Clinical trial NCT06215092: Perinatal and Psychological Correlates of Neurodevelopmental Disorders in Children.
Official title: Perinatal, Cognitive and Social-emotional Correlates of Neurodevelopmental Disorders and Learning Difficulties in Children and Adolescents, From a Biopsychosocial Perspective.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Perinatal Condition
Neurodevelopmental Disorders
Social Functioning
Child Development
Adolescent Development
Keywords: hypoxia
dyslexia
mild intellectual disability
ADHD
ASD
Learning difficulties
social-emotional functioning
Lead sponsor: Laboratory of Psychological and Educational Tests
Sponsor class: OTHER_GOV
First posted: 2024-01-22
Enrollment: 500
Sex: ALL
Minimum age (years): 5
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Polish children and adolescents attending to formal education schools in age 5 to 18 years old.

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?

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


Eligibility 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

Primary outcomes:
measure: Perinatal risks factors
timeFrame: Data collected immediately after childbirth.
measure: Memory and learning
timeFrame: Juli 1, 2022 until April 30, 2024
measure: Cognitive abilities
timeFrame: Juli 1, 2022 until April 30, 2024
measure: Social-emotional competence
timeFrame: Juli 1, 2022 until April 30, 2024
measure: Socio-demographic data
timeFrame: Juli 1, 2022 until April 30, 2024
Secondary outcomes:
measure: General intellectual functioning
timeFrame: Juli 1, 2022 until April 30, 2024
measure: Nonverbal intellectual functioning
timeFrame: Juli 1, 2022 until April 30, 2024
measure: Executive functions
timeFrame: Juli 1, 2022 until April 30, 2024
measure: Learning difficulties
timeFrame: Juli 1, 2022 until April 30, 2024
measure: Communication, social interaction, restricted and repetitive behaviors
timeFrame: Juli 1, 2022 until April 30, 2024
measure: Early social-emotional development
timeFrame: Juli 1, 2022 until April 30, 2024
measure: Social-emotional development
timeFrame: Juli 1, 2022 until April 30, 2024
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: Laboratory of Psychological and Educational Tests
state: Pomerania
Study officials:
affiliation: Laboratory of Psychological and Educational Tests
name: Urszula Sajewicz-Radtke, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Laboratory of Psychological and Educational Tests
name: Bartosz M Radtke, Ph.D.
role: STUDY_DIRECTOR
affiliation: Laboratory of Psychological and Educational Tests
name: Ariadna Łada-Maśko, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: