What is this study trying to find out about ADHD and related disorders?

This study is evaluating how pharmacological and psychotherapeutic treatments affect symptoms of ADHD, emotional-behavioral dysregulation, and externalizing disorders in children and adolescents. Researchers aim to understand treatment effects and identify patient characteristics linked to better responses to personalize future care. The study is sponsored by IRCCS Eugenio Medea.

Who may be eligible for this ADHD clinical trial?

Children and adolescents aged 8 to 15 years with a diagnosis of ADHD, externalizing disorders, or emotional dysregulation may be eligible. Participants must have an IQ of 75 or higher and no current substance abuse or neurological diseases. This study welcomes all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this ADHD clinical trial?

Study-related care, including all assessments and any study treatments, is provided at no cost. However, personal travel expenses to attend visits or assessments may vary and are not guaranteed to be covered.

Actively Recruiting

Age: 8Years - 15Years

All Genders

ID07273695

Evaluating Effectiveness of Drug and Group Psychological Treatments for Children and Teens with ADHD and Emotional Dysregulation

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

Participants Needed

Research Sites

N/A

Total Duration

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

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

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

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - At baseline before treatment or observation

Participants undergo multimodal assessments including clinical, neuropsychological, behavioral questionnaires, and neurophysiological measures before starting treatment or observation.

1 visit (in-person)

Treatment

Duration - 4 months for group psychological treatment or 8 to 12 weeks of pharmacological treatment

Participants receive either group psychological treatment consisting of 16 weekly sessions lasting 1.5 hours each, or pharmacological treatment with methylphenidate including a test dose and titration phase, as per clinical practice.

Weekly visits for group psychological treatment; 1 to 2 visits during pharmacological test dose and titration

Follow-up

Duration - 6 months after end of treatment

Participants are assessed to evaluate treatment effects at the end of treatment and again 6 months later to monitor changes in clinical symptoms and neurophysiological measures.

2 visits (in-person) at end of treatment and 6-month follow-up

Long-term Monitoring

Duration - 9 to 12 months depending on follow-up timing

Control participants on the treatment waiting list receive the same assessments over time without intervention to monitor symptom changes and learning effects.

3 visits (in-person) corresponding to baseline, mid-point, and 6 months after mid-point