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Genetic and Clinical Correlates of Disruptive Behavior Disorder With and Without Callous-Unemotional Traits

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07322055
Acronym
GENCU 2025
Enrollment
200
Registered
2026-01-07
Start date
2025-10-07
Completion date
2027-10-01
Last updated
2026-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Callous Unemotional Traits, Conduct Disorder, Oppositional Defiant Disorder

Keywords

Conduct Disorder, Oppositional Defiant Disorder, Callous Unemotional Traits, Genetics

Brief summary

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.

Interventions

None listed

Sponsors

IRCCS Fondazione Stella Maris
Lead SponsorOTHER
University of Pisa
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
7 Years to 16 Years
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Callous-unemotional traits - ICUAt baselineCallous-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 - APSDAt baselineCallous-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 traitsAt baselinePsychopathic 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.
Emotion processingAt baselineEmotion processing is evaluated by recording gaze pattern using a binocular eye-tracking system, while children are presented with emotional stimuli on a computer screen.

Secondary

MeasureTime frameDescription
Externalizing ProblemsAt baselineExternalizing problems are assessed using the self-report version of the Strengths and Difficulties Questionnaire (SDQ), a 25-item questionnaire. The composite Externalizing problems score is the sum of the Hyperactivity-Inattention and Conduct Problems scales. Items are rated on a 3-point Likert scale (0 = Not True, 1 = Somewhat True, 2 = Certainly True). Higher scores indicate higher externalizing problems (range 0-20).
Internalizing ProblemsAt baselineInternalizing problems are assessed using the self-report version of the Strengths and Difficulties Questionnaire (SDQ), a 25-item questionnaire. The composite Internalizing problems score is the sum of the Emotional Symptoms and Peer Problems scales. Items are rated on a 3-point Likert scale (0 = Not True, 1 = Somewhat True, 2 = Certainly True). Higher scores indicate higher internalizing problems (0-20).
Prosocial BehaviorAt baselineProsocial behavior are assessed using the self-report version of the Strengths and Difficulties Questionnaire (SDQ), a 25-item questionnaire. The Prosocial scale includes 5 items rated on a 3-point Likert scale (0 = Not True, 1 = Somewhat True, 2 = Certainly True). Higher scores indicate more prosocial behavior (range 0-10).
ParentingAt baselineParenting practices are assessed using the parent-report Alabama Parenting Questionnaire (APQ), a 42-item questionnaire. The APQ includes five subscales: Positive Involvement, Supervision/Monitoring, Discipline Practices, Consistency, and Corporal Punishment. Higher scores indicate higher levels of the respective parenting practices.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026