Brief 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?
5.With perinatal risks factors
6.With neurodevelopmental disorders:
7.Developmental learning disorder
8.Disorder of intellectual development, mild
9.Attention deficit hyperactivity disorder
10.Autism spectrum disorder
11.With Learning difficulties
12.Control group

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

500

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.5 years study duration

Study Start

First participant enrolled

July 1, 2022

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2024

Completed

12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2024

Completed

1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 20, 2025

Completed

29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3.4 years

First QC Date

January 10, 2024

Last Update Submit

February 4, 2026

Conditions

Perinatal Condition Neurodevelopmental Disorders Social Functioning Child Development Adolescent Development

Keywords

hypoxiadyslexiamild intellectual disabilityADHDASDLearning difficultiessocial-emotional functioning

Outcome Measures

Primary Outcomes (5)

Perinatal risks factors
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
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
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
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
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 Outcomes (7)

General intellectual functioning
Juli 1, 2022 until April 30, 2024
Nonverbal intellectual functioning
Juli 1, 2022 until April 30, 2024
Executive functions
Juli 1, 2022 until April 30, 2024
Learning difficulties
Juli 1, 2022 until April 30, 2024
Communication, social interaction, restricted and repetitive behaviors
Juli 1, 2022 until April 30, 2024
+2 more secondary outcomes