Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders
Recruiting · NCT07273695 · Observational (researchers observe without assigning treatment) · Lead sponsor: IRCCS Eugenio Medea
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
Where it is running
1 location listed.
- IRCCS E Medea Scientific Institute - Asssociazione La Nostra Famiglia - Bosisio Parini, Lecco, Italy