CompletedNot Applicable

Perinatal and Psychological Correlates of Neurodevelopmental Disorders in Children.

Poland500 participantsStarted 2022-07-01

Plain-language 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

Who can participate

Age range

5 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Perinatal risks factors

Timeframe: Data collected immediately after childbirth.

Memory and learning

Timeframe: Juli 1, 2022 until April 30, 2024

Cognitive abilities

Timeframe: Juli 1, 2022 until April 30, 2024

Social-emotional competence

Timeframe: Juli 1, 2022 until April 30, 2024

Socio-demographic data

Timeframe: Juli 1, 2022 until April 30, 2024

Trial details

NCT IDNCT06215092

SponsorBartosz M. Radtke

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2025-11-20

View on ClinicalTrials.gov More Perinatal Condition trials

Plain-language summary

Who can participate

Age range

5 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Perinatal risks factors

Timeframe: Data collected immediately after childbirth.

Memory and learning

Timeframe: Juli 1, 2022 until April 30, 2024

Cognitive abilities

Timeframe: Juli 1, 2022 until April 30, 2024

Social-emotional competence

Timeframe: Juli 1, 2022 until April 30, 2024

Socio-demographic data

Timeframe: Juli 1, 2022 until April 30, 2024