- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06215092
Perinatal and Psychological Correlates of Neurodevelopmental Disorders in Children.
Perinatal, Cognitive and Social-emotional Correlates of Neurodevelopmental Disorders and Learning Difficulties in Children and Adolescents, From a Biopsychosocial Perspective.
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:
- Is there a relationship between perinatal factors and the risk of occurrence of neurodevelopmental disorders and/or learning difficulties?
- Is there a specific pattern of cognitive functioning in children and adolescents with indicated neurodevelopmental disorders and/or learning difficulties?
- Is there a specific pattern of social-emotional functioning in children and adolescents with indicated neurodevelopmental disorders and/or learning difficulties?
- 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:
- With perinatal risks factors
With neurodevelopmental disorders:
- Developmental learning disorder
- Disorder of intellectual development, mild
- Attention deficit hyperactivity disorder
- Autism spectrum disorder
- With Learning difficulties
- Control group
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Pomeranian Voivodeship
-
Gdansk, Pomeranian Voivodeship, Poland, 80-239
- Laboratory of Psychological and Educational Tests
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Developmental learning disorder
Children above 5 years old, with formal diagnosis of Developmental learning disorder.
|
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 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 of cognitive and social-emotional functioning.
|
|
Autism spectrum disorder
Children above 5 years old, with formal diagnosis of Autism spectrum disorder (ASD).
|
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 of cognitive and social-emotional functioning.
|
|
Control group
Children above 5 years old without formal diagnosis of neurodevelopmental disorders.
|
Psychological assessment of cognitive and social-emotional functioning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Perinatal risks factors
Time Frame: Data collected immediately after childbirth.
|
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.
|
|
Memory and learning
Time Frame: Juli 1, 2022 until April 30, 2024
|
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
|
|
Cognitive abilities
Time Frame: Juli 1, 2022 until April 30, 2024
|
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
|
|
Social-emotional competence
Time Frame: Juli 1, 2022 until April 30, 2024
|
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
|
|
Socio-demographic data
Time Frame: Juli 1, 2022 until April 30, 2024
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
General intellectual functioning
Time Frame: Juli 1, 2022 until April 30, 2024
|
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
|
|
Nonverbal intellectual functioning
Time Frame: Juli 1, 2022 until April 30, 2024
|
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
|
|
Executive functions
Time Frame: Juli 1, 2022 until April 30, 2024
|
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
|
|
Learning difficulties
Time Frame: Juli 1, 2022 until April 30, 2024
|
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
|
|
Communication, social interaction, restricted and repetitive behaviors
Time Frame: Juli 1, 2022 until April 30, 2024
|
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
|
|
Early social-emotional development
Time Frame: Juli 1, 2022 until April 30, 2024
|
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
|
|
Social-emotional development
Time Frame: Juli 1, 2022 until April 30, 2024
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Urszula Sajewicz-Radtke, Ph.D., Laboratory of Psychological and Educational Tests
- Study Director: Bartosz M Radtke, Ph.D., Laboratory of Psychological and Educational Tests
- Principal Investigator: Ariadna Łada-Maśko, Ph.D., Laboratory of Psychological and Educational Tests
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Specific Learning Disorder
- Neurologic Manifestations
- Nervous System Diseases
- Mental Disorders
- Neurobehavioral Manifestations
- Signs and Symptoms, Respiratory
- Attention Deficit and Disruptive Behavior Disorders
- Communication Disorders
- Language Disorders
- Learning Disabilities
- Pathological Conditions, Signs and Symptoms
- Behavior
- Signs and Symptoms
- Social Behavior
- Neurodevelopmental Disorders
- Hypoxia
- Attention Deficit Disorder with Hyperactivity
- Dyslexia
- Social Adjustment
Other Study ID Numbers
- 2023/PTPiP/1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurodevelopmental Disorders
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker Cochin; Fondation Perce NeigeNot yet recruitingNeurodevelopmental Disorders With Severe Self-injuriesFrance
-
University of SevilleRecruitingNeurodevelopmental Disorders | Neurodevelopmental Disorders and Developmental AbnormalitiesSpain
-
University Hospital, Clermont-FerrandNot yet recruitingNeurodevelopmental Disorder (Diagnosis)France
-
University of Missouri-ColumbiaCompletedChildren With Neurodevelopmental DisordersUnited States
-
IRCCS Eugenio MedeaRecruitingNeurodevelopmental Disorder (Diagnosis)Italy
-
Haute Ecole Ilya PrigogineNot yet recruitingNeurodevelopmental Disorders
-
University Hospital, ToursInstitut National de la Santé Et de la Recherche Médicale, FranceNot yet recruitingNeurodevelopmental Disorders
-
IRCCS Centro Neurolesi Bonino PulejoRecruitingNeurodevelopmental DisordersItaly
-
Aiyoudong Children and Youth Sports Health Research...Not yet recruitingNeurodevelopmental DisordersChina
-
IRCCS Eugenio MedeaUniversity of Geneva, Switzerland; Scuola Universitaria Professionale della...Not yet recruitingNeurodevelopmental Disorder (Diagnosis)
Clinical Trials on Psychological assessment
-
Medical University of ViennaUnknown
-
Fondazione Policlinico Universitario Agostino Gemelli...Not yet recruitingHealthy | Spirituality | Coping Skills | Stress Response | Resilience | Alexithymia | Burnout, Healthcare Workers | Quality of Life Outcomes | Professional Quality of Life | Psychological Well Being | Empathy Skills | Technostress | Job-related Affective Well-being
-
Bartosz M. RadtkeRecruitingChild Development | Development Delay | Speech Delay | Social FunctioningPoland
-
European Institute of OncologyRecruitingChronic Pain | Spinal Cord Stimulation (SCS)Italy
-
Bartosz M. RadtkeRecruitingAphasia | Neuropathology | Development, HumanPoland
-
Meyer Children's Hospital IRCCSRecruiting
-
Assistance Publique - Hôpitaux de ParisCompleted
-
University of BarcelonaCompletedBorderline Personality DisorderSpain
-
Talebian, Alireza, M.D.CompletedIndication for Modification of Patient Psychological Status
-
Bartosz M. RadtkeRecruitingChild Development | Infant Development | Early Childhood DevelopmentPoland