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

NCT07322055 | Active Not Recruiting

• 1 other identifier: GENCU 2025
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

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.

Conditions

Conduct Disorder; Oppositional Defiant Disorder; Callous Unemotional Traits

Keywords

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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

Secondary Outcomes (4)

• Externalizing Problems

  At baseline

• Internalizing Problems

  At baseline

• Prosocial Behavior

  At baseline

• Parenting

  At baseline

Eligibility Criteria

• Age: 7 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Fondazione Stella Maris: lead
• University of Pisa: collaborator

Study Sites (2)

Università di Pisa

Pisa, Pisa, 56126, Italy

Location

IRCCS Fondazione Stella Maris

Pisa, Pisa, 56128, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

Each participant has provided a non-invasive saliva sample using a self-collection kit. The samples have been processed to extract genomic DNA, which is stored securely at -20°C.

MeSH Terms

Conditions

Conduct Disorder; Oppositional Defiant Disorder

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: October 7, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: January 26, 2026

Record last verified: 2025-12

Locations

IT (2)