Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders
报名条件（概要）
- 年龄：8 Years – 15 Years
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
Italy
药品与企业信息
其他名称：Drug treatment
According 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).
The 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.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
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.
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Maria Nobile, PhD, MDmaria.nobile@lanostrafamiglia.it+39031877563
- Maddalena Mauri, PhDmaddalena.mauri@lanostrafamiglia.it340031877813
研究中心联系方式
- IRCCS E Medea Scientific Institute - Asssociazione La Nostra FamigliaBosisio Parini，Lecco，Italy
问自己是否符合条件、如何预筛
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders ClinicalTrials.gov Identifier: NCT07273695 Sponsor: IRCCS Eugenio Medea Investigational product: methyphenidate, Group psychological treatment About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders 试验编号：NCT07273695 申办方：IRCCS Eugenio Medea 研究药物：methyphenidate、Group psychological treatment 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。