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Age: 8Years - 15Years
All Genders
ID07273695

Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders in Children and Adolescents with ADHD, Emotional Dysregulation, and Externalizing Disorders

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

80

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating how pharmacological and psychotherapeutic group treatments affect clinical symptoms in children and adolescents diagnosed with ADHD, emotional-behavioral dysregulation, and externalizing disorders. This observational study aims to determine the effectiveness of these treatments on symptoms and explore associations between individual characteristics and treatment responses using behavioral, neuropsychological, and neurophysiological data. The study seeks to develop more personalized interventions based on these findings. Participants will receive either pharmacological treatment with methylphenidate or group psychological therapy. The drug treatment involves a test dose followed by a varying daily dose 5-20 mg adjusted by a child neuropsychiatrist. The group psychological treatment includes 16 weekly sessions lasting 1.5 hours each over four months, divided into age-based groups. A control group of patients on a waiting list will undergo the same assessments but will not receive treatment. Participants will undergo assessments before treatment and at multiple follow-ups at treatment start, end of treatment or drug titration phase 2-3 months, and six months post-treatment. Assessments include clinical and socio-demographic questionnaires, computerized neuropsychological tests, and neurophysiological recordings using near-infrared spectroscopy, EEG during attention tasks, and data from a smartwatch. Researchers will analyze clinical symptoms, emotion regulation, neuropsychological performance, and neurophysiological measures to assess changes and predict treatment outcomes.

CONDITIONS

Brief 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, or emotional dysregulation confirmed by clinical assessment
  • Intelligence quotient (IQ) of 75 or higher
Not Eligible

You will not qualify if you...

  • IQ below 75
  • Substance abuse or addictions
  • Psychosis
  • Acute disorders
  • Organic brain disorders
  • Neurological diseases such as epilepsy
  • Genetic syndromes
  • Co-diagnosis with other psychiatric or neurodevelopmental disorders is recorded but not an exclusion
  • Prior psychopharmacological therapy is recorded but not an exclusion

Research Team

M

Maria Nobile, PhD, MD

M

Maddalena Mauri, PhD

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