Real-life effects of medication and group therapy for ADHD and disruptive behaviors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational project follows children and adolescents (8–15) with ADHD, externalizing disorders, or emotional dysregulation who receive pharmacological (methylphenidate) and/or group psychotherapeutic treatments. Participants undergo multimodal assessments including clinical scales, behavioral tests, and neural measures before and after treatment, with both prospective and retrospective data collection. The design is non-randomized and non-blinded and compares real-world responses to medication versus group psychotherapy to measure symptom changes. Analyses will seek associations between individual characteristics and treatment responses to generate predictive profiles that could guide more personalized interventions.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Children and adolescents aged 8-15 years;
* Diagnosis of externalizing disorder, ADHD, and/or emotional dysregulation (assessed with questionnaires, interviews, and/or clinical observation);
* Intelligence quotient ≥ 75.

Exclusion Criteria

* IQ \< 75;
* Substance abuse and addictions;
* Psychosis;
* Acute disorders;
* Organic brain disorders;
* Presence of neurological diseases, epilepsy;
* Genetic syndromes;
* Co-diagnosis with other psychiatric or neurodevelopmental disorders (e.g., autism, anxiety, depression, etc.) and prior psychopharmacological therapy will not be considered exclusion criteria but will be recorded and declared.

Where it's running

• IRCCS E Medea Scientific Institute - Asssociazione La Nostra Famiglia
  Bosisio Parini, Lecco, Italy Recruiting

Study contacts

• Principal investigator: Maria Nobile, PhD, MD — IRCCS E Medea Scientific Institute
• Study coordinator: Maria Nobile, PhD, MD
• Email: maria.nobile@lanostrafamiglia.it
• Phone: +39031877563

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.