Clinical Research Directory

Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders

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.

Psychological Intervention for Child Mental Health Based on Parental Reflective Functioning to Enhance Positive Parenting

In this study we aim to verify the effectiveness of a psychological intervention for preschool children, 3 to 6 years of age, with psychological problems or disorders, arising from adversity, Skills4Parenting+. Skills4Parenting+, with 6 to 8 weekly sessions, aims to treat the child's psychological problems or disorders, based on parental reflective functioning, to activate and develop parents' positive parenting skills, in response to situations of adversity. To assess the effectiveness, we plan to conduct an a simple two-arm RCT study, where children are randomly allocated to an immediate intervention group (IIG) or a delayed intervention group (DIG). The IIG will be assessed at 3 time-points: Time 0 (pre-test: before the 1st session); Time 1 (post-test: after the last session) and Time 2 (follow-up: 8 weeks after the last session). The DIG will be assessed at 4 time-points: Time 0 (pre-test 1: before the 1st session); Time 0+ (pre-test 2: 8 weeks after the 1st session); Time 1 (post-test: after the last session) and Time 2 (follow up: 8 weeks after the last session). A time period of 8 weeks will be maintained between each time point. In this study, we expect the (1) psychological intervention to significantly diminish the child's psychological problems or disorders (from pretest to posttest); (2) parental reflective functioning will mediate the effect of the psychological intervention on child's psychological problems or disorders; (3) the children from IIG will demonstrate a significant improvement in their mental health, in comparison to the children from the DIG; and (4) for the effects of the psychological intervention (i.e., improvement in the child's mental health) to be maintained in the medium-term (from posttest to follow-up).