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Perinatal and Psychological Correlates of Neurodevelopmental Disorders in Children.

B

Bartosz M. Radtke

Status

Completed

Conditions

Adolescent Development
Child Development
Neurodevelopmental Disorders
Social Functioning
Perinatal Condition

Treatments

Other: Psychological assessment

Study type

Observational

Funder types

Other

Identifiers

NCT06215092
2023/PTPiP/1

Details and patient eligibility

About

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

Enrollment

500 patients

Sex

All

Ages

5 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

500 participants in 6 patient groups

Developmental learning disorder
Description:
Children above 5 years old, with formal diagnosis of Developmental learning disorder.
Treatment:
Other: Psychological assessment
Disorder of intellectual development, mild
Description:
Children above 5 years old, with formal diagnosis of Disorder of intellectual development, mild.
Treatment:
Other: Psychological assessment
Attention deficit hyperactivity disorder
Description:
Children above 5 years old, with formal diagnosis of Attention deficit hyperactivity disorder (ADHD).
Treatment:
Other: Psychological assessment
Autism spectrum disorder
Description:
Children above 5 years old, with formal diagnosis of Autism spectrum disorder (ASD).
Treatment:
Other: Psychological assessment
Learning difficulties
Description:
Children above 5 years old, with difficulties in reading and/or writing without formal diagnosis of Developmental learning disorder.
Treatment:
Other: Psychological assessment
Control group
Description:
Children above 5 years old without formal diagnosis of neurodevelopmental disorders.
Treatment:
Other: Psychological assessment

Trial contacts and locations

1

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Central trial contact

Rafał Nowicki, M.A.

Data sourced from clinicaltrials.gov

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