Active — Not RecruitingNot Applicable

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

Italy200 participantsStarted 2025-10-07

Plain-language 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.

Who can participate

Age range

7 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Callous-unemotional traits - ICU

Timeframe: At baseline

Callous-unemotional traits - APSD

Timeframe: At baseline

Psychopathic traits

Timeframe: At baseline

Emotion processing

Timeframe: At baseline

Trial details

NCT IDNCT07322055

SponsorIRCCS Fondazione Stella Maris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-10

View on ClinicalTrials.gov More Conduct Disorder trials

Plain-language summary

Who can participate

Age range

7 Years – 16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.