity, Resistance to Distractors); 3) Reading and Writing (Decoding, Comprehension, Writing, Spelling); 4) Long-term Memory (Associative Memory, Memory of Meanings); 5) Knowledge (General Knowledge, Lexical Knowledge); 6) Processing Rate (Speed of Perception).
Measured: Juli 1, 2022 until April 30, 2024
Social-emotional competence
The Social-Emotional Evaluation (SEE). A standardized test designed to evaluate aspects of emotional and social awareness, wich are part of the social-emotional competence. The SEE contains four core subtests, one supplemental subtest, and a Social Emotional Questionnaire: 1) Identifying Common Emotions; 2) Identifying Emotional Reactions; 3) Understanding Social Gaffes; 4) Understanding Conflicting Messages; Supplemental Subtest: Recognizing Facial Expressions; The Social Emotional Questionnaire assesses general social-emotional intelligence, based on both a parent/caregiver and an educator/specialist responds.
Measured: Juli 1, 2022 until April 30, 2024
Socio-demographic data
Authors survey of socio-demographic data, including: gender, month and year of birth, size of place of residence, region of residence, school, class, age of starting education, average grade from the last semester, diagnosis (if any), parents education level
Measured: Juli 1, 2022 until April 30, 2024
Secondary outcomes (7)
General intellectual functioning
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: Juli 1, 2022 until April 30, 2024
Nonverbal intellectual functioning
Test of Nonverbal Intelligence-Fourth Edition (TONI-4). A norm-referenced instrument that measures a General Intelligence. The TONI-4 has two equivalent forms: Form A and Form B. Each form consists of 60 items, all of which are abstract/figural.
Measured: Juli 1, 2022 until April 30, 2024
Executive functions
Nonverbal Stroop Card Sorting Test (NSCST). A standardized, nonverbal Stroop test for cognitive-process, executive functioning and neuropsychological assessment. Test contain two groups of cards, which examinee have to sort cards according to presented visual stimulus. Additionally, the test includes an observational scale that allows to assessed the following processes: attention, impulse control, level of activity, anxiety and reactivity.
Measured: Juli 1, 2022 until April 30, 2024
Learning difficulties
The Battery for Assessment of the Causes of Learning Difficulties. A set of tests to assess the occurrence of developmental learning disorders of reading and writing in school-age children. The battery consists of tests diagnosing: visual-spatial Functions (visual-spatial perception and speed of visual perception when working with visual material, eye-hand coordination, structuring of perception, attention and visual-motor control when working with complex material and short-term visual memory capacity), auditory-linguistic functions (phoneme hearing, phonological memory, ability to perform sound-phoneme analysis, sound abstraction and synthesizing sounds, attention and phonological memory), perceptual-motor integration, reading and writing skills.
Measured: Juli 1, 2022 until April 30, 2024
Communication, social interaction, restricted and repetitive behaviors
The Autism Diagnostic Observation Schedule, Second Edition (ADOS-2). A tool consisting of a set of tests and standardized components that allow to observe the person being examined during a naturally occurring interaction with a diagnostician. It consists of five Modules intended for respondents of different ages and levels of development of linguistic expression. ADOS-2 allows to assess various aspects of behavior, representing five categories: Language and communication, Social interactions, Play/Imagination, Stereotypical behavior and Rigid interests, Other behaviors that differ from the norm. The obtained data are analyzed on two scales: Social Affect and Restricted and Repetitive Behavior, as well as a total score allowing to assess the occurrence and level of severity of Autism spectrum disorder.
Measured: Juli 1, 2022 until April 30, 2024
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: Juli 1, 2022 until April 30, 2024
Social-emotional development
A part of Intelligence and Development Scales - 2nd edition (IDS-2), assessing social-emotional skills in a school-aged children. A standardized test consisting of three diagnostic scales: 1) Recognizing Emotions, 2) Regulating Emotions, 3) Social Strategies.
Measured: Juli 1, 2022 until April 30, 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start1 Jul 2022
- Primary completion20 Nov 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perinatal ConditionStudies 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
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
- Urszula Sajewicz-Radtke, Ph.D., Principal investigator, Laboratory of Psychological and Educational TestsBartosz M Radtke, Ph.D., Study director, Laboratory of Psychological and Educational TestsAriadna Łada-Maśko, Ph.D., Principal investigator, Laboratory of Psychological and Educational Tests
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06215092
- Sponsor's protocol ID
- 2023/PTPiP/1
- Status last verified
- Feb 2026
- First submitted
- 10 Jan 2024
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Radtke BM, Jurek P, Olech M, Lada-Masko A, Sajewicz-Radtke U. Identifying dyslexia-consistent reading profiles in mild intellectual disability: cluster-derived severity gradients and severity-calibrated classification rules. Front Psychiatry. 2026 May 29;17:1805069. doi: 10.3389/fpsyt.2026.1805069. eCollection 2026.
PubMed 42290996Sajewicz-Radtke U, Radtke BM, Jurek P, Olech M, Lada-Masko A. Beyond Uniform Impairment: Investigating Declarative Memory Profiles in Nonspecific Mild Intellectual Disability Using Latent Profile Analysis. J Intellect Disabil Res. 2025 Dec;69(12):1425-1434. doi: 10.1111/jir.70039. Epub 2025 Sep 3.
PubMed 40903989
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perinatal, Cognitive and Social-emotional Correlates of Neurodevelopmental Disorders and Learning Difficulties in Children and Adolescents, From a Biopsychosocial Perspective.
- ClinicalTrials.gov ID
- NCT06215092
- Acronym / sponsor ID
- 2023/PTPiP/1
- Conditions
- Perinatal Condition, Neurodevelopmental Disorders, Social Functioning, Child Development, Adolescent Development
- Keywords
- hypoxia, dyslexia, mild intellectual disability, ADHD, ASD, Learning difficulties, social-emotional functioning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Bartosz M. RadtkeOther government
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 22 Jan 2024 (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 and social-emotional correlates of neurodevelopmental disorders and educational difficulties in children and adolescents.
The study group consist of minimal 500 childrens over 5 years of age who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: cognitive functioning, social-emotional functioning. Furthermore informations regarding social-emotional functioning of children, will be collected from parents and teachers.
The main questions it aims to answer are:
- Is there a relationship between perinatal factors and the risk of occurrence of neurodevelopmental disorders and/or learning difficulties?
- Is there a specific pattern of cognitive functioning in children and adolescents with indicated neurodevelopmental disorders and/or learning difficulties?
- Is there a specific pattern of social-emotional functioning in children and adolescents with indicated neurodevelopmental disorders and/or learning difficulties?
- Do gender and age moderates specific patterns of cognitive and social-emotional functioning in the studied groups?
Researchers will compare the following groups of children over 5 years old:
- With perinatal risks factors
- With neurodevelopmental disorders:
- Developmental learning disorder
- Disorder of intellectual development, mild
- Attention deficit hyperactivity disorder
- Autism spectrum disorder
- With Learning difficulties
- Control group
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Developmental learning disorder | – | Other: Psychological assessmentChildren above 5 years old, with formal diagnosis of Developmental learning disorder. |
| Disorder of intellectual development, mild | – | Other: Psychological assessmentChildren above 5 years old, with formal diagnosis of Disorder of intellectual development, mild. |
| Attention deficit hyperactivity disorder | – | Other: Psychological assessmentChildren above 5 years old, with formal diagnosis of Attention deficit hyperactivity disorder (ADHD). |
| Autism spectrum disorder | – | Other: Psychological assessmentChildren above 5 years old, with formal diagnosis of Autism spectrum disorder (ASD). |
| Learning difficulties | – | Other: Psychological assessmentChildren above 5 years old, with difficulties in reading and/or writing without formal diagnosis of Developmental learning disorder. |
| Control group | – | Other: Psychological assessmentChildren above 5 years old without formal diagnosis of neurodevelopmental disorders. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Polish children and adolescents attending to formal education schools in age 5 to 18 years old.
Key inclusion criteria (6 listed)
- age between 5 to 18 y.o.
- diagnosed neurodevelopmental disorders, depending on the study group: 1) Developmental learning disorder; 2) Disorder of intellectual development, mild; 3) Attention deficit hyperactivity disorder; 4) Autism spectrum disorder
- age between 5 to 18 y.o.
- difficulty in reading and/or writing without a diagnosis of Developmental learning disorder
- age between 5 to 18 y.o.
Key exclusion criteria (3 listed)
- diagnosis of Developmental learning disorder
- age below 5 y.o. and equal to or above 19 y.o.
- diagnosis of any neurodevelopmental disorders
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 and social-emotional functioning. | Other | Attention deficit hyperactivity disorder, Autism spectrum disorder, Control group, Developmental learning disorder, Disorder of intellectual development, mild, Learning difficulties |
Primary outcome
Perinatal risks factors
Time frame: Data collected immediately after childbirth.
Data from medical documentations including: birth weight, body length, head and chest circumference, Apgar score, interventions supporting breathing and blood circulation.
Memory and learning
Time frame: Juli 1, 2022 until April 30, 2024
Test of Memory and Learning (second edition). A standardized test measuring memory functioning and learning abilities in children and adolescents. The test includes four basic factors (Verbal Memory, Nonverbal Memory, Complex Memory, and Delayed Recall) and five supplementary factors (Attention/Concentration, Sequential Memory, Free Recall, Associative Recall and Learning).
Cognitive abilities
Time frame: Juli 1, 2022 until April 30, 2024
Specialized Learning Disabilities Battery. A standardized test allowing the assessment of cognitive processes important in learning and selected school skills in children and adolescents. The test consists of six scales and fifteen subscales: 1) Visuospatial Processing (Analysis and Synthesis, Rotation Rate, Visual Memory); 2) Auditory-Linguistic Processing (Phonetic Coding - Linguistic Aspect, Phonetic Coding - Cognitive Complexity, Resistance to Distractors); 3) Reading and Writing (Decoding, Comprehension, Writing, Spelling); 4) Long-term Memory (Associative Memory, Memory of Meanings); 5) Knowledge (General Knowledge, Lexical Knowledge); 6) Processing Rate (Speed of Perception).
Social-emotional competence
Time frame: Juli 1, 2022 until April 30, 2024
The Social-Emotional Evaluation (SEE). A standardized test designed to evaluate aspects of emotional and social awareness, wich are part of the social-emotional competence. The SEE contains four core subtests, one supplemental subtest, and a Social Emotional Questionnaire: 1) Identifying Common Emotions; 2) Identifying Emotional Reactions; 3) Understanding Social Gaffes; 4) Understanding Conflicting Messages; Supplemental Subtest: Recognizing Facial Expressions; The Social Emotional Questionnaire assesses general social-emotional intelligence, based on both a parent/caregiver and an educator/specialist responds.
Socio-demographic data
Time frame: Juli 1, 2022 until April 30, 2024
Authors survey of socio-demographic data, including: gender, month and year of birth, size of place of residence, region of residence, school, class, age of starting education, average grade from the last semester, diagnosis (if any), parents education level
7 secondary outcomes
General intellectual functioning
Time frame: Juli 1, 2022 until April 30, 2024
Nonverbal intellectual functioning
Time frame: Juli 1, 2022 until April 30, 2024
Executive functions
Time frame: Juli 1, 2022 until April 30, 2024
Learning difficulties
Time frame: Juli 1, 2022 until April 30, 2024
Communication, social interaction, restricted and repetitive behaviors
Time frame: Juli 1, 2022 until April 30, 2024
Early social-emotional development
Time frame: Juli 1, 2022 until April 30, 2024
Social-emotional development
Time frame: Juli 1, 2022 until April 30, 2024
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Derived from this study: PubMed 42290996Radtke BM, Jurek P, Olech M, Lada-Masko A, Sajewicz-Radtke U. Identifying dyslexia-consistent reading profiles in mild intellectual disability: cluster-derived severity gradients and severity-calibrated classification rules. Front Psychiatry. 2026 May 29;17:1805069. doi: 10.3389/fpsyt.2026.1805069. eCollection 2026.
- Derived from this study: PubMed 40903989Sajewicz-Radtke U, Radtke BM, Jurek P, Olech M, Lada-Masko A. Beyond Uniform Impairment: Investigating Declarative Memory Profiles in Nonspecific Mild Intellectual Disability Using Latent Profile Analysis. J Intellect Disabil Res. 2025 Dec;69(12):1425-1434. doi: 10.1111/jir.70039. Epub 2025 Sep 3.
- 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. This study is not recruiting at the moment.
Urszula Sajewicz-Radtke, Ph.D. principal investigator
Laboratory of Psychological and Educational Tests
Bartosz M Radtke, Ph.D. study director
Laboratory of Psychological and Educational Tests
Ariadna Łada-Maśko, Ph.D. 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 Perinatal Condition and Neurodevelopmental Disorders, 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 6 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perinatal risks factors (time frame: Data collected immediately after childbirth.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06215092, which also lists 2 linked publications.
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 6 Feb 2026.