跳至主要内容
临床试验/NCT06215092
NCT06215092已完成不适用

Perinatal, Cognitive and Social-emotional Correlates of Neurodevelopmental Disorders and Learning Difficulties in Children and Adolescents, 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: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
500
试验地点
1
主要终点
Memory and learning

研究概览

简要总结

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:

  3. Developmental learning disorder

  4. Disorder of intellectual development, mild

  5. Attention deficit hyperactivity disorder

  6. Autism spectrum disorder

  7. With Learning difficulties

  8. Control group

研究设计

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

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

Developmental learning disorder

Children above 5 years old, with formal diagnosis of Developmental learning disorder.

干预措施: Psychological assessment (Other)

Disorder of intellectual development, mild

Children above 5 years old, with formal diagnosis of Disorder of intellectual development, mild.

干预措施: Psychological assessment (Other)

Attention deficit hyperactivity disorder

Children above 5 years old, with formal diagnosis of Attention deficit hyperactivity disorder (ADHD).

干预措施: Psychological assessment (Other)

Autism spectrum disorder

Children above 5 years old, with formal diagnosis of Autism spectrum disorder (ASD).

干预措施: Psychological assessment (Other)

Learning difficulties

Children above 5 years old, with difficulties in reading and/or writing without formal diagnosis of Developmental learning disorder.

干预措施: Psychological assessment (Other)

Control group

Children above 5 years old without formal diagnosis of neurodevelopmental disorders.

干预措施: Psychological assessment (Other)

结局指标

主要结局

Memory and learning

时间窗: 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).

Perinatal risks factors

时间窗: 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.

Cognitive abilities

时间窗: 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).

Social-emotional competence

时间窗: 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.

Socio-demographic data

时间窗: 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

次要结局

  • General intellectual functioning(Juli 1, 2022 until April 30, 2024)
  • Executive functions(Juli 1, 2022 until April 30, 2024)
  • Learning difficulties(Juli 1, 2022 until April 30, 2024)
  • Nonverbal intellectual functioning(Juli 1, 2022 until April 30, 2024)
  • Early social-emotional development(Juli 1, 2022 until April 30, 2024)
  • Social-emotional development(Juli 1, 2022 until April 30, 2024)
  • Communication, social interaction, restricted and repetitive behaviors(Juli 1, 2022 until April 30, 2024)

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)

Loading locations...

相似试验