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

Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders

This project will test whether methylphenidate and/or group psychotherapy help children and adolescents (ages 8–15) with ADHD and emotional or behavioral dysregulation.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 8 Years to 15 Years
• Sex: All
• Sponsor: IRCCS Eugenio Medea (Academic / other)
• Locations: 1 site (Bosisio Parini, Lecco)
• Trial ID: NCT07273695 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children and adolescents aged 8–15 with a clinical diagnosis of ADHD, externalizing disorder, and/or emotional dysregulation and an IQ ≥ 75 are the intended participants.

Not a fit: Children with IQ below 75, active psychosis, significant neurological disease (including epilepsy), substance abuse, or certain genetic syndromes are unlikely to be appropriate or to benefit from this protocol.

Why it matters

Potential benefit: If successful, the project could help clinicians match children to medication or group therapy that is more likely to reduce ADHD and behavioral dysregulation symptoms.

How similar studies have performed: Randomized trials have shown methylphenidate reliably reduces core ADHD symptoms and some behavioral problems, group psychotherapies have shown mixed but promising effects, and using multimodal neural and behavioral measures to predict individual treatment response is a growing but still exploratory approach.

Eligibility criteria

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 this trial is running

Bosisio Parini, Lecco

• 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

Conditions Emotional Dysregulation; Externalizing Problems; Oppositional Defiant; Conduct Disorder; Disruptive Behaviours; Attention Deficit Hyerpactivity Disorder; attention deficit hyperactivity disorder; child training