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NCT Number: NCT07322055

Genetic and Clinical Correlates of Disruptive Behavior Disorder With and 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.

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Key information

Conditions

Conduct Disorder Attention Deficit and Disruptive Behavior Disorders Callous Unemotional Traits Mental Disorders Neurodevelopmental Disorders Oppositional Defiant Disorder

Age range

7 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Fondazione Stella Maris, Pisa, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Callous-unemotional traits - ICU

    Time frame: 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.

  2. Callous-unemotional traits - APSD

    Time frame: 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.

  3. Psychopathic traits

    Time frame: 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.

  4. Emotion processing

    Time frame: 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.

Secondary outcomes

  1. Externalizing Problems

    Time frame: At baseline

    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).

  2. Internalizing Problems

    Time frame: At baseline

    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).

  3. Prosocial Behavior

    Time frame: At baseline

    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).

  4. Parenting

    Time frame: At baseline

    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.

Sponsors and collaborators

Lead sponsor

IRCCS Fondazione Stella Maris

Other

Collaborators

  • University of Pisa

Registry information

Official study title

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

Acronym: GENCU 2025

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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