个性化注意力缺陷/多动症(ADHD)药物实验研究
2026年4月15日 更新者:Children's Hospital Medical Center, Cincinnati
个性化药物实验的开放标签试验,为未来注意力缺陷/多动症 (ADHD) 药物使用决策提供信息
该项目的主要目标是测试个性化药物实验,为未来药物使用决策提供信息。
我们的中心假设是,我们的干预将导致受试者内部青少年参与决策的程度增加,并减少未来药物使用的不确定性。
研究人员认为这项开放标签试验是一项试点研究,旨在测试药物实验干预的可行性、可接受性和初步疗效,因此有必要在未来更大规模的试验中进行进一步测试。
研究概览
详细说明
研究人员将对 30 名对继续用药感到不确定的青少年和家长进行药物实验干预的试点、单组、开放标签试验。 由于药物实验干预与服用非刺激性多动症药物的青少年没有临床相关性,因此他们将被排除在外。 登记时,家庭将以电子方式完成基线测量并安排亲自拜访。 研究人员将利用配药数据核实过去一年的处方药物和用药天数。 在访问期间,家长和青少年将选择五项药物实验中的一项一起完成,并在所需的时间内跟踪效果。
- 不做任何改变。 追踪当前状态:继续按照目前的处方服药。
- 在非上课日服用药物。 跟踪效果:如果当前没有在非上课日服药,请在这些日子开始服药并跟踪效果。
- 在非上课日停止服药。 轨道效果。 如果目前在非上课日服用药物,请在这些日子停止服用药物并跟踪效果。
- 进行正式的药物试验。 在跟踪期间按照当前处方服用当前药物 2 周,然后在继续跟踪的同时停止服药 2-4 周。
- 改变剂量或改变药物。 咨询研究医生后,考虑使用不同的药物或不同剂量的当前药物。 跟踪效果。
一旦两人完成药物实验,他们将完成后续研究访问,以审查实验结果,讨论软件的可行性,并完成研究结束措施。
研究类型
介入性
注册 (实际的)
31
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
-
Ohio
-
Cincinnati、Ohio、美国、45220
- Cincinnati Children's Hospital Medical Center
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
接受健康志愿者
不
描述
纳入标准:研究参与者必须满足以下所有标准:
- 同意:父母或法定监护人必须提供书面知情同意书
- 同意:青少年必须提供书面同意才能参与研究
- 11-15岁
- 由儿科医生治疗多动症
- 入组前一年多首次开出多动症药物
- 在过去一年中至少服用过一张兴奋剂药物处方
- 继续使用多动症药物的不确定性
- 每个家庭只能有一名儿童参加这项研究。 对于拥有多个可能符合资格的孩子的家庭,他们可以决定哪个孩子最适合这项研究。
排除标准: 排除标准: 如果参与者符合以下任何标准,则将被排除在研究之外:
- 在家中或其他地点无法可靠地访问互联网。
- 不会允许他们的孩子访问互联网进行与学习相关的活动。
- 无法或不愿意发送或接收短信。
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:干涉
所有人都将选择五个药物实验选项之一来完成。
|
所有父母/青少年二人组将选择并完成药物实验。
|
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 |
|---|---|---|
|
Decision Making Involvement Scale [Parent Seek] - Reported by Child
大体时间:The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
|
A 30-item scale to measure adolescent involvement in a decision.
The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child).
Each subscale has a range of 1-4, with higher scores indicating higher involvement.
Subscales are scored by calculating the average of pertinent questions.
|
The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
|
|
Decision Making Involvement Scale [Parent Seek] - Parent Report
大体时间:The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
|
A 30-item scale to measure adolescent involvement in a decision.
The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child).
Each subscale has a range of 1-4, with higher scores indicating higher involvement.
Subscales are scored by calculating the average of pertinent questions.
|
The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
|
|
Decision Making Involvement Scale [Child Express] - Child Report
大体时间:The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
|
A 30-item scale to measure adolescent involvement in a decision.
The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child).
Each subscale has a range of 1-4, with higher scores indicating higher involvement.
Subscales are scored by calculating the average of pertinent questions.
|
The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
|
|
Decision Making Involvement Scale [Child Express] - Parent Report
大体时间:The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
|
A 30-item scale to measure adolescent involvement in a decision.
The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child).
Each subscale has a range of 1-4, with higher scores indicating higher involvement.
Subscales are scored by calculating the average of pertinent questions.
|
The investigators will reference the Decision-Making Involvement interview guide to collect this measure at (pre) study visit 1 and the stand-alone version (post) 4-12 weeks later at study visit 2.
|
|
Decisional Conflict - Parent Report
大体时间:The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
|
The Decisional Conflict Scale (DCS) has an initial question to ascertain the option that has been selected.
Options presented will be: continue [medication regimen from experiment], resume previous medication/dosage, conduct another experiment, return to pediatrician to adjust dosage or change medication, other [write in].
The DCS then has 16 questions that are divided into five subscales: informed subscale, values clarity subscale, support subscale, uncertainty subscale, and an effective decision subscale.
The total DCS scores are calculated by summing item scores and then converting the scores to a 0-100 scale, where 0 implies no decisional conflict and 100 implies extremely high decisional conflict.
|
The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
|
|
Decisional Conflict - Child Report
大体时间:The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
|
The Decisional Conflict Scale (DCS) has an initial question to ascertain the option that has been selected.
Options presented will be: continue [medication regimen from experiment], resume previous medication/dosage, conduct another experiment, return to pediatrician to adjust dosage or change medication, other [write in].
The DCS then has 16 questions that are divided into five subscales: informed subscale, values clarity subscale, support subscale, uncertainty subscale, and an effective decision subscale.
The total DCS scores are calculated by summing item scores and then converting the scores to a 0-100 scale, where 0 implies no decisional conflict and 100 implies extremely high decisional conflict.
|
The DCS was collected at the first study visit, and then again after the medication experiment was completed (between 4 and 12 weeks later)
|
|
Decision Making Involvement Scale - Joint/Options
大体时间:The investigators will reference the Decision-Making Involvement interview guide to collect this measure at study visit 2 (post), which is 4-12 weeks after study visit 1.
|
A 30-item scale to measure adolescent involvement in a decision.
The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child).
Each subscale has a range of 1-4, with higher scores indicating higher involvement.
Subscales are scored by calculating the average of pertinent questions.
|
The investigators will reference the Decision-Making Involvement interview guide to collect this measure at study visit 2 (post), which is 4-12 weeks after study visit 1.
|
|
Decision Making Involvement Scale - Child Express
大体时间:The investigators will reference the Decision-Making Involvement Scale and Control Preferences Scale collected at Study Visit 2, which is 4-12 weeks after study visit 1.
|
A 30-item scale to measure adolescent involvement in a decision.
The five subscales are: "Child Seek" (child asks for an opinion or information from parent), "Child Express" (child expresses an opinion or information to parent), "Parent Seek" (parent expresses advice or opinion to child), "Parent Express" (parent expresses advice or opinion to child), and "Joint/Options" (negotiation or brainstorming between parent and child).
Each subscale has a range of 1-4, with higher scores indicating higher involvement.
Subscales are scored by calculating the average of pertinent questions.
|
The investigators will reference the Decision-Making Involvement Scale and Control Preferences Scale collected at Study Visit 2, which is 4-12 weeks after study visit 1.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Difference in Intention to Give/Take Medication on School Days
大体时间:Collected at study visit 1 and 4-12 weeks later at study visit 2.
|
This measure will capture the difference between the child and parent report of their intention to give/take ADHD medication on school days.
This was assessed using a scale question from the Unified Theory of Behavior Change.
Responses are on a 7-point scale from strongly agree (+3) to strongly disagree (-3) that assess intention to take medicine for ADHD on weekdays, weekends, and school vacations - this particular measure examined responses when asked their intentions regarding school days.
|
Collected at study visit 1 and 4-12 weeks later at study visit 2.
|
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Difference in Intention to Give/Take Medication on Weekend Days
大体时间:Collected at study visit 1 and 4-12 weeks later at study visit 2.
|
This measure will capture the difference between the child and parent report of their intention to give/take ADHD medication on weekend days.
This was assessed using a scale question from the Unified Theory of Behavior Change.
Responses are on a 7-point scale from strongly agree (+3) to strongly disagree (-3) that assess intention to take medicine for ADHD on weekdays, weekends, and school vacations - this particular measure examined responses when asked their intentions regarding weekend days.
|
Collected at study visit 1 and 4-12 weeks later at study visit 2.
|
|
Difference in Intention to Give/Take Medication on School Vacation Days
大体时间:Collected at study visit 1 and 4-12 weeks later at study visit 2.
|
This measure will capture the difference between the child and parent report of their intention to give/take ADHD medication on school vacation days.
This was assessed using a scale question from the Unified Theory of Behavior Change.
Responses are on a 7-point scale from strongly agree (+3) to strongly disagree (-3) that assess intention to take medicine for ADHD on weekdays, weekends, and school vacations - this particular measure examined responses when asked their intentions regarding school vacation days.
|
Collected at study visit 1 and 4-12 weeks later at study visit 2.
|
|
System Usability Scale Total Score
大体时间:Collected at study visit 2 (which is 4-12 weeks after study visit 1).
|
Parents and children completed the System Usability Scale (SUS) to assess the usability of the mehealth platform for completing a personalized medication experiment.
The SUS is a 10-item questionnaire with items rated on a 5-point agreement scale.
Item scores are converted and summed using standard scoring procedures to produce a total score ranging from 0 to 100, with higher scores indicating better usability/better outcome.
|
Collected at study visit 2 (which is 4-12 weeks after study visit 1).
|
|
Implementation of Decision
大体时间:3 months after study visit 2 (which is 4-12 weeks after study visit 1).
|
We obtained pharmacy dispensing records to confirm eligibility and to assess decision implementation within 90 days post-study, identifying cases where pharmacy records contradicted the dyad's decision about their future ADHD treatment.
|
3 months after study visit 2 (which is 4-12 weeks after study visit 1).
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:William Brinkman, MD, MEd, MSc、Cincinnati Children's
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2023年11月10日
初级完成 (实际的)
2025年5月1日
研究完成 (实际的)
2025年11月1日
研究注册日期
首次提交
2024年2月13日
首先提交符合 QC 标准的
2024年3月7日
首次发布 (实际的)
2024年3月12日
研究记录更新
最后更新发布 (实际的)
2026年5月5日
上次提交的符合 QC 标准的更新
2026年4月15日
最后验证
2026年2月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2023-0528
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.