NCT Number: NCT07420829
The goal of this observational study is to investigate perinatal, cognitive, linguistic and social-emotional correlates of developmental delays of preschool children.
The study group consist of minimal 500 children between 3 and 6 years of age who will be examined by qualified diagnosticians. Participants will be evaluated with tasks related to the studied variables: cognitive functioning, linguistic skills and social-emotional functioning. Furthermore informations regarding social-emotional functioning of children, will be collected from parents.
The main questions it aims to answer are:
1. Is there a relationship between perinatal factors and risk of occurrence of developmental delay disorder? 2. Is there a specific pattern of cognitive functioning in preschool children with indicated developmental delay disorder? 3. Is there a specific pattern of social-emotional functioning in preschool children with indicated developmental delay disorder? 4. Do gender and age moderates specific patterns of cognitive and socialemotional functioning in the studied groups?
Researchers will compare the following groups of children between 3 and 6 years old:
1. With perinatal risks factors 2. With developmental delay disorder:
1. children with early intervention 2. children with delayed speech development 3. Control group
Interested in participating?
Request Info3 year–6 year
All sexes
Observational
Gdansk, Pomeranian Voivodeship, 80-239, Poland
Location status: Recruiting
Ariadna Łada-Maśko, PhD
PRINCIPAL_INVESTIGATOR
Bartosz Radtke, PhD
PRINCIPAL_INVESTIGATOR
Dorota Kalka, PhD
SUB_INVESTIGATOR
Rafał Nowicki, MA
CONTACT
Urszula Sajewicz-Radtke, PhD
PRINCIPAL_INVESTIGATOR
Łucja Bielenik, PhD
SUB_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Psychological assessment of cognitive, linguistic and social-emotional functioning.
Time frame: Baseline
The Cognitive Functioning Index is a composite score derived from the Cognitive Area of the B3/6 battery. It evaluates visual-spatial processing (Blocks, Puzzles), working memory (Frog recall tasks, Sentence repetition), planning (Mazes), and naming speed. Data will be reported as a standardized score (mean=100, SD=15).
Time frame: Baseline
Description: This index assesses linguistic skills through the Phonological Processing scale of the B3/6 battery. It includes tasks measuring syllabic and phonemic analysis and synthesis, as well as sound abstraction. Data will be reported as a standardized score (mean=100, SD=15).
Time frame: Baseline
Description: This score evaluates the child's social-emotional competence through the Social-Emotional Area of the B3/6 battery. The assessment covers three key components: naming emotions, recognizing emotions, and empathy. Data will be reported as a standardized score (mean=100, SD=15).
Time frame: Baseline
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).
Time frame: Baseline
Description: The PTONI is a standardized, norm-referenced instrument designed to assess nonverbal reasoning and problem-solving skills in young children. It measures abilities such as analogical reasoning, categorical classification, and sequential reasoning. The test requires no verbal response from the child. The results will be reported as a standardized index score (mean=100, SD=15).
Time frame: Baseline
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.
Time frame: Baseline (retrospective data)
Description: The weight of the newborn at birth, collected retrospectively from medical records or parental report. Data will be reported in grams.
Time frame: Baseline (retrospective data)
Description: The number of completed weeks of pregnancy at the time of delivery, collected retrospectively. Data will be reported in weeks.
Time frame: Baseline (retrospective data)
Description: The Apgar score recorded 5 minutes after birth, representing the newborn's physical condition. The score ranges from 0 to 10, where higher scores indicate better health status.
Time frame: Baseline (retrospective data)
Description: Number of participants who experienced medical complications during the perinatal period (e.g., hypoxia, infections). Reported as a categorical frequency (Yes/No).
Time frame: Baseline
Authors survey of socio-demographic data, including: gender, month and year of birth, size of place of residence, region of residence, age of starting preschool, diagnosis (if any), parents education level
Contact information is provided by the study sponsor or research team.
Bartosz M. Radtke
Other Gov
Perinatal, Cognitive, Linguistic, and Social-emotional Correlates of Developmental Delay in Polish Preschool Children From a Biopsychosocial Perspective
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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