Genetic and Clinical Correlates of Disruptive Behavior Disorder With and Without Callous-Unemotional Traits (GENCU 2025)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Conduct Disorder; Oppositional Defiant Disorder; Callous Unemotional Traits

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Italy
  • Pisa
    • Pisa, Pisa, Italy, 56128
      • IRCCS Fondazione Stella Maris
    • Pisa, Pisa, Italy, 56126
      • Universita di Pisa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of children and adolescents aged 7-16 years diagnosed with Conduct Disorder or Oppositional Defiant Disorder and treated at a specialized outpatient clinic for childhood behavioral disorders.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion processing	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.	At baseline
Callous-unemotional traits - ICU	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.	At baseline
Callous-unemotional traits - APSD	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.	At baseline
Psychopathic traits	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.	At baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Externalizing Problems	Externalizing 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).	At baseline
Internalizing Problems	Internalizing 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).	At baseline
Prosocial Behavior	Prosocial 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).	At baseline
Parenting	Parenting 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.	At baseline

Collaborators and Investigators

• Sponsor: IRCCS Fondazione Stella Maris
• Collaborators: University of Pisa

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Genetics; Oppositional Defiant Disorder; Conduct Disorder; Callous Unemotional Traits
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Oppositional Defiant Disorder; Conduct Disorder
• Other Study ID Numbers: GENCU 2025

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No