Hemodynamic and behavioral peculiarities in response to emotional stimuli in children with attention deficit hyperactivity disorder: An fNIRS study.
Maddalena Mauri, Silvia Grazioli, Alessandro Crippa...
https://pubmed.ncbi.nlm.nih.gov/32911217Actively Recruiting
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
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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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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
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
M
Maddalena Mauri, PhD
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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Published Research Related To This Trial
The utility of NIRS technology for exploring emotional processing in children.
Maddalena Mauri, Alessandro Crippa, Andrea Bacchetta...
https://pubmed.ncbi.nlm.nih.gov/32664020Light up ADHD: II. Neuropharmacological effects measured by near infrared spectroscopy: is there a biomarker?
Silvia Grazioli, Maddalena Mauri, Alessandro Crippa...
https://pubmed.ncbi.nlm.nih.gov/30332620Patterns of Response to Methylphenidate Administration in Children with ADHD: A Personalized Medicine Approach through Clustering Analysis.
Silvia Grazioli, Eleonora Rosi, Maddalena Mauri...
https://pubmed.ncbi.nlm.nih.gov/34828721Light up ADHD: I. Cortical hemodynamic responses measured by functional Near Infrared Spectroscopy (fNIRS): Special Section on "Translational and Neuroscience Studies in Affective Disorders" Section Editor, Maria Nobile MD, PhD. This Section of JAD focuses on the relevance of translational and neuroscience studies in providing a better understanding of the neural basis of affective disorders. The main aim is to briefly summarise relevant research findings in clinical neuroscience with particular regards to specific innovative topics in mood and anxiety disorders.
Maddalena Mauri, Maria Nobile, Monica Bellina...
https://pubmed.ncbi.nlm.nih.gov/29195758