跳至主要内容
临床试验/NCT07805668
NCT07805668招募中不适用

Clinical Characterization of Preschool Children With Internalizing and Externalizing Symptoms: The Role of Empathy, Restricted and Repetitive Behaviors, Emotional-Behavioral Dysregulation, and Executive Functions

IRCCS Fondazione Stella Maris1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年10月14日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
EDI-YC (Emotional Dysregulation Inventory-Young Child)

研究概览

简要总结

The purpose of the study is to investigate the emotional-behavioral dysregulation and its possible correlation with the main demographic and psychopathological variables in a sample of preschool children with internalizing and externalizing disorders.

详细描述

This observational study aims to collect data (both prospective and retrospective from 2025) regarding a sample of children aged between 3 and 6 years who were referred in a naturalistic setting to the Department of Developmental Psychiatry and Psychopharmacology at the IRCCS Stella Maris Foundation and to the Child Neuropsychiatry Unit of the IRCCS Giannina Gaslini (multicenter study) for diagnostic assessment, and who received a diagnosis of an internalizing and/or externalizing disorder following the clinical assessment. Through a back-translation procedure, our research group translated and adapted into Italian the "Emotion Dysregulation Inventory Young Child (EDI-YC)" questionnaire for the assessment of emotional-behavioral dysregulation in preschool children. Children will be enrolled according to the eligibility criteria and after informed consent for participation in the study has been signed by both parents/legal guardians. For the collection of retrospective data only, as provided for by the study, and where explicit consent from the parents/legal guardians could not be obtained, the data will be collected in accordance with Article 110-bis, paragraph 4, of the Italian Privacy Code. The data about emotional-behavioral dysregulation obtained from the completion of the EDI-YC will be correlated with data obtained from other questionnaires and from the clinical assessment in order to achieve a characterization of clinical phenotypes based on the psychopathological dimensions investigated.

Executive functions will be investigated in the sample of preschool children through a correlation analysis between BRIEF-P scores and EEG recordings

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

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

  • Inclusion criteria:
  • Age between 3 and 6 years
  • Presence of an internalizing and/or externalizing disorder
  • Parent completion of the questionnaires
  • Parent/caregiver signed informed consent for participation in the study

排除标准

  • Age greater than 6 years

结局指标

主要结局

EDI-YC (Emotional Dysregulation Inventory-Young Child)

时间窗: Baseline

EDI-YC is a questionnaire developed to assess emotional dysregulation (ED) in children aged 2 to 5 years, both with and without neuropsychological disabilities. Parents are asked to rate their children's emotional behaviors by assigning a score reflecting the frequency and intensity of emotional dysregulation manifestations (0 = not at all; 4 = very serious).

次要结局

  • BRIEF-P (Behavior Rating Inventory of Executive Function-Preschool Version)(Baseline)
  • Sleep-wake EEG recording(Up to 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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