Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical Global Impressions - Severity Scale
研究概览
简要总结
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.
详细描述
Study Objectives The research protocol involves a multimodal assessment of participants before and after various types of treatment. The ultimate goal is to evaluate the effectiveness of treatment on symptoms of emotion-behavioral dysregulation, externalizing disorders, and/or ADHD. This is done by analyzing the multimodal data collected before treatment. This allows us to predict treatment effectiveness and propose a more personalized and targeted intervention for each patient.
Primary Objective To evaluate the effectiveness of pharmacological and psychotherapeutic treatments on the clinical symptoms of patients with ADHD.
Secondary Objective To evaluate the effectiveness of pharmacological and psychotherapeutic treatments for symptoms of emotion-behavioral dysregulation.
Exploratory Objective To evaluate behavioral and neural correlates in preadolescents and adolescents with traits of emotional-behavioral dysregulation, externalizing disorders, and/or ADHD, using a panel of multimodal measures, in order to explore possible associations between individual characteristics and treatment responses. The data collected may contribute to the definition of profiles useful for generating predictive hypotheses, to be validated in subsequent studies, aimed at developing more personalized interventions.
Study Design The objectives will be pursued within a multicenter, non-profit, prospective and retrospective interventional study, non-randomized and non-blinded.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 8 Years 至 15 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
participants beguinning drug treatment
children and adolescents with emotional dysregulation, externalizing disorders and/or ADHD beguinning drug treatment (MPH)
干预措施: methyphenidate (Drug)
participants beguinning group psychotherapy
children and adolescents with emotional dysregulation externalizing disorders and/or ADHD beguinning group psychotherapy (child training)
干预措施: Group psychological treatment (Behavioral)
结局指标
主要结局
Clinical Global Impressions - Severity Scale
时间窗: T2 (2-3 months), T3 (6 months)
Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = "normal, not ill"; maximun value: 7 = "very severely ill" )
次要结局
- Difficulties in Emotion Regulation Scale - DERS(T2 (2-3 months), T3 (6 months))
