Conduct DisorderGENCU 2025NCT07322055
Genetic and Clinical Correlates of Disruptive Behavior Disorder With and Without Callous-Unemotional Traits
An observational study of Conduct Disorder and Oppositional Defiant Disorder, run by IRCCS Fondazione Stella Maris at 2 sites in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 16 years
- Conditions the study is for
- Conduct Disorder, Oppositional Defiant Disorder, Callous Unemotional Traits
- How many people
- 200 participants
- Where
- 2 sitesItaly
- Study dates
- 7 Oct 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 16 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- Lack of signed Informed Consent;
- Diagnosis of Pervasive Developmental Disorder according to K-SADS-PL.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Università di Pisa
Pisa, Pisa, 56126
IRCCS Fondazione Stella Maris
Pisa, Pisa, 56128
About this study
Official title: 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.
- Keywords
- Conduct Disorder, Oppositional Defiant Disorder, Callous Unemotional Traits, Genetics
- Medical subject headings
- Conduct Disorder, Oppositional Defiant Disorder
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At baseline
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start7 Oct 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduct DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Fondazione Stella Maris
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pisa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322055
- Sponsor's protocol ID
- GENCU 2025
- Acronym
- GENCU 2025
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Correlational Study Between Genetic Profiles and Clinical Characteristics in Subjects With Disruptive Behavior Disorder Diagnosis, With or Without Callous-Unemotional Traits.
- ClinicalTrials.gov ID
- NCT07322055
- Acronym / sponsor ID
- GENCU 2025 / GENCU 2025
- Keywords
- Conduct Disorder, Oppositional Defiant Disorder, Callous Unemotional Traits, Genetics
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Fondazione Stella MarisUniversity, hospital or other
- Collaborators
- University of Pisa
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Lack of signed Informed Consent;
- Diagnosis of Pervasive Developmental Disorder according to K-SADS-PL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
4 secondary outcomes
Externalizing Problems
Time frame: At baseline
Internalizing Problems
Time frame: At baseline
Prosocial Behavior
Time frame: At baseline
Parenting
Time frame: At baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Conduct Disorder and Oppositional Defiant Disorder, run by IRCCS Fondazione Stella Maris at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Callous-unemotional traits - ICU (time frame: At baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.