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.
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.
IQ < 75;
Substance abuse and addictions;
Psychosis;
Acute disorders;
Patients with symptoms of emotional-behavioral dysregulation, externalizing disorders, and/or ADHD will be recruited. The presence of these symptoms and diagnoses must be assessed prior to entry into the research project by experienced clinicians through clinical interviews and questionnaires. Children and adolescents aged 8-15 will be recruited. For psychotherapeutic treatment, participants will be divided into separate groups based on age and skills: 8-11 and 12-15. Patients with an IQ greater than 75 will be recruited, and, for the psychotherapeutic treatment group, those with good mentalization skills. Pharmacological intervention will be proposed in indicated cases following international guidelines (for example, for ADHD, treatment with methylphenidate is administered in cases of Clinical Global Index severity (CGI-S) ≥ 4). A control group will be recruited consisting of patients on the waiting list for treatment, with the same diagnoses and comparable age.
Case-control
Prospective
methyphenidate
DrugAccording to clinical practice and national guidelines, subjects who meet the severity criteria and who express their consent to undertake pharmacological therapy undergo the medical tests required for the initiation of therapy. Only subsequently, according to standard clinical practice, the patient is subjected to the test dose of methylphenidate in the facility, in order to monitor any side effects. The dosage prescribed to patients varies depending on the subject's characteristics (5-20 mg/day) and is set by the child neuropsychiatrist based on the response to treatment, tolerability, and adverse effects, , according to Italian clinical guidelines for children and adolescents (SINPIA, 2002).
Group psychological treatment
BehavioralThe treatment consists of 16 weekly sessions lasting 1.5 hours. The total duration of the intervention is 4 months for a total of 16 sessions. The therapeutic group will be a closed group with approximately 6 patients per group. Patients will be assigned to different groups based on age and skills (8-11 and 12-15 years). The proposed interventions are based on the theoretical principles and techniques of Schema Therapy for developmental age (Christof Loose, Peter Graaf, Gerhard Zarbock \& Ruth A. Holt; Italian edition edited by Stefano Terenzi and Rosario Capo, 2013) or Acceptance and Commitment Therapy (Vanzin et al., 2020a; 2020b) for externalizing disorders.
Clinical Global Impressions - Severity Scale
Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = "normal, not ill"; maximun value: 7 = "very severely ill" )
Difficulties in Emotion Regulation Scale - DERS
Questionnaire, total score, t scores
explanatory outcomes
functional Near Infrared Spectroscopy
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