自闭症谱系障碍中 ADHD 的治疗
患有自闭症谱系障碍的儿童和青少年 ADHD 药物治疗的疗效
研究概览
地位
详细说明
目前的数据显示,美国每 54 名儿童中就有 1 名被诊断患有自闭症谱系障碍 (ASD)。 其他数据显示,那些被诊断患有自闭症的人也有被诊断出患有同时发生的疾病的风险,例如注意力缺陷/多动障碍(ADHD)。 对于医疗服务提供者、患者和家长来说,管理每种症状都具有挑战性。
被诊断患有多动症的自闭症谱系障碍患者经常面临寻找治疗症状的最佳药物选择的挑战。 众所周知,自闭症谱系障碍 (ASD) 和多动症 (ADHD) 儿童对这些治疗的反应通常与正常发育 (TD) 儿童不同。 目前,尚无明确的建议可供父母或提供者遵循,以指导自闭症谱系障碍和多动症患者的最佳药物选择。 缺乏药物知识和次优的药物管理可能会导致效果不佳,并对患者及其家人的生活产生重大负面影响。
这项研究的主要目的是确定治疗 TD 儿童 ADHD 的最常用药物对于同时患有自闭症的患者是否也同样有效。 这项研究的结果将提高提供者对 ASD 患者一线兴奋剂药物、哌醋甲酯和安非他明化合物的了解。 家长将通过与孩子和医生的讨论以及自己的观察来确定药物的有效性,并推动药物调整过程。 家长将每两周使用临床总体印象测量来提供有效性评级,异常行为检查表和范德比尔特家长评级量表将每月完成。 对于那些对一线药物没有反应的患者,本研究将进一步加深对二线药物选择、α2 激动剂胍法辛和可乐定的了解。 家长将使用与以前相同的措施进行评分。 其他研究措施将在确定继续用药的过程中收集和审查家长/看护者的意见。 大多数措施将通过电子门户完成,从而减少家庭来医院参与这项研究的需要。
虽然这些药物通常用于治疗患有 ASD 的儿童和青少年的 ADHD,但它们的相对有效性尚不清楚。 以这种形式将参与者随机分配到这些不同的药物,称为 SMART(序贯多重分配随机化试验)设计,将提供有关这些药物对自闭症谱系障碍和多动症儿童的疗效、它们相互比较的效果以及各自的疗效的数据效果与 TD 儿童的使用不同。 这项研究还将检查这些药物对父母发现的目标问题(例如逆反行为)的影响。 父母/照顾者将成为捕获的数据和输入的重要组成部分,以确定是否应该继续或停止用药。 由患者、家长和提供者组成的护理团队在该项目中表现出色,将为未来的自闭症患者提供最佳的决策途径。
这项研究概述的目标对自闭症患者及其家人/护理人员有益,他们经常帮助他们终生享受医疗保健服务。 在做出药物决策时获得基于证据的最佳实践可以影响并加速管理多动症症状的积极成果。 当症状得到最佳控制时,患者可以专注于培养生活技能并获得实现有意义的生活成果的机会。
这项研究与家长和医疗服务提供者共同开展,旨在减少多动症药物处方的反复试验,并建立医疗服务提供者和家长的最佳实践知识。 患者和家属的声音是研究设计过程中不可或缺的一部分。 这种治疗证据的共同产生有助于确保患者获得最佳结果,并得到利益相关者的支持。 参与者将是从自闭症护理网络招募的 4 至 17 岁儿童,该网络是同类中第一个也是唯一一个专注于更好的自闭症护理的网络,大规模、快速地提供服务,以改善自闭症儿童的健康和生活质量,他们的家人遍布北美。 20 个网络站点中的 12 个将参与这项研究,每个站点的提供者和患者家长都承诺确保超过 500 名患者参与这项研究,并且他们还致力于不断改善全人和全家庭自闭症护理。
研究类型
注册 (估计的)
阶段
- 第四阶段
联系人和位置
学习联系方式
- 姓名:Amanda James, BS
- 电话号码:(614) 722-4006
- 邮箱:Amanda.James@nationwidechildrens.org
研究联系人备份
- 姓名:Samantha Sharpe
- 电话号码:(614) 722-8509
- 邮箱:Samantha.Sharpe@nationwidechildrens.org
学习地点
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Edmonton、加拿大
- 招聘中
- University of Alberta, Glenrose Rehabilitation Hospital
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接触:
- Shannon Mah
- 电话号码:780-735-8285
- 邮箱:shannon.mah@ahs.ca
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首席研究员:
- Lonnie Zwaigenbaum, MD
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Toronto、加拿大
- 招聘中
- Holland Bloorview Kids Rehabilitation Hospital
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首席研究员:
- Danielle Baribeau, MD, PhD
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接触:
- Christina Tsetsos
- 电话号码:3561 416-425-6220
- 邮箱:ctsetsos@hollandbloorview.ca
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California
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Irvine、California、美国、92697
- 招聘中
- University of California, Irvine
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首席研究员:
- Peter Chung, MD
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接触:
- Aisa Green-Hurley
- 电话号码:657-579-4100
- 邮箱:apgreen@hs.uci.edu
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Los Angeles、California、美国、90027
- 招聘中
- Children's Hospital Los Angeles
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接触:
- Grace Anaya
- 邮箱:granaya@chla.usc.edu
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首席研究员:
- Kathryn Smith, RN, MN, DrPH
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Maine
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Portland、Maine、美国、04102
- 招聘中
- Maine Medical Center
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首席研究员:
- Danielle Sipsock, MD
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接触:
- Nicki Goldfeder
- 电话号码:207-661-5999
- 邮箱:nichole.goldfeder@mainehealth.org
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Massachusetts
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Boston、Massachusetts、美国、02421
- 招聘中
- Massachusetts General Hospital Lurie Center for Autism
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首席研究员:
- Ann Neumeyer, MD
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接触:
- Alexander Cordova
- 邮箱:acordova1@mgh.harvard.edu
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New York
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Rochester、New York、美国、14642
- 招聘中
- University of Rochester
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接触:
- Emily Wagner
- 邮箱:Emily_wagner@urmc.rochester.edu
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首席研究员:
- Lynn Cole, DNP
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Ohio
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Cincinnati、Ohio、美国、45229
- 招聘中
- Cincinnati Children's Hospital Medical Center
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首席研究员:
- Julia Anixt, MD
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接触:
- Courtney Herberger
- 邮箱:Courtney.Herberger@cchmc.org
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Columbus、Ohio、美国、43205
- 招聘中
- Nationwide Children's Hospital
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接触:
- Johnny Dudley
- 电话号码:614-355-7584
- 邮箱:Johnny.Dudley@nationwidechildrens.org
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首席研究员:
- Eric Butter, PhD
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19178
- 招聘中
- Children's Hospital of Philadelphia
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首席研究员:
- Carlyn Glatts, MD
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接触:
- Danielle Collins
- 邮箱:collinsd2@chop.edu
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Pittsburgh、Pennsylvania、美国、15262
- 招聘中
- University of Pittsburgh
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首席研究员:
- Benjamin Handen
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接触:
- Sarah McAuliffe-Bellin
- 电话号码:412-235-5447
- 邮箱:mcausj@upmc.edu
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Virginia
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Charlottesville、Virginia、美国、22903
- 招聘中
- University of Virginia
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首席研究员:
- Richard Stevenson, MD
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接触:
- Susie Hoffman
- 邮箱:SRH@uvahealth.org
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参与标准
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
描述
纳入标准:
- 患者和/或合法授权代表必须愿意并且能够给予参与本研究的知情同意/同意。
- 患者及其护理人员必须愿意并且能够(根据研究者的意见)遵守所有研究要求。
- 患者入组时年龄必须在 4 岁至 17 岁之间(含 4 岁和 17 岁)。
- 患者必须根据支持性证据(例如,自闭症谱系障碍)确诊 ASD。 转诊医生的报告、病历,例如ADOS(自闭症诊断观察量表)或CARS(儿童自闭症评定量表)等)。
- 患者必须能够持续服药(通过药丸、液体或与食物/液体混合)。
- 患者必须确诊为 ADHD(基于 DSM-5 标准和支持性证据)。
- 患者必须有一位始终如一的报告者(例如父母)定期陪伴孩子。
- 如果在同意前剂量稳定> 4周并且在研究期间没有计划改变剂量,则患者可以服用其他精神药物(选择性5-羟色胺再摄取抑制剂(SSRI)、非典型抗精神病药、抗惊厥药)。
- 根据临床医生对先前试验失败原因的判断,患者在入组前一年以上曾尝试过 ADHD 药物。
- 患者和/或家人/护理人员的英语或西班牙语必须足够流利,才能完成与本研究相关的调查问卷。
排除标准:
- 患者在过去一年内曾多次尝试过 ADHD 药物。
- 距离上次服用 ADHD 药物还不到 4 周。
可能阻止患者安全服用研究药物的任何其他风险因素。
- 没有基于参与者智商的纳入/排除标准。 我们将涵盖整个认知范围的个体,就像医生被要求治疗整个智商范围内的自闭症谱系障碍儿童的多动症一样。
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:第一阶段 - 兴奋剂
这项拟定的自然、务实的临床试验不涉及研究药物。 序贯、多重分配随机试验 (SMART) 实用临床试验。 第 1 阶段 - 随机分配为安非他明 (AMP) 或哌甲酯 (MPH)。 医生开具的具体药物将通过医生和家长/看护者之间的讨论以及对受试者的保险范围的审查来确定。 受试者将从他们的药房收到药物。 |
安非他明 (AMP) 药物名称:Adderall、Adderall XR、Adzenys ER、Adzenys XR-ODT、Dayanavel XR、Dexedrine(spansule)、Dexedrine(片剂)、Mydayis、Procentra Liquid 哌甲酯 (MPH) 药物名称:Adhansia XR、Aptensio XR、Azstarys、Concerta、Cotempla XR-ODT、Daytrana、Focalin、Focalin XR、Jornay PM。 Metadate CD、Mmethylin(液体)、利他林、Ritalin LA、Quillichew ER、Quillivant XR(液体) |
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有源比较器:第 2 阶段 - Alpha-2 激动剂或替代兴奋剂
第 2 阶段 - 随机分配至 Alpha-2 激动剂或其他未在第 1 阶段随机分配的兴奋剂:安非他明 (AMP) 或哌甲酯 (MPH)。 (频率、剂量、形式和持续时间取决于参与者和研究医生的讨论)。 |
如果一线兴奋剂治疗(安非他明/哌醋甲酯)被认为无效或无法耐受,则将重新随机分配至替代兴奋剂或 α-2 激动剂。 如果参与者对一线刺激治疗感到满意,则一线刺激治疗将继续。 Catapres、可乐定、胍法辛、Intuniv、Kapvay、Tenex |
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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范德比尔特家长评定量表
大体时间:16周
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主要结果指标是范德比尔特注意力缺陷多动症家长评定量表,由 18 个项目组成,每个项目的得分从 0 到 3。最低分为 0 分,最高分为 54 分。
分数越高表明结果越差。
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16周
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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家长报告临床总体印象
大体时间:16周
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家长报告临床总体印象 - 改善采用李克特量表,范围从 1 到 7。分数越高表明结果越差。
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16周
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异常行为检查表 - 多动/冲动子量表
大体时间:16周
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异常行为量表-多动/冲动子量表由16个项目组成,每个项目的得分从0到3分。最低分0分,最高分48分。
分数越高表明结果越差。
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16周
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合作者和调查者
赞助
合作者
调查人员
- 首席研究员:Daniel Coury, MD、Nationwide Children's Hospital
- 首席研究员:Karen Kuhlthau, PhD、Massachusetts General Hospital
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