New Technologies to Help Manage ADHD
2019年9月12日 更新者：Children's Hospital Medical Center, Cincinnati
Developing New Technologies to Improve ADHD Medication Continuity
Cluster randomized controlled trial to evaluate the general effectiveness of intervention compared to control on medication continuity as measured by prescriptions written and other more proximal outcomes during the first six months of treatment.
研究概览
详细说明
This cluster randomized controlled trial will evaluate the general effectiveness of the intervention (e.g.
enhanced myADHDportal.com),
compared to control (e.g.
treatment as usual standard portal), on medication continuity as measured by prescriptions written and other more proximal outcomes during the first six months of treatment.
研究类型
介入性
注册 (实际的)
85
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、45237
- William B Brinkman
-
-
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
6年 至 10年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
Parents of children are eligible to participate if
- their child receives ADHD care at one of the pediatric primary care practices that is partnering to conduct this trial
- child being registered on myADHDportal.com to initiate child assessment of ADHD
- child age 6-10 years
- child must not have been previously treated with ADHD medication
- child prescribed ADHD medication within 12 months of enrolling in the study
Exclusion Criteria:
- Unable to read and speak English
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：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：enhanced myADHDportal.com
Version of the myADHDportal.com
web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child
|
Version of the myADHDportal.com
web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child
|
|
有源比较器：treatment as usual standard portal
Standard version of myADHDportal.com
web software
|
Standard version of myADHDportal.com
web software
|
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 |
|---|---|---|
|
Medication Continuity: The Number of Days Covered With Medicine
大体时间：first 6 months of treatment
|
the number of days covered with medicine will be calculated from audit of prescriptions written
|
first 6 months of treatment
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Parent-reported Necessity to Concerns Differential (Beliefs About Medication Scale)
大体时间：6 months after starting treatment
|
Necessity to concerns differential score, range -4 to 4, positive scores mean necessity outweighs concerns, negative scores mean that concerns outweigh beliefs about necessity
|
6 months after starting treatment
|
|
Parent-reported Decisional Conflict (Decisional Conflict Scale)
大体时间：6 months after starting treatment
|
Total score calculated from parent-report on the Decisional Conflict Scale, range 0 to 100; higher scores are worse
|
6 months after starting treatment
|
|
Parent Trust in Provider (Trust in Provider Scale)
大体时间：6 months after starting treatment
|
Total score calculated from parent-report on the Trust in Provider Scale, range 10 to 50 with higher scores better (more trust)
|
6 months after starting treatment
|
|
Working Alliance Inventory
大体时间：6 months after starting treatment
|
range 12-60, higher scores better (more alliance)
|
6 months after starting treatment
|
|
Parent Perceived Social Support (Perceived Social Support Scale)
大体时间：6 months after starting treatment
|
Total score calculated from parent-report on the Perceived Social Support Scale, range 12-84, higher score better (more social support)
|
6 months after starting treatment
|
|
Parent Distress (Parenting Stress Index - Short Form)
大体时间：6 months after starting treatment
|
Parental distress subscale score calculated from the Parenting Stress Index - Short Form; range 36-180, higher scores is worse (more stress)
|
6 months after starting treatment
|
|
Number of Participants With Side Effects Rated by Parents as Moderate or Severe on the Pittsburgh Side Effects Rating Scale
大体时间：6 months after starting treatment
|
Number of Participants with side effects rated by parents as moderate or severe on the Pittsburgh Side Effects Rating Scale
|
6 months after starting treatment
|
|
Total Number of myADHDportal.Com Log-ins by Parent
大体时间：6 months after starting treatment
|
6 months after starting treatment
|
|
|
Total Number of Measures Completed by Parents to Track Child Response to Treatment
大体时间：6 months after starting treatment
|
6 months after starting treatment
|
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)
2015年9月1日
初级完成 (实际的)
2017年8月1日
研究完成 (实际的)
2017年8月1日
研究注册日期
首次提交
2015年3月4日
首先提交符合 QC 标准的
2015年3月17日
首次发布 (估计)
2015年3月18日
研究记录更新
最后更新发布 (实际的)
2019年9月13日
上次提交的符合 QC 标准的更新
2019年9月12日
最后验证
2019年8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
- R34MH101155 (美国 NIH 拨款/合同)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
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
在美国制造并从美国出口的产品
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.