NCT07273695 Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders
| NCT ID | NCT07273695 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Eugenio Medea |
| Condition | Emotional Dysregulation |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2025-09-19 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2025-09-19 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria * Children and adolescents aged 8-15 years; * Diagnosis of externalizing disorder, ADHD, and/or emotional dysregulation (assessed with questionnaires, interviews, and/or clinical observation); * Intelligence quotient ≥ 75. Exclusion Criteria * IQ \< 75; * Substance abuse and addictions; * Psychosis; * Acute disorders; * Organic brain disorders; * Presence of neurological diseases, epilepsy; * Genetic syndromes; * Co-diagnosis with other psychiatric or neurodevelopmental disorders (e.g., autism, anxiety, depression, etc.) and prior psychopharmacological therapy will not be considered exclusion criteria but will be recorded and declared.
Contact & Investigator
Maria Nobile, PhD, MD
PRINCIPAL INVESTIGATOR
IRCCS E Medea Scientific Institute
Frequently Asked Questions
Who can join the NCT07273695 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 15 Years, studying Emotional Dysregulation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07273695 currently recruiting?
Yes, NCT07273695 is actively recruiting participants. Contact the research team at maria.nobile@lanostrafamiglia.it for enrollment information.
Where is the NCT07273695 trial being conducted?
This trial is being conducted at Bosisio Parini, Italy.
Who is sponsoring the NCT07273695 clinical trial?
NCT07273695 is sponsored by IRCCS Eugenio Medea. The principal investigator is Maria Nobile, PhD, MD at IRCCS E Medea Scientific Institute. The trial plans to enroll 80 participants.