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Идёт набор NCT07420829

Psychological Correlates of Developmental Delays in Preschool Children

Наблюдательное Development Delay Child Development Social Functioning Speech Delay

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Psychological assessment.
Кому может быть актуально
Состояния в реестре: Development Delay, Child Development, Social Functioning, Speech Delay. Базовые параметры: 3 лет — 6 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Perinatal, Cognitive, Linguistic, and Social-emotional Correlates of Developmental Delay in Polish Preschool Children From a Biopsychosocial Perspective

Обзор

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

Вмешательства

  • Другое Psychological assessment
    Psychological assessment of cognitive, linguistic and social-emotional functioning.

Первичные конечные точки

  • Cognitive Functioning Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6) [Срок оценки: Baseline]
  • Phonological Processing Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6) [Срок оценки: Baseline]
  • Social-Emotional Development Score as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6) [Срок оценки: Baseline]
Вторичные конечные точки (8)
  • General intellectual functioning measured by the Stanford-Binet 5 (SB5) [Срок оценки: Baseline]
  • Nonverbal Intelligence Quotient (NIQ) as measured by the Primary Test of Nonverbal Intelligence (PTONI) [Срок оценки: Baseline]
  • Early social-emotional development [Срок оценки: Baseline]
  • Birth weight [Срок оценки: Baseline (retrospective data)]
  • Gestational age at birth [Срок оценки: Baseline (retrospective data)]
  • Apgar score [Срок оценки: Baseline (retrospective data)]
  • Occurrence of perinatal complications [Срок оценки: Baseline (retrospective data)]
  • Socio-demographic data [Срок оценки: Baseline]

Критерии участия

Критерии включения

  • Children aged 3 to 6 years at the time of assessment.
  • Attendance at preschool education.
  • Written informed consent provided by a parent or legal guardian.
  • Ability to participate in standardized psychological assessment.
  • Assignment to one of the predefined study cohorts based on developmental history and clinical information.

Критерии исключения

  • Age below 3 years or above 6 years.
  • Severe acute medical condition preventing participation.
  • Severe uncorrected sensory impairment interfering with valid assessment.
  • Lack of parental informed consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Другое

Центры проведения

Польша · 1 центр
  • Laboratory of Psychological and Educational Tests — Gdansk

Идентификаторы

NCT: NCT07420829 · 2024/PTPiP/2

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗