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