Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders

Summary

The goal of this observational study is to learn if and how pharmacological and psychotherapeutic group treatments can treat clinical symptoms of children and adolescent patients with ADHD.

The main questions it aims to answer are:

* Are pharmacological and psychotherapeutic treatments effective on the clinical symptoms of patients with ADHD?
* Are pharmacological and psychotherapeutic treatments effective on symptoms of emotion-behavioral dysregulation?
* Is it possible to find associations between individual characteristics and treatment responses evaluating behavioral and neural correlates in children and adolescents with traits of emotion-behavioral dysregulation, externalizing disorders, and/or ADHD, using a panel of multimodal measures. May the data collected contribute to the definition of profiles useful for generating predictive hypotheses aimed at developing more personalized interventions?

Researchers will compare the data collected from patients treated with pharmacological and psychotherapeutic group treatments with the data of subjects of comparable sex/gender, age, diagnoses, on the waiting list for treatment to see if pharmacological and psychotherapeutic treatments effects ADHD and emotional dysregulation symprtoms.

Participants, patients who are offered treatment by clinicians according to standard clinical practice, will be asked to participate in the study by undergoing experimental assessments before and after the treatment.

The multimodal panel of proposed assessments includes:

* behavioral assessments, conducted through the completion of clinical and socio-demographic questionnaires;
* neuropsychological assessments, conducted through standardized computerized neuropsychological tests;
* neurophysiological assessments, conducted through the recording of NIRS (near infrared spectroscopy) and EEG (electroencephalogram) signals during an attentional task (Go-NoGo) and via a smartwatch.

Conditions

• Emotional Dysregulation
• Externalizing Problems
• Oppositional Defiant
• Conduct Disorder
• Disruptive Behaviours
• Attention Deficit Hyerpactivity Disorder

Interventions

DRUG

methyphenidate

According to clinical practice and national guidelines, subjects who meet the severity criteria and who express their consent to undertake pharmacological therapy undergo the medical tests required for the initiation of therapy. Only subsequently, according to standard clinical practice, the patient is subjected to the test dose of methylphenidate in the facility, in order to monitor any side effects. The dosage prescribed to patients varies depending on the subject's characteristics (5-20 mg/day) and is set by the child neuropsychiatrist based on the response to treatment, tolerability, and adverse effects, , according to Italian clinical guidelines for children and adolescents (SINPIA, 2002).

BEHAVIORAL

Group psychological treatment

The treatment consists of 16 weekly sessions lasting 1.5 hours. The total duration of the intervention is 4 months for a total of 16 sessions. The therapeutic group will be a closed group with approximately 6 patients per group. Patients will be assigned to different groups based on age and skills (8-11 and 12-15 years). The proposed interventions are based on the theoretical principles and techniques of Schema Therapy for developmental age (Christof Loose, Peter Graaf, Gerhard Zarbock \& Ruth A. Holt; Italian edition edited by Stefano Terenzi and Rosario Capo, 2013) or Acceptance and Commitment Therapy (Vanzin et al., 2020a; 2020b) for externalizing disorders.

Sponsors & Collaborators

• IRCCS Eugenio Medea

  lead OTHER

Principal Investigators

• Maria Nobile, PhD, MD · IRCCS E Medea Scientific Institute

Eligibility

Min Age

8 Years

Max Age

15 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-09-19

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Italy

Study Locations