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临床试验/NCT07420829
NCT07420829招募中不适用

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

Bartosz M. Radtke1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2025年9月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
Cognitive Functioning Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6)

研究概览

简要总结

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:

  3. children with early intervention

  4. children with delayed speech development

  5. Control group

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Early intervention

Children between 3 to 6 years old with formal early development support.

干预措施: Psychological assessment (Other)

Delayed speech development

Children between 3 to 6 years old with formal diagnosis of delayed speech development

干预措施: Psychological assessment (Other)

Control group

Children between 3 to 6 years old without formal diagnosis of delayed speech development and without any formal early development support.

干预措施: Psychological assessment (Other)

结局指标

主要结局

Cognitive Functioning Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6)

时间窗: 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).

Phonological Processing Index as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6)

时间窗: 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).

Social-Emotional Development Score as measured by the Battery of Methods for the Diagnosis of Psychomotor Development in Children aged 3-6 (B3/6)

时间窗: 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).

次要结局

  • Occurrence of perinatal complications(Baseline (retrospective data))
  • General intellectual functioning measured by the Stanford-Binet 5 (SB5)(Baseline)
  • Nonverbal Intelligence Quotient (NIQ) as measured by the Primary Test of Nonverbal Intelligence (PTONI)(Baseline)
  • Early social-emotional development(Baseline)
  • Birth weight(Baseline (retrospective data))
  • Gestational age at birth(Baseline (retrospective data))
  • Apgar score(Baseline (retrospective data))
  • Socio-demographic data(Baseline)

研究者

发起方
Bartosz M. Radtke
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Bartosz M. Radtke

PhD

Laboratory of Psychological and Educational Tests

研究点 (1)

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