Perinatal and Psychological Correlates of Neurodevelopmental Disorders in Children.

Child Development Clinical Trial

Official title:

Perinatal, Cognitive and Social-emotional Correlates of Neurodevelopmental Disorders and Learning Difficulties in Children and Adolescents, From a Biopsychosocial Perspective.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215092
• Other study ID #: 2023/PTPiP/1
• Status: Recruiting
• Start date: July 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Laboratory of Psychological and Educational Tests
• Contact: Rafal Nowicki, M.A.
• Phone: +48509805591
• Email: nowicki[@]pracowniatestow.pl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Development
• Child Development
• Neurodevelopmental Disorders
• Social Functioning

Intervention

Other:
• Psychological assessment
Psychological assessment of cognitive and social-emotional functioning.

Locations

Country	Name	City	State
Poland	Laboratory of Psychological and Educational Tests	Gdansk	Pomerania

Sponsors (1)

Lead Sponsor	Collaborator
Bartosz M. Radtke

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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
Primary	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
Primary	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
Primary	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	General intellectual functioning	Stanford-Binet Intelligence Scales-Fifth Edition (SB5). A standardized test which assessment two main intellectual domain (Nonverbal and Verbal). Each domain consist of five scales (Fluid Reasoning, Knowledge, Quantitative Reasoning, Visual-Spatial Processing, and Working Memory). This test is based on the Cattel-Horn-Carroll Intelligence Theory (CHC).	Juli 1, 2022 until April 30, 2024
Secondary	Nonverbal intellectual functioning	Test of Nonverbal Intelligence-Fourth Edition (TONI-4). A norm-referenced instrument that measures a General Intelligence. The TONI-4 has two equivalent forms: Form A and Form B. Each form consists of 60 items, all of which are abstract/figural.	Juli 1, 2022 until April 30, 2024
Secondary	Executive functions	Nonverbal Stroop Card Sorting Test (NSCST). A standardized, nonverbal Stroop test for cognitive-process, executive functioning and neuropsychological assessment. Test contain two groups of cards, which examinee have to sort cards according to presented visual stimulus. Additionally, the test includes an observational scale that allows to assessed the following processes: attention, impulse control, level of activity, anxiety and reactivity.	Juli 1, 2022 until April 30, 2024
Secondary	Learning difficulties	The Battery for Assessment of the Causes of Learning Difficulties. A set of tests to assess the occurrence of developmental learning disorders of reading and writing in school-age children. The battery consists of tests diagnosing: visual-spatial Functions (visual-spatial perception and speed of visual perception when working with visual material, eye-hand coordination, structuring of perception, attention and visual-motor control when working with complex material and short-term visual memory capacity), auditory-linguistic functions (phoneme hearing, phonological memory, ability to perform sound-phoneme analysis, sound abstraction and synthesizing sounds, attention and phonological memory), perceptual-motor integration, reading and writing skills.	Juli 1, 2022 until April 30, 2024
Secondary	Communication, social interaction, restricted and repetitive behaviors	The Autism Diagnostic Observation Schedule, Second Edition (ADOS-2). A tool consisting of a set of tests and standardized components that allow to observe the person being examined during a naturally occurring interaction with a diagnostician. It consists of five Modules intended for respondents of different ages and levels of development of linguistic expression. ADOS-2 allows to assess various aspects of behavior, representing five categories: Language and communication, Social interactions, Play/Imagination, Stereotypical behavior and Rigid interests, Other behaviors that differ from the norm. The obtained data are analyzed on two scales: Social Affect and Restricted and Repetitive Behavior, as well as a total score allowing to assess the occurrence and level of severity of Autism spectrum disorder.	Juli 1, 2022 until April 30, 2024
Secondary	Early social-emotional development	The Emotional Development Scale for Children Aged 3-6. A standardized test for assessing the emotional development of preschool children, which consists of three diagnostic scales: 1) Recognizing emotions, 2) Naming emotions and 3) Emotions in social situations.	Juli 1, 2022 until April 30, 2024
Secondary	Social-emotional development	A part of Intelligence and Development Scales - 2nd edition (IDS-2), assessing social-emotional skills in a school-aged children. A standardized test consisting of three diagnostic scales: 1) Recognizing Emotions, 2) Regulating Emotions, 3) Social Strategies.	Juli 1, 2022 until April 30, 2024