Perinatal and Psychological Correlates of Neurodevelopmental Disorders in Children.

NCT ID: NCT06215092

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2024-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Perinatal Condition Neurodevelopmental Disorders Social Functioning Child Development Adolescent Development

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Developmental learning disorder

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

Psychological assessment

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

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

Intervention Type OTHER

Psychological assessment of cognitive and social-emotional functioning.

Control group

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

Psychological assessment

Intervention Type OTHER

Psychological assessment of cognitive and social-emotional functioning.

Interventions

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Psychological assessment

Psychological assessment of cognitive and social-emotional functioning.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

\- diagnosis of Developmental learning disorder


* age below 5 y.o. and equal to or above 19 y.o.
* diagnosis of any neurodevelopmental disorders
Minimum Eligible Age

5 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bartosz M. Radtke

OTHER_GOV

Sponsor Role lead

Responsible Party

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Bartosz M. Radtke

PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Urszula Sajewicz-Radtke, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Psychological and Educational Tests

Bartosz M Radtke, Ph.D.

Role: STUDY_DIRECTOR

Laboratory of Psychological and Educational Tests

Ariadna Łada-Maśko, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Laboratory of Psychological and Educational Tests

Locations

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Laboratory of Psychological and Educational Tests

Gdansk, Pomeranian Voivodeship, Poland

Site Status RECRUITING

Countries

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Poland

Central Contacts

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Rafał Nowicki, M.A.

Role: CONTACT

+48509805591

Facility Contacts

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Rafał Nowicki, M.A.

Role: primary

+48509805591

References

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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 Sep 3. doi: 10.1111/jir.70039. Online ahead of print.

Reference Type DERIVED
PMID: 40903989 (View on PubMed)

Other Identifiers

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2023/PTPiP/1

Identifier Type: -

Identifier Source: org_study_id

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