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临床试验/NCT07322055
NCT07322055进行中(未招募)不适用

A Correlational Study Between Genetic Profiles and Clinical Characteristics in Subjects With Disruptive Behavior Disorder Diagnosis, With or Without Callous-Unemotional Traits.

IRCCS Fondazione Stella Maris2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年10月7日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
200
试验地点
2
主要终点
Emotion processing

研究概览

简要总结

Disruptive Behavior Disorders (DBD), such as Conduct Disorder (CD) and Oppositional Defiant Disorder (ODD), affect children and adolescents in different ways. Research has shown that some individuals with DBD also display callous-unemotional (CU) traits, including a lack of guilt, uncaring behavior, and shallow emotions. This subgroup tends to have more severe symptoms and a higher risk of negative outcomes.

Previous studies suggest that genetic factors may play a role in the development of DBD with CU traits. For example, specific variations of the MAOA gene have been linked to difficulties in recognizing and processing emotions such as sadness and fear, which are often impaired in individuals with CU traits.

This study aims to explore how broader genetic profiles may affect DBD and CU traits. In the already enrolled sample, we will explore correlations between the collected clinical data and a larger set of genetic variants. The goal is to improve knowledge about the genetic factors that contribute to differences in behavior, which may help inform strategies to identify risk and resilience in individuals with disruptive behavioral traits.

研究设计

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

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Primary diagnosis of Conduct Disorder or Oppositional Defiant Disorder, obtained using the Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime version (K-SADS-PL);
  • Age 7-16 years;
  • Intelligence Quotient > 85;
  • Italian nationality and Caucasian ethnicity (excluding Sardinians for reasons of ethnic uniformity);
  • No relatives already enrolled in the study.

排除标准

  • Lack of signed Informed Consent;
  • Diagnosis of Pervasive Developmental Disorder according to K-SADS-PL.

结局指标

主要结局

Emotion processing

时间窗: At baseline

Emotion processing is evaluated by recording gaze pattern using a binocular eye-tracking system, while children are presented with emotional stimuli on a computer screen.

Callous-unemotional traits - ICU

时间窗: At baseline

Callous-unemotional (CU) traits are assessed using the child-report Inventory of Callous-Unemotional Traits (ICU), a 24-item questionnaire measuring Callousness, Uncaring, and Unemotional traits. Answers are rated on a 4-point Likert scale (0 = Not at All True, 3 = Definitely True). Total score range is 0 to 72, with higher scores indicating more prominent CU traits.

Callous-unemotional traits - APSD

时间窗: At baseline

Callous-unemotional traits are assessed with the Callous-Unemotional (CU) subscale of the child-report Antisocial Process Screening Device (APSD). The CU subscale includes 6 items rated on a 3-point Likert scale (0 = Not at All True, 1 = Sometimes True, 2 = Definitely True). Scores range from 0 to 12, with higher scores suggesting higher CU traits.

Psychopathic traits

时间窗: At baseline

Psychopathic traits are assessed with the Self-Report Psychopathy Scale, Fourth Edition (SRP-4), which provides scores across four dimensions (Interpersonal, Affective, Lifestyle, Antisocial) and a Total score, with item responses on a 5-point Likert scale, with higher scores indicating more psychopathic traits.

次要结局

  • Parenting(At baseline)
  • Externalizing Problems(At baseline)
  • Internalizing Problems(At baseline)
  • Prosocial Behavior(At baseline)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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