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CompletedNCT06215092Updated Feb 6, 2026

Perinatal and Psychological Correlates of Neurodevelopmental Disorders in Children.

An observational study in Perinatal Condition, Neurodevelopmental Disorders and Social Functioning, sponsored by Bartosz M. Radtke. Completed at 1 site in Poland. Open to participants aged 5 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-06.

Sponsored by Bartosz M. Radtke · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
500
Ages
5 Years to 18 Years
Sex
All
01

Study 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. 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:

  1. Is there a relationship between perinatal factors and the risk of occurrence of neurodevelopmental disorders and/or learning difficulties?
  2. Is there a specific pattern of cognitive functioning in children and adolescents with indicated neurodevelopmental disorders and/or learning difficulties?
  3. Is there a specific pattern of social-emotional functioning in children and adolescents with indicated neurodevelopmental disorders and/or learning difficulties?
  4. 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:

  1. With perinatal risks factors
  2. With neurodevelopmental disorders:

    1. Developmental learning disorder
    2. Disorder of intellectual development, mild
    3. Attention deficit hyperactivity disorder
    4. Autism spectrum disorder
  3. With Learning difficulties
  4. Control group
02

Conditions studied

  • Perinatal Condition
  • Neurodevelopmental Disorders
  • Social Functioning
  • Child Development
  • Adolescent Development

Keywords

  • hypoxia
  • dyslexia
  • mild intellectual disability
  • ADHD
  • ASD
  • Learning difficulties
  • social-emotional functioning
03

In context

Neurodevelopmental Disorders

352 studies on the registry are indexed under Neurodevelopmental Disorders; 141 are open to participants now.

This study's enrollment of 500 is above the median of 200 across 133 observational studies indexed under Neurodevelopmental Disorders.

Browse Neurodevelopmental Disorders 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
5 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Polish children and adolescents attending to formal education schools in age 5 to 18 years old.

Eligibility criteria

Inclusion criteria for neurodevelopmental disorder groups:

  • 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

Inclusion criteria for learning difficulties:

  • age between 5 to 18 y.o.
  • difficulty in reading and/or writing without a diagnosis of Developmental learning disorder

Inclusion criteria for control group

  • age between 5 to 18 y.o.
  • without a diagnosis of any neurodevelopmental disorder

Exclusion criteria for learning difficulties

- diagnosis of Developmental learning disorder

Exclusion criteria for all groups:

  • age below 5 y.o. and equal to or above 19 y.o.
  • diagnosis of any neurodevelopmental disorders
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
500 participants (actual)
Patient registry
No

Groups and cohorts

  • Developmental learning disorder

    Children above 5 years old, with formal diagnosis of Developmental learning disorder.

    Other: Psychological assessment

  • Disorder of intellectual development, mild

    Children above 5 years old, with formal diagnosis of Disorder of intellectual development, mild.

    Other: Psychological assessment

  • Attention deficit hyperactivity disorder

    Children above 5 years old, with formal diagnosis of Attention deficit hyperactivity disorder (ADHD).

    Other: Psychological assessment

  • Autism spectrum disorder

    Children above 5 years old, with formal diagnosis of Autism spectrum disorder (ASD).

    Other: Psychological assessment

  • Learning difficulties

    Children above 5 years old, with difficulties in reading and/or writing without formal diagnosis of Developmental learning disorder.

    Other: Psychological assessment

  • Control group

    Children above 5 years old without formal diagnosis of neurodevelopmental disorders.

    Other: Psychological assessment

Interventions

  • OtherPsychological assessment

    Psychological assessment of cognitive and social-emotional functioning.

06

What researchers measure

Primary outcomes

  1. Perinatal risks factors

    Data from medical documentations including: birth weight, body length, head and chest circumference, Apgar score, interventions supporting breathing and blood circulation.

    Time frame: Data collected immediately after childbirth.

  2. 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).

    Time frame: Juli 1, 2022 until April 30, 2024

  3. 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).

    Time frame: Juli 1, 2022 until April 30, 2024

  4. 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.

    Time frame: Juli 1, 2022 until April 30, 2024

  5. 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

    Time frame: Juli 1, 2022 until April 30, 2024

Secondary outcomes

  1. 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).

    Time frame: Juli 1, 2022 until April 30, 2024

  2. 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.

    Time frame: Juli 1, 2022 until April 30, 2024

  3. 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.

    Time frame: Juli 1, 2022 until April 30, 2024

  4. 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.

    Time frame: Juli 1, 2022 until April 30, 2024

  5. 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.

    Time frame: Juli 1, 2022 until April 30, 2024

  6. 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: Juli 1, 2022 until April 30, 2024

  7. 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.

    Time frame: Juli 1, 2022 until April 30, 2024

07

Study locations

1 site
  • Laboratory of Psychological and Educational Tests
    Gdansk, Pomeranian Voivodeship 80-239, Poland
08

References and documents

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 42290996 ↗
  • Sajewicz-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 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06215092
Lead sponsor
Bartosz M. Radtke
Responsible party
Bartosz M. Radtke (PhD, Laboratory of Psychological and Educational Tests) — Sponsor-investigator
First posted
Jan 22, 2024
Start date
Jul 1, 2022
Primary completion
Nov 20, 2025
Completion
Dec 19, 2025
Last update
Feb 6, 2026

Study contacts

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

Oversight

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

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