Perinatal and Psychological Correlates of Neurodevelopmental Disorders in Children.

February 4, 2026 updated by: Bartosz M. Radtke

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.

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

Study Overview

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Developmental learning disorder
Children above 5 years old, with formal diagnosis of Developmental learning disorder.
Psychological assessment of cognitive and social-emotional functioning.
Disorder of intellectual development, mild
Children above 5 years old, with formal diagnosis of Disorder of intellectual development, mild.
Psychological assessment of cognitive and social-emotional functioning.
Attention deficit hyperactivity disorder
Children above 5 years old, with formal diagnosis of Attention deficit hyperactivity disorder (ADHD).
Psychological assessment of cognitive and social-emotional functioning.
Autism spectrum disorder
Children above 5 years old, with formal diagnosis of Autism spectrum disorder (ASD).
Psychological assessment of cognitive and social-emotional functioning.
Learning difficulties
Children above 5 years old, with difficulties in reading and/or writing without formal diagnosis of Developmental learning disorder.
Psychological assessment of cognitive and social-emotional functioning.
Control group
Children above 5 years old without formal diagnosis of neurodevelopmental disorders.
Psychological assessment of cognitive and social-emotional functioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data collected immediately after childbirth.
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).
Juli 1, 2022 until April 30, 2024
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).
Juli 1, 2022 until April 30, 2024
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.
Juli 1, 2022 until April 30, 2024
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
Juli 1, 2022 until April 30, 2024

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General intellectual functioning
Time Frame: Juli 1, 2022 until April 30, 2024
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).
Juli 1, 2022 until April 30, 2024
Nonverbal intellectual functioning
Time Frame: Juli 1, 2022 until April 30, 2024
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.
Juli 1, 2022 until April 30, 2024
Executive functions
Time Frame: Juli 1, 2022 until April 30, 2024
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.
Juli 1, 2022 until April 30, 2024
Learning difficulties
Time Frame: Juli 1, 2022 until April 30, 2024
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.
Juli 1, 2022 until April 30, 2024
Communication, social interaction, restricted and repetitive behaviors
Time Frame: Juli 1, 2022 until April 30, 2024
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.
Juli 1, 2022 until April 30, 2024
Early social-emotional development
Time Frame: Juli 1, 2022 until April 30, 2024
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.
Juli 1, 2022 until April 30, 2024
Social-emotional development
Time Frame: Juli 1, 2022 until April 30, 2024
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.
Juli 1, 2022 until April 30, 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Urszula Sajewicz-Radtke, Ph.D., Laboratory of Psychological and Educational Tests
  • Study Director: Bartosz M Radtke, Ph.D., Laboratory of Psychological and Educational Tests
  • Principal Investigator: Ariadna Łada-Maśko, Ph.D., Laboratory of Psychological and Educational Tests

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

November 20, 2025

Study Completion (Actual)

December 19, 2025

Study Registration Dates

First Submitted

January 10, 2024

First Submitted That Met QC Criteria

January 10, 2024

First Posted (Actual)

January 22, 2024

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

February 4, 2026

Last Verified

February 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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