Actively Recruiting

Age: 8Years - 15Years
All Genders
NCT07273695

Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders

Led by IRCCS Eugenio Medea · Updated on 2025-12-09

80

Participants Needed

1

Research Sites

62 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders

Who Can Participate

Age: 8Years - 15Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Children and adolescents aged 8-15 years
  • Diagnosis of externalizing disorder, ADHD, and/or emotional dysregulation confirmed by questionnaires, interviews, or clinical observation
  • Intelligence quotient (IQ) of 75 or higher
Not Eligible

You will not qualify if you...

  • IQ below 75
  • History of substance abuse or addictions
  • Psychosis
  • Acute disorders
  • Organic brain disorders
  • Neurological diseases including epilepsy
  • Genetic syndromes
  • Co-diagnosis with other psychiatric or neurodevelopmental disorders (e.g., autism, anxiety, depression) and prior psychopharmacological therapy are allowed but recorded

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS E Medea Scientific Institute - Asssociazione La Nostra Famiglia

Bosisio Parini, Lecco, Italy

Actively Recruiting

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Research Team

M

Maria Nobile, PhD, MD

CONTACT

M

Maddalena Mauri, PhD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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